(35 days)
The Mammotome Biopsy System is indicated to provide tissue samples for diagnostic sampling of breast abnormalities.
- The Mammotome Biopsy System is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.
- The Mammotome Biopsy 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 Biopsy 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 MR Biopsy System consists of four major components: a disposable biopsy probe; a disposable, bladed, needle-like introducer; a reusable holster with detachable keypad, and a reusable control module. The following accessories are also provided with the system: disposable vacuum tubing set and canister, and control module cart.
The provided text describes the Mammotome® MR Biopsy System and its 510(k) submission but does not contain specific acceptance criteria, performance metrics, or details of a clinical study demonstrating the device meets such criteria.
The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (Mammotome EX Hand Held System) by highlighting similar technological characteristics and principles of operation, especially concerning its safety in an MR environment.
Here's what can be extracted and what is missing based on your request:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | MR safety testing demonstrated satisfactory material performance in a 3.0 Tesla magnet environment. |
| Not specified | The basic configuration, technology, and principles of operation are equivalent to the predicate device. |
2. Sample size used for the test set and data provenance:
- Sample Size: Not specified.
- Data Provenance: Not specified, but likely internal testing given the nature of MR safety testing. No mention of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as the performance data mentioned relates to MR safety testing, not diagnostic accuracy requiring expert ground truth for interpretation.
4. Adjudication method for the test set:
- Not applicable; MR safety testing does not typically involve adjudication in the way clinical diagnostic study results do.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs. without AI assistance:
- No, an MRMC study was not described. The device is a biopsy system, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The Mammotome MR Biopsy System is a medical device for tissue sampling, not an algorithm.
7. The type of ground truth used:
- For the described "Performance Data" (MR safety testing), the ground truth would be based on instrument readings and engineering standards to confirm safe operation within a 3.0 Tesla magnet environment. This is not a clinical ground truth like pathology or expert consensus.
8. The sample size for the training set:
- Not applicable. This is a hardware device submission, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable.
Summary of what is present:
The document primarily focuses on demonstrating the Mammotome® MR Biopsy System's substantial equivalence to a predicate device (Mammotome EX Hand Held System) and its safety in an MR environment. The "Performance Data" section specifically mentions MR safety testing, which verified satisfactory material performance in a 3.0 Tesla magnet. This testing would be based on engineering principles and regulatory guidelines for MR compatibility, not clinical diagnostic performance or AI model validation.
What is missing:
The document does not detail any clinical studies, diagnostic accuracy metrics (e.g., sensitivity, specificity, AUC), or acceptance criteria related to its ability to "provide tissue samples for diagnostic sampling of breast abnormalities." The indications for use are clinical, but the provided "Performance Data" section only addresses MR safety. For a device like this, clinical performance would typically be inferred from the predicate device's established performance and the demonstration of equivalent technological characteristics, rather than a new full-scale clinical trial if substantial equivalence is claimed.
§ 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.