(431 days)
The ultrasonic scaler is intended to:
- Remove supra and sub gingival calculus deposits and stain from the teeth;
- Carry out periodontal pocket lavage with simultaneous ultrasonic tip movement;
- Clean and irrigate root canals.
Ultrasonic scaler employs piezoelectric technology to produce a steady power. It is composed of a control unit housing a generator that produces piezo-electric vibrations. The working instrument for the ultrasonic scaler is the handpiece, which is connected to the control unit via a handpiece cord. A scaling tip specific to a particular procedure is attached to the end of the handpiece. The ultrasonic scaler connects to an external water supply and delivers water via connected handpiece.
The provided text is related to the FDA 510(k) premarket notification for an Ultrasonic Scaler P7. This document is a regulatory submission demonstrating substantial equivalence to a predicate device, not a study proving device performance against specific acceptance criteria in a clinical context with human interaction.
Therefore, many of the requested categories for a study proving acceptance criteria cannot be extracted from this document, as it focuses on demonstrating safety and efficacy through non-clinical testing and comparison to an already approved device.
Here's the information that can be extracted and a clear indication of what cannot be found in this type of document:
1. A table of acceptance criteria and the reported device performance
This document does not present acceptance criteria in a tabulated format for clinical performance or a direct measure of human improvement with AI. Instead, it lists the non-clinical tests performed to demonstrate safety and performance equivalent to the predicate device.
| Acceptance Criteria Category | Reported Device Performance (as per document) |
|---|---|
| Electrical Safety | Tested according to IEC 60601-1: 2005+CORR. 1 (2006)+CORR. 2 (2007) and passed. |
| Electromagnetic Compatibility | Tested according to IEC 60601-1-2:2007 and passed. |
| Output Characteristics (Bench Testing) | Tested according to IEC 61205:1993 (Ultrasonics-Dental descaler systems-Measurement and declaration of the output characteristics) and performance is similar to the predicate device (both operate at 28kHz ± 3kHz). |
| Biocompatibility | Tested according to ISO 10993-5:2009 (in vitro cytotoxicity) and ISO 10993-10:2006 (irritation and skin sensitization) for the metal handpiece shell. Results passed. |
| Moist Sterilization Validation | Validated according to AAMI / ANSI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 (Consolidated Text) and passed. |
| Intended Use Equivalence | "has the same intended use" as the predicate device (removal of supra and sub gingival calculus deposits and stain, periodontal pocket lavage, clean and irrigate root canals). |
| Technology Equivalence | "both employ piezoelectric technology and produce ultrasonic vibrations at a frequency of 28kHz ± 3kHz". |
| Component Equivalence | "Have similar main components, i.e. control unit, handpiece cord, handpiece and detachable scaling tips." (Note: handpiece material changed, but biocompatibility validated). |
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not applicable in this context. The testing described is non-clinical bench testing and biocompatibility. For these types of tests, "sample size" would refer to the number of units tested, which is not specified in the summary document. It's not a clinical study involving patients or a test set of data like images.
- Data provenance (country of origin, retrospective/prospective): Not applicable for the non-clinical tests described. The tests were performed to international standards (IEC, ISO, AAMI/ANSI). The manufacturing country is China.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This document describes non-clinical testing and regulatory equivalence, not a clinical study with expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is not a study involving expert adjudication of clinical cases.
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
No. This is not an AI/software device, and no MRMC study was conducted or reported.
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. For the non-clinical tests, "ground truth" is established by the specifications and standards outlined (e.g., electrical safety standards, biocompatibility thresholds). The "ground truth" for showing equivalence is the performance characteristics of the predicate device.
8. The sample size for the training set
Not applicable. This is a physical device, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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.