(683 days)
Intra-orally to surface clean and remove stain from teeth and dental restorations.
For Use by Dentists and Hygienists only.
Disposable Dental Air Polishing Handpiece
This document is an FDA 510(k) clearance letter for a disposable dental air polishing handpiece (Trade Name: Disposable Dental Air Polishing Handpiece, later identified as DispoProphy™). This clearance letter does not contain the detailed study information needed to fully answer your request regarding acceptance criteria and a study proving those criteria are met.
The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent... to devices marketed in interstate commerce prior to May 28, 1976, or to devices which have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act)."
This means that the device was cleared based on substantial equivalence to a predicate device (MiniPolisher™ by Henry Schein), not necessarily on a new clinical study demonstrating specific performance against predefined acceptance criteria for this particular device. In 510(k) submissions, manufacturers often rely on existing data and performance of the predicate device to argue for substantial equivalence, or conduct bench testing to ensure their device matches the performance of the predicate.
Therefore, most of the information you requested cannot be extracted from this document. It does not describe a new study with acceptance criteria and results for the cleared device.
However, I can provide the limited information that is available from the document:
1. A table of acceptance criteria and the reported device performance
This document does not specify quantitative acceptance criteria or a direct performance table for the DispoProphy™ device itself. The clearance is based on substantial equivalence to the predicate device, the MiniPolisher™ by Henry Schein. Therefore, the "acceptance criteria" implicitly are that the device performs at least as well as and is as safe and effective as the predicate device for its intended use.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not provided in this document. Substantial equivalence typically relies on bench testing, comparison to the predicate, and existing clinical understanding of similar devices, rather than a new clinical trial with a defined test set.
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 provided in this document. Ground truth establishment with experts is usually part of clinical trials, which are not detailed here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not provided in this document.
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 air polishing handpiece, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not explicitly stated for a new study. For substantial equivalence, the "ground truth" is often the established safety and efficacy profile of the predicate device.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable.
What the document does tell us:
- Trade Name: Disposable Dental Air Polishing Handpiece (later identified as DispoProphy™)
- Regulatory Class: II (Initially listed as III, then corrected to II, which is typical for 510(k) devices, as Class III devices usually require PMA) - Correction: The document states "Regulatory Class: III" but then immediately indicates it's a 510(k) clearance, which is for Class I or II devices. This is a common typo where the Classification is later clarified as Class II or I upon review or reclassification. The 510(k) number and statement of substantial equivalence confirm it's not a Class III device requiring PMA.
- Product Code: KOJ
- Predicate Device: MiniPolisher™ by Henry Schein
- Indications For Use: "Intra-orally to surface clean and remove stain from teeth and dental restorations." "For Use by Dentists and Hygienists only."
To get the detailed study information you're looking for, you would typically need to review the original 510(k) submission (K993182) publicly available on the FDA website. However, even then, for a substantial equivalence claim, the studies may involve bench testing to confirm material properties and mechanical performance equivalent to the predicate, rather than extensive new clinical trials with a test set of human patients.
§ 872.6080 Airbrush.
(a)
Identification. An airbrush is an AC-powered device intended for use in conjunction with articulation paper. The device uses air-driven particles to roughen the surfaces of dental restorations. Uneven areas of the restorations are then identified by use of articulation paper.(b)
Classification. Class II. The special control for this device is International Electrotechnical Commission's IEC 60601-1-AM2 (1995-03), Amendment 2, “Medical Electrical Equipment—Part 1: General Requirements for Safety.”