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The device is an air-powered dental handpiece for use by a trained professional in general dentistry.

The MK-dent® HS 2012/2014 shares virtually all specifications and design characteristics of the predicate devices. The only major design change refers to the strength of the auto chuck mechanism. By increasing the spring strength, we have created a more reliable version compared to KaVo 625. By increasing the bur retention strength from 6 lbs (as with the predicate device) to 8 lbs. (MK-dent® HS 2012/2014) we have been able to vastly reduce the odds of a bur prematurely ejecting from the handpiece. A few minor changes to the predicate device which do not affect the performance but we feel make the handpiece convenient to use are as follows: Reduction in the weight of the handpiece to 2 oz.. This reduces operator hand fatigue. Softening the knurling on the handle. This allows dirt, blood and salvia to be more easily removed from the body shell of the handpiece, thus allowing better conformity to sterilization procedures. It also provides better tactile sense to the operator while wearing gloves.

Here's an analysis of the provided text regarding the MK-dent® HS 2012/2014 dental handpiece, focusing on acceptance criteria and supporting studies:

This document is a 510(k) premarket notification for a Class I dental device, the MK-dent® HS 2012/2014. For Class I devices, the regulatory pathway often relies on demonstrating substantial equivalence to a legally marketed predicate device rather than extensive clinical efficacy studies typically required for Class II or III devices. Therefore, the "acceptance criteria" here primarily relate to matching or improving upon the predicate device's specifications and performance where relevant to safety, and proving adherence to general controls and applicable standards.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states "SAME" for most elements, indicating direct equivalence to the predicate device, KaVo 625 (K760929). The primary "acceptance criteria" are implied to be at least matching the predicate, with improvements considered a benefit.

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

The document does not detail a specific "test set" in the sense of a clinical trial or a formal performance evaluation with a defined sample size of devices or patients. The demonstration of equivalence relies primarily on:

• Design comparison: Stating that the device "shares virtually all specifications and design characteristics" with the predicate.
• Bench testing (for bur retention): The increase in bur retention strength from 6 lbs to 8 lbs implies a lab-based, bench test was performed. No sample size is given for this or the sterilization validation.
• Material comparison: Directly stating "SAME" for materials suggests a comparison of material specifications rather than a new "test set" of devices undergoing evaluation.

Data Provenance: Not explicitly stated for any tests mentioned. Given the manufacturer (MK-dent®) is German (implied by the address of Dr. Martina Günderoth in Lübeck, GERMANY), any internal testing would likely be performed in Germany. The FDA reviewed the submission in the United States.

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

Not applicable in the context of this 510(k) submission. This type of device (Class I dental handpiece) does not typically require expert-adjudicated test sets for performance or safety. The "ground truth" for design equivalence and material specifications would be based on engineering drawings, material safety data, and objective physical measurements.

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

Not applicable. There is no mention of a human expert test set requiring adjudication in this 510(k).

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 is a mechanical dental handpiece, not an AI-powered 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 mechanical device, not an algorithm.

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

The "ground truth" for this submission is primarily based on:

• Predicate device specifications: The established performance and material specifications of the legally marketed KaVo 625 Handpiece (K760929).
• Engineering specifications and material science: For details like material composition, dimensions, and bur retention force.
• Validation protocols: For confirming sterilization efficacy according to established standards.

8. The sample size for the training set

Not applicable. There is no concept of a "training set" for a mechanical device like this.

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

Not applicable.

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