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This device is intended for local coagulation of soft tissues during minimally invasive orthopedic surgeries, such as, but not limited to hip, knee, shoulder and elbow arthroplasty by use of high-frequency electrical current. This local coagulation serves to mark the tissue to aid the surgeon in the location of subsequent osteotomies.

The Osteotomy Guide will be used as an aid to help the surgeon mark the periosteal location of the osteotomy cut in the calcar of the femur as part of a replacement surgery.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Zimmer Minimally Invasive Solutions™ Osteotomy Guide Instrument:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not applicable. The "test set" described is a non-clinical "UL Testing" of electrical safety standards. It does not involve a data set of patient cases.
• Data Provenance: Not applicable. The testing was non-clinical.

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

• Not applicable. Ground truth as typically understood for medical device studies (e.g., expert clinical review, pathology) was not established. The "ground truth" here is the pass/fail criteria of the specified electrical safety standards. The "experts" would be the certified laboratory personnel performing the UL testing.

4. Adjudication Method for the Test Set

• Not applicable. The UL testing involved objective measurements against established electrical safety standards, not subjective interpretation requiring adjudication among experts.

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. This device is not an AI-powered diagnostic or interpretive tool; it is a surgical instrument for tissue coagulation. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant and was not performed.

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

• No. This is a physical surgical instrument, not an algorithm, so a standalone algorithm performance study is not applicable.

7. The Type of Ground Truth Used

• For the non-clinical performance, the "ground truth" was compliance with the specified electrical safety standard IEC 60601-1 (1988) second edition with Amendment No. 1 (1991) and No. 2 (1995).
• The document explicitly states: "Clinical data and conclusions were not needed for this device."

8. The Sample Size for the Training Set

• Not applicable. This device is a physical instrument, not an AI/ML algorithm that requires a training set.

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

• Not applicable. No training set was used.

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