(135 days)
The Mammotome revolve® Dual Vacuum Assisted Biopsy (VAB) System is indicated to provide tissue samples for diagnostic sampling of breast abnormalities.
• The Mammotome revolve® Dual Vacuum Assisted Biopsy (VAB) System is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.
• The Mammotome revolve® Dual Vacuum Assisted Biopsy (VAB) System is intended to provide breast tissue for histologic examination with partial removal of a palpable abnormality.
The extent of a histologic abnormality cannot always be readily determined from palpation or imaged appearance. Therefore, the extent of removal of the palpated or imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality, e.g., 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 procedures. In instances when a patient presents with a palpable abnormality that has been classified as benign through clinical and/or radiological criteria (e.g., fibroadenoma, fibrocystic lesion), the Mammotome revolve® Dual Vacuum Assisted Biopsy (VAB) System may also be used to partially remove such palpable lesions. Whenever breast tissue is removed, histological evaluation of the standard of care. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.
The Mammotome revolve® Dual Vacuum Assisted Biopsy (VAB) System is an electromechanical breast biopsy device indicated to provide tissue samples for diagnostic sampling of beast abnormalities for histologic examination.
The Mammotome revolve® Dual VAB System is comprised of three primary subsystems:
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- a sterile, single-use probe
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- a reusable holster, and
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- a reusable control unit.
The provided text describes a 510(k) premarket notification for the Mammotome revolve® Dual Vacuum Assisted Biopsy (VAB) System, seeking to demonstrate its substantial equivalence to previously marketed devices. The study conducted focuses on comparing the new device with predicate devices in terms of tissue sample collection.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Evaluation Metrics) | Reported Device Performance |
|---|---|
| For Tissue Sample Collection Comparison: | |
| Sample weight | "Testing results confirmed that the Mammotome revolve® Vacuum Assisted Biopsy (VAB) System would retrieve a tissue sample comparable to that of the predicate device." |
| Sampling reliability | "Testing results confirmed that the Mammotome revolve® Vacuum Assisted Biopsy (VAB) System would retrieve a tissue sample comparable to that of the predicate device." |
| Sample quality | "Testing results confirmed that the Mammotome revolve® Vacuum Assisted Biopsy (VAB) System would retrieve a tissue sample comparable to that of the predicate device." |
| For Ultrasound Functionality and System Enhancements: | |
| Sample weight | "Testing results confirmed that the Mammotome revolve® Vacuum Assisted Biopsy (VAB) System Ultrasound functionality and system enhancements was comparable to that of the predicate device." |
| Sampling reliability | "Testing results confirmed that the Mammotome revolve® Vacuum Assisted Biopsy (VAB) System Ultrasound functionality and system enhancements was comparable to that of the predicate device." |
| Sample quality | "Testing results confirmed that the Mammotome revolve® Vacuum Assisted Biopsy (VAB) System Ultrasound functionality and system enhancements was comparable to that of the predicate device." |
| Holster to Probe recognition | "Testing results confirmed that the Mammotome revolve® Vacuum Assisted Biopsy (VAB) System Ultrasound functionality and system enhancements was comparable to that of the predicate device." |
| Holster/Control Module communication | "Testing results confirmed that the Mammotome revolve® Vacuum Assisted Biopsy (VAB) System Ultrasound functionality and system enhancements was comparable to that of the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not explicitly state the numerical sample size for the test set (i.e., the number of biopsy procedures or tissue samples collected). It mentions "each sample" was evaluated, implying multiple samples were taken.
- Data Provenance: The study used an "in vivo porcine model." This indicates the data was collected from live pigs and is thus prospective animal data. The country of origin of the data is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- The document does not provide information on the number of experts or their qualifications used to establish ground truth for the test set. The evaluation criteria like "sample weight," "sampling reliability," and "sample quality" suggest objective measurements or potentially expert assessment, but the details are missing.
4. Adjudication Method for the Test Set:
- The document does not describe any adjudication method (e.g., 2+1, 3+1, none) for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. The study compared the device's performance against predicate devices, focusing on technical and functional aspects in an animal model, not on human reader performance with or without AI assistance. The device itself is a biopsy system, not an AI diagnostic tool that assists human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Yes, the performance testing described effectively serves as a standalone evaluation of the device in an animal model. The device's ability to collect tissue samples based on specified criteria (weight, reliability, quality) and its functional aspects (holster/probe recognition, communication) were assessed independently of human interpretation of diagnostic output (which is the role of the pathologist reviewing the collected tissue).
7. Type of Ground Truth Used:
- The ground truth for evaluating the device's performance seems to be based on objective measurements and qualitative assessment of physical samples. For example:
- "Sample weight" is a direct measurement.
- "Sampling reliability" and "sample quality" likely involve macroscopic and potentially microscopic assessment of the tissue collected, which could be considered a form of histological evaluation/pathology (though not explicitly stated as independent pathology reports).
- "Holster to Probe recognition" and "Holster/Control Module communication" are functional checks verified by the device's operational behavior.
8. Sample Size for the Training Set:
- The document does not mention a training set. This is because the Mammotome revolve® Dual VAB System is a medical device for tissue collection, not an AI or machine learning algorithm that requires a training set for model development. The software mentioned primarily handles system operation and user interface, not diagnostic analysis requiring learning from data.
9. How the Ground Truth for the Training Set Was Established:
- This question is not applicable as there is no mention of a training set for an AI/machine learning model.
§ 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.