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turbodent 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. turbodent 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 procedures

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

turbodent touch can be considered a functionally segmented version of the combi touch device (K231391), incorporating exclusively the air polishing functionality. It shares the main components, materials, and manufacturing processes as the combi touch, from which it is derived. The indication for use of turbodent touch is aligned with the air polishing indication of the combi touch.

The turbodent touch uses an operating principle based on the mechanical action of an accelerated powder jet, obtained thanks to compressed air. The kinetic energy imparted to the particles is almost completely dissipated in the impact against the dental surface, producing a delicate but effective cleaning action. The action is completed by a jet of water which, taking advantage of the depression created around the nozzle, is arranged in a bell-like shape surrounding the air and powder mixed flow. The water flow produces a double effect: continuous washing of the area treated from excess powder, and prevention of environmental dissemination of powder in the operating area.

In detail, the turbodent touch is mainly based on one polisher channel and it is equipped with three handpieces, AIR-POLISHING 90°, AIR-POLISHING 120° AND AIR-POLISHING PERIO (handpieces are already cleared, K231391). The device has a touch keyboard, displaying all selectable functions and the value scales that can be set by the user by simply gently pressing the finger at the chosen buttons.

The user-configurable settings include depressurization of the powder containers for safe removal, no powder cleaning mode and consequently the possibility of excluding water as well, circuit filling/rinsing, and air-polishing modes. For each selected air-polishing mode (PROPHY or PERIO), it is possible to choose different power levels (LOW, MEDIUM and HIGH) within a certain range preset by the manufacturer. The air-polishing action is activated by means of a foot pedal.

The irrigation system is completely external with irrigation tubing connecting the handpiece to the machine that has access to the external water network.

The turbodent touch is not intended to interact with other devices during use. About patient interaction, the SUBGINGIVAL PERIO TIPS (already cleared, K231391) attached to the terminal part of the handpiece AIR-POLISHING PERIO, enter into direct contact with the patient's body during use to allow the intended therapeutic functions to take place. These medical devices are supplied sterile and certified by external suppliers. Possible contact of the patient with the external part of the handpiece must be considered in the evaluation.

The production processes carried out internally at Mectron for processing the components of turbodent touch system are mainly assembly processes according to specific workflows and a dedicated production line.

The provided text describes the 510(k) clearance for the "turbodent touch" device, which is an air polishing unit for dental prophylaxis. However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria, especially not related to AI/ML performance.

The document details the device's function, comparison to a predicate device, and summaries of non-clinical testing (electrical safety, EMC, biocompatibility, software, performance, usability, distribution). Crucially, Section 9 explicitly states: "No clinical testing was conducted for this submission."

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as the provided text lacks this information. The device is a physical dental instrument, not an AI/ML-driven diagnostic tool, and its clearance relies on substantial equivalence to a predicate, not on a performance study against specific acceptance metrics for AI output.

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MT-Bone 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.

MT-Bone is a piezoelectric ultrasonic device designed for oral bone surgery.
MT-Bone uses piezoelectric ultrasound technology to generate mechanical micro vibrations that can cut, drill or abrade through mineralized structures using appropriate inserts.
This allows an efficient and safe action which preserves the integrity of the osteotomized surfaces.
The micrometric, ultrasonic vibrations of the inserts provide greater precision and a selective action compared to traditional methods such as drills or oscillating saws (which act with macro vibrations), therefore minimizing traumatic effect on soft tissues. Depending by the Indication for use a lot of different type of inserts are available in Mectron portfolio.

The provided text describes the MT-Bone device and its substantial equivalence to a predicate device (PIEZOSURGERY TOUCH, K122322). However, it does not contain specific acceptance criteria, reported device performance metrics in a table, or details of a study proving the device meets said criteria in the way typically found for AI/ML-based medical devices.

The document primarily focuses on demonstrating substantial equivalence through a comparison of technological characteristics, indications for use, and general safety/performance testing. There is no mention of an algorithm, AI, or machine learning in the context of device function.

Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set size) are not applicable or cannot be extracted from this document, as they pertain to a different type of device or evaluation method.

Here's a breakdown of what can be extracted based on the provided text, and where information is missing or not applicable:

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

The document states that a series of non-clinical bench performance tests were conducted to evaluate the efficacy and safety of the device. The "acceptance criteria" are implied by the statement "All tests passed successfully" or "The testing showed that..." without quantitative metrics.

