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The Misonix Inc. FS-1000-RF Bipolar Forceps Accessory is indicated for use in bipolar procedures to grasp, manipulate, coagulate and/or transect tissues in the following specialities:

Neurosurgery Plastic and Reconstructive Surgery General Surgery

Metal and plastic construction that approximates a tweezer assembly. Includes provision for connection to the output of a standard bipolar electrosurgical generator. Also includes provision for mechanical attachment to an ultrasonic surgical aspirator. There is no energy interaction between the ultrasound unit and the electrosurgery unit.

The Misonix Inc. FS-1000-RF Bipolar Forceps Accessory 510(k) summary provides information on the device's adherence to voluntary standards and non-clinical tests. This document does not describe an acceptance criteria table, a study explicitly proving the device meets said acceptance criteria, or details regarding sample sizes, ground truth establishment, or human-in-the-loop studies as typically expected for imaging algorithm performance.

However, based on the provided text, we can infer the acceptance criteria are met by the successful completion of various safety and performance tests to established voluntary standards.

Here's a breakdown of the information requested, as far as it can be extracted and inferred from the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes voluntary standards and non-clinical tests rather than a specific acceptance criteria table with numerical targets. The "performance" is reported as having successfully passed these tests.

The general conclusion, based on these tests and a review of published literature, is that the device is "safe and efficacious" and "substantially equivalent" to predicate devices.

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

• Sample Size for Test Set: Not specified. The document mentions "testing was done while attached to standard electrosurgical generator" and "testing of bipolar effect on animal tissue (bench top)". It does not provide numerical sample sizes for these tests.
• Data Provenance: The tests are described as "internal testing" and "in vitro tests performed". "Animal tissue (bench top)" is mentioned for the in vitro tests. The country of origin is not specified but is presumably the US, given the submission to the FDA. The tests are prospective as they were conducted specifically for this submission.

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

• Number of Experts: Not specified.
• Qualifications of Experts: The document mentions a "Surgeon assisted trial on animal tissue (bench top) for clinician feedback." This implies input from at least one surgeon, but specific qualifications (e.g., years of experience, specialty beyond "surgeon") are not detailed.

4. Adjudication Method for the Test Set

Not applicable/specified. The document does not describe a clinical study with a test set requiring adjudication. The tests mentioned are primarily engineering and bench-top evaluations.

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

No. The document does not describe an MRMC comparative effectiveness study where human readers' performance with and without AI assistance is evaluated. This is a medical device (forceps accessory), not an AI/software diagnostic tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This device is a physical electrosurgical accessory, not a software algorithm, so the concept of "standalone algorithm performance" does not apply. The device's performance is inherently "with human-in-the-loop" as it is operated by a surgeon.

7. The Type of Ground Truth Used

For the non-clinical and in vitro tests, the "ground truth" would be the expected performance according to the voluntary standards (e.g., specific thresholds for leakage current, dielectric strength) and the observable effects on animal tissue in bench-top settings (e.g., successful coagulation, lack of tissue adhesion). It is based on engineering measurements and physical observation/outcomes in a controlled environment as opposed to expert consensus, pathology, or clinical outcomes data from human subjects.

8. The Sample Size for the Training Set

Not applicable. As this is not a machine learning or AI-driven device, there is no "training set."

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

Not applicable, as there is no training set.

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