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combi touch incorporates, within a single device, the functions of an ultrasonic scaler and of an air-polishing prophylaxis unit.

Ultrasonic scaler function:

combi touch, by using the appropriate associated inserts and the ultrasonic handpiece, is intended for use in the following dental applications:

• Removing supra and subgingival calculus deposits and stains from teeth
• Periodontal therapy and debridement for all types of periodontal disease, including periodontal pocket lavage with simultaneous ultrasonic tip movement
• Scaling and root planing
• Releasing crowns, bridges, inlays, and posts as well as condensing gutta percha
• Plugging for amalgam condensation
• Amalgam burnishing
• Preparing, cleaning and irrigating roots canals
• Cavity preparation
• Cleaning restorations and implant surfaces

Air-polishing prophylaxis function:

By using the appropriate air polishing handpiece, combi touch is intended for a complete supra-gingival and sub-gingival prophylaxis treatment.

The prophylaxis treatment is obtained by the projection of water, air and appropriate dental prophylaxis powders, onto the tooth surface. The device removes dental plaque, soft deposits, and surface stains from pits, grooves, interproximal spaces, or smooth surfaces of teeth.

combi touch is intended for the following oral prophylaxis procedures:

• Plaque removal for placement of sealants
• Surface preparation prior to bonding/cementation of inlays, onlays, crowns and veneers
• Surface preparation prior to placing composite restorations
• Effective plaque and stain removal for orthodontic patients
• Cleaning prior to bonding ortho brackets
• Cleaning implant fixtures prior to loading
• Stain removal for shade determination
• Plaque removal prior to fluoride treatment
• Plaque and stain removal prior to whitening procedure

combi touch is also intended for use as an air-polisher in patients suffering from periodontal disease. combi touch is indicated for the non-surgical removal of subgingival plaque in pockets up to 5 mm after initial periodontal treatment.

The combi touch combines, in a single appliance, a multi-purpose piezoelectric scaler and water jet, air, and powder polisher, intended for complete supra- and subgingival dental prophylaxis.

In regards to the various possible ultrasonic treatments, combi touch can be used either connected directly to the main water supply in the dental practice, or with independent irrigation through the special liquid container, which can hold different types of medical solutions.

The appliance is equipped with an automatic tuning circuit which compensates the wear of the inserts, thus always allowing operation in conditions of maximum efficiency.

The operating principle of the polisher is based on the mechanical action obtained from a jet of various crystal types accelerated by a flow of compressed air. The kinetic energy thus imprinted at the particles, dissipates almost completely due to impact against the surface of the enamel, producing a gentle but effective cleaning action. The action is completed by a jet of water which, using the vacuum created around the air-polishing handpiece, has a bellshape around the main flow, thus producing a double effect: to prevent much of the rebound and the leakage of the cloud of powder and perform continuous washing of the treated area, dissolving the powder.

The provided documentation describes the acceptance criteria and a study demonstrating that the Mectron S.p.A. "Combi Touch" device meets these criteria. The device is an ultrasonic scaler and air-polishing prophylaxis unit.

Here's the breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

The acceptance criteria are implicitly defined by the comparison to the predicate device and the adherence to various non-clinical performance standards. The "reported device performance" is essentially that the "combi touch" meets or is comparable to the predicate device in all measured aspects and complies with the listed standards.

Study Proving Acceptance Criteria:

The documentation states that:

"The data presented in this submission demonstrates the identities existing between the combi touch device and the predicate devices, and thus support a finding of substantial equivalence between the subject device and the referenced predicated devices, which are already in commercial distribution in the United States."

And critically, regarding performance testing:

"The results of the tests indicated that combi touch, when used in combination with the commercially-available prophylaxis powders identified above: 1) was effective in the removal of simulated plaque from dental surfaces. 2) did not cause any damages to dental surfaces, as verified by the examination of tooth surfaces morphology after the treatment; 3) proved to be safe and effective for its intended use, producing erosion that is comparable to, or even lower than, the erosion produced by the predicate device."

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

The document explicitly states: "Animal or clinical testing were not required to prove combi touch's substantial equivalence when compared to the predicate/reference devices." This implies that the testing for the "Combi Touch" device focused on non-clinical performance and engineering standard compliance rather than a traditional clinical study with patient data.

• Sample Size for Test Set: Not specified for any clinical data. For the non-clinical performance involving "simulated plaque from dental surfaces" and "examination of tooth surfaces morphology," the specific sample size of tested dental surfaces or teeth is not provided within this document.
• Data Provenance: Not specified, as it's primarily non-clinical testing.

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)

Not applicable, as this was not a clinical study involving human ground truth assessment. The assessment of "simulated plaque" and "tooth surfaces morphology" would likely involve expert evaluation, but the number and qualifications are not detailed.

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

Not applicable, as this was not a clinical study requiring adjudication of expert interpretations.

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 ultrasonic scaler/air-polisher, not an AI-powered diagnostic or assistive tool, and no MRMC study was conducted.

