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The 360CAS is indicated for patients undergoing orthopaedic surgery and where reference to a rigid anatomical structure can be identified.

The 360CAS Knee is indicated for the following surgical procedures:

• · Any form of Total Knee Arthroplasty (TKA)
• · For conditions of the knee joint in which the use of computer assisted surgery may be appropriate

The 360CAS Hip is indicated for the following surgical procedures:

· Any form of Total Hip Arthroplasty (THA) e.g., open or minimally invasive, where a posterior or anterior approach is used

· For conditions of the hip joint in which the use of computer assisted surgery may be appropriate

The 360 Computer Assisted Surgery (360CAS) is a stereotaxic surgical navigation system for orthopaedic surgical procedures. The 360CAS is intended to be used as a planning and intraoperative quidance system with any manufacturers implant in open or percutaneous orthopaedic surgical procedures. The 360CAS uses optical tracking technology that allows surgeons to map subject's morphology, navigate surgical instruments and implants and assess state of the joint throughout the surgery. The system consists of 360CAS navigation software, which consists of two modules: 360CAS Knee and 360CAS Hip, surgical instruments, spatial tracking components and a navigation cart. 360CAS Knee is a 360CAS navigation software for knee replacement surgery. 360CAS Hip is a 360CAS navigation software for hip replacement surgery. The navigation software interfaces with the optical trackers which are attached to navigation instruments (e.g., pointer, bone fixator(s)).

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document indicates that "Sawbones mimicking patient's anatomy" were used for system accuracy testing and clinical workflow verification. However, the specific sample size (i.e., number of Sawbones or tests conducted) is not explicitly provided.

• Data Provenance: The tests were conducted using Sawbones, which are synthetic bone models, rather than actual patient data or cadavers. This suggests a bench-top testing environment, and thus the data is not tied to a specific country of origin in the same way clinical data would be. The testing is prospective in the sense that the device's performance was evaluated against a predefined protocol using these models.

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

The document does not specify the number of experts used to establish ground truth or their qualifications for the bench performance testing.

4. Adjudication method for the test set

The document does not describe any adjudication method for the test set. Given that the testing involved Sawbones and objective measurements against known accuracy standards, a formal adjudication process involving multiple human reviewers might not have been deemed necessary in the same way it would be for subjective clinical assessments.

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 MRMC comparative effectiveness study was done. The device (360CAS Knee and 360CAS Hip) is a computer-assisted surgical navigation system, not an AI-assisted diagnostic tool that would typically involve human readers interpreting images. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not directly apply to this device's reported evaluation. No effect size is mentioned.

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

Yes, the performance testing described appears to be a standalone (algorithm only) evaluation. The "System accuracy testing verifying the specified accuracy" and the "functional testing" assess the device's ability to perform its core functions and meet accuracy specifications independently of a human surgeon's real-time subjective assessment or intervention during the measurement process. The context is measuring the device's inherent accuracy and functionality.

7. The type of ground truth used

The ground truth used for performance testing was based on:

• Standardized test procedures and known measurements: For the ASTM accuracy testing (ASTM F2554-18 and ASTM F2554-22).
• Engineered precision/known values: For the "System accuracy testing verifying the specified accuracy of ±2mm and ±1º using Sawbones." This implies that the 'true' or target measurements on the Sawbones were precisely known or set.

8. The sample size for the training set

The document does not provide information on a "training set" as this device is a navigation system and not a machine learning or AI-based diagnostic algorithm that typically undergoes a distinct training phase with a labeled dataset. While software verification and validation were conducted, these generally involve testing the implemented code against requirements, rather than training a model.

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

As there is no mention of a training set in the context of machine learning, there is no information on how its ground truth would have been established. The device instead relies on established mechanical and optical principles for navigation.

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