(84 days)
For use with all DENTSPLY® Cavitron™ Prophy-Jet® Systems and DENTSPLY® Cavitron-Jet™ Systems for cleaning, polishing and restoring the natural esthetics of tooth enamel.
NEW PROPHY POWDER is for use in DENTSPLY dental air polishing units. When the air polishing unit is in the JET mode, it produces a spray mixture of air, water, and powder to clean, polish and restore the natural esthetics of tooth enamel. NEW PROPHY POWDER is a new formulation and is for use with all DENTSPLY® Cavitron™ Prophy-Jet® Systems and DENTSPLY® Cavitron-Jet™ Systems. NEW PROPHY POWDER will be offered in two size bottle/closure for sampling and an 8-oz. bottle/closure as standard). The bottles will have a wide mouth for easy dispensing and be packaged as six bottles per shipper.
The provided text (K014188) is a 510(k) summary for a "NEW PROPHY POWDER" device. It outlines the device's description, intended use, and technological characteristics, especially regarding its safety and biocompatibility. However, it does not contain any information about acceptance criteria, specific performance studies to meet those criteria, sample sizes, expert involvement, ground truth establishment, or comparison with human readers.
The document states: "We believe that the prior use of the components of NEW PROPHY POWDER in the legally marketed predicate device, the performance data provided, and the biocompatibility data provided support the safety and effectiveness of NEW PROPHY POWDER for the indicated William."
This indicates that the submission relies on:
- Prior use of components: The ingredients in the new powder have been used in previously marketed devices and found safe for dental use.
- Performance data: While mentioned, no details about this "performance data" or how it was collected and what it demonstrated are provided in the summary. It's likely related to the powder's ability to clean and polish, but specific metrics and comparison to acceptance criteria are absent.
- Biocompatibility data: The summary explicitly states, "NEW PROPHY POWDER has been evaluated and passed biocompatibility testing for cytotoxicity, acute oral toxicity, irritation, and sensitization." This is the only "study" mentioned with a clear outcome.
Without specific performance study details, it is impossible to complete the requested table and answer the detailed questions about the study design, sample sizes, expert involvement, or adjudication methods.
Therefore, based only on the provided text, I can infer the following about acceptance criteria and studies:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria (Inferred/Stated) | Reported Device Performance (as per document) |
|---|---|---|
| Biocompatibility | No cytotoxicity | Passed biocompatibility testing for cytotoxicity |
| No acute oral toxicity | Passed biocompatibility testing for acute oral toxicity | |
| No irritation | Passed biocompatibility testing for irritation | |
| No sensitization | Passed biocompatibility testing for sensitization | |
| Safety (Component Use) | Components previously used in legally marketed devices or found safe for dental use | All components found in NEW PROPHY POWDER have been used in legally marketed devices or were found safe for dental use (implies acceptance of prior safety). |
| Effectiveness (Cleaning/Polishing) | Functionality for cleaning, polishing, and restoring natural esthetics of tooth enamel (implied functionality similar to predicate) | "Performance data provided" (details not given in summary, but implies it supports effectiveness for cleaning, polishing and restoring natural esthetics). |
2. Sample size used for the test set and the data provenance:
- Biocompatibility: Not specified in the summary. Biocompatibility tests usually involve in vitro or animal models, not human "test sets."
- Performance Data: Not specified.
- Data Provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as no such study with a "test set" and "ground truth" established by experts is described for this device in the provided text. The assessment mainly relies on material properties and comparison to predicate devices.
4. Adjudication method for the test set:
- Not applicable for the reasons stated above.
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 a dental powder, not an AI or imaging diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a dental powder, not an algorithm.
7. The type of ground truth used:
- Biocompatibility: Lab-based assays (e.g., cell cultures for cytotoxicity, animal models for toxicity/irritation/sensitization).
- Component Safety: Historical use of components in legally marketed devices or established safety profiles.
- Performance: Unspecified "performance data" – likely involved qualitative or quantitative assessment of cleaning/polishing efficacy, but the ground truth method is not detailed.
8. The sample size for the training set:
- Not applicable. This device is a dental powder, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable.
§ 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.”