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Scaling:

• Interdental junction treatment
• Tooth neck and subgingival treatment
• Treatment of large deposits
• Treatment of coating and tobacco stains
• Interproximal treatment
• Prosthesis conservative/restorative:
• Inlay/onlay condensation
• Amalgam plugging
• Loosening prostheses (bridge, crown, post, pivot ... )

Endodontics:

• Canal preparation
• Canal cleaning
• Canal filling
• Gutta percha condensation
• Treatment resumption
• Retro surgery
• Micro retro surgery
• Surface smoothing after burring

Periodontics:

• Root planning
• Initial therapy
• Treatment of periodontal pockets
• Treatment of furcations
• Maintenance therapy

The NEWTRON CAN A Module is an Ultrasonic Control Module intended to be integrated in a Dental Delivery System. The NEWTRON CAN A Module contains an Embedded Software. The NEWTRON CAN A Module is an Ultrasonic Control Module intended to be integrated in a Dental Delivery System manufactured by the American Company named A-DEC. The A-DEC Dental Delivery System provides different function to the NEWTRON CAN A Module such as Ultrasonic Power Setting, Light Command through a communication frame. The communication frame is designed and imposed by A-DEC, the Manufacturer of the Dental Delivery System. The values of Ultrasonic Power Setting and the Light Command are coded and communication frame. Ultrasonic Power Setting and the Light Command are driven by the user with a touch pad embedded in the A-DEC Dental Delivery System. The only parameters of the NEWTRON CAN A Module that can be modified by the A-DEC Dental Delivery System are the values of Ultrasonic Power Setting and the Light Command. The NEWTRON CAN A Module converts a low voltage Power Supply provided by the A-DEC Dental Delivery System into an Ultrasonic Electric Signal. The NEWTRON CAN A Module is intended to be used in combination with a SATELEC Dental Ultrasonic Handpiece and a SATELEC range of Dental Tips. The electrical signal emitted by the NEWTRON CAN A Module supplies the Dental Ultrasonic Handpiece equipped with SATELEC Dental Tip. The amplitude of the ultrasonic micro-vibrations depends on the electrical Signal provided by the NEWTRON CAN A Module (amplitude). The SATELEC Dental Ultrasonic Handpiece is connected to the Dental Delivery System via a Handpiece cord. Mechanical micro- vibrations are transmitted to a Dental tip attached to the end of the SATELEC Dental Ultrasonic Handpiece.

This document is a 510(k) summary for the SATELEC NEWTRON CAN-A ultrasonic scaler. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed independent study on specific acceptance criteria for device performance metrics like sensitivity, specificity, or accuracy, which are typical for diagnostic AI devices.

Instead, the "acceptance criteria" here refer to conformity with established standards for medical devices and demonstration of similar performance characteristics to the predicate device. The "study" refers to the various tests and comparisons performed to prove this conformity and similarity.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present acceptance criteria and device performance in a typical clinical metrics table (e.g., sensitivity, specificity). Instead, it demonstrates "substantial equivalence" to a predicate device (SP NEWTRON Module, K033764) by showing that the new device (NEWTRON CAN A) has equivalent technological characteristics and meets relevant safety and performance standards.

The acceptance criteria are implied by the "Result / Impact of the differences on Safety / Effectiveness" column in Table 01, which consistently states "Identical" or "No Impact." The "reported device performance" are the characteristics of the NEWTRON CAN A.

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

The document describes performance testing based on engineering bench tests and compliance with recognized standards rather than a clinical study with a "test set" of patients or data.

• Sample Size for Test Set: Not applicable in the context of a clinical test set. The "test set" would be the device itself and its components undergoing engineering validation.
• Data Provenance: The tests are likely performed by the manufacturer, SATELEC-ACTEON GROUP, based in France (Z.I DU PHARE, MERIGNAC, Gironde, FR). The data comes from the results of the specified engineering and biocompatibility tests. This is not retrospective or prospective clinical data but rather controlled laboratory test results.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This type of information is not relevant for the provided document. The device is an ultrasonic scaler. Its performance is evaluated through compliance with electrical, mechanical, and biocompatibility standards, and comparison to a predicate device. "Ground truth" in the sense of expert consensus on medical images or patient outcomes, as would be relevant for an AI diagnostic device, is not established here. The "ground truth" for these tests are the objective measurement results compared against the requirements of the standards (e.g., maximum current, voltage, biocompatibility indices).

