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The Sirona Dental Systems SIROAIR L Air Scaler is an air-powered scaler intended for use in calculus removal (subgingival and supragingival).

The Sirona SIROAIR L Scaler (SIROAIR) consists of a handpiece, quick-action coupling and accessories for changing and cleaning the instrument tips. The SIROAIR handpiece connects to an air-driven handpiece hose on a dental operative unit. The power delivered to the handpiece is adjusted via a control ring located on the handpiece. Three types of couplings are available. Two types contain a halogen lamp and a control ring to adjust the water flow. The third type lacks the lamp and has a fixed water flow. A variety of instrument tips (SIROTIPS) are available that are designed for specific dental procedures and to access particular areas of the mouth.

This 510(k) submission for the SIROAIR L Air Scaler does not contain the specific acceptance criteria or details of a study proving the device meets said criteria.

The provided document is a 510(k) summary, which outlines the device's description, intended use, predicate devices, and a determination of substantial equivalence by the FDA. It does not include performance data or clinical study results in the level of detail requested.

Therefore, I cannot provide the requested information, which would typically be found in a more comprehensive clinical study report or performance testing documentation submitted to the FDA, but not in the public 510(k) summary.

Specifically, the following information is missing from the provided text:

1. A table of acceptance criteria and the reported device performance: No acceptance criteria or performance data are provided.
2. Sample sized used for the test set and the data provenance: No test set or data provenance is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth experts are mentioned.
4. Adjudication method: Not applicable as no test set or ground truth establishment is described.
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 an air-powered scaler, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an air-powered scaler, not an algorithm.
7. The type of ground truth used: Not applicable as no ground truth is described.
8. The sample size for the training set: Not applicable to this type of device.
9. How the ground truth for the training set was established: Not applicable to this type of device.

The document primarily focuses on establishing substantial equivalence to a predicate device (W&H Corsair Scaler K944714) based on similar design, intended use, and function for calculus removal. It does not present new performance data or clinical study results for the SIROAIR L Air Scaler.

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