(89 days)
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.
| Characteristic / Acceptance Criterion (Predicate Device Value) | NEWTRON CAN A Performance | Result / Impact on Safety/Effectiveness |
|---|---|---|
| Intended Use (Identical to Predicate) | Identical | Identical |
| Knumber (K033764) | K233922 | Identical |
| Product Code (ELC) | ELC | Identical |
| Common or Usual Name (Ultrasonic Scaler) | Ultrasonic Scaler | Identical |
| Classification Name (21 CFR 872.4850) | 21 CFR 872.4850 | Identical |
| Regulation Identification (Ultrasonic Scaler definition) | Identical | Identical |
| Regulatory Class (II) | II | Identical |
| Height (mm) (33) | 36.6 | No Impact (#01) |
| Depth (mm) (50) | 59.5 | No Impact (#02) |
| Width (mm) (60) | 85.95 | No Impact (#03) |
| Weight (g) (130) | 160 | No Impact (#04) |
| Mounting Unit (Embedded in Dental Delivery System) | Embedded | Identical |
| Typical Voltage (VAC) (24) | 24 | Identical |
| Minimum Voltage (VAC) (21.5) | 18.8 | No Impact (#05) |
| Maximum Voltage (VAC) (27.6) | 28.5 | No Impact (#06) |
| Input Frequency (Hz) (50 or 60) | 50 or 60 | Identical |
| Maximum Current Consumption (AC) (1) | 1.2 | No Impact (#07) |
| Maximum Power Consumption (VA AC) (26) | 29 | No Impact (#08) |
| Maximum Idle Current Consumption (mA AC) (100) | 100 | Identical |
| Maximum Idle Power Consumption (VA AC) (2) | 2 | Identical |
| Electrical Safety Class (B type) | B type | Identical |
| Fire aspects (for Casing) (UL94-V0) | UL94-V0 | Identical |
| Electrical Technology (NEWTRON Technology) | NEWTRON Technology | Identical |
| Minimum Output Frequency (KHz) (28) | 28 | Identical |
| Maximum Output Frequency (KHz) (36) | 36 | Identical |
| Minimum Output Power in Handpiece (mW) (10) | 10 | Identical |
| Maximum Output Power in Handpiece (W) (12) | 12 | Identical |
| Minimum Output Current in Handpiece (mA) ($8 \pm 10%$) | $8 \pm 10%$ | Identical |
| Maximum Output Current in Handpiece (mA) ($100 +20% -10%$) | $100 +20% -10%$ | Identical |
| Power Factor (More than 0.65) | More than 0.65 | Identical |
| Standard LED Ring Output Current (mA DC) (Not applicable for predicate) | 45 | No Impact (#10) |
| Low Voltage LED Ring Output Current (mA DC) (800) | $135 \pm 15$ | No Impact (#11) |
| Maximum Open Voltage (V DC) (5) | 14 | No Impact (#12) |
| Maximum Short-circuit Current (mA DC) (1000) | 180 | No Impact (#13) |
| Quantity of Connectors (2) | 3 | No Impact (#14) |
| Power Supply Connector (1) | 1 | No Impact (#15) |
| Command Connector (1 (one the same connector)) | 1 | No Impact (#16) |
| Handpiece Connector (1) | 1 | Identical |
| Type of Command / Input Setting (Digital Signal stepped in Volts 0 to 5 Volts) | Digital Values 0 to 100 Contained in the communication frame | No Impact (#17) |
| Where used (Dental Office) | Dental Office | Identical |
| Thermal Cooling (Natural Convection) | Natural Convection | Identical |
| Operating Temperature (+10°C to +30°C) | +10°C to +30°C | Identical |
| Storage Temperature (-20°C to +70°C) | 0°C to +50°C | No Impact |
| Operating Humidity (30% to 75%) | 30% to 75% | Identical |
| Storage Humidity (10% to 100%) | 10% to 95% | Identical |
| Operating Pressure (800 hPa to 1060 hPa) | 800 hPa to 1060 hPa | Identical |
| Storage Pressure (500 hPa to 1060 hPa) | 500 hPa to 1060 hPa | Identical |
| Maximum Operating Altitude (Less than 2000 m) | Less than 2000 m | Identical |
| Safety Standard (IEC 60601-1) | IEC 60601-1 | Identical |
| EMC Standard (IEC 60601-1-2) | IEC 60601-1-2 | Identical |
| Location of Fixation (Fixed in Dental Delivery System) | Fixed | Identical |
| Principles of fixation (Mounting bracket fixed with 2 screws) | Mounting bracket fixed with 2 screws | Identical |
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.
§ 872.4850 Ultrasonic scaler.
(a)
Identification. An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.(b)
Classification. Class II.