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The FMS Blades and Burrs are an accessory to the FMS Fluid Management Systems. FMS Blades and Burrs are intended to provide controlled cutting, burring, shaving and abrading of bone and tissue for use in arthroscopic surgery.

OMNICUT Blades are used with FMS™ Handpieces and Fluid Management Systems during arthroscopic surgery. OMNICUT Blades consist of stainless steel outer tube and a rotating inner tube connected to an inner and outer plastic hubs. Distal tips of the tubes contain sharp edges to facilitate the cutting.

The provided document is a 510(k) summary for the OMNICUT™ Resection Blade, which is a medical device for arthroscopic surgery. This type of submission focuses on demonstrating substantial equivalence to predicate devices, rather than a clinical study evaluating diagnostic performance (which would be expected for an AI/ML diagnostic device). Therefore, many of the requested categories related to AI/ML device studies (like "multi-reader multi-case study," "standalone performance," "training set size," and "ground truth establishment" via experts) are not applicable to this submission.

Here's an analysis based on the available information:

Acceptance Criteria and Device Performance for OMNICUT™ Resection Blade

This 510(k) summary proposes the OMNICUT™ Resection Blade to be substantially equivalent to predicate devices for use in arthroscopic surgery. The "acceptance criteria" here are based on comparative performance to predicate devices in pre-clinical tests, rather than diagnostic accuracy metrics.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific "sample size" for each test (e.g., number of blades tested, number of tissue samples). It refers to "Design verification activities" which implies a set of tests were performed. The data provenance is pre-clinical bench testing, likely conducted internally by the manufacturer (DePuy Mitek) or a contracted lab. The country of origin of the data is not specified but is implicitly associated with the submitter's location (Raynham, MA, USA). The studies are explicitly described as "Nonclinical Testing" and "preclinical studies."

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

Not applicable. This device is an arthroscopic blade, and the testing involves objective physical performance criteria (cutting efficiency, particulate generation), not a diagnostic assessment requiring expert interpretation or "ground truth" in the diagnostic sense.

4. Adjudication Method for the Test Set

Not applicable. The tests performed are objective pre-clinical measurements, not subjective evaluations requiring adjudication.

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

No. This document describes a 510(k) for a physical surgical tool, not an AI/ML diagnostic algorithm, so an MRMC comparative effectiveness study is not relevant or included.

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

Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

For the OMNICUT™ blade, the "ground truth" for the nonclinical testing is established by objective measurements against specified performance metrics (e.g., efficacy of cutting soft tissue/bone, amount of particulate generated). The predicate device performance serves as the benchmark against which the OMNICUT™ blade's performance is compared for demonstrating equivalence. This is not "expert consensus," "pathology," or "outcomes data" in the typical sense for a diagnostic device.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set or ground truth for such a set.

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