(83 days)
Impression Compound is intended for use as a rebasing and relining impression material as well as for general impressions including, but not limited to dentures, root surfaces and posts.
Impression Compound is a thermoplastic impression material available in cakes for full or partial impressions or in sticks for adding to the periphery of an impression or for copper band impressions. Impression Compound is available in three different working temperatures. The different colors signify the softening temperature of each compound.
The provided text describes a 510(k) submission for an "Impression Compound" device. This submission focuses on demonstrating substantial equivalence to a predicate device through biocompatibility and bench testing, rather than a study involving human readers or AI algorithms.
Therefore, many of the requested criteria, such as acceptance criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, are not applicable or mentioned in this document. The device is a physical material, not a diagnostic algorithm.
Here's the information that can be extracted from the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria in a table format. It states that an "In Vitro Cytoxicity biocompatibility study has been completed on Impression Compound, which demonstrates that the material is non-cytotoxic and is safe for its intended use." It also mentions "bench testing used to compare the physical properties of Impression Compound compared to the predicate device, ISO Functional." The success criteria for these tests are implied to be that the device performs similarly to or better than the predicate device and is non-cytotoxic.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Non-cytotoxic | Demonstrated to be non-cytotoxic and safe for its intended use |
| Physical properties comparable to predicate device | Bench testing used to compare physical properties, with the conclusion that it is "substantially equivalent." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The "test set" in this context refers to samples of the Impression Compound material itself for in vitro and bench testing, not a dataset for an algorithm. The sample sizes for these material tests are not specified. The document does not provide details on data provenance for the testing beyond indicating it was performed in vitro and in bench settings.
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. This device is a dental impression material, not a diagnostic tool requiring expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This study does not involve human readers or diagnostic interpretation methods that would require adjudication.
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
No, a multi-reader, multi-case comparative effectiveness study was not done. This is a physical dental material, 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 device is a material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the biocompatibility study was the outcome of an In Vitro Cytotoxicity test (e.g., cell viability, lack of toxic effects). For bench testing, the ground truth was the measured physical properties of the predicate device.
8. The sample size for the training set
Not applicable. This device is a material, not a machine learning model, so there is no training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of device.
§ 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).