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The AHP-101 fully autoclavable, straight, 1:1 ratio E-Type dental handpiece is intended for use in general dentistry procedures, such as removing carious material from the dentine.

The AHP-101 is a straight, fully autoclavable, 1:1 ratio E-Type dental handpiece intended for use in general dentistry procedures. It accepts standard 2.35mm (3/32") burs and may be used with prophy angles.

This document is a 510(k) summary for a dental handpiece (AHP-101 E-Type Straight Handpiece). As such, it reports on a determination of substantial equivalence to a predicate device, rather than a study designed to prove the device meets specific performance acceptance criteria.

Therefore, the information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not applicable in the context of this 510(k) submission.

Here's why and what information is provided:

• 510(k) process: A 510(k) submission demonstrates that a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves showing similar technological characteristics and indications for use, often without requiring new clinical studies or the establishment of new, specific performance acceptance criteria in the same way a PMA (Pre-Market Approval) would.
• Reliance on predicate device: The AHP-101 is deemed substantially equivalent to Aseptico's AHP-64 Handpiece [510(k) K020137]. The predicate device would have been evaluated for its safety and effectiveness, and the general understanding is that if the new device is substantially equivalent, it too is safe and effective for its intended use.

However, the document does list features of substantial equivalence which can be reinterpreted as a form of "acceptance criteria" based on similarity to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the other requested information:

• 2. Sample size used for the test set and the data provenance: Not applicable. This is not a study that involved a test set in the traditional sense of evaluating performance. The "test" involved demonstrating equivalence to a predicate device. The validation of the sterility assurance level (SAL) of 10⁻⁶ would have involved a specific, industry-standard sterilization validation study, but the details (sample size, provenance) are not provided in this summary.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The 510(k) process relies on demonstrating equivalence, not on establishing a new ground truth through expert consensus for a test set.
• 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. This device is a dental handpiece, not an AI-powered diagnostic tool.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a mechanical tool.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the purpose of the 510(k), the "ground truth" is the established safety and effectiveness of the predicate device (Aseptico's AHP-64 Handpiece). The AHP-101 essentially relies on the predicate's established performance based on its original clearance and compliance with recognized standards.
• 8. The sample size for the training set: Not applicable. There is no machine learning or AI training set involved.
• 9. How the ground truth for the training set was established: Not applicable.

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