(36 days)
The KaVo RONDOflex® plus 360 Handpiece is intended for the: preparation for fissure sealing by cleaning, opening, and extending the fissures; creation of micro-mechanical retention for adhesive restorations on enamel and dentine with subsequent acid etch technique; preparation-of small carious defects; removal of deep discolorations in the enamel; cleaning and removal of adhesive residues from bridges, crowns, etc.; and, preparation of adhesive surfaces of brackets.
This submission is for a modification of a device system cleared under K002708, KaVo Corund Handpiece 2013. The modification is in the form of adding dental water to the stream.
The RONDOflex plus 360 is an air abrasion system in which alumina particles are accelerated to high speed in an air jet in order to remove material from the tooth surface.
The provided text describes a 510(k) summary for the KaVo RONDOflex® plus 360 Handpiece, which is a modification of an existing device. The device is being submitted for substantial equivalence to predicate devices, and as such, the "acceptance criteria" discussed are largely related to demonstrating that the modified device performs as safely and effectively as the predicate devices, with no new questions of safety or effectiveness.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission for a modified device seeking substantial equivalence, the "acceptance criteria" are implicitly met by demonstrating that the new device shares the same indications for use and has comparable technical characteristics (e.g., abrasive material, sterilization methods) to the predicate devices. The "reported device performance" is essentially that it operates within the specified technical data and its indications for use are the same as the primary predicate.
| Acceptance Criteria (Implied by Substantial Equivalence Goal) | Reported Device Performance (KaVo RONDOflex® plus 360 Handpiece) |
|---|---|
| Indications for Use: Same as predicate device. | SAME as KaVo Corund Handpiece 2013 |
| Abrasive Material: Comparable to predicate devices. | 27 and 50 μ corundum powder and water |
| Sterilization: Same method as predicate device. | Autoclave |
| Technical Data: Operates within specified parameters. | Drive pressure: 3.2 - 6.0 bar |
| Water pressure: 1.5 ± 1.0 bar | |
| Air consumption: 5 - 11 1(S.T.P.)/min | |
| Water flow rate: approx. 40 cm3/min |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly mention a "test set" in the context of clinical trials or specific performance testing against ground truth. The submission is based on comparison to predicate devices and internal validation studies. There is no information provided about the sample size for these internal validation studies or their data provenance (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This 510(k) submission primarily relies on demonstrating substantial equivalence to predicate devices through technical comparisons and internal validation. There is no mention of a ground truth established by experts for a specific test set.
4. Adjudication Method for the Test Set
Not applicable. As there is no mention of an external test set requiring expert ground truth, no adjudication method is 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
Not applicable. This device is an air abrasion handpiece for dental procedures, not an AI-assisted diagnostic or therapeutic tool for which MRMC studies would typically be conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical medical device (handpiece), not an algorithm or AI system.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The term "ground truth" as typically used in the context of AI or diagnostic device evaluation is not directly applicable here. The device's safety and effectiveness are established by:
- Comparison to legally marketed predicate devices: The "ground truth" implicitly relies on the established safety and effectiveness of the predicate devices cleared by the FDA.
- Internal validation studies: These studies would typically verify that the device meets its design specifications and performs as intended, likely using engineering and performance metrics relevant to an air abrasion device (e.g., consistency of abrasive flow, pressure, sterilization efficacy). The specific nature of these "internal validation studies" (what they tested and how performance was measured) is not detailed in the provided text.
8. The Sample Size for the Training Set
Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set mentioned, no ground truth establishment for a training set is relevant.
§ 872.6080 Airbrush.
(a)
Identification. An airbrush is an AC-powered device intended for use in conjunction with articulation paper. The device uses air-driven particles to roughen the surfaces of dental restorations. Uneven areas of the restorations are then identified by use of articulation paper.(b)
Classification. Class II. The special control for this device is International Electrotechnical Commission's IEC 60601-1-AM2 (1995-03), Amendment 2, “Medical Electrical Equipment—Part 1: General Requirements for Safety.”