(63 days)
The Sonendo GentleWave(R) System is intended to prepare, clean, and irrigate teeth indicated for root canal therapy. When used with the Sonendo GentleWave(R) Molar Handpiece, the System is indicated for 1st and 2nd molar teeth. When used with the Sonendo GentleWave(R) Anterior/Premolar Handpiece, the System is indicated for and premolar teeth.
The Sonendo GentleWave® System is a medical device intended to prepare, clean and irrigate root canals. The Sonendo GentleWave® System is comprised of a Console, and a disposable single-use Handpiece. The Handpiece is offered in two versions: a Molar Handpiece which is intended to be used on 1st and 2nd molar teeth and an Anterior/Premolar Handpiece which is intended to be used on anterior and pre-molar teeth.
The provided text is a 510(k) premarket notification summary for the Sonendo GentleWave® System, which is an ultrasonic scaler for root canal therapy. It does not describe a study involving specific acceptance criteria and device performance metrics in the way that would typically be done for a new AI/medical device with diagnostic or prognostic capabilities where accuracy, sensitivity, or specificity are key.
Instead, this document is a submission to demonstrate substantial equivalence to a legally marketed predicate device (Sonendo GentleWave® System K153157) under the FDA's 510(k) pathway. The primary "acceptance criteria" here relate to demonstrating that the modified device (K160905) is as safe and effective as the predicate device, despite a change in the ability to select treatment fluid concentrations.
Therefore, the information requested cannot be fully provided in the context of this document as it focuses on demonstrating equivalence rather than establishing performance against new clinical endpoints or diagnostic accuracy.
Here's an analysis based on the provided text, highlighting what is (and isn't) present:
1. A table of acceptance criteria and the reported device performance
The document does not present a table of specific performance acceptance criteria (e.g., accuracy, sensitivity, specificity) for therapeutic efficacy or diagnostic output since it's an ultrasonic scaler. The "performance data" section states: "Based on the results of this testing, the modified GentleWave System performs as intended and is substantially equivalent to the predicate device." This implies the "acceptance criteria" are related to maintaining equivalence, not necessarily achieving specific clinical outcomes that are quantified in this document.
The key "performance data" criteria mentioned relate to software validation:
| Acceptance Criteria (Implicit) | Reported Device Performance (Summary) |
|---|---|
| Software validation | "Performs as intended" and "substantially equivalent to the predicate device" after validation in accordance with ANSI/AAMI/IEC 62304:2006 |
| Safety & Effectiveness | Maintained substantial equivalence to predicate device with modified fluid concentration settings. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. Software validation typically involves testing against requirements, but the specific "sample size" of test cases for software or the data provenance is not detailed.
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)
This information is not provided. The device is an ultrasonic scaler for root canal therapy; the concept of "ground truth" established by experts for a diagnostic output is not directly applicable in the context described here. The "ground truth" for a therapeutic device performance would typically relate to successful treatment, which is not quantified in this summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. Not applicable in the context of this 510(k) summary.
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
There is no indication of an MRMC study. This device is a therapeutic device (ultrasonic scaler), not a diagnostic device involving human readers or AI assistance in interpretation. The document explicitly focuses on changes to a therapeutic system and its software, not on interpretive capabilities.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable for this type of device. The GentleWave System is a physical medical device that prepares, cleans, and irrigates root canals. It has "software-controlled user interface" and "software validation," but it is not an "algorithm" operating in a standalone diagnostic capacity.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As noted previously, the concept of a "ground truth" as typically understood for diagnostic devices is not directly applicable here. The substantial equivalence relies on the fundamental scientific technology and indications for use remaining the same, and the modifications (fluid concentration selection) not affecting safety or effectiveness. The "ground truth" for the software validation would be that the software performs according to its specifications. For the device as a whole, it relies on being "substantially equivalent" to a predicate device already deemed safe and effective.
8. The sample size for the training set
This information is not provided. The device is not an AI/ML algorithm that is "trained" on a dataset in the typical sense for a diagnostic device. Software validation tests are run against detailed specifications, not a "training set."
9. How the ground truth for the training set was established
This information is not provided and is not applicable as there is no "training set" in the context of an AI/ML algorithm being developed or assessed here.
§ 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.