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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 Forest Dental Units are intended to serve as a base for ancillary dental devices and accessories by providing air, water, vacuum, and low voltage electrical power to hand-held dental instruments. The Forest Dental Units are intended for use by dental practitioners to provide diagnostic treatment to dental patients in a clinical environment.

The Forest Dental Unit serves as a base for ancillary dental devices and accessories by providing air, water, vacuum, and low voltage electrical power to hand-held dental instruments. The controls are contained in a Doctor's Unit, Assistant's Instrumentation Unit, Duo Unit (both Doctor's and Assistant's Control) and Cuspidor and are configured in a variety of mounts. Additional accessory items include a pneumatic unit foot control, utility center (aka junction box) that houses a power supply and air/water regulators, hoses, trays, and mounting assemblies. The dental unit is supplied air and water from the utility connections through air/water regulators via the umbilical chase. The dental unit is supplied SELV-24VAC from the output of the power supply, also routed through the umbilical chase and terminated on an internal terminal strip.

This document is a 510(k) Premarket Notification for the "Forest Dental Unit," a Class I device. The submission aims to demonstrate substantial equivalence to a predicate device, the "SPIRIT – K143696" dental delivery unit manufactured by Pelton & Crane.

Here's an analysis of the provided information concerning acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal, explicit table of "acceptance criteria" in the traditional sense of measurable performance metrics with pass/fail thresholds. Instead, it relies on demonstrating equivalence to a predicate device and compliance with various standards. The "reported device performance" is largely communicated through declarations of compliance with these standards and the successful outcome of testing.

However, we can infer some "acceptance criteria" from the comparative table (Table 5.2) and the descriptions of testing performed.

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

The document does not specify a "test set" in terms of patient data or a specific number of devices tested in a clinical trial setting. The evaluation is primarily based on:

• Engineering and Performance Testing: This involves testing physical devices (Forest Dental Unit models) against established standards (e.g., electrical safety, mechanical, biocompatibility, sterilization, cleaning, waterline disinfection). The number of individual units subjected to each specific test is not detailed, but it's implied that representative samples were tested to demonstrate compliance.
• Predicate Comparison: The comparison is made against the specifications and known performance of the Pelton & Crane Spirit 1500 (K143696) dental operative unit.

Therefore, the concept of "data provenance" (country of origin, retrospective/prospective) related to a patient-based test set is not applicable here as no clinical study with human subjects or patient data is described. The data provenance is from laboratory and engineering testing of the device components and systems.

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

This information is not applicable. The "ground truth" for this type of submission is established by engineering standards, regulatory requirements, and the characteristics of the predicate device. There is no mention of experts being used to establish ground truth for a clinical test set, as no such clinical test set is described. The compliance with standards and the demonstration of substantial equivalence are likely evaluated by internal qualified personnel (engineers, quality assurance) and potentially third-party testing labs.

4. Adjudication Method for the Test Set

This information is not applicable, as there is no clinical test set with human subjects and associated interpretations that would require an adjudication method. The evaluation method relies on objective measurements against engineering standards and a direct comparison to the predicate device's specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. The Forest Dental Unit is a physical dental care delivery system, not an AI-powered diagnostic or therapeutic device that would involve "human readers" or AI assistance.

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

This information is not applicable, as the device is not an algorithm or AI system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this submission is multi-faceted and derived from:

• Engineering Standards: Compliance with recognized international and national standards (e.g., ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 80601-2-60, ISO 7494-1, ISO 7494-2, ISO 14971, IEC 62366, ISO 10993-1, ISO 10993-5, ISO 17655-1, ISO 16954). The pass/fail criteria for these tests define the "ground truth" for performance and safety.
• Predicate Device Specifications: The detailed characteristics and performance of the legally marketed predicate device (Pelton & Crane Spirit 1500, K143696) serve as a benchmark for substantial equivalence.
• Biocompatibility/Material Safety: EPA standards for drinking water and established ISO standards for biocompatibility (e.g., cytotoxicity, irritation) define the "ground truth" for material safety.

8. The Sample Size for the Training Set

This information is not applicable. The Forest Dental Unit is a physical medical device, not a machine learning or AI model, and therefore does not involve a "training set."

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

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

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