(151 days)
The medical device is used in association with a dental ultrasound handpiece to which an ultrasound instrument is attached. It is designed for the treatment of scaling (prophylaxis), periodontics, endodontics and prosthesis (preservation and restoration dentistry).
The Satelec New Device is a Dental Ultrasonic Generator. The Sateler New Device uses Piezoelectric Technology.The Satelec New Device uses a Satelec Dental Piezoelectric Plezonecht - Technology. The Satelec New Device can use the same Handpiece Harroplece (NEWTRON OElin). In Option the School (K050895, cleared April 20, 2005). The Satelec New Device is designed to be used with Satelec Dental Tips previously cleared with The Satelec New Device is Gesigned to be association of the St. 430, cleared February 23, 2012) or other new Satelec Dental Tips.
The provided text is a 510(k) Summary for the NEWTRON BOOSTER, an ultrasonic scaler. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than providing new clinical study data to prove safety and effectiveness for novel devices.
Therefore, the document explicitly states that no new clinical studies were conducted to establish acceptance criteria or demonstrate device performance. Instead, the device's characteristics and performance are compared to those of already cleared predicate devices.
Here's a breakdown of why the requested information about acceptance criteria and studies cannot be fully provided from the given text:
1. A table of acceptance criteria and the reported device performance:
- This information is not present. The submission focuses on demonstrating similarity in technological characteristics, materials, design, and energy sources to predicate devices. There are no specific performance metrics or acceptance criteria presented in a table format.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable as no new test set or study was conducted to generate performance 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 as no new test set was created or evaluated by experts for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as no new test set.
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-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is hardware (ultrasonic scaler), not an algorithm. Its performance is demonstrated through substantial equivalence to existing devices.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable as no new ground truth was established for a new study. The "ground truth" in this context is the established safety and effectiveness of the predicate devices.
8. The sample size for the training set:
- Not applicable as no new training set was used.
9. How the ground truth for the training set was established:
- Not applicable.
Summary of the document's approach:
The submission for the NEWTRON BOOSTER relies entirely on demonstrating substantial equivalence to two predicate devices:
- SUPRASSON P5 NEWTRON (K020892, cleared April 20, 2005)
- ProUltra Piezo Ultrasonic (K113430, cleared February 23, 2012)
The manufacturer asserts that the New Device is substantially equivalent by comparing the following:
- Intended Use: "The Satelec New Device Indications for Use is similar to the Satelec Predicate Devices."
- Technological Characteristics:
- Uses the same Piezoelectricity Technology.
- Casings are made of the same self-extinguishing material (UL94V-0).
- Same Principle of User interface.
- Uses the same or a derivated Dental Ultrasonic Handpiece (Satelec NEWTRON and NEWTRON SLIM Handpiece, which are based on the predicate device handpieces).
- Energy Source:
- Uses the same input energy source (Electric Power Supply).
- Delivers the same output energy source (ultrasonic micro-vibration).
- Delivers the same Handpiece Current Values.
- Delivers similar irrigation Flow values.
- External Structure: Very similar, made from the same raw material (UL94-V0) and uses a single function footswitch.
- Patient Contact Materials: The materials in contact with the patient are the same.
Conclusion stated in the document:
"Because of the used technologies, characteristics and performances are similar to the Satelec Predicate Devices, the characteristics of the Satelec New Device do not affect the Safety or the Effectiveness of the Predicate Devices, the Safety and Effectiveness is the same as of the Predicate Devices."
§ 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.