| Device |
pathology software algorithm device analyzing digital images for cancer prognosis |
| Definition |
A pathology software algorithm device analyzing digital images for cancer prognosis is a software intended to analyze scanned whole slide images (WSIs) from prostate biopsies prepared from formalin fixed paraffin-embedded (FFPE) tissue and stained using Hematoxylin & Eosin (H&E) stains. The device provides prognostic risk estimates which are intended to assist physicians with prognostic risk-based decisions along with other clinicopathological factors. The device is not intended to determine a clinical diagnosis. |
| Physical State |
Software device that receives digitized pathology glass slide images as an input and provides the user with prognostic risk estimates (e.g., Distant Metastasis). |
| Technical Method |
Analyzes digitized pathology glass slide images using machine learning algorithms to provide prognostic risk estimates. |
| Target Area |
Human tissue biopsy images |
| Regulation Medical Specialty |
Pathology |
| Review Panel |
Pathology |
|---|
| Product Code | SFH |
|---|
| Premarket Review |
Division of Molecular Genetics and Pathology
(DMGP)
Division of Molecular Genetics and Pathology
(DMGP)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
864.3755
|
|---|
| 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 |
