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The dental scaler and air polisher, Model PT-A, is intended for use in dental (gum) therapy and polishing. The device polishes the teeth and removes calculus deposits and stains from pits, grooves, interproximal spaces, or smooth surfaces of teeth. By attaching the ultrasonic handpiece with different scaling tips, the device could fulfill the following functions: 1 Scaling Removal of supragingival calculus; Removal of stains 2 Endo Preparation, cleaning and irrigation of root canals: Retrograde preparation of root canals Condensing gutta-percha; Removal of crown, bridges and restorations 3 Restorative - Cavity preparation; Luting inlays and onlays; Condensing of amalgams 4 Perio Scaling and root planing; Periodontal treatments By using air polishing handpiece attached with corresponding nozzles, the device could fulfill the following functions - · Removing dental plaque - · Surface preparation before bonding/cementation of inlays, crowns and veneers - · Tooth surface preparation before placing the composite restoration - · Cleaning before sticking orthodontic brackets - · Effectively removing plaque for orthodontic patients - · Cleaning the implant fixture before loading - · Stain removal for shade determination - · Removing plaque before fluoride treatment - · Removing plaque before whitening procedure

The dental scaler and air polisher, Model PT-A, mainly consists of ultrasound scaler system and air polishing system. More specifically, it mainly contains a control module, a display panel with function keys, water bottle, powder tank, scaling handpiece, air polishing handpiece, scaling tips, sand blasting nozzle, foot pedal and power adapter. The device generates ultrasonic waves intended for dental applications such as scaling, root canal irrigation and periodontal preparation. For the ultrasonic system, a sinusoidal electrical signal is generated and delivered to the 'piezoelectric ceramic' located inside the ultrasonic handpiece. The electrical signal is converted into mechanical vibrations and propagated to the distal end of the handpiece. For air polishing system, the powder tank is driven by air pressure to flow into the nozzle attached with the air polishing handpiece and mixed with air and water to blast the teeth. By attaching the ultrasonic handpiece with appropriate scaling tips, the device could fulfill scaling, restorative, endodontal treatment. However, by attaching the corresponding nozzle to the air polishing handpiece, the device could remove calculus, stains, plaques and polish the teeth. The device is powered by a power adapter with input of 110V~ 50Hz/60Hz 800mA and output of 25V~ 50Hz/60Hz 2.8A. The ultrasonic handpiece, air polishing handpiece with or without non-disposal stainless steel sand blasting nozzles, and scaling tip are provided non-sterile, which will be sterilized by the user before use.

The provided text is a 510(k) summary for a dental scaler and air polisher. This type of regulatory document is typically focused on demonstrating "substantial equivalence" to a predicate device, rather than proving a device meets specific performance acceptance criteria through a detailed clinical study in the way a diagnostic AI device might.

Therefore, the document does not contain the kind of information requested in the prompt regarding acceptance criteria and performance studies for a diagnostic AI device. The device described (a dental scaler and air polisher) is a physical medical device, not a software or AI-driven diagnostic tool.

Specifically, the document does not provide:

• A table of acceptance criteria and reported device performance: While there's a comparison table to a predicate, it focuses on features, intended use, and technical specifications, not specific quantifiable performance metrics with predefined acceptance thresholds.
• Sample size and data provenance (test set): No test set of clinical data is described.
• Number of experts and qualifications for ground truth (test set): Not applicable as there's no diagnostic test set requiring expert ground truth.
• Adjudication method (test set): Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned, as it's not relevant for this type of device submission.
• Standalone (algorithm only) performance: Not applicable.
• Type of ground truth used: Not applicable.
• Sample size for the training set: Not applicable.
• How ground truth for the training set was established: Not applicable.

Instead, the document details physical and electrical specifications, biocompatibility, and sterilization validation, and compares these aspects to a predicate device to demonstrate substantial equivalence. The "Non-clinical Testing" section mentions adherence to various international standards (e.g., IEC 60601-1, ISO 10993-5, ISO 18397) to ensure safety and effectiveness, but these are general compliance requirements rather than specific performance acceptance criteria for a diagnostic algorithm. It also states that "Performance comparison test performed on subject device and predicate device aims to support the substantial equivalence of the subject device to the predicate device. Test's setup and execution was in accordance with applicable standards. Results of the testing demonstrate the compliance to the standards and comparable performance between subject device and predicate device." However, the exact metrics and acceptance criteria for these performance comparisons are not detailed in this summary.

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