(301 days)
The AIR-N-GO by SATELEC in supra-gingival configuration is intended for use in the polishing and cleaning of teeth by the projection of a mixture of dental powder, air, water on teeth surfaces. The device can remove soft deposits and areas of discolorali, watch can be used to prepare teeth for conventional dental procedures such as the placement of composite fillings, porcelain inlays, and laminate veneers... The device can be used to clean implant abutments and to clean teeth prior to treatments such as bhade matching, fluoridation, and bleaching. The device can be used to degrease crowns and bridges prior to placement and clean fixed bands and brackets on orthod ontic appliances.
The AIR-N-GO by SATELEC in sub-gingival configuration (with PERIO kit) is intended for patients suffering from periodontitis and peri-implantitis and it is indicated for the nonsurgical removal of sub-gingival plaque in pockets up to 5 mm after an initial period ontal treatment.
The AIR-N-GO is a dental handpiece intended for the projection of a mixture of air, water and dental powder on the surface of teeth. It is supplied on air and water provided by a dental operative unit. The equipment is connected to a standard turbine connection available on the dental operative units.
The AIR-N-GO can be used with two different nozzles. A SUPRA nozzle is dedicated for the Supra-gingival dental applications whereas a PERIO nozzle is dedicated for the subgingival dental applications. The used nozzle is fixed on the front of the device by screwing. The AIR-N-GO can be used with two different heads. The head is available in two lengths according to ergonomics considerations. A front plastic body is the part of the medical device held in the hand of the user during the clinical act. Metallic tubing is used for the conduction of the mixture of air / dental powder and of the water.
A rear body is intended to receive the turbine connector. The rear body can rotate around the metallic tubing. This principle allows the orientation of the nozzle by rotation. The AIR-N-GO can be used with two different tanks. The mixture of the dental powder and the air is realized inside the tank. Tanks are equipped with a bayonet system for a quick change. A blue tank is dedicated for the supra-gingival dental applications. A green tank is dedicated for the sub-gingiyal dental applications. A tank lid is equipped with a powder stop system which permits to use the device as an air / water syringe. The AIR-N-GO is equipped with a turbine connector according to the model of dental operative unit used by the practitioner.
The provided K110379 510(k) summary describes the SATELEC AIR-N-GO device, a dental handpiece for supra- and sub-gingival applications. The submission's focus is on demonstrating substantial equivalence to predicate devices rather than establishing novel acceptance criteria through a clinical study. Therefore, the information requested regarding acceptance criteria, study design, and performance metrics in the context of an FDA-regulated AI/ML device is largely not present in this document.
Here's an attempt to extract the relevant information where possible, and highlight what is not applicable or not provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not define specific, quantifiable acceptance criteria in the typical sense of an AI/ML device (e.g., sensitivity, specificity, F1 score thresholds). Instead, it demonstrates substantial equivalence by comparing the technical specifications and performance of the AIR-N-GO to three predicate devices. The "acceptance criteria" are implied to be the performance and safety profiles of the predicate devices.
| Feature / Performance Metric | Acceptance Criteria (Implied by Predicate Devices) | Reported Device Performance (AIR-N-GO) | Proof of Meeting Criteria (Comparison) |
|---|---|---|---|
| Supra-gingival Application Efficiency | Complete varnish removal, intact tooth surface, similar time efficiency to predicate devices. | Varnish completely eliminated, tooth surface remained intact. Time efficiency similar to predicate devices, except for a minor difference with tabletop unit's supra handpiece due to higher pressure. | Met: Direct comparative testing against predicate devices on dental study models showed similar effectiveness. |
| Sub-gingival Application Efficiency | Effective varnish removal on root surface and implant replica (up to 5mm depth), integrity of surface maintained. | Varnish removed effectively on root tooth and implant. Surface integrity maintained. | Met: Direct comparative testing against predicate devices on dental study models showed similar effectiveness. |
| Safety | No observed dangers or adverse effects compared to predicate devices. | No other danger was observed. Characteristics used with recommended dental powders do not affect safety. | Met: Evaluation tests stated no other dangers were observed and characteristics do not affect safety. |
| Technical Specifications (e.g., Weight, Operation Mode, Input Pressure, Operating/Storage Conditions) | Similar to predicate devices (as detailed in Table 2 of the original document). | Within comparable ranges or with minor, non-impactful differences. | Met: Table 2 explicitly compares and states "No difference" or "No impact" for most variables. |
| Technological Characteristics (e.g., Supply, Type, Technology, Materials, Nozzles, Tanks, Use Cases) | Similar to predicate devices (as detailed in Table 3 of the original document). | Similar technology, materials, and use cases, with some differences in convenience or reusability (e.g., reusable PERIO nozzle vs. single-use in predicates, which is seen as an economic advantage). | Met: Table 3 explicitly compares and states "No difference," "No impact," or explains advantageous differences. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size:
- Supra-gingival application: "Upper jaw central incisor of a dental study model." (Implies N=1 model, but testing was "repeatedly" on the "same tooth or implant.") The exact number of repetitions is not specified.
- Sub-gingival application: "Root of the upper jaw central incisor of a dental study model," and "an implant replica located on the lower jaw molar." (Implies N=2 distinct test sites on models). The varnish was applied "up to 5 mm."
- Data Provenance: The testing was conducted on "dental study models," not human or animal subjects. The location (country of origin for the data) is not specified but is presumably France, where SATELEC (the submitter) is based. The data is prospective for this submission, as tests were conducted specifically to demonstrate equivalence.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not mention any experts used to establish ground truth. The "ground truth" (e.g., complete varnish removal, intact tooth surface) appears to be based on direct observation and comparison against established expectations for dental cleaning tools, rather than complex diagnostic interpretations requiring expert consensus.
4. Adjudication Method for the Test Set
No adjudication method is described, as the evaluation was based on objective observation of varnish removal and surface integrity on dental models.
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
This is not applicable. The AIR-N-GO is a physical dental handpiece, not an AI/ML device, and no MRMC study, human reader performance, or AI assistance is mentioned or relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. The AIR-N-GO is a physical device operated by a human practitioner. It is not an algorithm.
7. The Type of Ground Truth Used
The ground truth used was observational:
- Complete removal of varnish: This indicated the effectiveness of the cleaning.
- Intact tooth/implant surface: This indicated the safety and non-damaging nature of the device's operation.
This is akin to "physical outcome" or "performance outcome" based on an experimental setup rather than clinical pathology or complex diagnostic outcomes.
8. The Sample Size for the Training Set
This is not applicable. The AIR-N-GO is a physical dental device, not an AI/ML algorithm. There is no concept of a "training set" for such a device.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reason as point 8.
§ 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.