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The Stryker Navigation System – OrthoMap® 3D Module is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery. The system is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intra-operative guidance where a reference to a rigid anatomical structure can be identified.

The system should be operated only by trained personnel such as surgeons and clinic staff.

The Stryker Navigation System - OrthoMap® 3D Module supports, but is not limited to, the following surgical procedures:

Orthopedic Oncology Procedures
Surgical Planning Procedures

• Segmentation to define volumes of interest using correlated, multi-modality . image data, e.q. to assist outlining and visualizing bony structures such as aberrant pathology
• Image based distance and anqular measurement tools, e.g. to define and maintain safety margins to outlined bony structures
• Image based resection plane planning to define resections relative to identified structures, e.g. to support limb salvage surgery taking safety margins into account
• Virtual screw placement planning in the image data with variable screw length, bead-length and diameter
• Image based annotation point placement and visualization, e.q. to support repositioning of bony anatomic points during surgery

rgical Navigation Procedures

• Intra-operative visualization of volume image data including visualization of pre-planned volumes of interest relative to the tracked instrument, supporting navigated excision of user-defined bony structures
• Intra-operative visualization of resection planes relative to the tracked instrument on bony structures assisting bony resections
• Intra-operative creation and visualization of annotation points, supporting recording of landmarks on bony anatomy, e.g. to assist oncology replacement prosthesis repositioning, leg length and rotation assessment or navigated implant placement
• Navigated intra-operative screw placement based on pre-planned or intraoperative virtual screw definition

The Stryker Navigation System - OrthoMap® 3D Module is part of the product series of the Stryker Navigation System. The system comprises software for surgical planning and computer assisted surgery based on a wireless optical tracking localization device for the use in navigated orthopedic oncology surgery.

The provided text is a 510(k) summary for the Stryker Navigation System - OrthoMap® 3D Module, submitted to the FDA. It focuses on establishing substantial equivalence to existing predicate devices rather than directly presenting acceptance criteria and a detailed study proving the device meets them with specific performance metrics.

Therefore, much of the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is not present in the provided document.

Here's an attempt to answer based on the available information, highlighting what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the given 510(k) summary. The document focuses on establishing substantial equivalence by stating that the device "does not raise any new safety and efficacy concerns when compared to similar devices already legally marketed." It does not present specific quantitative acceptance criteria or performance metrics for the OrthoMap® 3D Module itself.

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

This information is not provided in the 510(k) summary. There is no mention of a specific test set or data used for performance evaluation. The substantial equivalence argument relies on comparison to predicate devices and adherence to the manufacturer's Quality Management System.

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

This information is not provided in the 510(k) summary. No test set or ground truth establishment process by experts is described.

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

This information is not provided in the 510(k) summary. No test set or adjudication method 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

There is no mention of an MRMC comparative effectiveness study in the provided document. The device is a navigation system for surgical planning and guidance, not an AI or imaging diagnostic tool that would typically involve human "readers" in the context of an MRMC study.

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

This information is not explicitly provided in the context of a formal study with specific results. The device is described as a "planning and intraoperative guidance system," implying a human-in-the-loop interaction. The 510(k) does not present standalone algorithm performance metrics.

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

This information is not provided in the 510(k) summary. No specific ground truth methodology is described as the document focuses on substantial equivalence rather than a de novo performance study.

8. The sample size for the training set

This information is not provided in the 510(k) summary. There is no mention of a training set as would be relevant for machine learning or AI algorithm development.

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

This information is not provided in the 510(k) summary. As there is no mention of a training set, the establishment of its ground truth is also not discussed.

Summary of the Study type presented (Substantial Equivalence):

The provided document describes a Substantial Equivalence submission. This type of submission relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, without necessarily requiring new clinical trials or detailed performance studies.

The study described (implicitly, through the 510(k) process) is a demonstration that:

• The Stryker Navigation System - OrthoMap® 3D Module has the same intended use as the predicate devices (K062640 Cranial Module and K012380 Spine & Fluoroscopy Module).
• It has similar technological characteristics (a wireless optical tracking localization device for computer-assisted surgery).
• Any differences in technological characteristics do not raise new questions of safety or effectiveness.

The document states: "The Stryker Navigation System – OrthoMap® 3D Module does not raise any new safety and efficacy concerns when compared to similar devices already legally marketed. Therefore, the Stryker Navigation System - OrthoMap® 3D Module is substantially equivalent to these existing devices." It also notes that the device will be designed and manufactured in accordance with Stryker Leibinger's Quality Management System covered by QSR 21CFR 820. This indicates an adherence to established quality and manufacturing control processes rather than reporting specific performance study results.

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