(229 days)
This medical device is intended for prophylaxis, including scaling, for periodontics, for endodontics, and for preservation and restoration dentistry, including prosiblesis.
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 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 a 510(k) submission for a dental ultrasonic scaler, the NEWTRON P5 XS B.LED. The submission focuses on establishing substantial equivalence to previously cleared predicate devices through bench testing and comparison of technological characteristics, rather than a de novo study with acceptance criteria for device performance in a clinical setting. Therefore, many of the requested elements regarding acceptance criteria and study details (like sample size for test/training sets, ground truth establishment, expert qualifications, MRMC studies) are not applicable or not provided in this type of submission.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission based on substantial equivalence, there are no explicitly stated "acceptance criteria" in the traditional sense of a clinical trial showing performance against a benchmark. Instead, the "acceptance" is based on demonstrating similarity to predicate devices in key performance areas.
| Parameter Evaluated | Predicate Device Performance (Satelec PMAX NEWTRON XS - K071424) | NEWTRON P5 XS B.LED Performance | Acceptance/Similarity Criteria |
|---|---|---|---|
| Irrigation Flow | Measured values | Similar measured values | Similar irrigation flow values for considered clinics. Demonstrated through bench testing (Section 019 "Performance Testing - Bench"). |
| Current delivered in Piezoelectric Handpiece | Measured values | Similar measured values | Similar current delivered in the piezoelectric handpiece. Demonstrated through bench testing (Section 019 "Performance Testing - Bench"). |
| Electromagnetic Compatibility | Conforms to IEC 60601-1-2:2007 | Conforms to IEC 60601-1-2:2007 | Compliance with the standard. (Tests performed according to IEC 60601-1-2:2007). |
| Electrical Safety | Conforms to IEC60601-1:2005 | Conforms to IEC60601-1:2005 | Compliance with the standard. (Tests performed according to IEC60601-1:2005). |
| Sterilization Validation | Conforms to ISO 17665-1:2006 and ISO 17665-2:2009 | Conforms to ISO 17665-1:2006 and ISO 17665-2:2009 | Compliance with the standards. (Tests performed according to ISO 17665-1:2006 and ISO 17665-2:2009). |
| Technological Characteristics | Same technology (Piezoelectricity), casing material (UL94V-0), user interface, handpiece type | Same technology (Piezoelectricity), casing material (UL94V-0), user interface, handpiece type | "Similar" and "same" technological characteristics as predicate devices. The identified differences have no impact on intended use, safety, and effectiveness. |
| Energy Source | Same input (Electric Mains), same output (ultrasonic micro-vibration), same Handpiece Current, similar Irrigation Flow | Same input (Electric Mains), same output (ultrasonic micro-vibration), same Handpiece Current, similar Irrigation Flow | "Same" and "similar" energy source parameters as predicate devices. |
| Light Function | Same principle of LED ring, Optical Guide, quantity of LEDs, reference of LEDs, color of light | Same principle of LED ring, Optical Guide, quantity of LEDs, reference of LEDs, color of light | "Same" light function as predicate devices; does not induce temperature rise. |
2. Sample sized used for the test set and the data provenance
- Test Set Size: Not applicable. No clinical test set with human subjects/data was used for this 510(k) submission. The testing involved bench data and comparison of technical specifications to predicate devices.
- Data Provenance: Not applicable. The "data" primarily consists of engineering specifications, performance measurements (irrigation flow, current) from bench testing, and comparisons to predicate device data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. As no clinical test set requiring expert ground truth was performed, this information is not provided.
4. Adjudication method for the test set
- Not applicable. No clinical test set requiring adjudication was performed.
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, not an AI-powered diagnostic imaging tool, and no MRMC study was conducted or is relevant to this device's regulatory pathway.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is not an algorithm or AI system. Its performance is evaluated through its physical and electrical characteristics.
7. The type of ground truth used
- The "ground truth" for this submission is based on bench testing results and technical specifications of the NEWTRON P5 XS B.LED compared against the established safety and effectiveness of the legally marketed predicate devices. The claim is that the new device is "similar" and therefore equally safe and effective.
8. The sample size for the training set
- Not applicable. There is no AI component, and thus no "training set."
9. How the ground truth for the training set was established
- Not applicable. There is no AI component, and thus no "training set" or corresponding ground truth establishment.
§ 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.