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The Multipiezo Pro and Multipiezo are piezoelectric ultrasonic dental scalers intended for use, with the appropriate associated tip inserts, in the following dental applications:

• . Scaling: All general procedures for removal of supragingival and interdental calculus/ plaque deposits;
• Periodontology: Periodontal therapy and debridement for all types of periodontal diseases, including . periodontal pocket irrigation and cleaning;
• Endodontics: All treatments for root canal reaming, irrigation, filling, gutta-percha . condensation and retrograde preparation;
• Restorative and Prosthetics: All general restorative procedures including cavity preparation, removal . of prostheses, amalgam condensation, finishing of crown preparations, inlay/onlay condensation, implants/restorations cleaning.

The Multipiezo Pro and Multipiezo devices are dental piezoelectic ultrasonic devices that use ultrasonic energy to generate mechanical micro-vibration of the inserts to perform the dental procedures defined in their intended use.

The Multipiezo Pro consists of a base control unit (console) with two integrated peristaltic pumps which deliver irrigation liquid, contained in two independent detachable 500 ml bottles, to two sterilizable ultrasonic handpieces with connecting cords. The selection of the irrigation fluid occurs automatically when the operator removes the handpiece from the support associated with the tank containing the liquid that the dentist wants to use for the treatment. Only one handpiece can be used at a time.

The Multipiezo device consists of a base control unit with a single integrated peristaltic pump which delivers the irrigation liquid contained in one detachable tank to one single ultrasonic handpiece with connecting cord.

The consoles of both devices are connected to mains power by an electrical cord, and include connectors for the hand piece/s and for the footswitch. The consoles incorporate peristaltic pump/s which provide/s the irrigation fluid contained in the tank/s to the operation site.

The handpiece contains a piezoelectric ultrasonic transducer which is connected to the ultrasonic generator (inside the console) by a cable at one end and to which tip inserts are attached at the other end.

The ultrasonic generator, identical in both devices, is microprocessor-based and uses electronics to generate and control the appropriate drive signal (power and frequency) for the transducer in the handpiece. A touch screen on the console of both devices allows the setting of treatment parameters, as follows:

• Four type of functions (Endo, Perio/Scaler, Restorative, Soft Mode) that can be adjusted through 6 power levels
• . Seven different levels of irrigation (from 0 to 6)
• . Insert tip illumination (on, off or auto)
• Flush function. .

The provided text is a 510(k) Summary for medical device clearance, not a study report detailing acceptance criteria and performance against those criteria. Therefore, the information requested in the prompt (acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, etc.) is not present in the document.

This document focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than presenting a performance study with specific acceptance criteria that the device itself must meet against real-world data.

Here's what can be extracted, based on the type of document this is:

Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or report device performance against such criteria. Instead, the "acceptance criteria" for this 510(k) submission are met by demonstrating substantial equivalence to predicate devices, primarily through:

• Identical or very similar Indications for Use/Intended Use.
• Same Technological Characteristics (mechanism of action, piezoelectric technology, ultrasonic transducers, micro-vibration generation).
• Same accessories (insert tips, etc.).
• Same operative modes/signal information.
• Same parts to be sterilized and sterilization methods.
• Same performance (stated as a shared characteristic with the Multipiezo Pro and Multipiezo, implying performance comparable to the predicates, though not quantitatively detailed).
• Compliance with electrical safety and electromagnetic compatibility standards (IEC 60601-1 and IEC 60601-1-2).

The "reported device performance" in this context refers to the device's adherence to these characteristics, and compliance with the safety and EMC standards.

Summary of Information Not Found in the Document:

1. A table of acceptance criteria and the reported device performance: Not provided in the format requested as this is a substantial equivalence submission.
2. Sample size used for the test set and the data provenance: No "test set" in the context of a performance study is described. The assessment is comparative to predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for a test set is detailed.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No such study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical dental device, not an AI algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

What the document does state about testing:

• Non-clinical testing: Bench testing was conducted to confirm compliance with electrical safety (IEC 60601-1) and EMC requirements (IEC 60601-1-2). The details of these bench tests (e.g., specific parameters measured, number of units tested) are not provided in this summary.

In conclusion, this document serves as a regulatory submission demonstrating substantial equivalence to pre-existing devices, rather than a detailed report of a performance study designed to meet specific quantitative acceptance criteria of a novel device.

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