4. Adjudication Method for the Test Set

Not applicable. There is no "adjudication method" in the context of human expert review for establishing ground truth for a test set, as this is a physical device testing submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. These studies are typically conducted for AI-powered diagnostic tools to assess the impact of AI assistance on human reader performance in interpreting medical images or data. The device in question is an ultrasonic scaler, a therapeutic dental tool, not an AI diagnostic system.

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

Yes, in a way. The "performance data" described (Electromagnetic Compatibility, Electrical Safety, Software Verification and Validation, Biocompatibility Validation, Performance Testing bench) are all standalone tests of the device's technical specifications and compliance with standards, without human interaction as part of a clinical diagnosis or treatment decision process. The "algorithm" here refers to the embedded software and control systems of the device.

7. The Type of Ground Truth Used

The "ground truth" for this submission is:

• Engineering Specifications: Objective measurements of electrical output (frequency, power, current), physical dimensions, voltage, current consumption, etc., that meet specified design parameters.
• Regulatory Standards: Compliance with recognized international standards for medical electrical equipment (IEC 60601-1, IEC 60601-1-2), software (FDA guidance), and biocompatibility (ISO 10993 series).
• Predicate Device Equivalence: The characteristics and performance being substantially equivalent to the legally marketed predicate device (SP NEWTRON Module, K033764).

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML device that requires a training set of data for a machine learning model. The "NEWTRON Technology" and "feedback system" mentioned are likely traditional control algorithms, not AI that learns from data.

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

Not applicable, as there is no training set for an AI/ML model for this device.

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The PIEZOTOME CUBE is an ultrasonic surgical system that supply utilities to and serve as a base for dental tips. The PIEZOTOME CUBE consist of a control unit and handpiece intended for use in intraoral surgery procedures, including osteotomy, osteoplasty, periodontics and implantology.

SATELEC CUBE is an piezoelectric device that uses micro-vibrations of associated Tips, to perform the dental procedures defined in Indication for Use.

PIEZOTOME CUBE consists of a Console, a Multifunction footswitch and a reusable Handpiece.

The Console is the heart of the SATELEC PIEZOTOME CUBE. The Console contains the display board and the motherboard. Ultrasonic Handpiece and Footswitch are connected to the Console. The Touch screen present on the front panel is used to define the settings of the SATELEC PIEZOTOME CUBE (Ultrasonic modes, irrigation flow values).

The Ultrasonic Handpiece is held in the Practitioner's hand. The Ultrasonic Handpiece is connected to the Console via a Handpiece Cord. The Handpiece is dedicated to Dental Bone Surgery procedures. The Ultrasonic Handpiece is equipped with a Piezoelectric Transducer. The Piezoelectric transducer converts the Electrical Signal delivered by the Console into mechanical micro-vibrations. The Ultrasonic Handpiece is reusable and Sterilizable by autoclaving.

Tips are fixed by means of a Wrench at the extremity of the Ultrasonic Handpiece. Tip are in direct contact to the patient. The ultrasonic mechanical vibrations are transmitted to the Tip.

The Pump housing is designed to accommodate SATELEC Irrigation Tubing cassettes. Irrigation Tubings are Single Use and delivered under Sterile State. Irrigation is intended to cool the clinical site and rinse the fragments such as bone or teeth.

The provided text is a 510(k) Summary for the PIEZOTOME CUBE, an ultrasonic surgical system. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with defined acceptance criteria and performance metrics for clinical efficacy. Therefore, much of the requested information regarding an acceptance criteria table, sample sizes for test and training sets, number and qualifications of experts, adjudication methods, multi-reader multi-case studies, and specific ground truth types for a clinical performance study cannot be found or directly inferred from the provided text.

The document primarily relies on comparisons of technical characteristics and performance testing to the predicate device, PIEZOTOME SOLO.

Here's an attempt to answer the questions based on the available information:

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

The document does not provide a table of explicit acceptance criteria with corresponding performance results for clinical efficacy. Instead, it compares the technical characteristics and performance of the PIEZOTOME CUBE to its predicate device, PIEZOTOME SOLO, arguing that the differences have no impact on safety or effectiveness.

