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The MicroPower® Handpiece System functions as a powered instrument system consisting of drills, saws and associated handpieces to perform cutting of soft tissue and bone. The fields of application include: orthopedic, arthroscopic, neurosurgical, otolaryngological, plastic/reconstructive, and oral/maxillofacial procedures.

The MicroPower® OralMax Handpiece System functions as a powered instrument system consisting of drills, saws and associated handpieces to perform cutting of soft tissue and bone. The field of application includes only oral/maxillofacial.

The MicroChoice® Handpiece System functions as a powered instrument system consisting of drills, saws and associated handpieces to perform cutting of soft tissue and bone. The fields of application include: orthopedic, arthroscopic, otolaryngological, oral/maxillofacial, hand, foot, neuro, and plastic/reconstructive surgical procedures.

The MicroPower®, MicroPower® OralMax, and MicroChoice® Handpiece Systems are electric pencil grip handhelds that are used in conjunction with the Advantage®, E9000® and PowerPro® controllers. A cord connects the handpiece to the controller that supplies power to the device. The handpieces have a lever or footswitch that is used to actuate the device. The drills use a wide variety of attachments, including bur guards, drill bits and burs. The saws use a wide variety of blades.

This document is a 510(k) summary for the MicroPower®, MicroPower® OralMax, and MicroChoice® Handpiece Systems, seeking clearance for these surgical drill systems. A 510(k) summary focuses on demonstrating substantial equivalence to pre-existing devices, rather than establishing acceptance criteria and conducting studies to prove performance against those criteria in the way one might for a novel, higher-risk device.

Therefore, the provided text does not contain the detailed information required to answer all your questions about acceptance criteria and a study proving the device meets them. This type of submission relies on showing that the new device is essentially the same as already cleared predicate devices, and thus "meets the acceptance criteria" by being substantially equivalent, rather than proving performance against new, specific thresholds.

Here's a breakdown based on the information available in the document and what's missing:

The device doesn't have explicit performance acceptance criteria stated but infers "equivalence" to previously cleared devices as the main criteria based on the 510K submission.

1. A table of acceptance criteria and the reported device performance:

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

• Sample Size: Not specified. The document states "Testing conducted prior to product release," but does not detail the nature, sample size, or results of this testing.
• Data Provenance: Not specified. It's implied to be internal testing by ConMed Linvatec, but country of origin or retrospective/prospective nature is not mentioned.

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

• Number of experts: Not applicable. Ground truth, in the context of clinical studies, is not established for this type of 510(k) submission. The evaluation is based on engineering and design comparisons to predicate devices.
• Qualifications of experts: Not applicable.

4. Adjudication method for the test set:

• Not applicable. There's no mention of a test set requiring adjudication in the clinical or independent expert sense.

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:

• Not applicable. This device is a surgical drill system, not an AI or imaging diagnostic device. MRMC studies are not relevant here.

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

• Not applicable. This is a physical surgical device, not an algorithm.

7. The type of ground truth used:

• Ground Truth: In this context, "ground truth" for a 510(k) submission like this would be the established safety and effectiveness of the identified predicate devices, as recognized by the FDA. The new devices are deemed safe and effective because they are substantially equivalent to devices already cleared for market. There is no external "ground truth" in the sense of pathology or outcome data for this specific submission to prove device performance beyond substantial equivalence.

8. The sample size for the training set:

• Not applicable. There is no concept of a "training set" for a physical surgical device like this in the context of an AI/ML algorithm.

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

• Not applicable. There is no training set mentioned.

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