(22 days)
The Sirona Sirosonic L and Siroson L are an ultrasonic scalers intended for use in the following dental and periodontal applications:
- . Calculus removal (supragingival and subgingival)
- . Retrograde root treatment
- . Endodontics
- . Insertion of inlays
- . Micropreparation-(cavity preparation)
- . Periodontology
The proposed Sirona ultrasonic scalers consist of the ultrasonic handpiece, instrument tips, and control unit, which is part of the Sirona C8+ Dental Operative Unit. The Ultrasonic Scalers are electrically operated scalers driven by a piezo oscillator at 25 to 32 kHz. The piezo oscillator is located in the handpiece and the control/generator unit is located in the C8+ Dental Operative Unit. Both devices include a lamp located in the hose and a spray water controller. A number of optional tips are supplied with the Sirona ultrasonic scalers.
The provided 510(k) summary for the Siroson L and Sirosonic L Ultrasonic Scalers does not contain a study that establishes acceptance criteria and then proves the device meets those criteria in the way a clinical performance study would for an AI/ML device.
This document describes a traditional medical device (ultrasonic scaler) and focuses on demonstrating substantial equivalence to a predicate device (EMS Piezon Master 600) rather than a performance study with acceptance criteria and reported metrics in the context of AI/ML.
Here's an analysis based on the provided text, structured to address your points, with explanations of why certain information is not present:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Explicitly Stated for clinical performance metrics. | Not Applicable (N/A) for clinical performance metrics as this is not a study assessing diagnostic accuracy or similar. |
| For substantial equivalence, the criteria are based on comparison of: | The device's overall design, intended use, and technical features are similar to the predicate device. |
| * Intended Use | * Identical intended uses are stated. |
| * Principles of Operation | * Similar principles of operation (piezo oscillator, ultrasonic power adjustment, irrigation). |
| * Overall Design | * Overall design is similar, including handpiece, generator, control unit, and tips. |
| * Technical Features (e.g., ultrasonic power, irrigation control, operating modes) | * Both devices operate at 25-32 kHz (predicate is not explicitly stated in summary for frequency but implied to be similar). Both have adjustable power, multiple operating modes, and irrigation options. Specific quantitative performance values (e.g., power output, vibration amplitude) are not provided in this summary but would have been part of design verification. |
| Electrical Safety | Confirmed to meet appropriate standards. |
| Electromagnetic Compatibility (EMC) | Confirmed to meet appropriate standards. |
Explanation: In a 510(k) submission for a non-AI device like this, "acceptance criteria" are generally tied to demonstrating substantial equivalence to a legally marketed predicate device, adherence to recognized standards (e.g., for electrical safety, EMC), and verification/validation activities that address identified risks. There isn't a "performance study" in the sense of a clinical trial measuring diagnostic accuracy or treatment efficacy against a specific numerical threshold for this type of device and submission.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This device is an ultrasonic scaler, not a diagnostic or AI device that would typically use a "test set" of data or patient cases for performance evaluation. The "testing" referred to is design verification (electrical safety, EMC), not a study on a data sample.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Refer to point 2. Ground truth in this context would relate to direct assessment of the device's physical function and safety standards rather than expert-established clinical interpretations on a dataset.
4. Adjudication Method for the Test Set
Not applicable. Refer to point 2.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is relevant for AI/ML diagnostic tools where human readers potentially improve with AI assistance. This is a traditional dental instrument.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this type of device's safety and effectiveness relies on:
- Engineering specifications and standards: Confirming the device meets its design specifications (e.g., frequency output, power levels, safety features) and relevant national/international standards for electrical safety and electromagnetic compatibility (e.g., IEC 60601-1, IEC 60601-1-2).
- Comparison to predicate device: The predicate device (EMS Piezon Master 600) serves as a benchmark for established safety and effectiveness.
- Risk analysis: Ensuring all identified potential risks are mitigated through design and testing.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device, so there is no training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/ML device, so there is no training set or ground truth in that context.
§ 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.