(86 days)
Stryker's Bone and Vertebral Body Biopsy Kits can be used as a biopsy tool to remove a sample of bone tissue from a vertebral body for diagnostic purposes using a coring, cutting or aspiration technique.
Stryker's Capture Vertebral Body and Bone Biopsy Kits can be used as a stand alone biopsy tool to remove a sample of bone tissue from a vertebral body for diagnostic purposes using a coring, cutting or aspiration technique. The Stryker Capture Bone and Vertebral Body Biopsy Kit and Kit with Guidewire is used to remove a sample of bone tissue from a vertebral body for diagnostic purposes, as well as to provide and maintain access to the same surgical site.
Stryker's Bone and Vertebral Body Biopsy Kits can be used as a biopsy tool to remove a sample of bone tissue from a vertebral body for diagnostic purposes using a coring, cutting or aspiration technique.
Stryker's Capture Vertebral Body and Bone Biopsy Kits can be used as a stand-alone biopsy tool to remove a sample of bone tissue from a vertebral body for diagnostic purposes using a coring, cutting or aspiration technique. The Stryker Capture Bone and Vertebral Body Biopsy Kit and Kit with Guidewire is used to remove a sample of bone tissue from a vertebral body for diagnostic purposes, as well as to provide and maintain access to the same surgical site.
This document is a 510(k) summary for the Stryker Bone and Vertebral Body Biopsy Kit and Stryker Capture Bone and Vertebral Body Biopsy Kit. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than reporting on specific clinical study performance against acceptance criteria.
Therefore, this document does not contain the detailed information necessary to answer most of your questions regarding acceptance criteria and a study proving the device meets them. The 510(k) process for this type of device (Class II, biopsy instrument) often relies on comparisons to legally marketed predicate devices and bench testing to demonstrate safety and effectiveness, rather than extensive clinical efficacy studies with predefined acceptance criteria.
Here's what can be inferred or stated based on the provided text:
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A table of acceptance criteria and the reported device performance:
- Not provided. The document states "Stryker's Bone and Vertebral Biopsy Kits are equivalent and operate similar to the predicate devices listed." This is the core "performance" claim for a 510(k) submission, indicating similarity to existing devices, not specific quantitative performance against acceptance criteria.
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Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not provided. The document does not mention any specific clinical or performance testing involving a "test set" in the context of human data. It's likely that any testing performed for this 510(k) was bench testing, not clinical human studies.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. No clinical test set with associated ground truth established by experts is described.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. No clinical test set and adjudication process is described.
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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 kit, not an AI-powered diagnostic tool for human readers. Therefore, an MRMC study related to AI assistance would not be relevant.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a medical instrument (biopsy kit), not an algorithm. Standalone performance as an algorithm is not relevant.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable/Not provided. No clinical studies requiring ground truth are described. For a biopsy device, the ultimate "ground truth" would be the success of obtaining a diagnostic sample leading to accurate pathological diagnosis, but this is not reported in this 510(k) summary. The "ground truth" for showing equivalence would be compliance with recognized standards or comparison to predicate device specifications.
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The sample size for the training set:
- Not applicable/Not provided. No AI model training or associated training set is mentioned.
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How the ground truth for the training set was established:
- Not applicable/Not provided. No AI model training or associated ground truth establishment is mentioned.
In summary: This 510(k) document is concerned with demonstrating substantial equivalence of a medical device (biopsy kit) to existing predicate devices, not with presenting results from a clinical study against specific performance acceptance criteria typically seen for novel diagnostic algorithms or therapies. The "study" referenced would have been primarily engineering and bench testing to show the device functions similarly to its predicates.
§ 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.