(157 days)
The Sonendo OmniClean Endotherapy System is intended to prepare, clean and irrigate 181 and 2nd molar teeth indicated for root canal therapy.
The Sonendo OmniClean Endotherapy System is a medical device intended to prepare, clean and irrigate 15 and 2nd molar teeth indicated for root canal therapy. The Sonendo OmniClean Endotherapy System is comprised of a Console, Foot Pedal and Molar Procedure Kit with a Handpiece.
The provided 510(k) summary for the Sonendo OmniClean Endotherapy System does not contain detailed acceptance criteria or a study dedicated to proving the device meets specific performance metrics in the way often seen in AI/ML performance studies. Instead, it relies on demonstrating substantial equivalence to predicate devices through various performance tests.
Here's an analysis based on the provided text, addressing your points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not present a table of explicit acceptance criteria with corresponding performance results in a quantitative manner (e.g., "Device must achieve X% flow rate accuracy, and it achieved Y%"). Instead, it lists performance data categories and implies that testing within these categories showed the device performs as intended and is similar to predicate devices.
| Acceptance Criteria Category (Implied) | Reported Device Performance (Implied) |
|---|---|
| Simulated Use | Performed as intended, demonstrating substantial equivalence to predicate devices. |
| EMC and Electrical Safety | Complies with relevant standards, ensuring safe operation. |
| Thermal Safety | Complies with relevant standards, ensuring safe operation and preventing tissue damage. |
| Hydroacoustics | Similar hydroacoustic wave generation and fluid motion to predicate devices, confirming the reported Principle of Operation. |
| Apical Extrusion and Pressure | Demonstrated to be safe and effective, minimizing apical extrusion and maintaining appropriate pressure levels, similar to predicate devices. |
| Cleaning Effectiveness | Demonstrated effective cleaning of root canals, comparable to predicate devices for its intended use. (Note: Specific metrics or comparative results are not provided in this summary but are implied to be satisfactory for substantial equivalence). |
| Flow Rate | 45 +/- 10 ml/min. (This is a specific technical characteristic, and the testing implicitly confirmed it met this specification.) |
| Duration of Application | Leak test = 1 minute, Treatment time = 7 minutes and 45 seconds. (These are specific technical characteristics, and the testing implicitly confirmed the device operates within these parameters.) |
| Irrigation Fluid Compatibility | Compatible with NaOCl, EDTA, and Water. (Testing implicitly confirmed compatibility with these specified fluids, similar to predicates.) |
2. Sample Size Used for the Test Set and Data Provenance
The summary does not specify sample sizes for any of the performance tests. It states that "All testing was performed on test units representative of finished devices," but the number of units or teeth/canals tested is not provided.
The data provenance is also not specified. It's generally assumed that such testing for a 510(k) submission would be conducted by the manufacturer (Sonendo, Inc.) in a controlled lab or simulated environment during device development, but details regarding external data, country of origin, retrospective or prospective nature are absent.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable and not provided in the context of this 510(k) summary. This device is an endotherapy system for preparing, cleaning, and irrigating root canals, not an AI/ML diagnostic or image analysis device that would typically rely on expert ground truth for test sets.
4. Adjudication Method
This information is not applicable and not provided for the same reasons as #3.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study is not applicable and not mentioned. This type of study investigates the impact of AI assistance on human reader performance, which is not relevant for a physical endotherapy device.
6. Standalone (Algorithm Only) Performance
A standalone algorithm performance study is not applicable for this device, as it is a physical medical device, not an algorithm or software-only product.
7. Type of Ground Truth Used
The concept of "ground truth" in the AI/ML context doesn't directly apply here. The "ground truth" for a physical device like this would be derived from:
- Engineering specifications and standards conformance: The device performs according to its design and meets relevant safety and performance standards (e.g., electrical safety, thermal safety).
- Biomechanical/physiological effects: Demonstrating that the hydroacoustic waves and fluid motion effectively clean root canals without causing harm (e.g., minimal apical extrusion). This would likely involve in vitro or ex vivo models but not "expert consensus" in the diagnostic sense.
- Comparison to predicate devices: The primary "ground truth" or benchmark is the performance of legally marketed predicate devices, demonstrating that the new device is "substantially equivalent" and "performs as intended."
The specific methods for establishing these "truths" (e.g., documented lab tests, measurements, comparative data) are summarized but not detailed.
8. Sample Size for the Training Set
This is not applicable and not provided. This device does not involve a "training set" in the machine learning sense. The development and testing of this device would involve engineering design, prototyping, and various verification and validation tests, not machine learning model training.
9. How Ground Truth for the Training Set Was Established
This is not applicable and not provided for the same reasons as #8.
In summary:
This 510(k) summary for the Sonendo OmniClean Endotherapy System primarily relies on demonstrating substantial equivalence to existing predicate devices. The performance data section lists various categories of testing (Simulated Use, EMC/Electrical Safety, Thermal Safety, Hydroacoustics, Apical Extrusion/Pressure, Cleaning) that were conducted to confirm the device performs as intended and is comparable to its predicates. However, it does not provide quantitative acceptance criteria, specific sample sizes for testing, or details about expert involvement or ground truth establishment in the manner applicable to AI/ML or diagnostic devices.
§ 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.