(151 days)
The Power Plus 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 Power Plus Scaler is available in two models: a 25 kHz power output and a 30 kHz power output. The Power Plus comes equipped with a turbo mode and can be operated in scaling or perio mode functions. The Power Plus Scaler 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 Cavitron® and TPC Advance Technology tips.
The provided document describes the "Power Plus Scaler," an ultrasonic scaler for dental cleaning.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria in terms of specific performance metrics (e.g., how much calculus removed, depth of cleaning, etc.) with numerical targets. Instead, the "acceptance criteria" are implied by the performance bench testing conducted to verify conformity to "all emission and immunity standards" and the conclusion that the device "performs as intended."
| Criteria Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Functional Performance | Device performs intended function (remove calculus deposits from teeth using ultrasonic vibrating tip). | "Power Plus Scaler performs as intended." |
| Bench Testing Conformity | Conforms to applicable industry and clinical standards. | "Physical performance studies were conducted to verify that the Power Plus Scaler conformed to all emission and immunity standards in accordance with EN and IEC regulations." |
| Emission & Immunity Standards | Conforms to all emission and immunity standards in accordance with EN and IEC regulations. | "Conformed to all emission and immunity standards in accordance with EN and IEC regulations." |
| Substantial Equivalence | Device is substantially equivalent to predicate devices (Parkell Turbo 25/30 Ultrasonic Scaler, Tony Riso Co. 25/30 Multi-Function Ultrasonic Scaler). | "The Power Plus Scaler is substantially equivalent to the Turbo 25/30 Ultrasonic Scaler... and to the 25/30 Multi-Function Ultrasonic Scaler." |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "performance bench testing in accordance with applicable industry and clinical standards" and "physical performance studies." However, it does not specify any sample size for a test set (e.g., number of teeth, number of scaling procedures, etc.).
There is no information provided on data provenance regarding country of origin or whether the data was retrospective or prospective clinical data. The studies described are bench tests, not clinical trials on human subjects.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not mention the use of experts to establish ground truth for any test set, as the testing described is primarily bench testing against technical standards. It does not refer to clinical evaluations or expert assessments of clinical outcomes.
4. Adjudication Method for the Test Set
Since no clinical test set requiring expert interpretation or human assessment is described, there is no adjudication method mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study. The studies mentioned are bench tests on the device itself, not studies comparing human readers' performance with and without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-loop Performance) Study
The device described is a physical medical instrument (an ultrasonic scaler), not a software algorithm or an AI product. Therefore, the concept of a "standalone (algorithm only without human-in-the-loop performance)" study does not apply to this device.
7. Type of Ground Truth Used
The "ground truth" for the bench testing would be the technical specifications and regulatory standards (e.g., EN and IEC regulations for emission and immunity) that the device was tested against. There's no mention of pathology, outcomes data, or expert consensus in a clinical sense as ground truth for these tests.
8. Sample Size for the Training Set
The document does not mention a training set. This is consistent with the device being a physical instrument undergoing bench testing, not a machine learning model requiring a training dataset.
9. How the Ground Truth for the Training Set Was Established
Since there is no training set mentioned, this information is not applicable and not provided.
§ 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.