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 specified for any of the non-clinical tests. For the cadaver lab, it refers to "clinicians" but no number of cadavers or specific cases is given.
• Data Provenance: Not explicitly stated for any of the tests. It's internal testing by the manufacturer (Mectron S.p.A., Italy).

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):

• Number of Experts: For Usability Testing, it mentions "KOLs feedback and evaluations" (Key Opinion Leaders) but does not specify the number or their qualifications. For the Cadaver Lab, it states "clinicians" but again, no number or qualifications are provided.
• Qualifications of Experts: Not specified.

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

• Not applicable as the tests described are primarily bench, software, and usability/cadaver lab evaluations, not diagnostic accuracy studies requiring adjudication of ground truth by multiple experts.

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:

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The device described is a surgical instrument (piezoelectric ultrasonic device), not an imaging or diagnostic AI/ML device that assists human readers.

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

• Not applicable. The device is a surgical instrument requiring human operation. There is no mention of a standalone algorithm component that performs autonomously.

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

• For the non-clinical bench tests, "ground truth" is typically defined by engineering specifications, regulatory standards (e.g., IEC, ISO), and performance targets for the device's physical functions (e.g., amplitude, frequency, temperature, cutting efficacy).
• For Usability and Cadaver Lab tests, the "ground truth" or validation came from "KOLs feedback and evaluations" and "evaluation process conducted by clinicians," implying expert assessment of performance, safety, benefits, and usability.

8. The sample size for the training set:

• Not applicable. The document does not describe an AI/ML device that requires a training set.

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

• Not applicable. The document does not describe an AI/ML device that requires a training set.

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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 Piezosurgery White 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, revision, 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 White uses ultrasonic energy to generate mechanical micro-vibration of the available insert tips designed with different morphologies/shapes to perform the dental procedures defined in its intended use.
The Piezosurgery White consists of a table-top unit (console) containing the irrigation delivery system, the internal electric power supply, the ultrasonic generator, and the control keyboard.

The provided text is a 510(k) summary for a medical device called "Piezosurgery White." It describes the device, its intended use, and its equivalence to a predicate device. However, it does not contain the information requested in the prompt regarding acceptance criteria and a study proving the device meets those criteria, particularly in the context of an AI/human-in-the-loop system.

The device in question ("Piezosurgery White") is a surgical instrument that uses ultrasonic energy for bone cutting and other dental procedures. It is not an AI-powered diagnostic or assistive device that would typically involve acceptance criteria related to accuracy metrics (e.g., sensitivity, specificity, AUC), human reader performance, ground truth establishment by experts, or MRMC studies that are common for AI/ML medical devices.

The "Performance Data" section states:
"A features comparison and risk analysis of the modified devices was performed. The results demonstrate that the modifications do not alter the operating principle or mechanism of action of the inserts. The tuning frequency and vibration amplitude of each insert was evaluated via performance bench testing. The results demonstrated that the W1-W6 met the stipulated acceptance criteria and so are substantially equivalent to the predicate inserts."

This indicates that a bench test was performed to ensure the new inserts (W1-W6) met specific performance criteria (tuning frequency and vibration amplitude) to demonstrate substantial equivalence to existing inserts for a physical surgical device.

Therefore, I cannot extract the requested information from the provided text because the device and the nature of its evaluation are different from what the prompt is asking about (which seems to be tailored towards AI/ML device performance studies).

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The Piezosurgery FLEX is an ultrasonic surgical system consisting of handpieces and associated tips for cutting bone, osteotomy, osteoplasty and drilling in variety of surgical procedures, including but not limited to otolaryngological, oral/maxillofacial, hand, foot, neurosurgical, spine, and paalstic/reconstructive surgery. It may also be used with endoscopic visual assistance to perform the above listed procedures.

Piezosurgery FLEX is a piezoelectric ultrasonic device that uses ultrasonic energy to generate mechanical micro-vibration of tip inserts intended for bone cutting. The device consists of a base control unit with intearated peristaltic pump, a sterilizable handpiece with connecting cord, a range of sterile, single use tip inserts, a torque wrench, a foot-pedal, an irrigation set, and other minor attachments.

