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The Pmax Newtron XS is intended for use by qualified dental practitioners in the following dental applications:

Periodontics
Endodontics
Scaling
Prosthesis

The Pmax Newtron XS is an ultrasonic scaler for use by qualified dental practitioners in the four conventional dental applications of prophylaxis, periodontics, endodontics, and prosthesis.

The Pmax Newtron XS device uses piezoelectric ultrasound technology to generate mechanical microvibrations for ultrasonic scaling, with minimal trauma to soft tissue.

The Pmax Newtron XS™ function offers four utilization modes at pre-set ultrasound power settings. The power of the ultrasound can be finely adjusted by the user.

Range: Green, Ultrasound power: Low, Procedure: Periodontics mainly
Range: Yellow, Ultrasound power: Medium, Procedure: Endodontics mainly
Range: Blue, Ultrasound power: High, Procedure: Prophylaxis mainly
Range: Orange, Ultrasound power: Very high, Procedure: Prosthesis or Specific treatment modalities

Liquid irrigation is provided by two 300 mL self-contained solution tanks and the Newtron LED handpiece provides light and air functions. The light is provided by a light ring consisting of high-performance light-emitting diodes (LED) in the handpiece and air is delivered to the handpiece for air irrigation through connection of the control unit to the user's dental surgery's medical quality filtered air distribution system.

This 510(k) premarket notification (K071424) for SATELEC's Pmax Newtron XS ultrasonic scaler primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with specific acceptance criteria and performance metrics of the new device. Therefore, a direct response to some of the requested points is not possible from the provided text.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not contain a table of acceptance criteria or reported device performance metrics in the way typically found in studies for new features or algorithmic performance. The submission relies on establishing substantial equivalence to a predicate device.

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

Not applicable. The document describes a medical device (ultrasonic scaler), not a software algorithm that would typically have a "test set" in the context of AI/ML performance evaluation. The submission focuses on device characteristics and intended use.

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

Not applicable. This is not a study requiring expert-established ground truth.

4. Adjudication Method

Not applicable. This is not a study requiring adjudication.

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

Not applicable. This is not a comparative effectiveness study involving human readers or AI assistance.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This is a medical device, not a standalone algorithm.

7. Type of Ground Truth Used

Not applicable. The submission relies on demonstrating the safety and effectiveness of the device by showing its substantial equivalence to a legally marketed predicate device (Suprasson® P5 Newtron, K050895). The "ground truth" in this context is the established safety and effectiveness of the predicate device.

8. Sample Size for the Training Set

Not applicable. This is not a machine learning model, so there is no "training set."

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

Not applicable.

Summary of the Study and Acceptance Criteria (as per the 510(k) submission model):

The "study" in a 510(k) submission for substantial equivalence is a comparison of the new device to a predicate device. The acceptance criterion is that the new device (Pmax Newtron XS) is substantially equivalent to the predicate device (Suprasson® P5 Newtron, K050895) in terms of:

• Intended Use: Both are ultrasonic scalers for use by qualified dental practitioners in prophylaxis, periodontics, endodontics, and prosthesis.
• Technological Characteristics: Both use piezoelectric ultrasound technology to generate mechanical microvibrations for ultrasonic scaling.
• Performance: The submission asserts that "Differences that exist between the devices relating to technical specifications, performances and intended use are minor and do not affect the safety and effectiveness of the Pmax Newtron XS." While specific performance data is not provided in this summary, the FDA's clearance implies they were satisfied with the provided evidence of comparable performance and safety.

The FDA's letter states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent...". This acts as the "proof" that the device meets the acceptance criteria of substantial equivalence.

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