(42 days)
The Stryker iVAS® Bone Biopsy Kit can be used as a biopsy tool to remove sample tissue from bone or vertebral body using a coring, cutting or aspiration technique.
The Stryker iVAS® Bone Biopsy Kit can be used as a biopsy tool to remove sample tissue from bone or vertebral body using a coring, cutting or aspiration technique. The subject device is disposable, intended for single use, and is provided sterile to the end user. The mechanism of action for obtaining a biopsy is manual and the principle of operation is through suction. The biopsy device will be sold in a kit configuration consisting of a coaxial biopsy needle, obturator and syringe. The subject biopsy kit is used with an access cannula and stylet of compatible size. The access cannula and stylet are sold separately and are Class I exempt per 21 CFR 888.4200, product code OAR (injector, vertebroplasty (does not contain cement).
The provided text describes the Stryker iVAS® Bone Biopsy Kit and its substantial equivalence to a predicate device, focusing on non-clinical (bench) testing. There is no information about a study proving the device meets acceptance criteria in the context of AI/ML performance, multi-reader multi-case studies, or human-in-the-loop performance.
The document is a 510(k) summary for a medical device and is primarily concerned with establishing substantial equivalence to a legally marketed predicate device, rather than assessing an AI's performance.
Here's the information extracted from the provided text, keeping in mind that the request is geared towards AI/ML device studies, and this document does not describe such a study:
1. A table of acceptance criteria and the reported device performance
The document mentions acceptance criteria but does not provide a table specifying the criteria values alongside reported performance for each test. It broadly states that "All samples surpassed all acceptance criteria" for each test.
| Test Description | Acceptance Criteria (Not specified, but implied) | Reported Device Performance |
|---|---|---|
| Axial Torque and Non-axial Torque | Torsional performance requirements | All samples surpassed all acceptance criteria |
| Compressive force (obturator) | Compression requirements | All samples surpassed all acceptance criteria |
| Axial Tensile Force | Functional performance requirements | All samples surpassed all acceptance criteria |
| Compressive Force and Axial Tensile Force (obturator) | Functional and compressive performance requirements | All samples surpassed all acceptance criteria |
| Impact and Axial Compressive testing | Impact and compressive performance requirements | All samples surpassed all acceptance criteria |
| Impact testing | Functional specifications | All samples surpassed all acceptance criteria |
2. Sample sizes used for the test set and the data provenance
The document states "All samples" passed the tests, but does not specify the exact number of samples (sample size) used for each bench test.
Data Provenance: Not applicable in the context of "country of origin of the data" or "retrospective or prospective" as these were bench tests performed on physical device samples, not clinical or historical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The tests are mechanical bench tests on the device's physical properties. There is no ground truth established by experts in the context of interpretation or diagnosis for these types of tests.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically relevant for human interpretation of data, such as medical images. These were objective mechanical tests.
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 MRMC comparative effectiveness study was mentioned or performed. This document does not pertain to AI/ML software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No standalone algorithm performance study was mentioned or performed. This document does not pertain to AI/ML software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. For the bench tests, the "ground truth" would be the engineering specifications and performance requirements that the device needed to meet.
8. The sample size for the training set
Not applicable. This document describes a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As noted above, this document does not pertain to AI/ML software, so there is no training set or ground truth in that context.
§ 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.