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The Stryker Spine LITe® Decompression System - Light Cable is intended to provide surgical site illumination from a high intensity light source when Stryker decompression tubes are in use.

The Stryker Spine LITe® Decompression System - Light Cable is a single use, sterile and disposable component. The Stryker Spine LITe® Decompression System - Light Cable consists of fiber optic cables contained within silicone tubing which can be connected to a light generator on one end and the tube of the Stryker Spine LITe® Decompression System on the other end.

This 510(k) summary is for the Stryker Spine LITe® Decompression System - Light Cable, which is a fiber optic light cable intended to provide surgical site illumination. The document focuses on establishing substantial equivalence to predicate devices and does not describe a study involving performance metrics for AI or machine learning algorithms. Therefore, many of the requested details about acceptance criteria, study design, and ground truth establishment are not applicable.

Here's an analysis based on the provided text, indicating where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not contain specific acceptance criteria and detailed performance metrics in the way one would expect for an AI/ML device. Instead, it relies on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use. The "performance" described is in comparison to the predicate devices.

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

This information is not applicable. The device is a physical medical device (fiber optic light cable), not an AI/ML algorithm that processes data. Therefore, there is no "test set" of data in the context of AI/ML evaluation.

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

This information is not applicable, as there is no "ground truth" establishment in the context of an AI/ML test set. The evaluation is focused on the device's physical design, materials, and intended function compared to existing legally marketed devices.

4. Adjudication Method for the Test Set

This information is not applicable. There is no "adjudication method" for a test set as would be used for AI/ML performance evaluation. The substantial equivalence determination is made by the FDA based on the provided comparisons to predicate devices.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of human readers' improvement with AI vs without AI assistance

This information is not applicable. The device is a surgical light cable, not an AI system. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or is relevant.

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

This information is not applicable. The device is a physical light cable, not an algorithm.

7. The Type of Ground Truth Used

This information is not applicable. As stated, there is no "ground truth" in the context of AI/ML evaluation for this device. The evaluation relies on comparing the device's technical specifications and intended use against predicate devices.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical product, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable. As there is no training set for an AI/ML algorithm, there is no ground truth to establish for it.

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