(41 days)
The FINESSE™ Ultra Breast Biopsy System Driver is indicated to obtain tissue samples from the breast or axillary lymph nodes for diagnostic analysis of breast abnormalities. The instrument is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.
The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the 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.
The subject device, the modified FINESSE™ Ultra Breast Biopsy System Driver, is a non-sterile, self-contained, handheld, reuseable, electro-mechanical vacuum-assisted breast biopsy device that utilizes a rechargeable lithium-ion battery. The driver is designed to operate safely when used with the FINESSE™ Ultra Breast Biopsy System probe for diagnostic sampling of tissue during a breast biopsy procedure.
The provided text describes a 510(k) summary for a modified medical device, the FINESSE™ Ultra Breast Biopsy System Driver. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance criteria through a standalone clinical study. As such, much of the requested information regarding acceptance criteria and study details (like sample size, number of experts, ground truth, MRMC study, training data) is not present in this type of submission.
Here's a breakdown of the available information based on your request:
1. A table of acceptance criteria and the reported device performance
The document states: "The Modified FINESSE™ Ultra Breast Biopsy System Driver met all acceptance criteria for design verification and validation, as specified by applicable standards, guidance, test protocols and/or customer inputs."
However, the specific acceptance criteria and the quantitative or qualitative device performance results are not detailed in this 510(k) summary. The summary indicates that performance was evaluated via "data collected from bench testing," but the details of this testing are not provided.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in this document. The document states that the device "met all acceptance criteria for design verification and validation, as specified by applicable standards, guidance, test protocols and/or customer inputs." | Not specified in this document. The document states that performance data was collected from "bench testing" and demonstrate substantial equivalence, but no specific performance metrics or results are provided. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. The performance evaluation was conducted through "bench testing," which doesn't typically involve human subjects or patient data in the same way a clinical trial would.
- Data Provenance: Not applicable in the context of human data. The testing was "bench testing," meaning it was conducted in a laboratory setting.
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 applicable. As this was bench testing for an electromechanical device, there isn't a "ground truth" established by medical experts in the way that would apply to an AI diagnostic device. The "ground truth" for functions like software recovery from errors or current IR port functionality would be determined by engineering specifications and verification tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as there's no diagnostic test set requiring human adjudication.
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. This document describes a physical medical device (biopsy system driver), not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human reader performance with AI assistance is not relevant and was not conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical electromechanical device, not a software algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable in the conventional sense of clinical ground truth. The "ground truth" for this device's performance is likely defined by engineering specifications, successful completion of design verification and validation tests (e.g., successful recovery from errors, proper functioning of the IR port for software updates), and demonstration that it performs identically to the predicate device.
8. The sample size for the training set
Not applicable. This device is not an AI/machine learning model, so there is no training set.
9. How the ground truth for the training set was established
Not applicable, as there is no 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.