(150 days)
The Sonendo GentleWave™ System is intended to prepare, clean, and irrigate teeth indicated for root canal therapy. When used with the Sonendo GentleWave™ Molar Handpiece, the System is indicated for 1 and 200 molar teeth. When used with the Sonendo GentleWave™ Anterior/Premolar Handpiece, the System is indicated for anterior and premolar teeth.
The Sonendo GentleWave System (Console and Handpiece) delivers a stream of degassed treatment fluids into the tooth. The treatment fluids delivered to the tooth include a 3% Sodium Hypochlorite (NaOCI) solution and an 8% Ethylenediaminetetraacetic (EDTA) solution which are commonly utilized in traditional endodontic treatments. The stream of solutions delivered into the tooth come in contact with accumulated fluid and are redirected by a deflection plate, creating hydroacoustic and hydrodynamic effects which result in removal of organic and inorganic debris from the root canals. The Console collects the treatment fluid from the tooth into a waste collection canister.
The GentleWave System requires use with a Sonendo Handpiece which is used to treat 1* and 20 molar teeth or the Anterior/Premolar Handpiece which is used to treat anterior and premolar teeth. The Molar and Anterior/Premolar Handpieces are hand held dental instruments which are connected to the Console and provide treatment fluid delivery and waste fluid recovery. The Molar Handpiece is used with various accessories provided with the System. Both the Molar and Anterior/Premolar Handpieces are provided sterile and intended for single use only.
The provided document is a 510(k) summary for the Sonendo GentleWave™ System, an ultrasonic scaler intended for root canal therapy. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and validation study results for a new AI/software component.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details for an AI device cannot be entirely extracted from this document, as it describes a physical medical device.
However, I can extract information related to the software validation which is mentioned and could be considered a component of the device's overall performance.
Here's the closest possible interpretation of your request based on the provided text, focusing on the software component where applicable, and noting limitations:
Description of Acceptance Criteria and Study for Sonendo GentleWave™ System
The Sonendo GentleWave™ System is intended to prepare, clean, and irrigate teeth indicated for root canal therapy. The 510(k) summary indicates that "all necessary performance testing has been conducted... to assure substantial equivalence to the predicate devices and to demonstrate the device performs as intended."
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria Category (where applicable to AI/Software) | Acceptance Criteria/Test | Reported Device Performance | Reference |
|---|---|---|---|
| Software Validation | Validated per FDA Guidance: "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, 2005." | Passed all validation tests. | Performance Data section |
| Other Device Performance Tests | Sterility | Sterile per ISO 11137-1,-2 | Performance Data section |
| Biocompatibility | Biocompatible per ISO 10993-1, -5, -10, -11 | Performance Data section | |
| Electromagnetic Compliance and Electrical Safety | Certified per IEC 60601-1 and IEC 60601-1-2 | Performance Data section | |
| Thermal Test (External Tooth Surface) | Determined temperature generated on the external surface of the tooth. | Performance Data section (Internal Test Method) | |
| Cavitation Test | Evaluated transient cavitation bubbles which clean root canals. | Performance Data section (Internal Test Method) | |
| Hydroacoustics Test | Demonstrated hydroacoustic characteristics of the device. | Performance Data section (Internal Test Method) | |
| Cleaning Test | Demonstrated cleaning efficacy of the device on extracted teeth. | Performance Data section (Internal Test Method) | |
| Apical Pressure Test | Determined hydraulic pressure exerted at the apical terminus. | Performance Data section (Internal Test Method) | |
| Apical Extrusion Test | Measured relative volume of treatment fluid extruded through the apical terminus. | Performance Data section (Internal Test Method) |
2. Sample Size Used for the Test Set and Data Provenance
- For Software: The document states "Software: Validated per FDA Guidance." This generally implies that testing was performed on the software, but the specific sample size (e.g., number of test cases, scenarios, or patients if applicable to clinical data in this context) and data provenance (country, retrospective/prospective) are not provided in this summary.
- For Cleaning Test: The cleaning efficacy was demonstrated on "extracted teeth." The number of extracted teeth used for this test is not specified. The provenance (e.g., country of origin) of these extracted teeth is also not provided. This was a retrospective test on non-living material.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- For Software: This information is not provided. Software validation typically involves system engineers and test specialists, but not necessarily medical experts for ground truth establishment in the same way as, for example, diagnostic imaging AI.
- For Other Tests: For the physical device tests (e.g., Cleaning Test), experts (e.g., endodontists or dental researchers) would likely be involved in assessing cleaning efficacy, but the number of experts and their specific qualifications are not mentioned in this summary.
4. Adjudication Method for the Test Set
- Not explicitly stated for any of the tests. The document indicates passage of internal test methods and compliance with standards, implying that results met predefined specifications, but the specific adjudication process (e.g., 2+1, 3+1 consensus) for subjective assessments (like cleaning efficacy) is not detailed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was not done as described in the document. This type of study is specifically relevant for diagnostic or interpretive AI systems where human readers' performance with and without AI assistance is evaluated. The Sonendo GentleWave™ System is a treatment device, not a diagnostic imaging AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Given it is a physical device with an embedded software component for control, the "standalone" performance would refer to the device operating according to its specifications. The tests listed (Thermal, Cavitation, Hydroacoustics, Cleaning, Apical Pressure, Apical Extrusion) are demonstrations of the device's function in a standalone manner (without a "human-in-the-loop" influencing its intrinsic operation, though a human operates the device).
- However, if "standalone" refers to an AI purely making decisions without human oversight, this is not applicable to this device.
7. The Type of Ground Truth Used
- For Software: Ground truth for software validation would typically be defined by the pre-established functional and performance requirements of the software, and whether its outputs (e.g., control signals, UI responses, calculations) match expected values during testing.
- For Cleaning Test: The ground truth for "cleaning efficacy" (on extracted teeth) would likely be established through quantitative or qualitative assessment methods (e.g., microscopic evaluation, dye penetration, or histological analysis) to determine the removal of debris or bacteria within the root canal system. The specific method is not detailed, but it would presumably be an expert-determined assessment based on established dental evaluation techniques.
- For Other Tests: Ground truth is typically derived from physical measurements (e.g., temperature, pressure, flow rate) according to engineering and scientific principles.
8. The Sample Size for the Training Set
- This information is not provided. For a device cleared via 510(k), especially one not primarily an AI/machine learning diagnostic tool, details about a "training set" (in the machine learning sense) are typically not included in this type of summary. The software validation is likely based on traditional software engineering testing rather than AI model training.
9. How the Ground Truth for the Training Set was Established
- Not applicable or not provided, as details of an AI-specific training set or its ground truth establishment are absent from this 510(k) summary.
§ 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.