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

Not applicable. This device does not feature an AI algorithm for standalone performance evaluation.

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

For the non-clinical performance tests mentioned (plaque removal, dental surface damage/erosion), the ground truth appears to be based on:

• Objective measurements of simulated plaque removal.
• Laboratory examination of tooth surface morphology (e.g., microscopy) to assess damage/erosion after treatment.
• Comparison against the performance of the predicate device under similar testing conditions.

8. The sample size for the training set

Not applicable. This device does not appear to employ machine learning or AI that would require a 'training set.'

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

Not applicable.

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The Compact Piezo Led is an ultrasonic scaler device intended for use, with the appropriate associated insert tips, in the following dental applications:

· Scaling: Procedures for removal of supragingival and interdental calculus/plaque deposits:

· Periodontology: Periodontal therapy and debridement for periodontal diseases, including periodontal pocket irrigation and cleaning:

· Endodontics: Treatments for root canal reaming irrigation, filling, gutta-percha condensation and retrograde preparation;

· Restorative and Prosthetics: Restorative procedures including cavity preparation, removal of prostheses, amalgam condensation, finishing of crown preparations, inlay/onlay condensation and implants/restorations cleaning.

The Compact Piezo Led is a multipurpose piezoelectric ultrasonic scaler sub-assembly device intended to be supplied to manufacturers of dental unit devices and incorporated within such devices, to be used for ultrasonic treatment in scaling, periodontics and prosthetics dental applications.

The Compact Piezo Led uses ultrasonic energy to generate mechanical micro-vibration of the available tip inserts to perform the dental procedures defined in its intended use.

The Compact Piezo Led consists of an ultrasonic generator, a handpiece/cord incorporating a range of insert tips, a torque wrench, different wiring connection kits, and other minor accessories.

The range of tip inserts, handpiece and torque wrench are autoclavable.

The subject device is intended to be assembled inside a dental unit and connected to the dental unit's electrical supply by the wiring connection kit provided.

The handpiece/cord is connected directly to the device's ultrasonic generator, from which it receives the functional drive signals, including those for irrigation supply, from the dental unit. The ultrasonic power and water flow are simultaneously activated by pressing the footswitch of the dental unit. The power output and water flow are adjusted through the dental unit's controls.

The ultrasonic generator of the Compact Piezo Led is microprocessor-based and uses electronics to generate and control the appropriate drive signal (power and frequency) for the ultrasonic transducer, which is housed inside the handpiece.

The ultrasonic generator electronics search and locate the resonant frequency of the transducer/insert tip combination, which varies according to the geometry/morphology of the tip insert in use.

The functional ultrasonic frequency of the device is between approximately 24 and 36 kHz. The Compact Piezo Led handpiece transducer and family of inserts are designed to resonate within this frequency range.

The Compact Piezo Led device complies with the electrical safety and electromagnetic compatibility requirements established by the standards IEC 60601-1 and IEC 60601-1-2.

This document describes the Mectron Compact Piezo LED, an ultrasonic scaler device. However, it does not contain a study that establishes acceptance criteria and proves the device meets them in the context of clinical performance or diagnostic efficacy.

The document is a 510(k) summary for premarket notification to the FDA, demonstrating substantial equivalence to legally marketed predicate devices. This type of submission primarily focuses on comparing the new device's technological characteristics and safety with existing, cleared devices, rather than conducting new clinical performance studies with acceptance criteria for diagnostic accuracy or effectiveness.

Here's a breakdown of the information provided, specifically addressing the points in your request:

1. A table of acceptance criteria and the reported device performance

This document does not provide a table of acceptance criteria and reported device performance in terms of diagnostic or clinical efficacy (e.g., sensitivity, specificity, accuracy for a disease detection task). The device is an ultrasonic scaler, a therapeutic and dental hygiene tool, not a diagnostic imaging or AI-driven diagnostic device.

The "performance" discussed relates to technical specifications and compliance with safety and electromagnetic compatibility standards, which are:

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

Not applicable. This is not a study evaluating a diagnostic device with a test set of patient data. The "testing" mentioned is non-clinical, focusing on engineering, electrical safety, and regulatory compliance.

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)

Not applicable. There is no concept of "ground truth" as typically understood in diagnostic AI/imaging studies, as this is a dental scaling device undergoing technical and safety evaluation.

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

Not applicable. No expert adjudication for a test set is mentioned.

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 ultrasonic scaler, a physical tool used by dentists. It is not an AI diagnostic tool and does not involve "human readers" or AI assistance in the interpretation of information.

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

Not applicable. There is no standalone algorithm performance as this is a hardware device. The device has software that controls its functions, and this software was verified and validated.

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

Not applicable. As explained, the device is not being evaluated against a diagnostic "ground truth." The "truth" in this context refers to compliance with established engineering standards and functional specifications.

8. The sample size for the training set

Not applicable. This refers to a manufactured device and its components, not a machine learning model that undergoes training on a dataset.

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

Not applicable. See point 8.

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