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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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