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K Number
K033812
Device Name
SIROAIR L AIR SCALER
Manufacturer
SIRONA DENTAL SYSTEMS GMBH
Date Cleared
2004-02-23

(76 days)

Product Code
EFB
Regulation Number
872.4200
Type
Traditional
Panel
DE
Reference & Predicate Devices
K944714
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

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

Device Description

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.

AI/ML Overview

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.

§ 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.