(1 days)
- · Impression of inlay, onlay, crown, bridge, and veneer preparations
- · Functional impressions
The polyether impression material Permadyne consists of the two material components lightbodied consistency and heavy-bodied consistency. It's classified as impression materials (21 CFR 872.3660) because it's intended to reproduce the structure of a patient's teeth and qums. Permadyne is a hand mixed (base paste/catalyst paste) impression material used in one step technique. Thereby Permadyne – Light Bodied Consistency is used as wash material in combination with Permadyne – Heavy Bodied Consistency as tray material. The mixing ratio is 7 volumes base paste :1 volume catalyst paste.
Permadyne – Light Bodied Consistency is a light-bodied polyether impression material. The base paste is blueish colored and the catalyst paste reddish colored.
Permadyne - Heavy Bodied Consistency is a heavy-bodied polyether impression material. The base paste is salmon colored and the catalyst paste reddish colored.
The provided text describes a 510(k) summary for a medical device (Permadyne impression material) and focuses on demonstrating substantial equivalence to a predicate device rather than detailing a study that meets specific acceptance criteria for a novel AI/ML device. Therefore, much of the requested information (e.g., sample sizes for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) is not applicable or cannot be extracted from this document.
However, I can extract information related to the performance testing conducted to show equivalence.
Acceptance Criteria and Reported Device Performance
The device, Permadyne (reformulated), was tested against the requirements of ISO 4823:2015 Dentistry — Elastomeric Impression Materials. The reported performance indicates that the reformulated Permadyne fulfills the requirements of ISO 4823 and is similar to the predicate device (Permadyne K800031) for various physical and mechanical properties.
| Acceptance Criteria (ISO 4823:2015 Requirements) | Reported Device Performance (Permadyne Reformulated) |
|---|---|
| Colors (similarity to predicate) | Similar to Permadyne (K800031) |
| Mixing Time (similarity to predicate) | Similar to Permadyne (K800031) |
| Consistency (similarity to predicate) | Similar to Permadyne (K800031) |
| Working Time (similarity to predicate) | Similar to Permadyne (K800031) |
| Detail Reproduction (ISO 4823 requirements met) | Fulfills ISO 4823 requirements and similar to Permadyne (K800031) |
| Linear Dimensional Change (ISO 4823 requirements met) | Fulfills ISO 4823 requirements and similar to Permadyne (K800031) |
| Compatibility with Gypsum (Type 3 / Type 4 or 5) | Fulfills ISO 4823 requirements and similar to Permadyne (K800031) |
| Elastic Recovery (ISO 4823 requirements met) | Fulfills ISO 4823 requirements and similar to Permadyne (K800031) |
| Strain in Compression (ISO 4823 requirements met) | Fulfills ISO 4823 requirements and similar to Permadyne (K800031) |
| Biocompatibility (ISO 10993 series and ISO 7405) | Safe for intended use (assessed by board-certified toxicologist) |
Study Details
The document describes in vitro testing to demonstrate that the reformulated Permadyne meets the requirements of the FDA-recognized standard ISO 4823. Additionally, a comparison was made to the predicate device (Permadyne K800031) for various physical and mechanical properties.
- Sample size used for the test set and the data provenance: Not specified in the document. The tests are in-vitro, meaning they are laboratory tests, not clinical data from patients. The manufacturer is 3M Deutschland GmbH, located in Germany, suggesting data provenance from Europe. The study is an in-vitro performance test, making it a "prospective" test in the sense that the new device was created and then tested.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For material science tests against an ISO standard, the "ground truth" is established by the standard's methodology and acceptance criteria, not by expert consensus on individual cases. Biocompatibility was assessed by a "board-certified toxicologist."
- Adjudication method for the test set: Not applicable for material performance tests against a standard.
- 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 device is an impression material, not an AI/ML-driven diagnostic or assistive device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
- The type of ground truth used: The ground truth for performance avaluation of the impression material is defined by the ISO 4823:2015 standard, which specifies acceptable physical and mechanical properties for elastomeric impression materials. For biocompatibility, the ground truth is established by recognized international standards (ISO 10993 series, ISO 7405) and assessment by a board-certified toxicologist.
- The sample size for the training set: Not applicable. This is not an AI/ML device requiring a training set.
- How the ground truth for the training set was established: Not applicable.
§ 872.3660 Impression material.
(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).