Below is a summary of the technical performance comparisons, which serve as the "reported device performance" in the context of demonstrating substantial equivalence, effectively meeting the "acceptance criteria" of being similar to the predicate.

The acceptance criterion, in essence, is that the new device's performance is either identical to the predicate or that any differences have no impact on safety or effectiveness.

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 refers to "Performance Testing bench" and various validation tests (Electrical Safety, EMC, Software V&V, Sterilization, Cleaning, Biocompatibility). These are bench tests or validation processes, not clinical studies with human patient data or specific "test sets" in the context of AI/ML performance evaluation. Therefore, sample size and data provenance (country, retrospective/prospective) in the clinical sense are not applicable here.

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. The device is a physical ultrasonic surgical system, not an AI/ML diagnostic tool that requires ground truth established by medical experts for image interpretation or diagnosis.

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

Not applicable, as this is related to expert consensus for ground truth establishment in studies involving interpretation, which is not the case for this device.

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 such study was mentioned or performed, as the PIEZOTOME CUBE is a surgical tool, not an AI-assisted diagnostic or interpretation system for human readers.

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

This is not applicable, as the device is an ultrasonic surgical system, not an algorithm. Performance testing was primarily bench testing and direct comparison to a predicate device's technical specifications.

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

Ground truth in the context of this submission refers to the established technical specifications and performance characteristics of the predicate device, as well as compliance with recognized standards (e.g., IEC 60601-1, ISO 10993-1). For the validation tests performed (sterilization, cleaning, biocompatibility), the "ground truth" would be the successful adherence to the requirements of the specified standards and guidance documents. There is no mention of clinical outcome data or pathology reports for ground truth.

8. The sample size for the training set

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

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

Not applicable.

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SCANWAVE PEN is a source of illumination for the polymerization of light-curing dental materials curing in the wavelength range of 390 nm - 505 nm.

SCANWAVE PEN is a Dental Curing Light. More precisely, SCANWAVE PEN is a source of illumination used for the polymerization of light-curing dental materials curing in the wavelength range of 390 nm - 505 nm. SCANWAVE PEN is equipped with a LED (Light Emitting Diode) which permit to polymerize a large range of dental materials present on the market. SCANWAVE PEN is an Electro-medical Device. SCANWAVE PEN is compatible with only ADEC Dental units. The Handpiece contains the electronic command board, the power board and the light source. The rigid protection shield to the Handpiece reduces the light propagation outside the initial site. This accessory is used to protect the eyes of the patient and the user during the Curing Light polymerization act. The O.E.M. Module is a power supply module intended to deliver the electrical source needed for the Handpiece functioning. The O.E.M. Module is integrated in an ADEC Dental Unit. The User Manual contains all needed information for a correct using (description, safety aspects, problems, cleaning, disinfecting and sterilization procedures).

This document describes the SCANWAVE PEN, an Ultraviolet Activator for Polymerization used for dental applications. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria or conducting a study to prove meeting those criteria in the traditional sense of a clinical trial for diagnostic performance.

However, based on the provided text, we can extract details about the performance evaluation conducted.

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

Since this is a substantial equivalence submission for a dental curing light, "acceptance criteria" are implicitly tied to the performance of the predicate devices and compliance with relevant standards. The key performance aspect mentioned is "Depth of Cure."

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

• Sample Size: The document does not specify a numerical sample size for "non-clinical tests (on test bench)." It refers to "the comparison of the obtained values of SCANWAVE PEN and the bellowed values of Depth of Cure shows that the depths of polymerization of SCANWAVE PEN are substantially equivalent to the valuation of the Predicate Devices." This indicates a comparative test but without specific numbers of samples (e.g., how many measurements for depth of cure, how many dental materials tested).
• Data Provenance: The tests are described as "non-clinical tests (on test bench)." The country of origin of the data is not explicitly stated, but the manufacturer (SATELEC) is based in France. The data appears to be prospective as it involves evaluations of the new device intended to support its market clearance.

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

This information is not applicable to the provided document. The "ground truth" for a dental curing light's performance in this context is based on objective measurements like "Depth of Cure" using standardized methods, not on expert consensus or clinical interpretation of images. The tests were performed on a test bench.

4. Adjudication Method for the Test Set:

Not applicable. The performance evaluation was based on objective, non-clinical bench tests of polymerization depth and compliance with technical standards, rather than subjective interpretation requiring adjudication.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices where human readers interpret medical images or data. The SCANWAVE PEN is a dental curing light, and its performance is evaluated through objective physical measurements, not human interpretation.

