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The Stryker Xia 4.5 Polyaxial Screwdriver is a Stryker Navigated Manual Surgical Instrument.

Stryker Navigated Manual Surgical Instruments are intended to be used as accessories to the Stryker Spine Navigation System, when used with the SpineMap 3D Navigation software. They are manual surgical instruments intended to be used in spine surgery to facilitate placement of Stryker Spine implants.

Stryker Navigated Spine Instruments may be used as part of the Stryker Spine Navigation System, which is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified.

Stryker Navigated Spine Instruments are intended for exclusive use with the Rotational Adaptor and associated Trackers to facilitate the placement of the Stryker Spine XIA® 3, XIA® 4.5, MANTIS®, MANTIS® Redux, and ES2® Spinal Fixation Systems using the STRYKER SpineMap® 3D Navigation System.

The surgeon must also refer to the Stryker Spine XIA® 3, XIA® 4.5, MANTIS®, MANTIS® Redux, or ES2® package insert/instructions for use, product label, and surgical technique guide to obtain detailed product information and recommended surgical procedure.

The Navigated XIA® 4.5 Polyaxial Screwdriver, a Stryker Navigated Spine Instrument, is a manual tool for bone screw placement, insertion, and removal. The tip of the navigated screwdriver inserts into the screw head to turn it. The screwdriver also has an interface to allow a connection to the Rotational Navigation Adapter, a Stryker Spine Navigation System accessory, and to a handle.

The provided text is a 510(k) summary for the Navigated XIA® 4.5 Polyaxial Screwdriver. It describes the device, its intended use, and the performance data submitted to support its substantial equivalence to predicate devices. However, the document does not contain the specific level of detail required for a comprehensive answer to your request, especially regarding acceptance criteria and the specifics of a study proving device performance against those criteria as you would find for an AI/ML powered device.

This document describes a medical instrument, not an AI/ML powered device. Therefore, many of your requested points (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, ground truth used) are not applicable to this type of submission.

Based on the information provided for this instrument, here's what can be extracted and inferred:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test Set Sample Size: Not explicitly stated for the "Simulated Use" or "Navigation Accuracy" tests. The "Simulated Use" mentions a "cadaveric setting," implying a limited number of cadavers were used, but the exact count is not provided. For "Navigation Accuracy," it implies measurements were taken, but the number of measurements or samples is not specified.
• Data Provenance: Not explicitly stated. The applicant is Stryker Leibinger GmbH & Co. KG, located in Germany, suggesting testing may have occurred there or at a Stryker facility elsewhere. The nature of the tests (simulated use, bench testing) suggests prospective data collection for these specific tests.

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. For an instrument like this, "ground truth" as it relates to expert consensus on images or diagnoses is not relevant. The "ground truth" for navigation accuracy would be established by precise metrology equipment. For simulated use, the assessment would be by surgical engineers or potentially observing surgeons. No number or specific qualifications of experts are mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are typically employed in studies involving subjective interpretation (e.g., image reading). For objective performance tests of an instrument, this concept doesn't apply.

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 surgical instrument, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.

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

Not applicable. This is a manual surgical instrument. Its "performance" is inherently tied to human action and its interaction with a navigation system. It does not have a standalone algorithmic component in the sense of AI/ML. The navigation system itself performs the calculations, and the instrument's role is to be precisely tracked. The accuracy testing focuses on the instrument's trackability as part of the system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the Navigation Accuracy test would be based on physical metrology/measurement standards (e.g., using a coordinate measuring machine or similar high-precision setup to verify the instrument's position and orientation reported by the navigation system against its true physical position). The document refers to verification against ASTM F2554:2010, which specifies methods for testing the accuracy of image-guided surgical systems.

8. The sample size for the training set

Not applicable. As a physical surgical instrument without AI/ML components, it does not have a "training set" in the context of machine learning.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this type of device.

Summary based on the document:

The Navigated XIA® 4.5 Polyaxial Screwdriver's performance was evaluated through simulated use in a cadaveric setting and navigation accuracy testing. The key acceptance criterion for accuracy was $\pm$ 2 mm and $\pm$ 2°, and the device met this by demonstrating a tracking accuracy of < $\pm$ 1.5 mm (80th percentile) according to ASTM F2554:2010. The device's substantial equivalence was based on its similar technological characteristics and intended use to predicate devices, and the fact that its modifications did not negatively impact its function or the overall navigation system's performance. The specific numbers of cadavers or individual measurements for the tests were not detailed in this summary.

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