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The Stryker OrthoMap Express Knee system, which is comprised of the OrthoMap Express Knee 2.0 Software and a platform of the NAV31 platform family, is intended as a planning and intra-operative guidance system to enable open or percutaneous image-guided surgery.

The system can be used for intraoperative guidance where a rigid anatomical structure can be identified.

The system is indicated for conditions of the knee joint in which the use of computer assisted surgery may be appropriate.

The Stryker OrthoMap Express Knee system is intended to be used as a planning and intraoperative guidance system to enable open or percutaneous image guided knee 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 leg (femur and tibia). The computed model is based on an intra-operative anatomy survey of the leg. The system consists of a Stryker surqical software application (software), which runs on a platform, consisting of a Stryker 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 Express Knee 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 NAV3i platform family consists of the following three platforms that have been previously cleared independently or with other Stryker surgical software applications:

• . Stryker NAV3 Platform (K141551)
• Stryker NAV3i Platform (K130874) ●
• Stryker NAVSuite3 Kit (K150301) ●

The platforms consist of the following components:

• Stryker computer
• Navigation camera ●
• IO-Tablet
• Monitor ●
• Mobile cart (if applicable) ●

The provided document is a 510(k) Premarket Notification for the Stryker OrthoMap Express Knee System, cleared by the FDA on July 7, 2016. This document details the device's intended use, comparison to predicate devices, and performance testing to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Description: The performance testing for system accuracy involved a "mechanical leg mimicking the patient's anatomy."
• Sample Size: The document does not explicitly state the specific number of measurements or "samples" taken during the system accuracy testing using the mechanical leg. It only describes the methodology.
• Data Provenance: The testing was conducted as "bench performance testing," implying it was performed in a controlled laboratory setting. There is no information on the country of origin of this data, but it would typically be conducted by the manufacturer (Stryker) or a contracted testing facility. It is retrospective in the sense that results are reported from completed tests.

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

• The document does not mention the use of human experts or consensus to establish ground truth for system accuracy testing.
• The ground truth for system accuracy was established using a "mechanical leg mimicking the patient's anatomy" and a standardized test procedure (ASTM Standard F2554-10). This suggests a physical, measurable, and objective ground truth rather than subjective expert opinion.

4. Adjudication method for the test set

• No adjudication method (e.g., 2+1, 3+1) is mentioned, as the ground truth was established through a mechanical setup and standardized tests, not human interpretation.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance

• No multi-reader multi-case (MRMC) comparative effectiveness study was performed. The device is a "planning and intra-operative guidance system" for knee surgery, not an AI-assisted diagnostic tool that aids human readers in interpreting images. Therefore, the concept of human readers improving with AI assistance is not applicable in this context.

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

• The system accuracy testing ("mean translational error of < 2 mm" and "mean rotational error of < 1°") is a standalone (algorithm only) performance assessment of the device's ability to precisely track and measure anatomical structures and surgical alignments. This testing evaluates the core functionality of the guidance system independent of a specific surgical outcome.
• The device is intended for "intra-operative guidance," meaning it always involves a "human-in-the-loop" (the surgeon). However, the accuracy testing described focuses on the device's intrinsic measurement capabilities.

7. The type of ground truth used

• The ground truth for the system accuracy testing was objective, physically defined measurements obtained from a "mechanical leg mimicking the patient's anatomy" and using the "standardized test procedure according to ASTM Standard F2554-10." This ground truth is based on engineering specifications and verifiable physical properties rather than expert consensus, pathology, or outcomes data.

8. The sample size for the training set

• The document does not provide details about a "training set" or "training data." The Stryker OrthoMap Express Knee system appears to be a rule-based or algorithmic navigation system, rather than a machine learning or AI system that undergoes explicit training on a dataset. The emphasis is on its accuracy in tracking and calculating measurements based on known physical principles.

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

• As no "training set" is mentioned or implied for this type of navigation system, the question of how its ground truth was established is not applicable based on the provided information.

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