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

The Vector F series handpiece shares virtually all specifications and design characteristics of the predicate devices. The only major design or engineering change is the strength of the autochuck mechanism. By increasing the spring strength we have created and even safer version of the KaVo 625CD. By increasing the bur retention strength form 6 lbs (as with the predicate device) to 8 lbs (Vector F series) we have been able to vastly reduce the odds of a bur prematurely ejecting for the handpiece. A few minor changes to the predicate device which do not affect the performance but we feel make the handpiece even safer are as follows: Reduction in the weight of the handpiece to 2 oz.. This reduces operator hand fatigue. Softened the knurling on the handle. This allows dirt, blood and saliva 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.

The provided text describes a 510(k) summary for the "Vector F Series" High-speed Dental Handpieces, aiming to demonstrate substantial equivalence to existing predicate devices. The information provided focuses on the physical and functional characteristics of the device compared to its predicates, rather than a clinical study evaluating diagnostic or treatment performance with specific acceptance criteria.

Therefore, many of the requested details about acceptance criteria, study design, expert involvement, and ground truth establishment are not applicable or cannot be extracted from this document as it pertains to a medical device clearance process for a dental handpiece, not an AI-powered diagnostic tool.

However, I can extract the information relevant to the device's characteristics and its comparison to the predicate devices, which serve as the basis for its "acceptance" from a regulatory standpoint (substantial equivalence).

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (dental handpiece), "acceptance criteria" are typically defined by demonstrating substantial equivalence to predicate devices in terms of intended use, materials, energy source, and sterilization methods. The performance is assessed against these established characteristics of the predicate, not against clinical outcome metrics you'd expect from a diagnostic AI.

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

This information is not applicable to this document. The submission is for a physical medical device (dental handpiece) and does not involve a "test set" of data in the context of an AI or diagnostic study. The "test" here refers to validation protocols for manufacturing and sterilization, not a clinical trial or performance study on a patient dataset.

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

This information is not applicable. There is no "ground truth" establishment by experts in the context of a dataset for a dental handpiece's mechanical performance.

4. Adjudication method for the test set

This information is not applicable. There is no test set or adjudication method described for a diagnostic or AI study.

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 information is not applicable. This is not an AI-assisted device, and no MRMC study was conducted or described.

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

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

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

This information is not applicable. The "ground truth" for a dental handpiece relates to its engineering specifications, material properties, and functionality (e.g., sterilization effectiveness, bur retention strength), which are verified through engineering tests and validation protocols, not clinical ground truth.

8. The sample size for the training set

This information is not applicable. There is no "training set" in the context of a machine learning model for a physical dental handpiece.

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

This information is not applicable. As there is no training set, there is no ground truth for one to be established.

Summary based on the provided document:

The "acceptance criteria" for the Vector F Series dental handpiece, as described in this 510(k) summary, are met by demonstrating its "substantial equivalence" to legally marketed predicate devices (Star Dental 430 Series and KaVO 625/634 Handpieces). This means the device's intended use, materials, energy source, and sterilization methods are either identical or functionally equivalent to the predicates. The primary "study" proving this substantial equivalence is the comparison of specifications and design characteristics presented in the 510(k) submission, along with a validation protocol for repeated sterilization to confirm its effectiveness. The document highlights specific improvements in bur retention strength (8 lbs vs. 6 lbs of predicate) and reduced weight, which are presented as enhancements without compromising safety or effectiveness.

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