(105 days)
Used for ultrasonic procedures:
- All general supra and subgingival scaling applications .
- Periodontal debridement for all types of periodontal diseases .
The Cavitron Touch™ Ultrasonic Scaling System is an ultrasonic scaling unit that is used in all general supra and subgingival scaling applications and periodontal debridement for all types of periodontal diseases. The Cavitron Touch™ Ultrasonic Scaling System includes a digital touch screen interface and Bluetooth technology. This device is equipped with the Tap-On™ Wireless Foot Pedal with Tap-On™ technology.
The provided text describes a medical device, the Cavitron Touch™ Ultrasonic Scaling System, and its substantial equivalence to a predicate device, the Cavitron® RF Ultrasonic Scaler System with Sterimate Handpiece (K052334). However, the document does not contain specific acceptance criteria or a study proving the device meets those criteria with quantitative performance metrics for the reasons listed below for each criterion. This is a 510(k) submission, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a de novo clinical trial with explicit acceptance criteria for efficacy.
Here's a breakdown of the requested information based on the provided text:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Explicitly Stated) | Reported Device Performance |
|---|---|
| Not explicitly stated as pass/fail metrics. The submission focuses on demonstrating substantial equivalence to the predicate device. | The design verification and functional testing (listed in Section 7 of the 510(k) Summary) support the substantial equivalence of the proposed device to the predicate device. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document does not specify sample sizes for any test sets related to performance characteristics (e.g., number of units tested, duration of tests).
- The data provenance is internal testing performed by DENTSPLY International Inc. (Section 7, "Internal specification and testing"). Country of origin is not specified but the company is based in York, Pennsylvania, USA. The testing would be prospective in nature for a new device design.
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. This submission focuses on engineering and performance verification against existing standards and internal specifications, not on establishing ground truth for diagnostic or clinical interpretation using expert readers.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. As the "ground truth" and "expert" roles are not relevant in this type of engineering and performance verification submission, there is no adjudication method described.
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, an MRMC comparative effectiveness study was not done. This device is an ultrasonic scaler; it is a tool used by dental professionals, not an AI-powered diagnostic system that assists human readers in case interpretation. The document explicitly states "No data from human clinical studies has been included to support the substantial equivalence of the Cavitron Touch™ Ultrasonic Scaling System" (Section 9, page 9).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is an ultrasonic scaler. Its function is to perform ultrasonic scaling procedures, which inherently involves a human operator (a dental professional). It is not an algorithm that functions in a standalone capacity without human intervention.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable/Not explicitly defined in the clinical sense. For a device like an ultrasonic scaler, "ground truth" for non-clinical performance would relate to engineering specifications, safety standards (e.g., electrical safety, electromagnetic compatibility), and functional requirements (e.g., power output, water flow, touch screen responsiveness). The closest to "ground truth" would be the standards themselves (e.g., AAMI ANSI ES 60601-1, IEC 60601-1-2) and the internal specifications against which the device was tested.
8. The sample size for the training set
- Not applicable. This device is not an AI/machine learning system that requires a "training set" in the conventional sense. The development likely involved iterative design and testing, but not a formally defined "training set" for an algorithm.
9. How the ground truth for the training set was established
- Not applicable. As there is no training set for an AI/ML algorithm, the concept of establishing ground truth for it does not apply.
Summary of Study Type:
The document describes non-clinical performance data (Section 7, page 9) which includes:
- Verification of design
- Ultrasonic scaling performance
- Function of the device
- Adherence to international standards (AAMI ANSI ES 60601-1, IEC 60601-1-2)
- Guidance for software validation (FDA - Guidelines for the Content of Premarket Submissions for Software Contained in Medical Devices- Software Validation)
- Internal specification and testing for handpiece operation, autocycle operation, touch screen/user interface, and radio frequency distance for the wireless foot pedal.
This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device through engineering and performance testing, rather than through extensive clinical trials with explicit performance metrics and acceptance criteria for patient outcomes.
§ 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.