(94 days)
The Air Solfy can be used to remove calculus deposits from teeth by application of an air-powered vibrating scaler tip from the teeth during dental cleaning and periodontal therapy.
The Air Solfy is a dental air-powered handpiece scaler and tips that can remove calculus deposits from the teeth by application of an air-powered vibrating scaler tip to the teeth during dental cleaning and periodontal therapy.
This device receives energy resorces in handpiece such as air for high speed air turbine, cooling water for scaling and light source for illumination, through the tubes connected to a dental unit.
The cooling water is fed on the part of scaling treatment through pouring holes.
Air Solfy is classified into the model as is shown below Table-1 from the variations of connection, light or power adjuster.
This is a 510(k) premarket notification for a dental scaler, a medical device. The document states that the device, "Air Solfy," is substantially equivalent to a legally marketed predicate device, the "Siroair L air" from Sirona Dental System, Inc. (K#033812).
It's important to understand that a 510(k) submission generally focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel claims of efficacy or safety through new clinical studies. Therefore, the information you're asking for, such as acceptance criteria based on device performance, sample sizes for test and training sets, and details about ground truth establishment, is typically not required or provided in this type of submission for a Class I device like a dental handpiece. The acceptance criteria here are primarily about meeting existing standards and having comparable performance to the predicate device.
Let's break down what is available in the provided text:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are implicitly defined by the substantial equivalence comparison to the predicate device, Siroair L. The "reported device performance" is essentially that the Air Solfy performs in a "similar" manner to the predicate and complies with relevant international standards.
| Acceptance Criteria (Implicit) | Reported Device Performance (Air Solfy) |
|---|---|
| Indication for use: Identical to predicate | Identical to predicate (remove calculus deposits from teeth) |
| Target population: Identical to predicate | Identical to predicate (patients requiring dental cleaning/periodontal therapy) |
| Design: Similar to predicate | Similar |
| Materials: Similar to predicate | Similar |
| Performance: Similar to predicate (as per ISO 15606:1999) | Similar (complies with ISO 15606:1999) |
| Sterility: Similar to predicate | Similar (Autoclavable models available) |
| Biocompatibility: Similar to predicate | Similar |
| Mechanical safety: Similar to predicate | Similar |
| Chemical safety: Similar to predicate | Similar |
| Anatomical sites: Similar to predicate | Similar |
| Human factors: Similar to predicate | Similar |
| Energy used and/or delivered: Similar to predicate | Similar (air-powered, cooling water, light source) |
| Compatibility with environment and other devices: Similar to predicate | Similar (connects to dental unit via tubes, specific couplings) |
| Where used: Identical to predicate | Identical (dental cleaning and periodontal therapy) |
| Standards met: Similar to predicate | Similar (complies with ISO 15606:1999) |
| Electrical safety: Similar to predicate | Similar |
| Thermal safety: Not applicable (for both) | Not applicable |
| Radiation safety: Not applicable (for both) | Not applicable |
The critical "study" or evidence provided is the declaration that "Air Solfy is in compliance with ISO 15606:1999" (a standard for dental air-powered scalers) and the direct comparison to the predicate device, showing "similar" or "identical" characteristics with "minor differences" that "do not raise new questions of safety or effectiveness."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
There is no mention of a "test set" or specific clinical study with human or animal subjects in the provided text for the Air Solfy itself. The submission relies on demonstrating compliance with standards and equivalence to a predicate device.
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. As noted above, there's no mention of a "test set" or ground truth established by experts for a new study of the Air Solfy's performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set mentioned.
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 mechanical dental scaler, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The ground for acceptance is primarily the device's compliance with established international standards (ISO 15606) and its proven substantial equivalence to an already legally cleared device. No specific "ground truth" derived from patient data is described for the Air Solfy itself.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As above, no training set is relevant to this device's submission.
§ 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.