(211 days)
The Mammotome® elite Biopsy System is indicated to obtain tissue samples from the breast or axillary lymph nodes for diagnostic analysis of breast abnormalities.
- The Mammotome® elite Biopsy System is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.
- The Mammotome® elite Biopsy System is intended to provide breast tissue for histologic examination with partial removal of a palpable abnormality.
The Mammotome® elite Biopsy System is composed of a reusable Holster and a single-patient use, sterile Probe that may be used with ultrasound imaging guidance to excise and collect diagnostic samples with a single insertion of the Probe. The components of the system are designed to operate safely when used together for diagnostic sampling of tissue during a biopsy procedure. The Holster is a self-contained, handheld, reusable electromechanical vacuum-assisted biopsy device that consists of a rechargeable lithium-polymer battery and includes AC power cord and accessories. The Probe consists of an outer trocar shaft, a telescoping inner hollow coaxial cutter and an integrated coaxial cannula. The Probe incorporates a distal needle aperture and a proximal specimen collection cup with a tissue sample basket and specimen collection cap. The Holster contains one alignment tab that inserts into the holster notch located on the body of the Probe body also contains two locking tabs to secure the Probe into the Holster creates vacuum inside the device to assist in pulling tissue into the aperture while the sharpened inner cutter rotates at high speeds and extends across the aperture to acquire targeted tissue. The tissue sample is transported by vacuum to the specimen collection cup. The integrated coaxial cannula may be detached after the biopsy and remain in the breast to the biopsy site when placing a biopsy site identifier.
The Mammotome® elite Biopsy System is a biopsy instrument. The provided text describes the acceptance criteria and performance of the device based on a 510(k) submission (K112411).
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Tissue sample weight | Comparable to identified predicate devices |
| Tissue transport reliability | Comparable to identified predicate devices |
| Sample quality | Comparable to identified predicate devices |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: The document does not explicitly state the sample size for the test set. It mentions "ex vivo and in vivo models" were used for side-by-side comparison.
- Data Provenance: Not specified in terms of country of origin. The study involved both "ex vivo and in vivo models," suggesting a mix of laboratory (ex vivo) and potentially live subject (in vivo) testing. The document does not specify if the in vivo study involved human subjects or animal models. It does not indicate whether the data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The study focuses on comparing the device's ability to collect tissue samples against predicate devices, not on diagnostic accuracy requiring expert ground truth establishment for a test set.
4. Adjudication method for the test set
This information is not provided in the document. The study design, as described, does not appear to involve a diagnostic accuracy assessment that would necessitate an adjudication method for a test set.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a biopsy instrument, not an AI-powered diagnostic tool, so such a study is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone (algorithm only) performance study was not done. This device is a manual-use biopsy instrument with integrated software (firmware) for mechanical control, not a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the performance testing was based on the physical characteristics of the obtained tissue samples (weight, transport reliability, and quality) as compared to samples obtained using predicate devices. This implies an objective assessment of the tissue samples themselves, likely through established laboratory methods, rather than clinical outcomes or diagnostic accuracy requiring a ground truth like pathology for specific lesions.
8. The sample size for the training set
This information is not applicable/not provided. The device is a mechanical biopsy system with embedded firmware, not a machine learning model that requires a "training set" in the conventional AI sense. The software's function is to control the mechanical actions of the device, not to learn from data.
9. How the ground truth for the training set was established
This information is not applicable/not provided. As mentioned above, the device does not involve a machine learning training set.
§ 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.