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The Stryker OrthoMap Versatile Hip system, which is comprised of the OrthoMap Versatile Hip 2.0 Software and a platform of the NAV3i platform family, is intended as a planning and intraoperative guidance system to enable open or percutaneous image guided surgery.

The system can be used for intraoperative guidance where a reference to a rigid anatomical structure such as but not limited to the pelvis, or femur, can be identified.

The system is indicated for conditions of the hip joint in which the use of image guided surgery may be appropriate.

The Stryker OrthoMap Versatile Hip system is indicated for the following surgical procedures:

· Any form of Total Hip Athroplasty (THA), e.g. open or minimally-invasive

• · Precisely position instruments, implants and bony tissue during orthopedic hip surgery
  · Revisions

The Stryker OrthoMap Versatile Hip system is intended to be used as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery. The system uses wireless optical tracking technology to display to the surgeon the intraoperative location of navigated surgical instruments relative to a computed anatomical model of the patient's hip (pelvis and femur). The computed model is based on an intra-operative anatomy survey of the pelvis and leg as described in the following chapters. The system consists of a Stryker surgical software application (software), which runs on a platform, consisting of a Stryker computer (computer), a navigation camera, an IO-Tablet and a monitor. The Stryker surgical software application interfaces with smart instruments (e.g. patient trackers, instrument trackers or pointers) and several accessories enabling the tracking of surgical instruments.

The Stryker OrthoMap Versatile Hip software, as well as the dedicated instruments, are compatible and represent an open platform for different implant systems. The Stryker OrthoMap Versatile Hip software provides alignment and orientation of instruments, trials and ultimately implants. The system also enables intra-operative and post implantation assessments of the patient's joint stability, ROM, and leg length and leg offset.

The Stryker OrthoMap Versatile Hip software allows the user to customize workflow by selecting to navigate either the cup, the stem, or both. The user settings can be adjusted to match the surgeon's preferences. The Stryker Navigation System enables navigation of dedicated Stryker Cup and Stem Instruments as well as generic navigation of various major cup instruments.

The Stryker OrthoMap Versatile Hip 2.0 Software is compatible with the NAV3i Platform Family. The NAV3i platform family is a family of platforms that, when used with a surgical software application, displays patient specific images and/or patient specific anatomical landmark information and tracks the position and movement of surgical instruments in relation to a target anatomical site on a patient.

The provided text describes the Stryker OrthoMap Versatile Hip System and its substantial equivalence to a predicate device. Here's a breakdown of the acceptance criteria and the study that proves the device meets those criteria, based on the provided document:

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

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

• Sample Size for Test Set: The document does not specify a numerical sample size for the bench testing or performance testing. It mentions "a mechanical leg mimicking the patient's anatomy" for system accuracy testing and "Sawbones mimicking the patient's anatomy" for clinical workflow testing. This implies a lab-based, synthetic, or cadaveric setup rather than patient data.
• Data Provenance: The data provenance is bench testing and simulated procedures using mechanical models and Sawbones. No real patient data is mentioned for testing. The document explicitly states: "No animal studies were performed to support substantial equivalence." and "No clinical studies were performed to support substantial equivalence."

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 or their qualifications for establishing ground truth for the test set. The ground truth appears to be established through engineering measurements against known physical standards (e.g., target angles/distances for accuracy testing using mechanical models).

4. Adjudication method for the test set

• No adjudication method is mentioned as there are no human readers or subjective assessments described for establishing ground truth in the performance tests. The tests are objective measurements against defined standards.

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

• No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical studies were performed to support substantial equivalence." This device is a surgical navigation system, not an AI-assisted diagnostic tool that would typically involve human readers interpreting images.

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

• The performance data described ("System accuracy testing," "ASTM accuracy testing," "Functional testing") can be interpreted as standalone performance of the system's capabilities (localization, tracking, software functionality) without direct human intervention impacting the measurement itself, although a human operates the system. It's a "human-in-the-loop" device in its intended clinical use, but the performance testing focuses on the system's inherent accuracy and functionality.

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

• The ground truth for the performance tests appears to be based on mechanical reference standards and pre-defined specifications. For example, the "mechanical leg mimicking the patient's anatomy" would have known, precise target measurements for angles and translations, against which the device's measurements are compared. The ASTM accuracy testing also implies a known, standardized reference.

8. The sample size for the training set

• This device is a surgical navigation system, not an AI/machine learning model that typically requires a distinct "training set" for model development. Therefore, the concept of a training set sample size is not applicable in the context of the information provided for this specific device. The software "algorithms" mentioned are likely deterministic algorithms for geometric calculations and tracking, not statistical learning algorithms.

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

• As the concept of a training set is not applicable (see point 8), the method for establishing its ground truth is also not applicable.

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