(120 days)
The Axenic Dental, Inc. DHP™ "Disposable High-Performance" sterile, pyrogen free, maintenance free handpiece, with appropriate burs, is indicated for all dental practice procedures for which metal handpieces are used, including cutting, shaping and preparing teeth for cavity repair, crowns and bridges. The device is suitable for use in circumstances where infectious, inter-patient contamination is a concern. The device can be used for duration of 12 to 14 minutes cutting time during single patient use.
The Axenic Dental, Inc. DHP™ "Disposable High-Performance Handpiece" is a sterile, single patient use, disposable instrument that is substantially equivalent to standard, re-usable, metal or plastic handpieces. All Axenic DHP™, high-speed, dental hand pieces are designed to operate at maximum specification outputs for 12 to 14 minutes of use. The single patient use nature of the instrument precludes any necessity for maintenance, cleaning, or sterilization.
The provided text is a 510(k) summary for the Axenic Dental, Inc. DHP™ "Disposable High-Performance" Handpiece. It describes the device, its intended use, and comparison to a predicate device. However, it does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert reviews.
The 510(k) summary focuses on demonstrating substantial equivalence to a legally marketed predicate device (OralSafe™ Disposable Handpieces, K923469) rather than presenting a performance study with detailed acceptance criteria and results. The key claims made are about the device being sterile, pyrogen-free, and maintenance-free, and operating for 12-14 minutes. These are stated as features rather than the outcome of a performance study with numerical results.
Therefore, I cannot provide the requested table and detailed study information based on the given document.
Here's what I can extract based on the structure of your request and the information not present in the document:
Acceptance Criteria and Device Performance Study (Information Not Provided in Document)
The provided 510(k) summary does not contain a specific performance study with acceptance criteria and reported device performance in the typical format you've requested for AI/diagnostic devices. The submission focuses on demonstrating substantial equivalence to a predicate device ("OralSafe™ Disposable Handpieces, K923469") by highlighting similar materials and additional features like sterility, pyrogen-free status, and being maintenance-free.
No specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy, F1 score, AUC) are presented, nor are there acceptance criteria for such metrics. The document asserts that the enhancements (sterility, pyrogen-free, maintenance-free) will not negatively affect safety or effectiveness, which is a qualitative statement, not a quantitative performance result against acceptance criteria.
Therefore, the following sections will indicate that the information is "Not provided in the document."
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Table of Acceptance Criteria and Reported Device Performance
- Not provided in the document. The 510(k) summary does not present a table of acceptance criteria or specific quantitative performance metrics for the device. It focuses on functional equivalence and additional features.
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Sample size used for the test set and the data provenance
- Not provided in the document. No specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective) are mentioned.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not provided in the document. As no specific performance study with a test set is detailed, information about experts for ground truth establishment is absent.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not provided in the document. No adjudication method is mentioned as there is no described test set or performance evaluation.
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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/Not provided in the document. This device is a dental handpiece, a physical instrument, not an AI or diagnostic software. Therefore, an MRMC study related to human reader improvement with AI assistance would not be relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not provided in the document. This device is a physical dental handpiece, not an algorithm. Standalone algorithm performance is not relevant.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not provided in the document. As no specific performance study is detailed, the type of ground truth used is not mentioned.
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The sample size for the training set
- Not applicable/Not provided in the document. As this is a physical device and not an AI/ML algorithm, the concept of a "training set" in the context of data for model development is not relevant.
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How the ground truth for the training set was established
- Not applicable/Not provided in the document. As noted above, the concept of a training set and its ground truth is not relevant for this type of device based on the provided document.
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.