(23 days)
The EleVation Breast Biopsy System is indicated to obtain tissue samples from the breast or axillary lymph nodes for diagnostic analysis for breast abnormalities. The 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 essue margins be examined for completeness of removal using standard surgical procedures.
The ELEVATION™ Breast Biopsy System is a handheld, self-contained, single insertion, multiple sample vacuum-assisted biopsy device and is intended to be used with ultrasound guidance. The device can obtain and store multiple samples with a single insertion probe. The components of the system are designed to operate safely when used together for diagnostic sampling during a breast biopsy procedure. The device consists of a battery-powered, reusable driver and a disposable probe with a sample container.
The provided text is a 510(k) summary for the "EleVation Breast Biopsy System". This document focuses on demonstrating substantial equivalence of a modified device to a previously cleared predicate device, rather than proving the device meets specific performance acceptance criteria through clinical studies in the typical sense of a novel AI/medical device.
Therefore, the information requested regarding acceptance criteria, extensive studies, sample sizes, expert ground truth, MRMC studies, standalone performance, and training data is not directly applicable or available in this document. The FDA 510(k) process for this type of device relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through a comparison of technological characteristics and non-clinical performance testing.
Here's how to interpret the available information in the context of your questions:
1. A table of acceptance criteria and the reported device performance
The document doesn't present a table of specific clinical acceptance criteria (e.g., sensitivity, specificity, AUC) and corresponding reported performance values for diagnostic tasks. Instead, it refers to performance criteria for mechanical and functional aspects of the device.
| Acceptance Criteria Category (Implied) | Reported Device Performance (Summary from text) |
|---|---|
| Functional/Mechanical Performance | |
| Software Validation | Passed (demonstrates substantial equivalence) |
| Penetration Force | Performed comparable to predicate device |
| Tensile Strength | Performed comparable to predicate device |
| Prime/Pierce Testing | Performed comparable to predicate device |
| Reliability | Performed comparable to predicate device |
| Sample Mass | Performed comparable to predicate device |
| Safety and Effectiveness | Demonstrated to be as safe and effective as the legally marketed predicate device. |
2. Sample size used for the test set and the data provenance
- Not applicable for clinical diagnostic performance. The document describes non-clinical performance testing (e.g., mechanical tests), not a clinical study with a test set of patient data.
- Data Provenance: The studies are non-clinical and relate to engineering and mechanical performance of the device components.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. There is no "ground truth" in the diagnostic sense (e.g., pathology confirmed diagnosis) established by experts for this type of non-clinical device testing. The "ground truth" for the non-clinical tests would be the established engineering specifications and performance of the predicate device.
4. Adjudication method for the test set
- Not applicable. There is no clinical test set requiring expert 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
- Not applicable. This device is a biopsy system, not an AI diagnostic tool that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical biopsy system, not an algorithm.
7. The type of ground truth used
- Non-clinical/Engineering Ground Truth: The "ground truth" for the tests performed (Software Validation, Penetration Force Testing, Tensile Testing, Prime/Pierce Testing, Reliability Testing, Sample Mass Testing) would be established engineering specifications and the performance characteristics of the predicate device (K192948), to which the modified device is compared for substantial equivalence.
8. The sample size for the training set
- Not applicable. There is no "training set" in the context of this device's non-clinical performance testing, as it's not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable. (See point 8)
§ 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.