(28 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 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 tissue is 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 EX System is an electromechanical breast biopsy device indicated to provide tissue samples for diagnostic sampling of beast abnormalities for histologic examination.
The Mammotome revolve EX 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 Mammotome revolve EX System is an electromechanical breast biopsy device. The provided text describes conformity with various performance tests, but it does not contain details of a clinical study with acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, or accuracy) or a comparative effectiveness study involving human readers.
Here's an analysis of the provided information, focusing on what is available and explicitly noting the absence of details requested in some points:
1. Table of Acceptance Criteria and Reported Device Performance
The document describes several non-clinical bench performance tests where the acceptance criterion was "PASSED." The specific numerical acceptance criteria for each test (e.g., maximum acceptable bacterial count for sterility) are not detailed, only the outcome.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Sterility Testing | PASSED |
| Biocompatibility Testing | PASSED |
| Software Verification and Validation Testing | PASSED |
| Electrical Safety and Electromagnetic Compatibility (EMC) Testing | PASSED |
| Animal Lab Study (Tissue Sample Testing - Sample Weight, Sample Reliability, Sample Quality) | PASSED |
| Usability Testing | PASSED |
Note: This table reflects the non-clinical tests reported. Clinical diagnostic performance acceptance criteria (e.g., sensitivity/specificity for abnormality detection) are not provided or assessed in this document.
2. Sample Size Used for the Test Set and Data Provenance
The document describes non-clinical bench testing, animal lab studies, and software verification/validation. It does not refer to a "test set" in the context of human patient data for diagnostic performance.
- Test Set Sample Size: Not applicable for diagnostic performance as described in the provided text, which focuses on device functionality and safety.
- Data Provenance: The animal lab study uses an animal model, but no specific country of origin is mentioned. The other tests are bench tests or software validation. All are likely controlled laboratory or in-house tests. The studies are described as "Non-Clinical Bench Performance Testing," implying retrospective analysis of these tests was performed for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. For a diagnostic device, ground truth would typically be established by expert interpretation or pathology, which is not described.
4. Adjudication Method for the Test Set
This information is not provided because a clinical test set with diagnostic adjudication is not described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No Multi-Reader Multi-Case (MRMC) comparative effectiveness study is mentioned in the provided text. The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance and safety testing.
6. Standalone Performance Study
No standalone diagnostic performance study (algorithm only without human-in-the-loop performance) is described. The device is a biopsy system, meaning it collects samples for diagnosis, but its own diagnostic performance (like an AI system for image interpretation) is not assessed here. The standalone performance studies relate to the device's functional integrity (e.g., sterility, electrical safety, software function, tissue sampling in an animal model).
7. Type of Ground Truth Used
For the animal lab study's tissue sample testing, the "ground truth" implicitly relates to the properties of the tissue samples collected (e.g., weight, reliability, quality). However, the specific method for establishing this ground truth (e.g., histological examination of collected animal tissue, quantitative measurements) is not explicitly detailed beyond "Tissue Sample Testing - Sample Weight - Sample Reliability - Sample Quality."
For other tests (sterility, biocompatibility, software, electrical safety), the ground truth is defined by the technical specifications and recognized standards (e.g., ISO standards for sterility and biocompatibility).
8. Sample Size for the Training Set
Not applicable. This document describes a medical device, not an AI/ML model that requires a training set of data for diagnostic purposes. The software mentioned is for controlling the device's functions, not for diagnostic interpretation based on learned patterns from a dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/ML model described in this document.
§ 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.