(83 days)
The EMS AIR-FLOW handy PERIO is intended for patients suffering from periodontal disease.
The EMS AIR-FLOW handy PERIO is indicated for the non-surgical removal of subgingival plaque in pockets up to 5 mm after initial periodontal treatment.
The EMS AIR-FLOW handy PERIO is a modification of the AIR-FLOW handy 2 Dental Handpiece that was cleared for marketing as K022119. The proposed EMS AIR-FLOW handy PERIO handpiece is supplied with a flexible thermoplastic nozzle and a prophylaxis powder (cleared for use with the AIR-FLOW MASTER, subject of K.082791) that are specially designed to permit use of the device for the non-surgical removal of subgingival plaque.
The provided document is a 510(k) summary for the EMS AIR-FLOW handy PERIO, a dental handpiece. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with detailed acceptance criteria and results.
Therefore, many of the requested sections about specific study design details (sample size, expert qualifications, adjudication, MRMC, standalone performance, training set) cannot be answered from the provided text.
Here's an analysis of what can be extracted based on the document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or detailed reported performance metrics for the EMS AIR-FLOW handy PERIO. Instead, it relies on demonstrating "substantial equivalence" to predicate devices. The closest statement to performance is:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Fulfill prospectively defined performance specifications | "Testing conducted demonstrates that the EMS AIR-FLOW handy PERIO fulfills the prospectively defined performance specifications." (No specific metrics or thresholds are provided in this summary.) |
| Similar intended use, operational characteristics, and functional technological characteristics to predicate devices. | "The similarities in intended use, operational characteristics, and functional technological characteristics between the AIR-FLOW handy PERIO, the AIR-FLOW handy 2, and the PERIO-FLOW handpiece component of the AIR-FLOW MASTER lead to a conclusion of substantial equivalence between the proposed and predicate devices." |
| Indicated for non-surgical removal of subgingival plaque in pockets up to 5mm after initial periodontal treatment. | As stated in "Indications for Use" section. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a sample size for a test set or the data provenance. It generally refers to "Testing conducted" without providing details on the study design for such testing.
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. The document does not describe a study involving expert-established ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The document does not describe a study involving adjudication of a test set.
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 system. No MRMC study was conducted or reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a dental handpiece, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The document does not detail a study involving the establishment of ground truth for performance evaluation in the context of diagnostic accuracy. The "testing" mentioned likely refers to physical and functional performance testing of the device itself (e.g., air flow, powder delivery, structural integrity) rather than clinical accuracy for a diagnostic task.
8. The sample size for the training set
Not applicable. The device is a dental handpiece; there is no mention of a training set as would be relevant for an AI/ML algorithm.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
§ 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.