(65 days)
Intended for use during dental procedures to:
-Remove supra and subgingival calculus and stains
- Remove ouple and Subge with simultaneous ultrasonic tip movement
- Scaling and root planning
- Releasing crowns, bridges, inlays and posts as well as condensing gutta percha
- Plugging for amalgam condensation
- Amalgam burnishing
- Preparing, cleaning, and irrigating root canals
- Preparing approximal cavities
- Cementing inlays and onlays
- Retrograde preparation of root canals
The Cleanse S+ is an ultrasonic scaler consisting of a main chassis containing an external electric power supply, controls for water flow and ultrasonic intensity, displays, and ultrasonic generator. The device is connected directly to a water supply for irrigation during use. A footswitch used for on/off control is connected to the main chassis by a footswitch cord. A handpiece is connected to the main chassis by a handpiece cord. Instruments (stainless steel tips) designed for specific dental procedure are attached to the distal end of the handpiece.
This submission pertains to the Cleanse S+ Ultrasonic Scaler.
1. A table of acceptance criteria and the reported device performance
The provided text does not contain explicit "acceptance criteria" for performance metrics in the traditional sense, nor does it report specific quantitative performance outcomes that would be measured against such criteria. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through comparisons of design, intended use, and non-clinical testing for safety standards.
The closest to a "performance" comparison is the table detailing "OUTPUT CHARACTERISTICS" between the Cleanse S+ and the predicate EMS miniPiezon.
| Characteristic | Acceptance Criteria (Predicate EMS miniPiezon) | Reported Device Performance (Cleanse S+) |
|---|---|---|
| Maximum output power with load | 8W | 8W |
| Frequency range available | 25-32 kHz | 24-32 kHz |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable. No clinical or performance testing involving a "test set" of patient data was conducted or described.
- Data Provenance: Not applicable. The submission states, "No clinical testing was conducted." The non-clinical tests relate to electrical safety and electromagnetic compatibility standards (IEC 60601-1, EN 55011, EN 60601-1-2).
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 clinical testing was performed, and therefore no "ground truth" was established by experts for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical testing was performed requiring adjudication.
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 an ultrasonic scaler, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No clinical testing was performed. The "ground truth" for demonstrating safety and effectiveness was based on adherence to recognized electrical and electromagnetic compatibility standards and comparison to a legally marketed predicate device.
8. The sample size for the training set
Not applicable. This device is an ultrasonic scaler. No training set for an algorithm was used.
9. How the ground truth for the training set was established
Not applicable. No training set for an algorithm was used.
§ 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.