(87 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® EX Hand Held System is a mechanical breast biopsy device used in incisional breast biopsy of microcalcifications, masses, spiculated masses, asymmetric densities, multi-focal discase, and diffused tissue.
The Mammotome EX Hand Held System consists of three major components, a disposable bladed trocar tipped needle-like probe, a reusable holster, and a reusable control module. The following accessories are also provided with the system: disposable vacuum tubing set and canister, footswitch, remote keypad, support arm and cart.
The provided document describes the Mammotome® EX Hand Held System, a breast biopsy device, and its 510(k) Premarket Notification. However, it does not contain detailed information about specific acceptance criteria or a dedicated study proving performance against those criteria in the context of device accuracy for diagnosis or treatment decision-making.
The document states:
- "Preclinical testing was performed to ensure the device performs as intended. Testing demonstrated satisfactory performance in breast tissue biopsy." This is a very general statement and does not provide specifics about acceptance criteria or the study design.
- The device is a "modification of the currently marketed Mammotome Hand Held System" with "refinement in design, software and ergonomic enhancements." The submission primarily focuses on establishing substantial equivalence to predicate devices, implying that its performance is expected to be similar to already cleared devices.
Therefore, the following information cannot be fully extracted from the provided text:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in the document for diagnostic accuracy.
- Reported Device Performance: The document only generically states "satisfactory performance in breast tissue biopsy." No specific metrics (e.g., sensitivity, specificity, diagnostic yield, pathology correlation rates) are provided.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not detailed in the provided text. The term "preclinical testing" usually refers to bench testing or animal studies, not human clinical trials.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not detailed in the provided text.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not detailed in the provided text.
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/mentioned. This device is a biopsy system, not an AI-assisted diagnostic imaging tool. No MRMC study or AI assistance is discussed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable/mentioned. This is a physical biopsy device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The intended use is to "provide breast tissue for histologic examination." Therefore, for any study assessing the device's ability to obtain diagnostic tissue, pathology would be the standard ground truth for the tissue obtained. However, the details of such a study are not provided.
8. The sample size for the training set:
- Not applicable/mentioned. This is a physical device, not a machine learning algorithm requiring a "training set."
9. How the ground truth for the training set was established:
- Not applicable/mentioned.
In summary: The provided 510(k) summary focuses on establishing substantial equivalence for the Mammotome® EX Hand Held System based on its technological characteristics and intended use being similar to predicate devices. It states that "Preclinical testing was performed to ensure the device performs as intended" and "demonstrated satisfactory performance in breast tissue biopsy," but it does not provide the specific details of acceptance criteria or the study design and results typically expected for a detailed performance evaluation in terms of diagnostic accuracy metrics.
§ 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.