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The Concentrix MX-AC High-Speed Handpiece is used by trained dental professionals for a variety of procedures including but not limited to caries and amalgam removal, restorative work and crown preparations.

The Concentrix MX-AC High-Speed Handpiece is a pneumatically driven, non-fiber optic, 2/3 line fixed backend handpiece that is capable of reaching rotational speeds of 302,000 rpms at a recommended air pressure of 32 PSI. The handpiece is constructed of stainless steel, including the internal air and water tubes which provide drive air to the turbine assembly and cooling water to the work site. The stainless steel and aluminum air driven turbine assembly provides spin to the bur and incorporates steel lubricated bearings and a push button autochuck. The burs used with the Concentrix MX-AC High Speed Handpiece are ISO 1797-1, type 2 burs. Only burs with hardened, tempered steel shanks or carbide shanks should be used.

This document is a 510(k) premarket notification for a dental handpiece, not an AI/ML device. Therefore, the requested information about acceptance criteria, study details, ground truth, and training sets for an AI/ML device is not applicable.

The document discusses the substantial equivalence of the Concentrix MX-AC High-Speed Handpiece to predicate devices. The "performance data" section outlines tests conducted to demonstrate functional performance and safety, but these are for the mechanical device itself, not an AI algorithm.

Here's a breakdown of the relevant information provided, while noting the requested AI-specific details are not present:

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

The document doesn't present a table with specific acceptance criteria and reported device performance in the way one might expect for a quantitative AI/ML study (e.g., sensitivity, specificity thresholds). Instead, it states that the device's functional performance and safety were evaluated against established international standards.

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

This information is not applicable. The performance data refers to physical testing of the device, not a data-driven test set for an algorithm.

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 as there is no ground truth or expert review for an AI/ML device mentioned.

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

Not applicable.

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 as this is not an AI/ML device.

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

Not applicable as this is not an AI/ML device.

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

Not applicable. The "ground truth" for this device's performance would be the physical measurements and observations of its mechanical and biological characteristics as defined by the referenced ISO/AAMI standards.

8. The sample size for the training set:

Not applicable as this is not an AI/ML device.

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

Not applicable as this is not an AI/ML device.

In summary, the provided document is a 510(k) summary for a physical medical device (dental handpiece), not an AI/ML product. Therefore, the specific questions related to AI/ML device studies, ground truth, and data sets are not relevant to this document. The device meets its acceptance criteria by conforming to established international standards for physical, mechanical, and biocompatibility performance.

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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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