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Stryker Navigation Enabled Instruments are intended to be used in the preparation and placement of Stryker screws (including XIA 3 (including Serrato), XIA 4.5 (including XIA CT), ES2, Mantis Redux, and XIA 2) during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are specifically designed for use with the Medironic System, which is indicated for anv medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model. fluoroscopy images, or digitized landmarks of the anatomy. Stryker Navigation Enabled Screwdrivers are also compatible with the Medtronic IPC POWEREASE System.

Navigation Enabled Instruments are nonsterile, reusable instruments, including taps which are operated manually and drivers that can be manually operated or operated with the Medtronic IPC POWEREASE System. These instruments are intended to be used with the Medtronic StealthStation system.

The provided document is a 510(k) Summary for "Navigation Enabled Instruments" from Stryker. It details the device's intended use and claims substantial equivalence to predicate devices but does not include a specific study that proves the device meets detailed acceptance criteria with numerical performance data. The summary mentions "Design validation testing, including registration, and accuracy, was conducted" but does not provide the results of this testing.

Therefore, I cannot provide all the requested information. However, I can extract what is available regarding the performance data and criteria mentioned.

Here's the information that can be extracted from the provided text:

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

The document mentions "Design validation testing, including registration, and accuracy, was conducted" to ensure the instruments are "acceptable for their intended use," functionality, and compatibility. However, specific numerical acceptance criteria (e.g., "Registration accuracy must be within X mm") and reported device performance (e.g., "Registration accuracy was Y mm") are not provided in this 510(k) summary.

2. Sample size used for the test set and the data provenance

The document indicates "Design validation testing" was performed, which likely involved a test set. However, the sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective) are not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document makes no mention of experts being used to establish ground truth for testing. The testing described appears to be technical validation (e.g., accuracy, registration) rather than evaluations requiring clinical expert interpretation.

4. Adjudication method for the test set

Not applicable, as no expert evaluation is described.

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

An MRMC study is not mentioned. The device described is "Navigation Enabled Instruments," which are physical tools for surgical navigation, not an AI-assisted diagnostic or interpretive system that would typically be evaluated with MRMC studies for human reader improvement.

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

Not applicable, as this is a physical instrument for surgical navigation, not a standalone algorithm.

7. The type of ground truth used

The document states "Registration testing was performed to ensure that the instruments can be registered to the StealthStation®. Accuracy testing was completed for comparison to the predicate instruments." This implies a ground truth based on measurable physical properties and established benchmarks (e.g., a known precise measurement or a predicate device's performance). The specific method of establishing this precise "ground truth" (e.g., using a highly accurate measurement system, phantom models) is not detailed.

8. The sample size for the training set

This device does not appear to be an AI/ML device in the traditional sense that requires a training set of data. Therefore, a training set sample size is not applicable or not specified.

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

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

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