(50 days)
Metacryl___ is intended for the chairside fabrication of soft relines for dentures.
Metacryl is a chemically cured soft denture reline. All components have been used in legally marketed devices or have been found to be safe for dental use.
The provided text describes the "Metacryl" soft denture reline device. However, it does not contain specific acceptance criteria, a detailed study proving device performance against such criteria, or the requested details about statistical methods, expert involvement, or training data.
The document primarily focuses on establishing substantial equivalence to a predicate device (Flexacryl Soft) for 510(k) clearance.
Here's an analysis based on the information available:
Acceptance Criteria and Device Performance
The document does not explicitly state numerical acceptance criteria in a dedicated table format. Instead, it lists the properties evaluated and concludes that the device's performance, along with its similarity to the predicate and biocompatibility results, supports its safety and effectiveness.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Mechanical Properties | Evaluated |
| Hardness | Evaluated |
| Water Absorption | Evaluated |
| Discoloration | Evaluated |
| Peel Strength | Evaluated |
| Biocompatibility | ISO Agar Overlay Cytotoxicity Test: non-cytotoxic |
Note: The document states that Metacryl was "evaluated as follows" for mechanical properties, hardness, water absorption, discoloration, and peel strength. It does not provide the specific quantitative results for these evaluations, nor does it define what specific values would constitute "acceptance." The conclusion is a general statement of similarity and support for safety and effectiveness.
Additional Information Not Available in the Provided Text:
- 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 provided. The document states "Metacryl was evaluated," but does not detail the size or nature of the test set for the performance parameters.
- 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 as this device is a material, not an AI or diagnostic device requiring expert interpretation of ground truth in the context of imaging or clinical outcomes. The "ground truth" here would be the physical and chemical properties measured in a lab setting.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for this type of material testing.
- 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-assisted diagnostic or imaging device.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a material, not an algorithm.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): For the performance properties (mechanical, hardness, water absorption, discoloration, peel strength), the ground truth would be the measured values obtained through established laboratory testing protocols for dental materials. For biocompatibility, the ground truth was the result of the ISO Agar Overlay Cytotoxicity Test.
- The sample size for the training set: Not applicable. This is not an AI or machine learning device requiring a training set.
- How the ground truth for the training set was established: Not applicable.
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.