The console is equipped with a touch panel that allows the surgeon to control device operation. The control panel also provides monitoring information, by means icons, in case of malfunction of the device. Inside the console are located the ultrasonic generator, the electrical power supply module and the micro-processor electronic board that controls and supervises the functional parameters of the device. The console is connected to mains power by an electrical cord, and includes connectors for the handpiece and for the foot-pedal. The console incorporates a peristaltic pump which provides, through the irrigation tubing set, a sterile fluid supply to the surgical site. Ultrasonic power and irrigation flow to the handpiece are simultaneously activated by pressing the foot-pedal. The handpiece contains a piezoelectric ultrasonic transducer which attaches to the generator (inside the console) by a cable at one end of the handpiece. Tip inserts are attached to the other end of the handpiece.

The touch panel of the console allows the operator to set the treatment parameters, as follows:

• Seven levels of power: .
• Six levels of irrigation: .
• Three ultrasonic output modes; .
• · The pump function.

The Piezosurgery FLEX uses piezoelectric ultrasonic technology to generate mechanical microvibrations of the tip insert connected to the handpiece, the piezoelectric transducer converting the electrical voltage supplied by the ultrasonic generator into mechanical energy that induces vibration of the tip insert at the resonant frequency of the tip insert.

This 510(k) summary describes a traditional submission for the Mectron Spa Piezosurgery FLEX, an ultrasonic surgical system.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The provided document describes non-clinical testing focused on compliance with electrical safety and electromagnetic compatibility (EMC) standards. It does not contain information about a "test set" in the context of clinical performance evaluation (e.g., patient data). The testing performed was related to device characteristics.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The document describes compliance testing against established engineering standards (IEC 60601-1, EN 60601-1-2), not a study requiring expert-established ground truth for a clinical dataset.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies involving human interpretation or performance, which is not described here.

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 surgical system, not an AI-based diagnostic or assistive technology that would involve human "readers" or an MRMC study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a surgical instrument. "Standalone" performance testing would relate to its engineering specifications and functionality, which are covered by the non-clinical testing mentioned (IEC and EMC standards compliance).

7. The Type of Ground Truth Used

For the non-clinical testing: The "ground truth" was defined by the requirements and specifications outlined in the international standards IEC 60601-1 (medical electrical equipment safety) and EN 60601-1-2 (electromagnetic compatibility).

8. The Sample Size for the Training Set

Not applicable. The Piezosurgery FLEX is a hardware surgical device, not a machine learning or AI model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As noted above, this device does not utilize a "training set" in the context of machine learning.

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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 Touch is a piezoelectric ultrasonic device, consisting of handpieces and associated tip inserts.

This is a 510(k) premarket notification for a medical device (Piezosurgery Touch), not a study report. Therefore, much of the requested information about device performance and ground truth establishment from a study is not present in this document.

However, I can extract information related to the device name, classification, and intended use.

Here's a breakdown of what can be inferred or explicitly stated:

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

This document describes a premarket notification for a medical device, not a performance study result. Acceptance criteria and reported device performance from a clinical study are not provided. The FDA's letter states that the device is "substantially equivalent" to legally marketed predicate devices, which is the regulatory acceptance criteria for 510(k) clearance.

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 document is a regulatory approval notice, not a study report.

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. This document is a regulatory approval notice, not a study report.

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

Not applicable. This document is a regulatory approval notice, not a study report.

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 a bone cutting instrument and ultrasonic scaler, not an AI-powered diagnostic device that would involve human readers for comparative effectiveness.

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

Not applicable. This device is a physical medical instrument, not an algorithm.

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

Not applicable. This document is a regulatory approval notice, not a study report. The "ground truth" for 510(k) clearance is substantial equivalence to a predicate device, which is based on similar technological characteristics and intended use, not necessarily comparison to a 'ground truth' in a clinical study sense.

8. The sample size for the training set

Not applicable. This document is a regulatory approval notice, not a study report involving a training set for an algorithm.

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

Not applicable. This document is a regulatory approval notice, not a study report involving a training set for an algorithm.

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The Compact Piezo P2K and Powercare devices are ultrasonic scalers intended for use, with the appropriate associated insert tips, 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: Cavity preparation, removal of prostheses, amalgam condensation, finishing of crown preparations and inlay/onlay condensation.

The Compact Piezo P2K and Powercare are multipurpose piezoelectric ultrasonic scaler sub-assembly devices intended to be incorporated into a dental unit/table-top device and used for ultrasonic treatment in scaling. periodontics, endodontics and prosthetics dental applications.

