(428 days)
This device, Varios 970 / Varios 970 Lux, an electronic scaler, is intended for use with an appropriate tip for following use: Scaling, Perio, Implant Maintenance, Endodontic, Retrograde Endo, Restorative (for ・ Minimal Intervention/ Finishing/Trimming/ Polishing/Caries of Dentin), Prosthetics (Condensation / Loosening / Plugging)
Varios 970 is a stand-alone ultrasonic scaler device powered by the iPiezo® engine. The Varios 970 consists of the Varios 970 Control Unit, two independent 400 mL irrigation bottles, handpiece, and a wide range of tip inserts. The tip inserts, when attached at the distal end of the handpiece transducer, resonate at ultrasonic frequencies of 28 -32 kHz. The 400 mL bottles each can carry different solutions with independent pumps. The Varios 970 LUX features twin LED lights that last longer, are more durable, and generate less heat than halogen bulbs.
The provided text is a 510(k) summary for the NSK Varios 970 / Varios 970 Lux Ultrasonic Scaler. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and expert-adjudicated ground truth.
Therefore, an exhaustive response to all specific points regarding acceptance criteria, study details, expert involvement, and ground truth establishment, as typically expected for studies proving AI device performance, cannot be fully provided based solely on the given extract. This document describes a medical device's regulatory submission, not the results of a specific clinical performance study for an AI algorithm.
However, I can extract and infer information relevant to what would be the "acceptance criteria" and the "study" in the context of a 510(k) submission for a non-AI medical device, which relies heavily on demonstrating equivalence to an already legally marketed product.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device (ultrasonic scaler), the "acceptance criteria" revolve around demonstrating that the new device operates similarly and safely to the predicate device, especially in terms of fundamental performance characteristics and compliance with electrical safety and EMC standards.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Intended Use Equivalence | Varios 970 has the same intended use: Scaling, Perio, Implant Maintenance, Endodontic, Retrograde Endo, Restorative (MI/Finishing/Trimming/Polishing/Caries), Prosthetics (Condensation/Loosening/Plugging). |
| Principle of Operation Equivalence | Both Varios 970 and Varios 75 utilize the iPiezo® engine to generate ultrasonic frequencies of 28-32 kHz. Both convert electrical signals into mechanical vibrations propagated to the handpiece. |
| Technological Characteristics Equivalence | Both have the same operating modes, irrigation modes, and operating time. Varios 970 uses LED lights, which are longer-lasting, more durable, and generate less heat than the predicate, considered an improvement but not a change in fundamental performance. |
| Electrical Safety Standards Compliance | The Varios 970 has been tested in accordance with applicable standards for medical device electrical safety. |
| Electromagnetic Compatibility (EMC) Compliance | The Varios 970 has been tested in accordance with applicable standards for electromagnetic compatibility. |
| Sterilization Requirements Compliance | The Varios 970 has been tested in accordance with the particular requirements for sterilization. |
| Design Rationale Equivalence | Basis for the conclusion of substantial equivalence. |
2. Sample Size for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify a "sample size" in terms of patient data or clinical cases for a performance study. For a traditional medical device like an ultrasonic scaler demonstrating substantial equivalence, the "test set" primarily refers to the device itself being subjected to engineering verification and validation tests rather than a cohort of patients.
- Data Provenance: The 'data' mentioned refers to the results of engineering tests (electrical safety, EMC, sterilization). This data would be generated in a lab setting by the manufacturer (Nakanishi, Inc. in Japan). It is not retrospective or prospective in the clinical sense.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- This is not applicable in the context of this 510(k) submission for an ultrasonic scaler. Ground truth establishment by clinical experts is typically required for diagnostic or AI-driven devices where interpretation of medical data is central. For an ultrasonic scaler, performance is evaluated against engineering specifications and safety standards, not against "ground truth" established by radiologists or other clinical experts for comparative diagnostic accuracy.
4. Adjudication Method for the Test Set
- This is not applicable. Adjudication methods (like 2+1, 3+1) are used to resolve discrepancies in expert interpretations to establish a definitive ground truth in a clinical study. As explained above, this 510(k) relies on engineering and performance testing against objective standards and comparison to a predicate device, not on interpreting medical images or data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
- No, an MRMC comparative effectiveness study was not done. Such studies are relevant for evaluating the impact of an AI diagnostic aid on human reader performance, typically in interpreting medical images. This 510(k) is for a physical medical device (an ultrasonic scaler), not a diagnostic AI.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- No, this is not an AI device, so the concept of a "standalone" or "algorithm only" performance study is not applicable. The device itself is a standalone physical instrument.
7. The Type of Ground Truth Used
- Not applicable in the AI context. For this device, the "ground truth" for performance is effectively defined by:
- Compliance with specific engineering and safety standards (e.g., ISO, IEC for electrical safety, EMC, sterilization).
- Demonstrated functionality (generating ultrasonic frequencies, irrigation, operating modes) matching the predicate device.
- The predicate device itself (Varios 75) serving as the benchmark for "acceptable" performance and safety.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI device, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set for an AI algorithm, no ground truth needed to be established for it.
§ 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.