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510(k) Data Aggregation
(80 days)
Infibra is intended for use by dentists to provide reinforcement to acrylic or composite resins used for dental restorations. It can be used for the following applications: As reinforcement in manufacturing and/or repairing full or partial dentures as well as overdentures, night-guards and orthodontic appliances. To repair and reinforce resin or composite prostheses including temporary and permanent bonded and removable bridges. To reinforce splints used to immobilize teeth.
InFibra is a fiber reinforcement used to reinforce dental resins. It is made of ultra-high-molecularweight polyethylene (UHMW). The fibers are braided and not leno-weave treated.
The device in question, InFibra, is a fiber reinforcement material for dental resins. The provided text is a 510(k) summary and associated FDA correspondence, not a detailed study report for a medical AI device. Therefore, much of the requested information regarding AI-specific acceptance criteria and study details (like sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance of an algorithm, etc.) is not applicable or available in this document.
However, I can extract the acceptance criteria and performance relevant to this material science device based on the provided FDA submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| Biocompatibility: ISO 10993-5 "Biological evaluation of medical devices - Tests for cytotoxicity: in vitro methods" | "show no evidence of cytotoxic response" |
| Mechanical Strength: ISO 3597-2 (Three-point Bending standards) | "The results showed the material to be suitable for reinforcing 1) removable dentures 2) crown and bridges 3) provisional crown and bridges 4) splint device reinforcement 2) splinting of teeth 6) orthodontic appliances" |
| Comparison to Predicate: Substantial equivalence in quality of mechanical characteristics, mechanical safety, materials, design, performance, and indication for use with Ribbond™ (K913040) and EZ Connect (K000346). | "InFibra is made of UHMW fiber braided. Tests show that InFibra has greater load carrying capacity than the leno-weave. The different design characteristics of InFibra are primary differences of minor changes to the materials and dimensions and does not raise new questions of safety and effectiveness and demonstrates that the device is as safe and effective as the predicate device." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified.
- Data Provenance: Not specified (implied to be laboratory testing for material properties).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable as this is a material science device, not an AI diagnostic device. Ground truth is established by standardized laboratory tests.
4. Adjudication method for the test set
- Not applicable. Performance is determined by quantitative measurements against ISO standards.
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 is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI device.
7. The type of ground truth used
- For biocompatibility: In vitro cytotoxicity test results based on ISO 10993-5.
- For mechanical properties: Quantitative measurements (e.g., load carrying capacity) based on ISO 3597-2.
- For substantial equivalence: Comparison against the characteristics and performance of legally marketed predicate devices.
8. The sample size for the training set
- Not applicable. This is a material science device, not an AI device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable.
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(104 days)
Intended for temporary root canal filling during endodontic therapy.
CIMOFLUOR
The provided text is a 510(k) clearance letter from the FDA for a device called CIMOFLUOR, which is a root canal filling resin. This document grants market clearance based on substantial equivalence to a predicate device, rather than providing details of a clinical study or acceptance criteria.
Therefore, the document does not contain the information required to answer the questions about acceptance criteria and study details.
Specifically:
- A table of acceptance criteria and the reported device performance: Not provided.
- Sample size used for the test set and the data provenance: Not provided. The document refers to a "premarket notification" but does not detail the testing performed or the data provenance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
- Adjudication method for the test set: Not provided.
- 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 provided. The device is a root canal filling resin, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a physical product, not an algorithm.
- The type of ground truth used: Not provided.
- The sample size for the training set: Not applicable (not an AI device).
- How the ground truth for the training set was established: Not applicable (not an AI device).
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