(92 days)
Myerson Economy Denture Base Material is intended for use in the fabrication of full and partial dentures.
The Myerson Economy Denture Base Material is a conventional dough pack heat cure denture base material that consists of a polymethyl methacrylate polymer powder with a heat cure monomer consisting of methyl methacrylate, crosslinker (either EGDMA or TEGDMA), 0-1% UV Light Absorber.
The polymer is shaded to simulate the color of gum tissue using pigments that appear on the FDA list of approved products.
Here's an analysis of the provided text in the context of your request for device acceptance criteria and study details.
Based only on the provided text, it's immediately apparent that this document describes a traditional medical device (denture base material) submission from 1997, not an AI/ML-driven device. Therefore, many of the typical questions for AI/ML device evaluations (like ground truth establishment, MRMC studies, training sets, etc.) are not applicable to this specific submission.
The "acceptance criteria" here are more about compliance with existing standards and substantial equivalence to predicate devices, rather than performance metrics from a clinical study for a diagnostic AI.
Analysis of Provided Text for K970522: Myerson Economy Denture Base Material
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from Text) | Reported Device Performance (Inferred from Text) |
|---|---|
| Material Composition: Polymethyl methacrylate polymer powder, heat cure monomer (methyl methacrylate, crosslinker (EGDMA or TEGDMA), 0-1% UV Light Absorber). | The device is formulated with these specified components. |
| Shade: Pigments simulate gum tissue color. | The polymer is shaded to simulate gum tissue using FDA-approved pigments. |
| Substantial Equivalence: To predicate denture base systems. | The product is substantially equivalent to predicate denture base systems (pre-amendment or 510(k) notified). |
| Safety and Effectiveness: Well documented in dental literature for similar systems. | Safety and effectiveness of these systems (predicate devices) are well documented. The subject product is formulated to comply. |
| Compliance with Standards: Applicable American Dental Association (ADA) Standards for denture base materials and repair materials. | The subject products have been formulated to comply with the applicable ADA Standards for denture base materials and repair materials. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. The provided text does not describe a clinical study with a "test set" in the context of an AI/ML device. The submission relies on substantial equivalence and compliance with material standards, not performance against a specific test dataset.
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. Ground truth establishment, as typically understood for AI/ML devices, is not a concept relevant to this type of traditional material device submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No test set or human adjudication process 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
- Not Applicable. This is a material science device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithm; it's a physical material.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. The "truth" here is compliance with material specifications and established dental standards, and the physical properties of the material itself, not clinical outcomes directly measured with a "ground truth" dataset for performance evaluation.
8. The sample size for the training set
- Not Applicable. There is no "training set" for this type of device.
9. How the ground truth for the training set was established
- Not Applicable. There is no "training set" or corresponding ground truth.
Summary for K970522:
This 510(k) notification for Myerson Economy Denture Base Material is a pre-AI era submission. The "study" proving it meets acceptance criteria is primarily based on:
- Formulation Compliance: The material's composition (polymethyl methacrylate, methyl methacrylate, crosslinker, UV absorber, FDA-approved pigments) explicitly meets the described specifications.
- Substantial Equivalence: The device is compared to existing, legally marketed predicate denture base systems. This implies that the new device shares similar technological characteristics and is as safe and effective as the predicates.
- Adherence to Standards: The product is formulated to comply with applicable American Dental Association (ADA) Standards for denture base materials and repair denture base materials. These standards themselves are the "acceptance criteria" and meeting them is the "demonstration."
- Documentation: The safety and effectiveness of similar systems (predicates) are "well documented in the dental literature," which supports the substantial equivalence claim.
There are no direct performance metrics, clinical studies, or AI-related evaluations described in this summary. The "proof" is foundational to material science and regulatory compliance of the time.
§ 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.