The Compact Piezo P2K and Powercare devices are intended to be supplied as modular sub-assemblies devices to OEM manufacturers of dental units.

The subject devices consist of an ultrasonic generator, a handpiece with cord, a range of insert tips, a torque wrench and a wiring connections kit.

The subject devices are intended to be assembled inside a dental unit and connected to the unit's electrical supply by the wiring connections kit provided.

The handpiece cord is connected directly to the ultrasonic generator from which it receives the functional drive signals, including those for water supply from the dental unit for water irrigation. 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 by the dental unit's controls.

The Compact Piezo P2K and the Power Care devices use a piezoelectric transducer inside the handpiece to generate the insert tip oscillation. The ultrasonic transducer uses four piezoceramic disks to convert the generator's electrical signal to ultrasonic mechanical vibration of the insert tip.

A key function of the ultrasonic generator is to locate the optimal frequency of the transducer/insert tip and then to drive the output at this resonant frequency.

The provided text describes the "Compact Piezo P2K" and "Powercare" ultrasonic scalers and their "510(k) Summary," which is an submission to the FDA demonstrating substantial equivalence to a legally marketed predicate device. This type of submission relies on comparing a new device to an existing one, rather than presenting novel clinical studies with specific acceptance criteria and performance metrics for the new device itself.

Therefore, the text does not contain the information requested for a detailed description of acceptance criteria and a study proving the device meets those criteria, as typically found in clinical trial reports or performance validation studies for devices demonstrating new functionalities or efficacy claims.

Instead, the document focuses on demonstrating that the Compact Piezo P2K and Powercare devices are substantially equivalent to predicate devices (Piezosurgery 3 and SP Newtron Module). This means the acceptance criteria are implicitly related to meeting the standards and characteristics of the predicate devices and relevant industry standards.

Here's a breakdown of why the requested information cannot be fully provided from the given text:

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

   • The document does not outline specific, quantitative acceptance criteria for the Compact Piezo P2K and Powercare's clinical performance (e.g., successful calculus removal rate, time to complete a procedure, patient discomfort levels).
   • It lists non-clinical testing for compliance with standards (IEC 60601-1 for safety, IEC 60601-1-2 for EMC, and tip vibrational mode testing). While these are criteria, they are not presented with specific performance values or a table format in the document. The implicit "performance" is compliance with these standards.

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

   • No clinical test set is mentioned because this is a 510(k) submission based on substantial equivalence, not a standalone clinical efficacy study for the new device.
   • The non-clinical testing for compliance would have involved specific test setups, but the document doesn't provide details on sample sizes for these internal engineering tests.

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 there is no mention of a human-read clinical test set requiring ground truth establishment by experts. The "ground truth" for non-clinical compliance testing would be established by reference to the specified standard requirements.

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

   • Not applicable as there is no mention of a clinical test set requiring adjudication.

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, not an AI-powered diagnostic tool, and no MRMC studies are mentioned.

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

   • Not applicable. This device is a physical medical instrument, not an algorithm.

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

   • For the non-clinical tests mentioned (safety, EMC, tip vibration), the "ground truth" is defined by the technical specifications and requirements of the referenced standards (IEC 60601-1, IEC 60601-1-2, and internal tip design specifications).

8. The sample size for the training set:

   • Not applicable. This is not an AI or machine learning device requiring a training set.

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

   • Not applicable.

Summary of available information related to acceptance criteria and "study" (non-clinical testing):

1. Table of implicit Acceptance Criteria and Reported "Performance" (Compliance):

2. Sample size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Training Set, Training Ground Truth:
As explained above, these sections are not applicable to the information provided in this 510(k) summary, which focuses on substantial equivalence rather than original clinical efficacy studies or AI performance validation. The document states "Non-clinical testing of the device components covered by this 510(k) submission includes" the tests listed above, indicating these were internal verification tests against established standards.

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The Starlight Pro and Silverlight devices are dental curing light units intended for use in the oral cavity for the polymerization of photo-hardening dental materials that are activated in the 440 - 480 nm wavelength range.

