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The VSP® Orthopedics System is intended to be used as a surgical instrument to assist in preoperative planning and/or in guiding the marking of bone and/or in guiding surgical instruments in non-acute, non-joint replacing osteotomies for adult patients in the distal femur, tibia, and non-sacrum pelvis.

The VSP® Orthopedics System is intended to assist a surgeon with pre-operative planning and transfer of the pre-operative plan to the surgery in orthopedic procedures. The system contains several physical and digital outputs including patient-specific anatomical models, and guides (physical outputs); and patient-specific surgical plans and digital files (digital or documentation outputs).

Outputs of the VSP® Orthopedics System are designed with physician input and reviewed by the physician prior to finalization and distribution.

The VSP® Orthopedics System also contains Stainless Steel Drill Inserts (VSP® Orthopedics System Accessories) which are intended to be used by the physician to guide drilling activities during the surgical procedure. The inserts fit into a standard hole in the cutting / drill guides and can be used across all VSP® Orthopedics System guides and templates.

The VSP® Orthopedics System is intended to assist a surgeon with pre-operative planning and transfer of the pre-operative plan to the surgery in orthopedic procedures.

Here's a breakdown of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a specific table of numerical acceptance criteria or reported device performance metrics like sensitivity, specificity, or accuracy for the overall system. Instead, it states that:

"All design, process, and other verification and validation testing, which were conducted as a result of risk analyses and design impact assessments, showed conformity to pre-established specifications and acceptance criteria. The acceptance criteria was established in support of device performance, and testing demonstrated substantial equivalence of the system to the predicate device."

This indicates that the acceptance criteria were qualitative and focused on demonstrated compliance with pre-established specifications and substantial equivalence to the predicate device.

The "Performance Testing" section lists the types of tests performed:

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

The document specifies "Bench and cadaveric testing was conducted" and includes "Cadaver Study" as a test type. However, it does not provide any details on the sample size (number of cadavers or specific test scenarios) used for the cadaver study or any other test set.

The data provenance is not explicitly mentioned (e.g., country of origin, retrospective or prospective).

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

The document states: "Outputs of the VSP® Orthopedics System are designed with physician input and reviewed by the physician prior to finalization and distribution." While this indicates physician involvement in the design and review process, it does not specify the number of experts used to establish ground truth for a test set or their specific qualifications (e.g., "radiologist with 10 years of experience").

4. Adjudication method for the test set

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for a test set.

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size for human readers improving with AI assistance. The system is described as a "surgical instrument to assist in pre-operative planning and/or in guiding..." which implies human-in-the-loop, but no comparative study to measure assistance effectiveness is detailed in this summary.

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

The document does not explicitly state if a standalone (algorithm only) performance study was conducted. The description of the system's outputs ("patient-specific anatomical models, and guides (physical outputs); and patient-specific surgical plans and digital files (digital or documentation outputs)") suggests that the system generates these outputs, which are then reviewed by a physician.

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

The document implies that the ground truth for the system's performance, particularly in the cadaver study, would be based on direct observation of surgical guidance and accuracy against the pre-operative plan. Since the system assists in planning and guiding, the "ground truth" would likely be the surgical outcome or accuracy of instrument placement as verified in the cadaveric setting. However, the exact nature of this "ground truth" and how it was established is not detailed. It mentions "physician input" and "reviewed by the physician," suggesting expert judgment forms a basis, but not explicitly as a ground truth for a test set.

8. The sample size for the training set

The document does not provide any information regarding a training set or its sample size. This summary focuses on verification and validation testing, not the development or training of an AI component, if one exists within the system's planning features.

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

Since no information on a training set is provided, there is also no information on how its ground truth was established.

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