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The Q Guidance System, when used with the Spine Guidance Software, is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery in adult and pediatric (adolescent) patients.

The system is indicated for any surgical procedure on the spine 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 such as the skull, pelvis or spine can be identified.

The system assists in the positioning of instruments for procedures on the pelvis and spine, including:
• Screw and Needle placement in the spine or pelvis.

The Spine Guidance 5.0 system is an image guided stereotaxic, planning, and intraoperative guidance system intended to enable open or percutaneous computer-assisted surgery. It assists the surgeon in precisely positioning manual and powered instruments and locating patient anatomy during spinal surgery.

The system is comprised of the Spine Guidance 5.0 Software, the Q Guidance System (computer platform), navigated accessories/ instruments (e.g., powered drills, pointers), and various system components (e.g., calibration devices, navigation adaptors, patient/ instrument trackers, etc.). The system provides intraoperative guidance to the surgeon using passive and active wireless optical tracking technologies. The computer platform consists of a computer, camera, big touchscreen monitor, and a small touchscreen monitor. The Spine Guidance 5.0 software functionality is described in terms of its capabilities that feature planning, registration, and navigation of medical devices.

The provided document is an FDA 510(k) summary for the Stryker Spine Guidance Software (version 5.0) and associated instruments. It details the device's characteristics, intended use, and comparison to predicate devices, as well as the non-clinical testing performed to establish substantial equivalence.

Here's a breakdown of the requested information based on the provided text:

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)

The document does not specify the exact sample size for the test set used in the accuracy testing. It mentions "anatomically representative phantoms" and "a subset of system components and features that represent the worst-case combinations of all potential system components." The data provenance (country of origin, retrospective/prospective) is not mentioned.

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

The document does not mention the use of experts to establish a ground truth for the test set. The accuracy testing was performed using "anatomically representative phantoms," implying a technical or engineering validation rather than clinical or expert-based ground truth.

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

No adjudication method for a test set is described, as the testing focused on technical accuracy using phantoms, not on human interpretation or clinical outcomes adjudicated by experts.

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

The document explicitly states: "No clinical testing was required to support this submission." Therefore, no MRMC comparative effectiveness study was performed or reported. The device is a guidance system, not an AI diagnostic tool requiring human reader improvement comparison.

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

The document describes non-clinical testing for system accuracy and software validation. The reported accuracy of "mean error ≤ 2.0 mm for positional displacement and < 2.0 degrees for trajectory angle displacement" refers to the standalone performance of the system as measured against known phantom parameters. This suggests that the algorithm's performance in guiding instruments was assessed directly against a predefined ground truth in a controlled environment.

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

For the accuracy testing, the ground truth was established by the precise measurements of "anatomically representative phantoms." This implies a technical or engineered ground truth rather than expert consensus, pathology, or outcomes data.

8. The sample size for the training set

The document does not provide information about a training set. This is a 510(k) summary focusing on a device that is substantially equivalent to a predicate, not necessarily a de novo submission for a novel AI algorithm requiring a specific training set size to establish performance. The software verification and validation would have involved testing against requirements, but not necessarily a "training set" in the machine learning sense.

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

Since no training set is mentioned, the method for establishing its ground truth is not provided.

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