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The Stryker iVAS® 13G 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.

Device Description

The Stryker iVAS ®13G 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.

AI/ML Overview

The provided document is a 510(k) summary for the Stryker iVAS® 13G Bone Biopsy Kit. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific performance acceptance criteria in the context of an AI/human-in-the-loop diagnostic device.

Therefore, many of the requested elements for an AI medical device study (such as MRMC studies, expert consensus for ground truth, sample sizes for training sets, etc.) are not applicable to this specific document as it pertains to a mechanical biopsy device.

However, I can extract the information related to the acceptance criteria and the "study" (bench testing) that proves the device meets those criteria, as detailed in the "Non-Clinical" section.

Here's the breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Test Performed)	Description of Acceptance Criteria	Reported Device Performance (Result)
Biocompatibility Evaluation	Meet requirements of ISO 10993-1 and FDA Guidance (Use of International Standard ISO-10993-1, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" June 2016) for limited exposure (≤24 hours) externally communicating, tissue/bone/dentin devices.	All testing completed met the requirements of the respective test methods.
Bench Testing - Material Information (Handles)
Biopsy Handle Colorant Changed
Obturator Handle Colorant Changed	Biopsy needle handle does not touch the patient and is out of scope of ISO 10993.
Obturator does not touch the patient and is out of scope of ISO 10993.	N/A (Explanation provided that these components are not patient-contacting and therefore out of scope for biocompatibility testing).
Bench Testing - Size Information (Needle)
Axial Torque on the needle	Device withstands twisting (specific quantitative criteria are not detailed but implied by "surpassed all acceptance criteria"). Each test would have a defined torque value it needed to withstand.	All samples surpassed all acceptance criteria.
Bench Testing - Size Information (Needle)
Non-axial Torque on the needle	Device withstands bending (specific quantitative criteria are not detailed but implied by "surpassed all acceptance criteria").	All samples surpassed all acceptance criteria.
Bench Testing - Size Information (Needle)
Impact and Compressive Force on the needle	Simulate impact and compression during advancement into bone. Each test would have a defined force value it needed to withstand.	All samples surpassed all acceptance criteria.
Bench Testing - Size Information (Needle)
Tensile Force on needle	Force required to pull the needle off of the handle is higher than the force needed to remove the device from bone.	All samples surpassed all acceptance criteria.
Bench Testing - Size Information (Obturator)
Compressive Force on the obturator	Simulate compression of the device when removing the sample from the needle.	All samples surpassed all acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance

The document states "All samples surpassed all acceptance criteria" for various bench tests, but does not specify the exact sample sizes (N). It implies that multiple units were tested for each criterion.
Data Provenance: The testing was "non-clinical" (bench testing) performed by Stryker Instruments. The country of origin for the data is implicitly the USA, where Stryker is headquartered and testing would likely take place. The testing is prospective in the sense that it was conducted specifically to address the risks and demonstrate equivalence for this 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not Applicable. For a mechanical device, "ground truth" as it applies to diagnostic accuracy (e.g., expert consensus on medical images) is not relevant. The "truth" for these tests is based on engineering specifications and physical measurements (e.g., how much force something can withstand).

4. Adjudication Method for the Test Set

Not Applicable. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert interpretations of data for diagnostic purposes. For mechanical bench testing, results are typically objective measurements against engineering specifications, not subject to subjective interpretation requiring 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 is a mechanical biopsy device, not an AI-powered diagnostic tool. No MRMC study was performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not Applicable. This is a mechanical biopsy device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical bench testing was based on engineering specifications and pre-defined acceptance criteria derived from risk assessment (EN ISO 14971:2012). This includes quantitative measurements of physical properties (e.g., force, torque limits). For biocompatibility, the ground truth was compliance with ISO 10993-1 and FDA guidance.

8. The Sample Size for the Training Set

Not Applicable. This is a mechanical device, not an AI 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, this question is not relevant.

Summary of Relevant Information:

The study proving the device meets acceptance criteria was non-clinical bench testing and biocompatibility evaluation, as detailed in section 8 of the 510(k) summary. These tests were conducted according to established engineering and material standards to ensure the device's mechanical integrity and biological safety after design modifications (specifically, changes in gauge size and handle colorants). The acceptance criteria were based on the device's ability to withstand various physical stresses and to be biocompatible, and all tested samples reportedly met these criteria. The details regarding specific quantitative thresholds for "acceptance criteria" are not provided in this 510(k) summary, but it states "All samples surpassed all acceptance criteria", implying successful performance against pre-defined internal specifications.

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