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Periodontics Endodontics Scaling Prosthesis Please refer to the attached listing for a complete description. Periodontics: - Root planing . - Initial therapy . - Treatment of periodontal pockets . - Treatment of furcations . - Maintenance therapy . - Implant maintenance . Endodontics: - Canal preparation . - Canal cleaning . - Canal filling . - Gutta percha condensation . - Treatment resumption . - Retro Surgery . - Micro Retro Surgery . Scaling (prophylaxis): - 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…) .

The SUPRASSON P5 NEWTRON is a multi-purpose piezoelectric ultrasonic generator: it is an upgraded generation of the SUPRASSON P5 Booster Piezoelectric Ultrasonic Scaling Generators from SATELEC which received 510(k) clearance for dental applications (K961158) on May 23, 1996, including the technology of the SP NEWTRON module which received 510(K) clearance for dental applications (K033764) on March 1, 2004. The SUPRASSON P5 NEWTRON maintains all the functions and the key components of the SUPRASSON P5 Booster and SP NEWTRON Module; it is a stand-alone device manufactured by SATELEC, all with the same components and materials used in the manufacture of the original SUPRASSON P5 Booster and SP NEWTRON module. The intended use, technical performance, and clinical indications are equivalent to those of their predicate devices, the SUPRASSON P5 Booster (K961158) and SP NEWTRON Module (K033764). The SUPRASSON P5 NEWTRON consists of three main components: the ultrasonic handpiece instrument, the control panel case, and the footswitch. The ultrasonic handpiece instrument (cleared by FDA - K033764) is held in the physician's hand, but it can also be stored in the holder located onto the case. The handpiece is connected to the control panel case via a fixed electrical cable connection.

The provided text does not contain information about acceptance criteria for a device, nor does it detail a study that proves a device meets such criteria.

The document is a 510(k) summary for the "SUPRASSON P5 NEWTRON" piezoelectric ultrasound scaling generator, seeking FDA clearance. It describes:

• Submitter Information: SATELEC, France.
• Device Identification: SUPRASSON P5 NEWTRON, an ultrasonic scaler.
• Predicate Devices: SUPRASSON P5 Booster (K961158) and SP NEWTRON Module (K0033764). The new device is stated to be substantially equivalent to these previously cleared devices.
• Device Description: A multi-purpose piezoelectric ultrasonic generator, an upgraded generation maintaining functions and key components of the predicate devices. It consists of an ultrasonic handpiece instrument, control panel case, and footswitch.
• FDA Clearance Letter: Confirms the 510(k) clearance for the SUPRASSON P5 NEWTRON (K050895) based on substantial equivalence to predicate devices.
• Indications For Use: Specifies the dental applications in Periodontics, Endodontics, Scaling (prophylaxis), and Prosthesis (conservative/restorative).

The document focuses on establishing substantial equivalence to previously cleared devices for FDA marketing clearance, rather than presenting a performance study with acceptance criteria. Therefore, most of the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types for training/test sets) is not available in the provided text.

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The BONART CO., LTD. ART Ultrasonic Scaler is intended for use during dental cleaning and periodontal therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.

The Bonart ART-P3 comes equipped with a turbo mode and can be operated in scaling or perio mode functions. The Bonart ART Ultrasonic Scaler ART-P3 is equipped with water adjustment and power adjustment. The unit is operated by a footswitch and comes complete with a handpiece. The handpiece is compatible with EMS ,SATELEC and Bonart tips.

The provided document is a 510(k) premarket notification for the ART Ultrasonic Scaler ART-P3. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than independent performance studies to meet acceptance criteria in the same way a de novo or PMA submission might.

Therefore, the information you're looking for regarding acceptance criteria and a study proving the device meets them, especially in the context of AI/algorithm performance, multi-reader studies, and ground truth establishment, is not present in this document. The document describes a traditional medical device (ultrasonic scaler), not an AI-powered diagnostic or therapeutic device.

Here's why each point you requested cannot be addressed from this document:

1. Table of acceptance criteria and reported device performance: This document explicitly states in section 14.8 that "The Bonart ART Ultrasonic Scaler ART-P3 was subjected to performance bench testing in accordance with applicable industry and clinical standards. Physical performance studies were conducted to verify that the Bonart ART Ultrasonic Scaler ART-P3 conformed to all emission and immunity standards in accordance with EN and IEC regulations. Results of the testing showed that the Bonart ART Ultrasonic Scaler ART-P3 performs as intended." However, it does not provide specific quantitative acceptance criteria (e.g., in terms of sensitivity, specificity, accuracy, F1-score) or reported device performance metrics against those criteria. It only states that the device "conformed" and "performs as intended."

2. Sample size used for the test set and the data provenance: Not applicable. This device is not an AI/algorithm that uses test sets or data. The "performance bench testing" mentioned would refer to engineering and electrical safety tests, not data-driven human performance or AI performance tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no mention of "ground truth" or expert review in the context of this device being an ultrasonic scaler.

4. Adjudication method for the test set: Not applicable.

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 not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.

8. The sample size for the training set: Not applicable. There is no AI model to train.

9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) premarket notification for a physical medical device (ultrasonic scaler). The "performance data" described refers to compliance with safety and electrical standards through bench testing, not to the kind of clinical performance or AI algorithm validation you're asking about.

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