6. Standalone Performance:

Yes, a standalone performance evaluation was done through the "non-clinical tests (on test bench)" which demonstrated the "Depth of Cure performance" of the SCANWAVE PEN itself and its compliance with applicable standards. However, its effectiveness is framed in direct comparison to predicate devices, rather than an absolute measure independent of any benchmark.

7. Type of Ground Truth Used:

The ground truth used was objective measurements based on standardized test methods (specifically for "Depth of Cure" and compliance with standards like ANSI / ADA Standard No. 48 for Dental Curing Lights). This is a form of scientific/engineering validation rather than clinical ground truth like pathology or outcomes data.

8. Sample Size for the Training Set:

Not applicable. The SCANWAVE PEN is a physical medical device (a dental curing light) and not an algorithmic or AI-based device 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 this type of device.

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This medical device is intended for prophylaxis, including scaling, for periodontics, for endodontics, and for preservation and restoration dentistry, including prosiblesis.

The Satelec New Device is a Dental Ultrasonic Generator. The Satelec New Device uses Piezoelectric Technology. The Satelec New Device uses a Satelec Dental Piezoelectric Handpiece (NEWTRON SLIM B.LED). The Satelec New Device is designed to be used with Satelec Dental Tips previously cleared with Predicate Devices (K050895, cleared April 20, 2005 and K113430, cleared February 23, 2012).

The provided text describes a 510(k) submission for a dental ultrasonic scaler, the NEWTRON P5 XS B.LED. The submission focuses on establishing substantial equivalence to previously cleared predicate devices through bench testing and comparison of technological characteristics, rather than a de novo study with acceptance criteria for device performance in a clinical setting. Therefore, many of the requested elements regarding acceptance criteria and study details (like sample size for test/training sets, ground truth establishment, expert qualifications, MRMC studies) are not applicable or not provided in this type of submission.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission based on substantial equivalence, there are no explicitly stated "acceptance criteria" in the traditional sense of a clinical trial showing performance against a benchmark. Instead, the "acceptance" is based on demonstrating similarity to predicate devices in key performance areas.

2. Sample sized used for the test set and the data provenance

• Test Set Size: Not applicable. No clinical test set with human subjects/data was used for this 510(k) submission. The testing involved bench data and comparison of technical specifications to predicate devices.
• Data Provenance: Not applicable. The "data" primarily consists of engineering specifications, performance measurements (irrigation flow, current) from bench testing, and comparisons to predicate device data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. As no clinical test set requiring expert ground truth was performed, this information is not provided.

4. Adjudication method for the test set

• Not applicable. No clinical test set requiring adjudication was performed.

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 imaging tool, and no MRMC study was conducted or is relevant to this device's regulatory pathway.

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

• Not applicable. This device is not an algorithm or AI system. Its performance is evaluated through its physical and electrical characteristics.

7. The type of ground truth used

• The "ground truth" for this submission is based on bench testing results and technical specifications of the NEWTRON P5 XS B.LED compared against the established safety and effectiveness of the legally marketed predicate devices. The claim is that the new device is "similar" and therefore equally safe and effective.

8. The sample size for the training set

• Not applicable. There is no AI component, and thus no "training set."

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

• Not applicable. There is no AI component, and thus no "training set" or corresponding ground truth establishment.

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This medical device is intended for prophylaxis, including scaling, for periodontics, for endodontics, and for preservation and restoration dentistry, including prosthesis.

The Satelec New Device is a Dental Ultrasonic Generator. The Satelec New Device uses Piezoelectric Technology. The Satelec New Device uses a Satelec Dental Piezoelectric Handpiece (NEWTRON SLIM or NEWTRON SLIM B.LED). The Satelec New Device is designed to be used with Satelec Dental Tips previously cleared with Predicate Devices (K050895, cleared April 20, 2005 and K113430, cleared February 23, 2012).

The provided text describes the regulatory submission for the Satelec NEWTRON P5 and NEWTRON P5 B.LED ultrasonic scalers, focusing on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria through novel performance data.

