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Piezosurgery Touch is a piezoelectric ultrasonic device, consisting of handpieces and associated tip inserts, intended for:

• Bone cutting, osteotomy, osteoplasty and drilling in a variety of oral surgical procedures, including implantology, periodontal surgery, surgical orthodontic, and surgical endodontic procedures;
• Scaling applications, including:
• 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: Cavity preparation, removal of prostheses, amalgam condensation, finishing of crown preparations and inlay/onlay condensation.

Piezosurgery White is a piezoelectric ultrasonic device, consisting of handpieces and associated tor:

• Bone cutting, osteotomy, osteoplasty and drilling in a variety of oral surgical procedures, including implantology, periodontal surgery, surgical orthodontic and surgical endodontic procedures;
• Scaling applications, including:
• 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: Cavity preparation, removal of prostheses, amalgam condensation, finishing of crown preparations and inlay/onlay condensation.

The Piezosurgery Touch and Piezosurgery White use ultrasonic energy to generate mechanical microvibrations of the available tip inserts to perform the dental procedures defined in its intended use.

They consist of a table-top unit (console) containing the irrigation delivery system, the internal electric power supply, the ultrasonic generator, and the control keyboard. They also includes the piezoelectric ultrasonic handpiece and foot-pedal, both connected directly to the console by means cords, and a variety of insert tips designed with different morphologies/shapes to be used for different dental procedures, according to device's intended use.

The table-top units use piezoelectric ultrasonic technology to generate mechanical micro-vibrations of the insert tip attached to the handpiece. A piezoelectric transducer, located inside the handpiece, and driven by the ultrasonic generator electronics, induces vibrations at ultrasonic frequencies in the insert tip.

The ultrasonic generator electronics searches and locates the resonant frequency of the transducer/insert tip combination, which varies according to the geometry/morphology of the insert tip in use. The functional ultrasonic frequency of the device is between approximately 24 and 36 kHz.

Each of the insert tips is available separately.

The purpose of this 510(k) is to add additional insert tip designs to the PIEZOSURGERY TOUCH and PIEZOSURGERY WHITE to extend the number of insert tips already cleared for sale in the US under K122322 and K151248.

This FDA 510(k) summary describes the submission for new insert tips for the Piezosurgery Touch and Piezosurgery White devices. The purpose of the submission is to add these new tips and establish their substantial equivalence to already cleared devices and tips.

Here's an analysis of the provided text in relation to your request:

1. Table of acceptance criteria and the reported device performance:

The document outlines acceptance criteria implicitly through the non-clinical testing performed and the conclusions drawn regarding substantial equivalence. The "acceptance criteria" are essentially that the new inserts perform comparably to predicate devices in specific areas.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Sample Size for Test Set: Not explicitly stated as a number of devices or tips. The text refers to "the subject inserts (SLC, SLO-H, SLS, SLE1 and SLE2)" for comparative performance bench testing, which implies at least one of each listed subject insert. For reprocessing and biocompatibility, it refers to "a typical worst case reprocessed insert tip," suggesting one or a representative sample.
• Data Provenance: The manufacturer is MECTRON S.p.a, located in Carasco - (GE) - ITALY. The tests were performed to support a U.S. FDA 510(k) submission, suggesting the data originates from tests conducted by or on behalf of the Italian manufacturer. The data is most likely from prospective bench testing and laboratory analyses.

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):

This information is not provided in the document. The evaluations are based on non-clinical, bench-top testing, and biocompatibility studies, which are typically performed by engineers, technicians, and laboratory scientists rather than clinical experts establishing "ground truth" in terms of patient outcomes or diagnoses.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not applicable and therefore not provided. "Adjudication method" usually refers to a process for resolving discrepancies among multiple human readers or experts, which is relevant for clinical studies or image interpretation. The studies described here are non-clinical bench tests.

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:

This information is not applicable and therefore not provided. An MRMC study involves human readers, typically in the context of diagnostic performance or AI-assisted workflows. This submission is for new surgical device inserts, and the studies are non-clinical bench tests evaluating physical properties and performance characteristics, not diagnostic effectiveness or human reader performance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This information is not applicable and therefore not provided. The devices (Piezosurgery Touch and Piezosurgery White) are physical medical devices (ultrasonic instruments and tips) used in surgery, not software algorithms or AI systems. The "standalone" performance here refers to the device's inherent physical characteristics, which were evaluated through the non-clinical tests described.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the non-clinical tests is based on engineering specifications and established scientific methodologies.

• For tuning frequency and vibration amplitude: "Ground truth" is the empirically measured values compared against the expected operational range (24-36 kHz) and predicate device values.
• For reprocessing: "Ground truth" is the successful outcome of sterilization and cleaning protocols as per validated methods.
• For biocompatibility: "Ground truth" is the absence of cytotoxic effects, determined by a standardized in vitro test (ISO 10993-5:2009).

8. The sample size for the training set:

This information is not applicable and therefore not provided. "Training set" refers to data used to train machine learning models. The devices in this submission are physical instruments with no machine learning or AI components described.

9. How the ground truth for the training set was established:

This information is not applicable and therefore not provided. As there is no training set for an AI model, the method for establishing its "ground truth" is irrelevant.

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