(198 days)
Breast Bolster was specifically designed to enable stereotactic breast biopsy procedures to be performed on thin-breasted patients.
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Analysis of Acceptance Criteria and Study for the Breast Bolster Device
Based on the provided document, the "Breast Bolster" (K020624) is a Class II medical device, and the FDA's decision is a Substantial Equivalence (SE) determination to a legally marketed predicate device. This means the device met acceptance criteria not through a standalone performance study with defined metrics, but by demonstrating that it is as safe and effective as a device already on the market.
Therefore, the requested information categories about direct performance metrics, sample sizes, expert involvement, and ground truth for a diagnostic AI/ML device do not directly apply to this 510(k) submission for the Breast Bolster. The 510(k) process for this type of device focuses on comparison to a predicate, not on a primary clinical performance trial with novel acceptance criteria.
However, I can extract information relevant to the 510(k) process as it relates to acceptance for marketing.
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) for substantial equivalence, the "acceptance criteria" is primarily demonstrating similarity to a predicate device in terms of intended use, technological characteristics, and safety/effectiveness. There are no specific performance metrics like sensitivity or specificity reported in this document.
| Acceptance Criteria (Implied for 510(k) SE) | Reported Device Performance (as per 510(k) process) |
|---|---|
| Intended Use Equivalence: Device's intended use is the same as the predicate. | "Breast Bolster was specifically designed to enable stereotactic breast biopsy procedures to be performed on thin-breasted patients." (This intent would be compared to a predicate device's intended use). |
| Technological Characteristics Equivalence: Device has similar technological characteristics, or any differences do not raise new questions of safety or effectiveness. | Not explicitly detailed in this letter, but would have been part of the full 510(k) submission. This would involve comparing materials, design, mechanism of action, etc. with the predicate. |
| Safety and Effectiveness Equivalence: Device is as safe and effective as the predicate. | Not explicitly detailed in this letter. This would be demonstrated through comparison of non-clinical and/or clinical data with the predicate, or justification that new aspects do not impact safety/effectiveness. |
| Regulatory Compliance: Adherence to general controls and relevant specific controls. | The FDA letter confirms the device can be marketed "subject to the general controls provisions of the Act," and notes that it may be subject to additional controls if classified as Class II. |
Regarding the Study that Proves the Device Meets Acceptance Criteria:
The "study" that proves the device meets acceptance criteria in a 510(k) substantially equivalent submission is the comparison to a legally marketed predicate device.
- The document explicitly states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified..."
The information requested below for a performance study is generally not applicable to this type of 510(k) submission where direct clinical performance metrics are not the primary basis for market clearance.
2. Sample size used for the test set and the data provenance: Not applicable. The 510(k) focused on comparison to a predicate, not an independent test set for performance metrics.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for performance metrics was not established as part of this 510(k) for substantial equivalence.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This device is a "Breast Bolster," a physical accessory for mammography, not an AI/ML diagnostic software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as detailed performance metrics and ground truth are not the basis for this type of 510(k) clearance. The "ground truth" for a 510(k) SE is the established safety and effectiveness of the predicate device.
8. The sample size for the training set: Not applicable. This is a physical device, not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established: Not applicable.
§ 892.1710 Mammographic x-ray system.
(a)
Identification. A mammographic x-ray system is a device intended to be used to produce radiographs of the breast. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.