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The HSA system is a computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instrumentation structures during stereotactic orthopedic surgical procedures. The HSA system facilitates the accurate positioning of implants, relative to these alignment axes.

Example orthopedic surgical procedures include but are not limited to:

• · Total Knee Arthroplasty
• · Unicompartmental Knee Arthroplasty: Tibial transverse resection.

The OrthAlign Harvey® Surgical Assistant System is a non-invasive computer assisted surgical navigation system for use in total knee and Unicompartmental knee arthroplasty procedures. The Harvey® Surgical Assistant System is configured to detect, measure, and display angular and positional measurement changes in a triaxial format. The Harvey® Surgical Assistant System utilizes a palm-sized computer module and reference sensor to generate positional information in orthopedic procedures providing a sequence of steps for registration of anatomical landmarks, calculation of mechanical axes, and positioning of instruments relative to the mechanical axes.

In knee arthropolasty procedures, the device assists the surgeon in:

• . Establishing the mechanical axis of the femur. determining the varus/valgus angle and the flexion/extension angle of the cutting block relative to the femur.
• Establishing the mechanical axis of the tibia. determining the varus/valgus andle and . the posterior slope angle of the cutting block relative to the tibia.

In unicompartmental knee arthroplasty procedures, the device assists the surgeon in:

• . Establishing the mechanical axis of the tibia, determining the varus/valgus angle and the posterior slope angle of the cutting block relative to the tibia, for the transverse resection.
  The Harvey® Surgical Assistant System comprises a single use computer module and reusable instrumentation.

Here's a breakdown of the acceptance criteria and study information for the Harvey® Surgical Assistant System, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary does not explicitly state specific numerical acceptance criteria for the Harvey® Surgical Assistant System's performance. Instead, it relies on demonstrating substantial equivalence to a legally marketed predicate device (OrthAlign Plus® System K162962). The performance testing aims to confirm that the modified device performs "as well as" the existing device.

The reported device performance is described in terms of functional verification and validation, ensuring the device meets its intended use.

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not specify numerical sample sizes for the test set. It mentions "various use sequences" for software testing.

The data provenance is not explicitly stated in terms of country of origin or retrospective/prospective nature. However, the evaluation is a premarket notification for a medical device in the United States, so the testing would likely be performed to U.S. regulatory standards.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

The document does not mention the use of experts or establish ground truth through expert consensus for the performance testing. The testing appears to be functional and software-oriented verification and validation, rather than a clinical study requiring expert interpretation of outcomes.

4. Adjudication Method for the Test Set

As there's no mention of expert involvement or ground truth established by experts, there's no adjudication method described for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study is not described in the provided document. This submission is for a modification to an existing stereotaxic instrument, and the testing focuses on the functional performance of the modified device, not a comparative clinical effectiveness study with human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The performance testing described, particularly "Software verification and validation to ensure the integrity of the code and functionality and reliability of the software in various use sequences," would largely be a standalone (algorithm only) evaluation of the software's ability to process inputs and generate correct outputs. The device itself is a "computer-controlled system intended to assist the surgeon," indicating it provides outputs (angular and positional measurements) that the surgeon then uses. Therefore, the core functional tests of the software would be standalone.

7. The Type of Ground Truth Used

The ground truth for the performance testing appears to be based on:

• Engineering specifications and expected outputs: For software verification and validation, the "ground truth" would be the pre-defined correct functionality, calculations, and expected visual displays based on engineering requirements.
• Predicate device performance: The ultimate "ground truth" for substantial equivalence is the performance of the legally marketed predicate device (OrthAlign Plus® System K162962). The testing aims to show the modified device performs comparably.

8. The Sample Size for the Training Set

The document does not mention a training set or any machine learning/AI model training in the conventional sense. The device is described as a "computer-controlled system" that utilizes algorithms to convert sensor outputs into spatial coordinates. This implies deterministic programming rather than a machine learning model that would require a distinct training set.

9. How the Ground Truth for the Training Set Was Established

Since there is no mention of a training set for a machine learning model, the concept of establishing ground truth for a training set does not apply here. The algorithms in this device are likely based on established biomechanical and mathematical principles, validated through traditional software and system engineering methods.

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