(148 days)
The Hologic Brevera breast biopsy system with CorLumina imaging technology is intended to provide breast tissue samples for diagnostic sampling of breast abnormalities. The Brevera breast biopsy system excises and optionally delivers in-line radiographic images of the excised tissue. The Brevera breast biopsy system is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. In instances when a patient presents with a palpable abnormality that has been classified as benign through clinical and/or radiological criteria (for example, fibrocystic lesion), the Brevera breast biopsy system may also be used to partially remove such palpable lesions. The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of histological abnormality, for example, malignancy. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedure.
The Brevera breast biopsy system with CorLumina imaging technology enables a physician to utilize vacuum-assisted breast tissue biopsy technology and cabinet x-ray technology to remove suspicious lesions and confirm the suspect lesion has been collected at the point of care. The vacuum assisted breast biopsy subsystem collects breast tissue and transports it through tubing into a collection tray located in the console. Within the console, the in-line cabinet x-ray subsystem then allows the user to visually confirm calcifications that may be present in the collected breast tissue. The overall system is intended to be used with a stereotactic biopsy guidance system
Here's an analysis of the acceptance criteria and study information for the Brevera Biopsy System with Corlumina Imaging Technology, based on the provided text:
Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices, not on a full-scale clinical trial to prove a device meets specific efficacy acceptance criteria against a clinical endpoint. Therefore, much of the information typically found in such a study (like detailed sample sizes for test sets, expert qualifications for ground truth, MRMC studies, or training set details) is not present in this document. The "studies" described are primarily performance testing to ensure the device functions as intended and is safe.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test Method) | Reported Device Performance (Results) |
|---|---|
| Specimen Acquisition & Core Handling: | All Acceptance Criteria Met |
| Confirm the device fires and arms when instructed. | Demonstrated that the device has an inner cannula that rotates and advances to cut tissue. |
| Confirm that a core is sucked into the aperture and the inner cannula cuts the tissue. | Demonstrated that the average cycle time for the acquisition of each core is less than or equal to 8 seconds for all cycles except for the first and last cycle. |
| To confirm that the core travels the correct pathway to the tissue filter and travels in a consistent time. | Demonstrated that the average cycle time for the acquisition of each core is less than or equal to 8 seconds for all cycles except for the first and last cycle. |
| To confirm that the core is the intended weight. | Core weight is equivalent or larger than the predicate device (ATEC) with the same size needle and aperture. |
| Integrated Specimen Collection: | All Acceptance Criteria Met |
| Confirm the device pulls saline consistently into the cannulas and to the body cavity. | Demonstrated that the system delivered 0.9% buffered saline into the aperture as well as not leak fluid when exposed to twice the volume of a saline bag (500 mL). |
| To confirm that the console supplies suction to pull the core and any excess liquid to the canister. | Demonstrated that core specimens are transported into a tissue filter via vacuum and that waste fluids are collected in a disposable vacuum canister. |
| Confirm the console responds to all commands (Setup and Test Mode). | The Brevera System software performs as intended. |
| Integrated Specimen Imaging: | All Acceptance Criteria Met |
| Confirm that the x-ray takes an image of the core at the correct time and populates the image to the screen. | Demonstrated that it allows collection and imaging of up to two cores in each filter chamber. A user can visually recognize calcifications without obstruction by the tissue. |
| Visually recognize calcifications as small as 240um from the radiographic images. | Demonstrated the system enables a user to visually recognize calcifications as small as 240um from the radiographic images based on predicate (Trident) imaging capability. |
| Disposable/Sterile Biopsy Handpiece Component: | All Acceptance Criteria Met |
| Testing per ISO 11737-1 & 11737-2 and ASTM F1980-07 (Sterility). | Disposable components maintained sterile barrier integrity after simulated aging conditions. |
| Testing per ISO-10993-1 and G95-1 (Biocompatibility). | Disposable components met required biocompatibility requirements. |
| System Performance (Software for both biopsy and imaging): | All Acceptance Criteria Met |
| Integration testing of electro-mechanical system. | Provides correct power to the Corlumina Imaging Technology and Vacuum Assisted Biopsy subsystems to allow for successful integration of core collection and imaging of core specimens. |
| Monitoring and controlling of performance requirements. | The Brevera System software performs as intended. |
| Animal Testing (Live Model - System's ability to successfully biopsy and transport tissue): (Implicit acceptance: successful operation) | Successfully biopsied and transported tissue to the tissue filter. (This is derived from the summary statement, specific metrics are not provided in the table). |
| Bench Testing (Functional, packaging, usability): (Implicit acceptance: successful operation) | Equivalence in performance to predicate devices (ATEC and Trident), and demonstrated to be as safe and effective, meeting all acceptance criteria. (This is a summary conclusion, specific metrics for these tests are not individually detailed). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify a distinct "test set" sample size in terms of patient cases or a large dataset for imaging analysis. The testing described is primarily engineering and functional performance testing.
- For the "core weight" test, it compares the Brevera System cores to the ATEC Biopsy System, implying multiple cores were tested.
- For imaging, it states the system enables a user to visually recognize calcifications, suggesting evaluation by human observation, but specific numbers of images or observers are not given.
- Animal testing was performed in a "live model," but the number of animals or biopsies is not specified.
- Data Provenance: Not explicitly stated for specific data sets. The testing itself is presented as internal performance testing conducted by Hologic, Inc.
- The animal model testing would be prospective for that specific test.
- Bench testing would be specific to manufactured components.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
- The visual recognition of calcifications would necessarily involve trained personnel (e.g., radiologists or technologists), but their number and specific qualifications are not detailed.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified. Given the nature of the performance tests (e.g., measuring cycle time, core weight, fluid flow, software function), "adjudication" in the sense of resolving conflicting expert opinions is likely not applicable. The tests likely had predefined objective pass/fail criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC comparative effectiveness study is not described in this document. The studies are focused on direct device performance and comparison to predicate device capabilities rather than a comparative effectiveness study involving human readers' diagnostic accuracy with vs. without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Not applicable. The Brevera Biopsy System is a hardware device with integrated imaging and software, designed to be used by a clinician. The imaging component ("Corlumina Imaging Technology") is for visual confirmation by a user, not for an AI algorithm to provide diagnostic output in a standalone manner. The device does not appear to employ an AI algorithm for diagnostic interpretation that would have standalone performance metrics.
7. The Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" for the various performance tests is specific to the test itself:
- Functional tests: The expected operational behavior of the device components (e.g., firing, suction, software commands).
- Measurement tests: Quantitative measurements (e.g., core weight, cycle time, fluid volume) compared against design specifications or predicate device performance.
- Imaging capability: The ability to physically display calcifications of a certain size, validated by visual inspection and comparison to predicate device capabilities (Trident System). This would likely involve phantoms with known calcification sizes or actual calcified specimens.
- Sterility/Biocompatibility: Standards (ISO, ASTM) are the ground truth references.
- Animal Model: Direct observation of successful biopsy and transport of tissue.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. The Brevera Biopsy System, as described, is a mechanical and imaging device. It does not appear to utilize machine learning or AI that would require a "training set" for an algorithm. The software mentioned is for system control and image display, not for learning-based diagnostic interpretation.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable, as there is no mention of a training set for an AI algorithm.
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.