The Starlight Pro and Silverlight are dental curing light units intended for the polymerization of photo-hardening dental materials in the oral cavity. A light emitting diode (LED) with a wavelength between 440 nm is used in both devices as the light source. The spectrum of the light emitted by the LED corresponds to the absorption spectrum of camphorquinone photo-initiator, which is the most common and widely used visible light photo-initiator in among available photohardening dental materials. Camphorquinone photo-initiator has an light absorption curve ranging approx. from 400 - 500 nm, with a peak absorption at approx. 468 nm. This range falls within the emission spectrum of the LED used in the subject devices, making the units effective for the polymerization of camphorquinone-based dental materials. The subject devices consist of a cordless handpiece, powered by a rechargeable battery, and incorporating a LED as light source, a battery charger unit and a fiber optic that directs the light onto the material being polymerized. The devices allow the user to activate two curing modes ('Fast' and 'Slow Rise') by pressing the relevant push-button on the handpiece. These two curing modes differ in the light exposure and in the mode with which the light is emitted. In particular: The fast curing mode has an exposure time of 10 sec. at the maximum light intensity. The slow rise exposure mode has an exposure time of 20 sec. with a gradual increase of light during the first 3 seconds up to the maximum intensity. Acoustic signal timings are emitted by the handpiece during program execution. The charger unit allows recharging of the battery and it has an integrated light meter to check the light output. On the charger unit are three signaling LED lamps, indicating the on/off unit state, the battery charge state, and the functionality of the battery.

Here's a summary of the acceptance criteria and study information for the Mectron Starlight Pro and Silverlight dental curing light units, based on the provided 510(k) summary:

Overview of Device and Study Type:

The Mectron Starlight Pro and Silverlight are dental curing light units used for polymerizing photo-hardening dental materials. This 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device (Translux Power Blue (K042199) - Heraeus Kulzer GmbH) rather than establishing novel clinical performance. Therefore, the "acceptance criteria" and "study" are geared towards proving this equivalence through non-clinical functional and performance testing.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical "acceptance criteria" in a typical pass/fail format with specific thresholds. Instead, it describes general compliance and functional equivalence. The reported performance is an affirmation of compliance and functional similarity to the predicate.

• Operational Principles: Identical to the predicate, including a cordless handpiece, rechargeable battery, LED light source, removable fiber optic.
• Curing Modes: Both devices (and the predicate) offer two curing modes: 'Fast' (10 sec at max intensity) and 'Slow Rise' (20 sec with gradual increase to max intensity over 3 sec).
• Built-in Light Meter: Both subject devices and the predicate have a built-in light meter to check light output/intensity. |
  | Safety and Effectiveness (Non-clinical testing): Functional and performance evaluation. | The following non-clinical tests were conducted:
• Measurements of spectrum and irradiance: Confirmed the devices' light emission characteristics.
• Depth of cure (mm) on resin samples: Assessed the effectiveness of polymerization.
• Software validation: Ensured proper functioning of device software.
• Electromagnetic compatibility: Compliance with EN IEC 60601-1 and EN IEC 60601-1-2 standards was demonstrated.
  Results from these tests confirm that the proposed devices are safe and effective for the polymerization of photo-hardening dental materials in the oral cavity and support substantial equivalence. |

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: The document does not specify a numerical sample size for the "test set" in terms of how many devices were tested or how many resin samples were used for the depth of cure measurement. It generically states "resin samples."
• Data Provenance: The data is from non-clinical testing conducted by the manufacturer, Mectron S.p.A. The country of origin for the data (testing location) would be Italy, where Mectron S.p.A. is based. The data is prospective in the sense that it was generated specifically for this submission to demonstrate device performance and safety.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is not applicable to this submission. The "ground truth" here is objective physical measurements and compliance with standards, not expert interpretation of clinical images or outcomes.

4. Adjudication Method for the Test Set

This is not applicable. The non-clinical tests involved objective measurements (e.g., spectrum, irradiance, depth of cure, EMC compliance) rather than subjective assessments requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a MRMC comparative effectiveness study was not done. This submission relies on non-clinical testing and comparison to a predicate device for substantial equivalence, not a clinical trial evaluating human reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable in the context of an "algorithm" as this is a physical dental curing light, not an AI or software algorithm in the conventional medical device sense. The device's "standalone performance" was evaluated through the non-clinical tests (spectrum, irradiance, depth of cure, software validation, EMC).

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical testing was based on:

• Physical measurements: Objective measurements of light spectrum, irradiance, and depth of cure in resin samples.
• Established standards: Compliance with electromagnetic compatibility standards (EN IEC 60601 -1 and EN IEC 60601-1-2).
• Performance specifications: Validation of the device's software functionality.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for an AI/ML algorithm.

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