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HiCut™ Highspeed Instruments are surgical burs indicated for trephination, incision, cutting, removal, shaping, sawing of soft and hard tissue, bone, and biomaterials in Orthopedic Surgery, Neurological and Spinal Surgery, Plastic and Maxillofacial Surgery, Arthroscopy, Sternotomy and General Surgery.

The HiCut™ Highspeed Instrument is a sterile packed, single-use cutting device with numerous tip designs and various lengths. The rear end is designed to fit in various commonly marketed surgical motor drill systems. The tip designs are similar to the commonly used tip designs.

The HiCut™ Highspeed Instrument is classified Class II (USA) (Class IIa in EU) per CFR, Part 882.4310. The HiCut™ Highspeed Instruments are simple powered burs to be inserted in pneumatic or electric powered motor drill devices.

The provided document is a 510(k) summary for a surgical bur, the HiCut™ Highspeed Instrument. This type of submission focuses on demonstrating substantial equivalence to predicate devices rather than proving novel effectiveness through clinical studies with specific performance criteria. Therefore, the information typically requested in your prompt regarding acceptance criteria, study design, and AI performance metrics is not applicable to this document.

Here's an analysis based on the available information:

1. Table of acceptance criteria and the reported device performance:

This device is a surgical bur, a mechanical device. The "acceptance criteria" and "reported device performance" in this context refer to the successful completion of non-clinical performance testing confirming that the device is safe and performs as intended, demonstrating substantial equivalence to legally marketed predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: The document mentions "Samples for each system of both the subject and predicate devices were compared" for parameter comparison. It does not specify an exact number of samples. For biocompatibility, sterility, and packaging tests, standard industrial testing protocols would have been followed, likely using a sufficient number of samples as required by the relevant ISO and ASTM standards.
• Data Provenance: The studies are non-clinical (laboratory/bench testing) and were conducted by the manufacturer, adeor Medical AG, a German company ("Kirchplatz 1, 82049 Pullach, Germany"). The document indicates the device is marketed in the European Union, suggesting testing would adhere to international standards commonly accepted in both the EU and USA. This is prospective testing related to device manufacturing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable. The product is a surgical bur, a mechanical instrument. "Ground truth" in this context is established through objective performance metrics derived from laboratory testing, adherence to international standards (ISO, ASTM), and comparison to the physical and material characteristics of predicate devices, rather than through subjective expert consensus on diagnostic images or clinical outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable as there is no subjective assessment requiring adjudication. The tests (biocompatibility, sterility, mechanical parameter comparison) are objective, laboratory-based analyses against defined standards.

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

This is not applicable. This device is a mechanical surgical instrument, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI performance metrics are irrelevant.

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

This is not applicable. This device is a mechanical surgical instrument, not an algorithm.

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

The "ground truth" for demonstrating substantial equivalence for this type of device is:

• Objective Test Results: Data from standardized laboratory tests (e.g., biocompatibility according to ISO 10993, sterility according to ISO 11137, packaging integrity according to ISO 11607 and ASTM F 1980).
• Engineering and Material Specifications: Directly comparing the materials, design specifications, and mechanical performance characteristics of the subject device to those of the predicate devices.
• Adherence to Standards: Compliance with recognized international standards indicates that the device meets established safety and performance benchmarks.

8. The sample size for the training set

This is not applicable. There is no "training set" as this is a physical medical device, not a machine learning model.

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

This is not applicable. There is no "training set."

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