Search Results
Found 1 results
510(k) Data Aggregation
(194 days)
Uni-flex Resin is a flexible material that is used to produce the denture base in prosthetic partials.
Uni-flex Resin is packed and sealed in aluminum cartridges which are especially made to fit the Injection Mold System machine. To begin the production of a partial a cartridge is heated to 490'F. This allows the material becomes molten. The process of melting lasts ten minutes. After the material becomes molten the operator turns the handle of the Injection Mold System. This forces the material to inject into a previously prepared dental mold encased in an Injection Mold Flask. After the injection the cool down period lasts three minutes, the operator must remove the flask from the machine during this time. Then a twenty minute bench cool down period follows, only after the twenty minutes mold is removed from the flask. After this elapsed time the denture is now ready for finishing and high shine polish.
This document is a 510(k) clearance letter from the FDA for a dental resin product, Uni-Flex Resin. It's not a study report and therefore does not contain any information about acceptance criteria, device performance metrics, or study details.
The letter only states that the device is "substantially equivalent" to legally marketed predicate devices for its stated indications for use (producing a denture base in prosthetic partials).
Therefore, I cannot provide the requested information based on the given text.
If this were a study report, the typical structure for a response would look like this:
1. Table of Acceptance Criteria and Reported Device Performance
This would be extracted directly from a study results section, comparing a pre-defined performance target with the observed performance.
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| [e.g., Sensitivity] | [e.g., ≥ 90%] | [e.g., 92.5% (95% CI: 90.1-94.2%)] |
| [e.g., Specificity] | [e.g., ≥ 80%] | [e.g., 85.1% (95% CI: 83.0-87.1%)] |
| [e.g., AUC] | [e.g., ≥ 0.85] | [e.g., 0.88] |
2. Sample size used for the test set and the data provenance
This information would be found in the "Methods" or "Study Design" section.
- Test Set Sample Size: [e.g., 500 cases/images]
- Data Provenance: [e.g., Retrospective, collected from 3 hospitals in the USA and Canada]
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This would also be in the "Methods" section, specifically detailing ground truth ascertainment.
- Number of Experts: [e.g., 3 independent experts]
- Qualifications: [e.g., Board-certified radiologists with an average of 15 years of experience in oncological imaging, specialized in breast MRI.]
4. Adjudication method for the test set
This would describe how disagreements among experts were resolved.
- Adjudication Method: [e.g., 2+1 (majority vote of initial two readers, with a third reader resolving disagreements), or Consensus meeting, or None (all experts had to agree)]
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 would be in a comparative study section.
- MRMC Study Conducted?: [e.g., Yes]
- Effect Size (Improvement with AI): *[e.g., Human readers improved statistically significantly (p
Ask a specific question about this device
Page 1 of 1