Here's an analysis of the requested information based on the provided text:

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

The document does not explicitly state quantitative "acceptance criteria" for the new device, nor does it present device performance against a pre-defined set of criteria in a table format. Instead, it relies on demonstrating similarity to legally marketed predicate devices.

The performance data that is reported is in the context of similarity:

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 states, "Clinical Data is not needed for this 510(k) process." Performance data was primarily based on bench testing. Therefore, there is no sample size for a clinical test set, nor is there information on data provenance in terms of country of origin or retrospective/prospective nature for clinical data. The bench tests involved comparing measured values, so the "sample size" would relate to the number of units tested during the bench comparison. This specific number is not provided, but it would typically be a small N for engineering verification.

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. Since no clinical data or human-in-the-loop performance study was conducted, there are no experts establishing ground truth for a test set in the traditional sense of medical image analysis or clinical outcomes. The "ground truth" for the performance evaluation appears to be the measured physical parameters from the predicate device.

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

Not applicable. As no clinical test set requiring expert interpretation or adjudication was used, there is no mention of an adjudication method.

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 is an ultrasonic scaler. The submission focuses on demonstrating substantial equivalence based on technological characteristics and bench performance, not on AI assistance or human reader performance.

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

Not applicable. This is a medical device (ultrasonic scaler), not an AI algorithm. The performance evaluation was done through bench testing of its physical characteristics (irrigation flow, current) by comparing it to a predicate device.

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

The "ground truth" for the performance evaluation in this 510(k) submission is the measured physical properties and performance characteristics of legally marketed predicate devices. The new device aims to be "similar" in these aspects. specifically:

• Bench Test Measurements: Irrigation Flow and Current delivered in the Piezoelectric Handpiece (for K050895).
• Technological Characteristics: Piezoelectricity Technology, materials (self-extinguishing material UL94V-0), user interface principles, energy sources, output energy, and light function principles (for K071424).

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device. There is no concept of a "training set" in this context.

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

Not applicable. As this is not an AI/machine learning device, there is no training set or corresponding ground truth establishment process.

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For use by dentists in standard endodontic procedures using rotary endodontic files or reciprocating endodontic files or use by dentists in periodontics, endodontics, scaling, prosthesis procedures with ultrasonic tips.

The ENDO CENTER is an electric motor-driven handpiece combined with an ultrasonic scaler intended for root canal preparation procedures in endodontic industry. In ULTRASONIC mode, the device is able to drive piezo-electric resonator for root canal treatment at selectable power and fixed frequency . In ROTATING mode, the device is able to drive electrical micromotor for rotary files for root canal treatment at selectable speed and torque. In RECIPROCATING, mode, the device is able to drive electrical micromotor for reciprocating files for root canal treatment at selectable speed and rotational angle. The New Device is a combination of two existing devices already in consolidated use in endodontic field.

The provided text describes a 510(k) submission for a dental device called ENDO CENTER. This submission focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving performance against predefined acceptance criteria through a clinical study. Therefore, much of the requested information (such as sample sizes, expert qualifications, and adjudication methods for a clinical study) is not present in this document.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly define "acceptance criteria" in the typical sense of a clinical trial (e.g., a specific statistical endpoint to be met). Instead, the performance evaluation was conducted to demonstrate similarity to the predicate devices. The "evaluated Performances" section lists the parameters that were compared.

Study Proving Device Meets Acceptance Criteria:

The study conducted was a non-clinical bench test comparing the performance of the ENDO CENTER device to its predicate devices: I-ENDO DUAL (for motor functions) and SUPRASSON P5 NEWTRON (for ultrasonic functions). The document states, "After tests, the obtained results for the New Device have been directly compared to the Predicate Device Performances. The results of the comparison show that the Performances of the New Device and the Predicate Device are similar."

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

• Sample Size for Test Set: Not specified. The study was a non-clinical bench test, so "sample size" would likely refer to the number of units tested, but this information is not provided.
• Data Provenance: The tests were non-clinical bench tests, likely performed by the manufacturer (SATELEC) at their facility in France. The provenance is therefore internal R&D/engineering data. It is retrospective in the sense that the device was developed and then tested against existing predicate devices.

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

This information is not applicable as the study was a non-clinical bench test comparing technical specifications, not a clinical study requiring expert ground truth for diagnostic accuracy or similar endpoints. The "ground truth" was the technical specifications and measured performance of the predicate devices.

