(200 days)
The AIR-FLOW handy 3.0 PERIO is intended for patients suffering from periodontal disease.
The AIR-FLOW handy 3.0 PERIO is indicated for the non-surgical removal of subgingival plaque in pockets up to 5 mm after initial periodontal treatment.
The proposed AIR-FLOW handy 3.0 PERIO is a modification of the AIR-FLOW handy PERIO Dental Handpiece previously cleared under K092289. This device modification has been submitted as a Special 510(k) Premarket Notification because the indications for use for the proposed AIR-FLOW handy 3.0 PERIO are identical to the parent AIR-FLOW handy PERIO. The fundamental technology and design of the proposed AIR-FLOW handy 3.0 PERIO are essentially identical to the AIR-FLOW handy PERIO dental handpiece.
Both the proposed AIR-FLOW handy 3.0 PERIO and the predicate AIR-FLOW handy PERIO connect to a standard turbine connection on a dental operative unit and deliver a mixture of water, air, and dental powder to a treatment site.
Modifications made to the AIR-FLOW handy PERIO Dental Handpiece to produce the AIR-FLOW handy 3.0 PERIO were limited to minor design changes to enhance the ergonomics of the design, including:
- Location of the powder chamber is modified to improve the visibility of the mouth of the patient by the practitioner during the treatment
- Slimmer shape of the powder chamber to be in-line with the body of the device to improve the visibility of the mouth of the patient by the practitioner during the treatment.
- Diameter of the powder chamber cap is reduced to be in-line with new design of the powder chamber.
- The powder chamber capacity has been slightly decreased to 21g from 23g to fit new ergonomic design.
- The body of the AIR-FLOW handy 3.0 PERIO is made of 2 glued molded parts instead of 1 molded part
- The handpiece is shorter and slimmer to improve ergonomics.
Accessories were included to aid in filling the powder chamber and removing residual powder from the handpiece channels.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the AIR-FLOW handy 3.0 PERIO device:
The provided document (K132480) is a 510(k) Premarket Notification for a dental handpiece, the AIR-FLOW handy 3.0 PERIO. This is a Special 510(k), indicating a modification to a previously cleared device (AIR-FLOW handy PERIO, K092289). The focus of this submission is on demonstrating substantial equivalence to the predicate device, primarily through non-clinical performance testing.
Acceptance Criteria and Reported Device Performance
The document states that the modifications were "limited to minor design changes to enhance the ergonomics of the design," and that "The fundamental technology and design...are essentially identical to the AIR-FLOW handy PERIO dental handpiece." This implies that the key acceptance criteria revolve around maintaining the functional performance of the predicate device while incorporating ergonomic improvements.
Since this is a Special 510(k) for minor design changes, the acceptance criteria are not explicitly numerical targets for performance metrics like accuracy or sensitivity, as would be common for diagnostic AI devices. Instead, they are more about demonstrating that the changes do not adversely affect the device's original intended function and safety, and that the ergonomic improvements are indeed effective.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Equivalence | |
| Maintains original intended use for non-surgical removal of subgingival plaque in pockets up to 5mm. | The "indications for use...are identical to the parent AIR-FLOW handy PERIO." The device "deliver[s] a mixture of water, air, and dental powder to a treatment site," similar to the predicate. |
| Delivers mixture of water, air, and dental powder effectively. | Functionally equivalent to the predicate device in its core mechanism. |
| Safety and Material Compatibility | |
| Materials are safe and remain compatible with intended use. | "similar in design and materials to the AIR-FLOW handy PERIO Dental Handpiece." |
| Structural integrity of modified parts (e.g., glued body parts). | Not explicitly detailed, but implied by "functional verification of the hardware modifications." |
| Ergonomic Improvement Validation | |
| Improved visibility of the patient's mouth due to powder chamber modification. | "Location of the powder chamber is modified to improve the visibility..." "Slimmer shape of the powder chamber to be in-line with the body...to improve the visibility..." |
| Improved handling due to shorter and slimmer design. | "The handpiece is shorter and slimmer to improve ergonomics." |
| Ease of use for filling powder chamber and removing residual powder. | "Accessories were included to aid in filling the powder chamber and removing residual powder from the handpiece channels." |
Study Details
The primary "study" described is a non-clinical performance testing effort.
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Sample size used for the test set and the data provenance:
- The document does not specify a numerical sample size for the devices tested. It refers to "functional verification of the hardware modifications at the component and finished device level." This likely involved testing a certain number of manufactured units, but the exact count is not provided.
- Data Provenance: The testing was "Non-clinical," meaning it was conducted in a laboratory or simulated environment, likely at the manufacturer's facility (E.M.S. ELECTRO MEDICAL SYSTEMS S.A. in Switzerland). It is retrospective in the sense that the testing was performed after the design changes were made to verify them.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document explicitly mentions "user evaluations to validate the design improvements." However, it does not specify the number of users/experts involved in this evaluation, nor their qualifications (e.g., dentists, dental hygienists, or engineering evaluators). The "ground truth" here would be subjective user feedback on ergonomics and ease of use.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- No formal adjudication method is mentioned. The "user evaluations" would likely involve collecting feedback, but there's no indication of a structured multi-expert consensus process.
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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:
- No MRMC study was done. This device is a dental handpiece, not an AI-powered diagnostic tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No standalone algorithm performance study was done. This device does not incorporate AI or algorithms in its function.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the functional verification, the "ground truth" was engineering specifications and performance targets (i.e., verifying that the device still sprayed correctly, held powder, etc.).
- For the user evaluations, the "ground truth" was subjective user feedback regarding ergonomic improvements (visibility, handling, ease of use).
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The sample size for the training set:
- Not applicable. This device does not involve machine learning or AI, so there is no "training set."
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How the ground truth for the training set was established:
- Not applicable. As above, no training set exists for this type of 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.