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510(k) Data Aggregation
(22 days)
MODIFIED 650 MAMMOGRAPHY SYSTEM
The Modified 650 Mammography System is intended to produce radiographic images of the breast. Its specific intended use is for screening and diagnostic mammography. Screening mammography involves the production of images for initial examination for breast cancer diagnosis. Diagnosis mammography involves the production of magnified breast images, crease spot compression views, and the thorough examination of breast determined suspicious through screening mammography by a physician in preparation for biopsy.
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This submission describes a mammography system (Modified 650 Mammography System, also referred to as Affinity System), which is a device for producing radiographic images of the breast for screening and diagnostic mammography. It is not an AI/ML device. The provided text details regulatory compliance and clearances, rather than performance studies of an AI algorithm.
Therefore, the requested information elements related to AI/ML device performance and studies cannot be extracted from the provided text.
Here's a breakdown of what can be extracted, and why other elements cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Design Standards/Certifications) | Reported Device Performance |
|---|---|
| UL Standard 187 (Underwriters Laboratories, Inc.) | Designed for classification to this standard. |
| CSA Standard C22.2 No. 114 (Canadian Standards Association) | Designed for classification to this standard. |
| IEC-601-1 (International Electrotechnical Commission) | Designed for certification to this standard. |
| Federal Performance Standards for Ionizing Radiation Emitting Products (21 CFR 1000) | Tested and conforms to these standards. |
| ACR Standards for image quality and radiation dose limits | Designed to meet requirements for ACR accreditation. |
| User-friendly and comprehensive Operator's Manual | Ensures safe and effective operation (mentioned as a design feature). |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Cannot be extracted. This information is relevant for AI/ML device studies, not for the regulatory compliance and design specifications of a mammography imaging system as described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Cannot be extracted. This refers to AI/ML ground truth establishment, which is not applicable here.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Cannot be extracted. This refers to AI/ML study methodologies, not applicable here.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Cannot be extracted. This refers to AI/ML comparative studies, not applicable here.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Cannot be extracted. This refers to AI/ML performance, not applicable here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Cannot be extracted. This refers to AI/ML ground truth, not applicable here.
8. The sample size for the training set
- Cannot be extracted. This refers to AI/ML training data, not applicable here.
9. How the ground truth for the training set was established
- Cannot be extracted. This refers to AI/ML training data ground truth, not applicable here.
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