4. Adjudication Method for the Test Set

This is not applicable as the study was a non-clinical bench test. No human adjudication was involved in comparing the technical performance parameters.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This submission is for a dental handpiece and scaler, and the evaluation relies on demonstrating technical equivalence and safety based on existing technologies, not on human reader performance with or without AI assistance.

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

This is not applicable. The device is a physical dental instrument, not a medical AI algorithm. Therefore, "standalone algorithm performance" is not a relevant concept for this submission.

7. The Type of Ground Truth Used

For the non-clinical bench tests, the "ground truth" was essentially the measured performance and technical specifications of the predicate devices. The new device's performance (ultrasonic frequency, motor speed, motor torque) was compared directly to these established benchmarks of the predicate devices.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" in the context of this device. It is a physical medical device, not an AI model that requires training data.

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

This is not applicable, as there is no training set for this type of device.

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The medical device is used in association with a dental ultrasound handpiece to which an ultrasound instrument is attached. It is designed for the treatment of scaling (prophylaxis), periodontics, endodontics and prosthesis (preservation and restoration dentistry).

The Satelec New Device is a Dental Ultrasonic Generator. The Sateler New Device uses Piezoelectric Technology.The Satelec New Device uses a Satelec Dental Piezoelectric Plezonecht - Technology. The Satelec New Device can use the same Handpiece Harroplece (NEWTRON OElin). In Option the School (K050895, cleared April 20, 2005). The Satelec New Device is designed to be used with Satelec Dental Tips previously cleared with The Satelec New Device is Gesigned to be association of the St. 430, cleared February 23, 2012) or other new Satelec Dental Tips.

The provided text is a 510(k) Summary for the NEWTRON BOOSTER, an ultrasonic scaler. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than providing new clinical study data to prove safety and effectiveness for novel devices.

Therefore, the document explicitly states that no new clinical studies were conducted to establish acceptance criteria or demonstrate device performance. Instead, the device's characteristics and performance are compared to those of already cleared predicate devices.

Here's a breakdown of why the requested information about acceptance criteria and studies cannot be fully provided from the given text:

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

• This information is not present. The submission focuses on demonstrating similarity in technological characteristics, materials, design, and energy sources to predicate devices. There are no specific performance metrics or acceptance criteria presented in a table format.

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 as no new test set or study was conducted to generate performance data.

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 no new test set was created or evaluated by experts for ground truth establishment.

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

• Not applicable as no new test set.

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-assisted diagnostic tool.

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

• Not applicable. This device is hardware (ultrasonic scaler), not an algorithm. Its performance is demonstrated through substantial equivalence to existing devices.

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

• Not applicable as no new ground truth was established for a new study. The "ground truth" in this context is the established safety and effectiveness of the predicate devices.

8. The sample size for the training set:

• Not applicable as no new training set was used.

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

• Not applicable.

Summary of the document's approach:

The submission for the NEWTRON BOOSTER relies entirely on demonstrating substantial equivalence to two predicate devices:

• SUPRASSON P5 NEWTRON (K020892, cleared April 20, 2005)
• ProUltra Piezo Ultrasonic (K113430, cleared February 23, 2012)

The manufacturer asserts that the New Device is substantially equivalent by comparing the following:

• Intended Use: "The Satelec New Device Indications for Use is similar to the Satelec Predicate Devices."
• Technological Characteristics:
  • Uses the same Piezoelectricity Technology.
  • Casings are made of the same self-extinguishing material (UL94V-0).
  • Same Principle of User interface.
  • Uses the same or a derivated Dental Ultrasonic Handpiece (Satelec NEWTRON and NEWTRON SLIM Handpiece, which are based on the predicate device handpieces).
• Energy Source:
  • Uses the same input energy source (Electric Power Supply).
  • Delivers the same output energy source (ultrasonic micro-vibration).
  • Delivers the same Handpiece Current Values.
  • Delivers similar irrigation Flow values.
• External Structure: Very similar, made from the same raw material (UL94-V0) and uses a single function footswitch.
• Patient Contact Materials: The materials in contact with the patient are the same.

Conclusion stated in the document:
"Because of the used technologies, characteristics and performances are similar to the Satelec Predicate Devices, the characteristics of the Satelec New Device do not affect the Safety or the Effectiveness of the Predicate Devices, the Safety and Effectiveness is the same as of the Predicate Devices."

