(98 days)
The PrepAir is intended for the cutting and preparation of all classes of cavity restorations; removal of composite resin fillings; surface roughening of enamel, dentin, metals and composite surfaces prior to adhesive resin bonding; preparation of pits and fissures prior to sealing; cleaning and removal of cements and adhesives from bridges and crowns prior to re-cementation; and preparation of adhesive surfaces of orthodontic bands and brackets to increase retention.
The PrepAir is a dental airbrush using aluminum oxide to prepare all classes of cavity prior to restoration.
This document is a 510(k) Summary of Safety and Effectiveness for a dental airbrush device called PrepAir. It primarily focuses on demonstrating substantial equivalence to previously marketed predicate devices, rather than presenting a study with specific acceptance criteria and performance data in the format requested.
Therefore, many of the requested sections cannot be directly extracted from the provided text as they relate to a different type of study (e.g., performance testing with acceptance criteria, human reader studies, or detailed ground truth establishment), which is not present in this 510(k) submission.
Here's an analysis based on the information available in the document, noting what cannot be provided:
1. A table of acceptance criteria and the reported device performance
This information is not present in the provided 510(k) summary. The document focuses on demonstrating substantial equivalence based on intended use, device description, and comparison to predicate devices, rather than presenting a performance study against specific, quantified acceptance criteria.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not present. No specific test set or data provenance is detailed for performance evaluation, as the submission relies on substantial equivalence to predicate devices.
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)
This information is not present. There is no ground truth establishment described for a test set in this document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not present. No test set or 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
This information is not present. This device is a physical dental airbrush, not an AI or imaging diagnostic tool. Therefore, an MRMC study or AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not present. This device is a physical tool, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not present. Ground truth is not relevant in the context of this 510(k) submission, which focuses on substantial equivalence for a physical device.
8. The sample size for the training set
This information is not present. No training set is mentioned as this is not an AI/algorithm-based device.
9. How the ground truth for the training set was established
This information is not present. Ground truth for a training set is not applicable here.
Summary of what is available from the document:
- Device Name: PrepAir
- Intended Use: For cutting and preparation of all classes of cavity restorations; removal of composite resin fillings; surface roughening of enamel, dentin, metals, and composite surfaces prior to adhesive resin bonding; preparation of pits and fissures prior to sealing; cleaning and removal of cements and adhesives from bridges and crowns prior to re-cementation; and preparation of adhesive surfaces of orthodontic bands and brackets to increase retention.
- Predicate Devices: PrepStart by Danville Engineering (K970589), PrepTech by Prep Technology Corp (K974655), AirDent by Air Techniques (K981564), and Rondoflex by Kavo America (K002708).
- Regulatory Conclusion: The FDA determined the device is "substantially equivalent" to legally marketed predicate devices, meaning it meets the requirements for marketing without a full Pre-Market Approval (PMA) application, based on its similarity in intended use and technological characteristics to devices already on the market.
Conclusion:
The provided document is a 510(k) summary, which is a premarket submission to FDA to demonstrate that a device is "substantially equivalent" to a legally marketed predicate device. This process typically focuses on comparing the new device's intended use, technological characteristics, and safety/effectiveness data to a predicate, rather than detailing a specific study with quantitative acceptance criteria and performance metrics unique to the new device in the way requested for an AI/algorithm-based product. Therefore, the information requested regarding acceptance criteria, sample sizes, expert ground truth, and study design is not contained within this specific type of regulatory document.
§ 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.”