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The Naviswiss Hip Navigation System is a computer-controlled system intended to assist the surgeon in determining reference alignment axes to aid in the positioning of orthopedic implant system components where a reference to a rigid anatomical structure can be identified. The system is only compatible with acetabular cup impactors that have a parallel and straight segment. The system aids the surgeon in performing intra-operative measurements of leg length, offset, and cup inclination/anteversion.

An example of a stereotaxic orthopedic surgical procedure includes Total Hip Arthroplasty: Lateral/Supine.

The equipment is intended for use by trained surgeons in operating theaters.

The Naviswiss Hip Navigation System is an image-free surgical navigation system intended to assist the orthopedic surgeon during the implantation of an artificial joint (hip). The device consists of a handheld navigation device, used to register the patient's anatomy into a software platform. Subsequently the navigation system helps the surgeon maneuver the surgical instruments with precision. Thus, the surgeon can position the implant in accordance to pre-operative planning.

The Naviswiss Hip Navigation System is comprised of two major sub-systems: the Naviswiss Hip (M42) and Naviswiss Platform (M59).

The Naviswiss Hip (M42) is composed of:

• . NAVItags used for reference and registration
• . Ancillary instruments
• . Application Software

The Naviswiss Platform (M59) is composed of:

• . Computer
• Camera ●
• . Software

The M42 employs the base computing, power supply, and programing in the M59 Platform. The NAVItags allow the surgeon to determine anatomical landmarks or navigate an instrument.

The camera utilizes application and tracking software to guide the surgeon through a workflow process for the surgery. The camera is covered by a sterile, single use drape for use of the navigation device in a sterile environment.

The provided text does not contain a specific table detailing acceptance criteria and reported device performance. It states broadly that "All performance tests were passed successfully" for both the subject and predicate devices.

However, based on the Summary of Testing section and the Indications for Use, we can infer some details related to accuracy and successful operation for the Naviswiss Hip Navigation System.

Here's an attempt to structure the information you requested based on the available text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• System Accuracy (ASTM F2554-18): Not explicitly stated, but the testing simulated "normal conditions, and a variety of worst-case use scenarios and realistic tracking disturbances."
• Benchtop Accuracy: Not explicitly stated, but verified using "calibrated test fixtures."
• Anatomical Phantom Simulated Use: Not explicitly stated how many phantom tests were conducted, but it was stated that the test was performed on a "metallic bone simulator." The data provenance is a "simulated use" scenario.
• Cadaver Simulated Use: "multiple cadaver wet labs" were used. The data provenance is human cadaver specimens.
• OUS Prospective Clinical Study: The study was designed to evaluate 35 patients undergoing elective THA surgery. The data provenance is prospective, clinical study data from Australia.

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

• Anatomical Phantom Simulated Use: Tests were performed by "orthopedic surgeons." The number of surgeons is not specified, nor are their specific qualifications (e.g., years of experience). Ground truth for this test was "known values" from the metallic bone simulator.
• Cadaver Simulated Use: Tests were performed by "trained surgeons." The number of surgeons and their specific qualifications are not specified. Ground truth for this test is implied to be the intended clinical use and performance on human specimens.
• OUS Prospective Clinical Study: The primary outcome involved agreement between intraoperative data from the Naviswiss system and post-operative CT measurements. This suggests the ground truth was based on objective imaging data (CT scans), not expert consensus from the study. The surgeons were involved in using the device but not specifically for establishing ground truth post-operatively. The number of experts interpreting the CT scans is not mentioned.

4. Adjudication method for the test set

• The document does not describe a formal adjudication method (like 2+1 or 3+1 expert review) for any of the performance tests. For the clinical study, the primary outcome involved comparing system measurements to post-operative CT measurements, which is an objective measurement rather than a consensus-based adjudication.

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

• A MRMC comparative effectiveness study, as typically understood in the context of reader performance with and without AI assistance, was not explicitly described in the provided text. The OUS Prospective Clinical Study focuses on system accuracy against CT measurements, not on comparing human reader performance with and without the system's assistance. The device assists the surgeon, but there's no study detailed on the improved performance of surgeons due to the assistance quantified as an effect size.

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

• The Naviswiss Hip Navigation System is described as a "computer-controlled system intended to assist the surgeon." Its indications for use clearly state it "aids the surgeon." Therefore, it is inherently designed for human-in-the-loop performance. While "System Accuracy" and "Benchtop Accuracy" tests evaluate the algorithm and hardware, they are still within the context of a system that provides guidance to a human surgeon. A purely standalone (algorithm-only) performance evaluation independent of surgeon interaction is not described.

7. The type of ground truth used

• System Accuracy (ASTM F2554-18) & Benchtop Accuracy: Verified against objective, known values provided by calibrated test fixtures and simulated conditions.
• Anatomical Phantom Simulated Use: Compared measurements obtained with the system against known values of the phantom.
• OUS Prospective Clinical Study: Ground truth for component positioning was established by post-operative CT measurements.

8. The sample size for the training set

• The document does not explicitly mention a training set or its sample size. The tests described are primarily verification and validation studies to demonstrate the device's accuracy and performance. If there was a machine learning component for which a training set was used, it is not detailed in this summary.

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

• Since a training set and its sample size are not mentioned, the method for establishing its ground truth is also not provided in this document.

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