(114 days)
Cleaning, polishing and restoring natural esthetics of tooth enamel.
The ß-Powder system is comprised primarily of ßtricalcium phosphate. X-ray diffraction methods were used to identify the crystalline structure. These studies showed that the main constitutent of the device is ßtricalcium phosphate with a small amount of hydroxyapatite, but no other contaminants. Inductively coupled plasma/mass spectroscopy was used for cadmium (Cd) and lead (Pb) analyses, and atomic absorption spectrophotometry was used for mercury (Hg) and arsenic (As). The levels of these harmful elements were below 0.5 ppm
The provided text is a 510(k) summary for a medical device (B-Powder) and a clearance letter from the FDA. This type of documentation focuses on establishing substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through extensive clinical studies.
Therefore, the information requested in your prompt (acceptance criteria, study details, sample sizes, expert ground truth, MRMC studies, standalone performance, etc.) is not present in the provided text.
Here's why and what can be extracted:
- No Acceptance Criteria or Performance Reporting: The 510(k) process for this device (B-Powder) establishes that it is "substantially equivalent" to already marketed devices. This means the manufacturer did not have to conduct new clinical trials to prove efficacy or safety against specific performance metrics, but rather demonstrate that its characteristics and intended use are similar enough to existing, cleared devices.
- Focus on Material Composition and Intended Use: The summary focuses on the material composition (beta-tricalcium phosphate with some hydroxyapatite) and its intended use (polishing/prophy powder) being similar to predicate devices.
- Analytical Testing, Not Clinical Studies: The "studies" mentioned (X-ray diffraction, ICP/MS, atomic absorption spectrophotometry) are analytical tests to characterize the material, not clinical performance studies. These tests confirm the material content and the absence of harmful elements, but they don't assess clinical outcomes like cleaning effectiveness or polishing quality in a human population.
- MRMC, Standalone Performance, Ground Truth, Training Set: These concepts are typically relevant for AI-powered diagnostic or prognostic devices that perform classifications or measurements. The B-Powder is a physical dental material, so these types of studies are not applicable.
In summary, based only on the provided text, I cannot fill in the table or answer the specific questions about acceptance criteria, study details, expert ground truth, or AI study specifics because this information is not part of a 510(k) submission for this type of device.
The document states: "Compliance with Performance Standards: No performance standards are applicable." This directly indicates that there aren't formal quantitative acceptance criteria for this device that would be proven by a performance study.
Here's what I can extract and explain based on the provided text, addressing the spirit of your request where possible by highlighting what was not done or not required for this type of submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Not explicitly stated for this device) | Reported Device Performance (Focus on equivalence to predicates) |
|---|---|
| Material Composition Equivalence | X-ray diffraction showed the main constituent is β-tricalcium phosphate with a small amount of hydroxyapatite, demonstrating similarity to materials used in existing devices. |
| Purity/Safety (Harmful Elements) | Inductively coupled plasma/mass spectroscopy (ICP/MS) for cadmium (Cd) and lead (Pb) and atomic absorption spectrophotometry for mercury (Hg) and arsenic (As) showed levels of these harmful elements below 0.5 ppm. This indicates acceptable material purity for its intended use and similarity to established safe materials. |
| Intended Use Equivalence | The device is intended for use as a polishing or prophy powder, which is the "same as that for Clinpro Prophy Powder (K021450) and New Prophy Powder (K014188)." |
| Technological Characteristics Equivalence | Described as "fine powders, relatively inert, biocompatible and previously used for periodontal purposes," similar to predicate devices. |
| Biocompatibility | Implicitly established by material composition and a history of use in similar devices. No specific biocompatibility study report is provided, but the materials are described as "well-established and well understood in the industry." |
| No performance standards are applicable. ("Compliance with Performance Standards" section in {0}) | The device does not have specific quantitative performance standards to meet; rather, it demonstrates substantial equivalence to predicate devices which have already established safety and effectiveness for their intended use. Therefore, no direct clinical performance metrics (e.g., "removes X% of stain") are provided or required in this 510(k). |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
No test set or clinical study data is reported as part of this 510(k) submission. The evaluation was based on material characterization and comparison to predicate devices, not clinical performance testing.
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)
Not applicable. No ground truth establishment by experts for a test set was required or mentioned for this type of device submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No test set requiring adjudication was used or mentioned.
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 polishing powder, not an AI-powered diagnostic tool. MRMC studies are not relevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a dental polishing powder, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. The basis for clearance was "substantial equivalence" to legally marketed predicate devices, not performance against an independently established clinical ground truth. The "ground truth" implicitly relies on the established safety and effectiveness of the existing predicate devices.
8. The sample size for the training set
Not applicable. There was no "training set" for this device, as it is a material and not an algorithm.
9. How the ground truth for the training set was established
Not applicable. As above, no training set or ground truth in the context of an algorithm's development was relevant or established for this submission.
§ 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.”