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The ProUltra Piezo Ultrasonic is a Dental Ultrasonic Generator intended for use with The Frookia , lead on for, scaling, periodontics, prosthesis and endodontic Dental Applications.

ProUltra Piezo Ultrasonic is a Dental Ultrasonic Generator.

This document is a 510(k) clearance letter from the FDA for a dental ultrasonic generator for use in scaling, periodontics, prosthesis and endodontics. It does not contain information about acceptance criteria or a study proving that a device meets those criteria. Therefore, I cannot fulfill your request based on the provided text.

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I-Endo Dual is indicated for use by dentists in standard endodontic procedures using endodontic files and endodontic drills.

The I ENDO DUAL is an electric motor-driven handpiece intended for root canal preparation procedures in the endodontic industry. It works in both reciprocating mode and continuous rotation.

The motor allows the dentist to program 10 settings of their choice for speed and torque control in rotating mode and to program 10 setting of their choice for speed and angles in reciprocating mode.

The device consists of a control unit with an LCD screen for selection of settings. A foot pedal is connected to the control unit so the dentist can selectively activate and deactivate the motor.

The provided text describes the acceptance criteria and the study that proves the device meets the acceptance criteria for the "I-ENDO DUAL" dental motor.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state a sample size in terms of the number of devices tested for the performance evaluations. It generally refers to "the I-ENDO DUAL" being tested.

The data provenance is not specified in terms of country of origin or whether it was retrospective or prospective. The testing was performed by a "Notified Laboratory."

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

This information is not provided. The study focuses on compliance with technical standards through laboratory testing rather than expert-derived ground truth.

4. Adjudication Method for the Test Set:

This information is not applicable and is not provided. The testing involves standardized laboratory measurements against defined technical standards, not expert adjudication of results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No, an MRMC comparative effectiveness study was not done. The document describes technical performance testing against standards and a comparison to a predicate device based on technical characteristics and intended use, not on human reader performance with or without AI assistance.

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

No, a standalone (algorithm only) performance study was not done, as the I-ENDO DUAL is a physical dental motor, not an AI algorithm. The performance data relates to the device's adherence to safety and electromagnetic compatibility standards.

7. The Type of Ground Truth Used:

The "ground truth" used in this context refers to the specified technical requirements and limits defined within the cited international and national standards (e.g., IEC 60601-1, IEC 60601-1-2, ISO 11498:1997). The device performance was compared against these predefined physical and electrical safety benchmarks.

8. The Sample Size for the Training Set:

This information is not applicable and is not provided. The I-ENDO DUAL is a physical medical device, not an AI system that requires a "training set."

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

This information is not applicable and is not provided, as the device is not an AI system requiring a training set.

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The intended use of the Satelec Implant Center is to supply utilities to and serve as a base for dental tools and accessories for use by qualified dental practitioners.

The Satelec Implant Center is a dental operative unit that supplies utilities to and serves as a base for dental tools and accessories for use by qualified dental practitioners.

The provided text is a 510(k) summary for a dental operative unit. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way a medical AI/ML device submission would. This document is for a physical medical device.

Therefore, I cannot extract the requested information as it is not present in the provided text.

Here's why and what kind of information is present instead:

• Type of Device: The "Implant Center" is described as a "dental operative unit that supplies utilities to and serves as a base for dental tools and accessories." This is a hardware device, not an AI/ML algorithm.
• Approval Type: This is a 510(k) premarket notification, which establishes substantial equivalence to a predicate device. This is a common pathway for physical medical devices and typically focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than proving specific performance metrics through a clinical study with detailed acceptance criteria.
• "Study" Information: The document states that the "Satelec Implant Center is substantially equivalent to the predicate device by Satelec, the Cocoon Hygienist (K040529)." This "substantial equivalence" is the core of the evaluation, not a performance study against acceptance criteria.
• Missing Details: There is no mention of sensitivity, specificity, AUC, or any other performance metrics typically associated with AI/ML diagnostic or assistive devices. Likewise, no human reader studies, ground truth establishment, sample sizes for test/training sets, or expert qualifications are discussed because they are not relevant to this type of device submission.

In summary, the provided document describes a traditional medical device (dental operative unit) and its 510(k) clearance process based on substantial equivalence, not an AI/ML device with performance studies against acceptance criteria.

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