| Device |
digital pathology image artifact detection software device |
| Regulation Description |
Whole slide imaging system. |
| Definition |
Digital Pathology Image Artifact Detection Software device is an artificial intelligence-based software intended to identify specific artifacts in scanned digital whole slide images (WSIs) of pathology slides prepared from human samples. It is intended to identify WSIs that should undergo further evaluation for image quality prior to diagnostic review of the images by pathologists. Device output is not intended for use in diagnosis, prognosis, or prediction of disease. |
| Physical State |
AI-based software and/or firmware, system components |
| Technical Method |
Analyzes digitized pathology glass slide images using machine learning algorithms to detect and identify artifacts in digital images of pathology slides, providing users with information regarding the presence, location, and characteristics of those artifacts. |
| Target Area |
Scanned digital images of pathology slides prepared from human-derived samples |
| Regulation Medical Specialty |
Pathology |
| Review Panel |
Pathology |
|---|
| Product Code | SIX |
|---|
| Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Molecular Genetics and Pathology
(DMGP)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
864.3700
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
