(90 days)
Periodontics
Endodontics
Scaling
Prosthesis
Please refer to the attached listing for a detailed 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 Piezotome™ is an ultrasonic scaler for use by dental practitioners.
The Piezotome™ device uses piezoelectric ultrasound technology to generate mechanical microvibrations for ultrasonic scaling, with minimal trauma to soft tissue.
In Newtron® function, it can be used for mechanical ultrasound treatment in prophylaxis, periodontics, endodontics or prosthesis.
This device is fitted with two handpiece cord connectors. Depending on the application, the practitioner may connect two handpieces at the same time.
The Piezotome™ function offers four utilization modes at pre-set ultrasound power settings. In Newtron® function, the power of the ultrasound can be finely adjusted by the user.
| Range | Ultrasound power | Procedure |
|---|---|---|
| Green | Low | Periodontics mainly |
| Yellow | Medium | Endodontics mainly |
| Blue | High | Prophylaxis mainly |
| Orange | Very high | Prosthesis or Specific treatment modalities |
The user regulates the flow rate of the irrigation fluid.
The practitioner controls the device using a keyboard and a multi-function footswitch.
The irrigation fluid flow rate and the ultrasound power are monitored on a screen. For enhanced efficacy, the last settings are memorized by the machine.
This document is a 510(k) Summary for the SATELEC Piezotome™ ultrasonic scaler, which seeks to prove substantial equivalence to a predicate device, the Suprasson® P5 Newtron (K050895). As such, it does not contain the information requested for a detailed study description with acceptance criteria, sample sizes, expert qualifications, and comparison to AI performance. This type of regulatory document primarily focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than providing a detailed scientific study with defined acceptance criteria and performance metrics in the way you've outlined.
Therefore, many of the requested fields cannot be filled from the provided text.
Here is what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or detailed reported device performance in the way a clinical study report would. The basis for clearance is "substantial equivalence" to a predicate device.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a regulatory submission for substantial equivalence, not a clinical study with a test set of data.
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. No ground truth establishment from experts for a test set is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set or adjudication method is mentioned.
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 device is an ultrasonic scaler; it is not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No such ground truth data is presented. The "ground truth" for regulatory clearance is the performance and safety established for the predicate device.
8. The sample size for the training set
Not applicable. This is not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
Summary of available information related to the device and its regulatory clearance:
- Device Name: Piezotome™
- Device Type: Ultrasonic scaler
- Predicate Device: Suprasson® P5 Newtron (K050895) by Satelec
- Basis for Clearance: Substantial Equivalence to the predicate device. The document explicitly states: "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 Piezotome™."
- Operating Modes/Power Settings:
- Green: Low (Periodontics mainly)
- Yellow: Medium (Endodontics mainly)
- Blue: High (Prophylaxis mainly)
- Orange: Very high (Prosthesis or Specific treatment modalities)
- Indications for Use (from Enclosure):
- 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).
In conclusion, the provided document is a regulatory submission demonstrating substantial equivalence, not a detailed study report with the specific metrics and study design elements you requested.
§ 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.