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510(k) Data Aggregation
(85 days)
The Myerson Company Limited
The product is a thermoplastic dental resin intended for the fabrication of partial or full removable dentures, as well as occlusal splints and night guards.
The product is a thermoplastic dental resin intended for the fabrication of partial or full removable dentures, as well as occlusal splints and night guards. The material is an acetal thermoplastic resin. The pellet version of the resin are melted and reshaped to form the dental device. The disc version of the material is milled to form the dental device.
This document is a 510(k) premarket notification for a dental device, "Duracetal," a thermoplastic dental resin. It focuses on demonstrating substantial equivalence to a predicate device, "Duraflex," rather than presenting a study proving that an AI/ML powered device meets acceptance criteria.
Therefore, the requested information regarding acceptance criteria and study details for an AI/ML device (e.g., sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) cannot be extracted from this document.
The document details the device's technical specifications, indications for use, and a comparison with the predicate device, along with the performance standards it conforms to for demonstrating equivalence in a traditional medical device context.
Here's a summary of what is available in the document regarding performance and comparison, rephrased to align with the spirit of your request as much as possible for a non-AI/ML device:
Device: Duracetal (thermoplastic dental resin)
Predicate Device: Duraflex (thermoplastic dental resin)
1. A table of (performance) criteria and the reported device performance:
The document provides a comparison table (Table A on page 5) outlining the characteristics of Duracetal against its predicate, Duraflex. These are not "acceptance criteria" in the sense of a numerical performance threshold, but rather a demonstration of equivalence across key attributes.
| Criteria | Duracetal results | Predicate results (Duraflex) | Comparison |
|---|---|---|---|
| Indications for use | To be used for the fabrication of partial or full removable dentures, as well as occlusal splints and night guards. | To be used for the fabrication of partial or full removable dentures, as well as occlusal splints and night guards. | The indications for use are the same |
| Raw material | Thermoplastic dental resin | Thermoplastic dental resin | Both are the same |
| Sterility | Non-sterile | Non-sterile | Both are the same |
| Anatomical site | mouth | mouth | Both are the same |
| Single use | Not intended for single use | Not intended for single use | Both are the same |
| Re-processing | Not intended for re-processing | Not intended for re-processing | Both are the same |
| Rx use | yes | yes | Devices made from both resins are per a doctor's prescription / intervention. |
Additional Performance Data (not in a direct comparison table with specific results, but stated as conformance):
"The Duracetal thermoplastic resin was tested for conformance and / or developed in accordance with the following standards:" (page 6)
- ISO 10993-1: Biological evaluation of medical devices
- Specific biocompatibility tests conducted: Cytotoxicity, Sensitization, Irritation - intracutaneous reactivity, Subchronic toxicity
- ISO 20795-1: Dentistry - base polymers- part 1: Denture base polymers
- ASTM D792 Density
- ASTM D638 Tensile Strength
- ASTM D638 Tensile Modulus
- ASTM D790 Flexural strength
- ASTM D790 Flexural / Bending Modulus
- ASTM D570 Water sorption
- ASTM D256 Izod Impact, Notched
- ISO 13485: Medical devices- Quality management systems-requirements for regulatory purposes.
Reported Device Performance (Stated Conclusion):
"Results from the performance data (discussed above) demonstrated that the device is as safe, as effective, and performs as well as or better than the predicate device." (page 7)
2. Sample sized used for the test set and the data provenance: Not applicable. This is not an AI/ML development or validation study. The performance data is based on material testing to established standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Material testing to standards does not use human experts in this way for ground truthing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For this type of device, "ground truth" is derived from adherence to established material performance standards (e.g., ASTM, ISO standards for dental materials and biocompatibility).
8. The sample size for the training set: Not applicable. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established: Not applicable.
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