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The ultrasonic scaler is intended to:

1. Remove supra and sub gingival calculus deposits and stain from the teeth;
2. Carry out periodontal pocket lavage with simultaneous ultrasonic tip movement;
3. Clean and irrigate root canals

The Ultrasonic scaler employs piezoelectric technology to produce a steady power. It is composed of a control unit housing a generator that produces piezo-electric vibrations. The working instrument for the ultrasonic scaler is the handpiece, which is connected to the control unit via a handpiece cord. A scaling tip specific to a particular procedure is attached to the end of the handpiece. The ultrasonic scaler models VET-W3 and VST-W3 connect to an external water supply and delivers water via connected handpiece.
Ultrasonic scaler consists of main generator, VE and VS handpiece, optional scaler tips (G series, P series, E series), power adapter and foot switch;
The main part is as follows:

1. Power adapter: DC 24V, input frequency: 3-20W
2. Main engine: The main engine is the major part of the circuit control, including ultrasonic pulse circuit, modulator circuit and oscillatory circuit. It is used for converting the ultrasonic oscillatory signal to ultrasonic mechanical oscillatory signal by magnifying and improving the vibrating frequency.
3. Handpiece: It mainly converts the signal from circuit,which will drive the ultrasonic scaler tips vibrating.
4. Scaler tip: The scaler tip is used to remove the calculus and plague by vibrating on the teeth surface.

This document describes a 510(k) premarket notification for an Ultrasonic Scaler, which is a dental device. The request asks for details related to acceptance criteria and a study proving the device meets those criteria, typically found in submissions for Artificial Intelligence (AI) or machine learning (ML) enabled medical devices.

However, the provided text does NOT describe an AI/ML-enabled device or a study designed to evaluate its performance against specific acceptance criteria for AI/ML outputs.

The document states:

• "Clinical evaluation is not applicable for the proposed device." (Page 6)
• The comparison is primarily focused on technological characteristics and bench testing against existing standards (IEC, ISO), not clinical performance metrics related to AI/ML.
• The device is an "Ultrasonic Scaler" for removing calculus and stain, periodontal pocket lavage, and root canal cleaning. This is a mechanical device, not described as having any AI or ML components.

Therefore, many of the requested points, such as "effect size of how much human readers improve with AI vs without AI assistance," "standalone (i.e. algorithm only without human-in-the loop performance)," "number of experts used to establish ground truth," and "sample size for training set," are not applicable to the content of this 510(k) submission.

Based on the provided text, I can only address how the device's equivalence and safety were established, not how an AI/ML component meets specific performance criteria.

Summary of Device Acceptance (for a non-AI/ML device based on this 510(k)):

The acceptance of the "Ultrasonic Scaler" (Models VET-W3, VST-W3, VET-1, VST-1) is based on demonstrating substantial equivalence to a legally marketed predicate device (Nanning Baolai Medical Instruments Co., Ltd.'s Ultrasonic scaler P7, K140233) rather than proving performance against specific AI/ML acceptance criteria.

The acceptance involves showing the proposed device has the same intended use, similar product design, same sterilization conditions, and comparable technological characteristics as the predicate device. Bench testing against recognized international standards was conducted to support safety and performance.

1. Table of acceptance criteria and reported device performance:

1. Remove supra and sub gingival calculus deposits and stain from the teeth;
2. Carry out periodontal pocket lavage with simultaneous ultrasonic tip movement;
3. Clean and irrigate root canals. | Same as predicate device. |
   | Technological Characteristics (similar to predicate) | Working Principle: Piezoelectric effect (same as predicate)
   Sterilization: Handpiece: autoclaved 135°C/0.22MPa; Scaler tip: autoclaved high temp/pressure (same as predicate)
   Operating Conditions: Temp 5-40℃, RH 30-80%, Pressure 50-106kPa (same as predicate)
   Storage Conditions: Temp -10-+50℃, RH ≤ 80%, Pressure 50-106kPa (same as predicate) | Key technological aspects are similar. |
   | Power Supply (meet safety standards) | Input voltage: 30VDC 50HZ; Output power: 3-20W. (Predicate: 24VDC 1.5A 50HZ, 3-20W) | Slight difference in input voltage, but both meet IEC 60601-1. |
   | Safety and Performance Standards Compliance | IEC 60601-1:2006+A1:2012 (Electrical safety)
   IEC 60601-1-2:2007 (EMC)
   IEC 61205:2001 (Measurement & declaration of output characteristics)
   ISO 10993-5:2009 (Biocompatibility - cytotoxicity)
   ISO 10993-10:2010 (Biocompatibility - irritation/sensitization) | All listed standards were used for non-clinical bench testing. |
   | Software Level of Concern | Moderate (same as predicate) | Addressed as "Moderate." (Details on software testing not provided in text). |

2. Sample size used for the test set and the data provenance:

• Not applicable for AI/ML performance testing.
• The device underwent bench testing against international standards (IEC, ISO). This typically involves testing a few representative units to confirm compliance with electrical safety, EMC, performance characteristics, and biocompatibility. The specific number of units tested is not detailed in this summary, but it would not be a "sample size" in the context of AI/ML validation with a large dataset.
• Data provenance for such tests would be from the manufacturer's internal testing labs, likely in China (based on submitter's address). These are prospective tests performed to demonstrate compliance.

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

• Not applicable. This device is not an AI/ML device requiring human expert annotation for ground truth. Ground truth for this device is based on physical measurements of device characteristics against engineering and safety standards.

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

• Not applicable. There was no human reader/adjudication involved in establishing ground truth for performance of this mechanical 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, this was not done. This is a mechanical dental device, not an AI/ML tool designed to assist human readers.

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

• Not applicable. This is not an algorithm. Device performance was assessed via bench tests.

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

• For this type of device, "ground truth" is typically defined by established engineering standards and specifications. For example, electrical safety is confirmed by measuring parameters against limits set in IEC 60601-1, and biocompatibility is assessed by testing against ISO 10993 standards. It's objective measurement against a known reference, not human expert consensus on diagnostic image interpretation.

8. The sample size for the training set:

• Not applicable. This device does not use an AI/ML training set.

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

• Not applicable. This device does not have a training set or associated ground truth.

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