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The Ti-Max X450 is an air-powered dental handpiece with intended use of being a surgical tool for impacted third molar removal and periodontal procedures for which a conventional handpiece would be used.

The. Ti-Max X450 is intended for use with a friction grip bur that conforms to ISO 1797-1 standard. Recommended supply air pressure is between 0.22 and 0.30 MPa, which results in high-speed bur rotation (approximately 380,000 to 450,000 RPM).

The Ti-Max X450 air-powered high-speed dental handpiece capable of reaching rotational speeds of 380,000 to 450,000 revolutions per minute. The device includes non-optic, fiber-optic, and LED models. All models have a 45 degree back angle. Models are available to connect directly to the couplings of specific brands.

The provided text describes a 510(k) summary for a dental handpiece, the Ti-Max X450, and mentions its conformance with technical standards and internal specifications through bench testing. However, it does not include specific acceptance criteria, detailed study data, or information about AI/algorithm performance.

Therefore, many of the requested sections about acceptance criteria, study details, expert involvement, and AI performance cannot be answered from the provided text.

Here's a breakdown of what can be extracted and what cannot:

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

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

• Not explicitly stated. The document mentions "bench testing" but does not provide details on sample size or data provenance. The submitter is Nakanishi, Inc. from Japan.

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)

• Not applicable / Not explicitly stated. This device is a dental handpiece, not an AI or diagnostic device that requires expert ground truth for its performance evaluation in this context. Performance is based on physical characteristics and standards.

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

• Not applicable / Not explicitly stated. Adjudication methods are typically relevant for diagnostic or AI studies involving human interpretation. This document describes physical device performance.

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

• No. This document is for a dental handpiece, not an AI or diagnostic device. There is no mention of MRMC studies or AI assistance.

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

• No. This document is for a dental handpiece, not an algorithm.

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

• Not applicable in the AI/diagnostic sense. The "ground truth" for this device's performance is established by technical standards and internal specifications (e.g., ISO 1797-1, ISO 9168) and directly measured physical properties (RPM, torque, dBA).

8. The sample size for the training set

• Not applicable. This is a physical medical device, not an AI model that requires a training set.

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

• Not applicable. As above, no training set for an AI model is involved.

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