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An over the counter temporary Denture Reliner, intended to replace a worn denture lining.

ProSoft™ is an over the counter temporary Denture Reliner kit. The device contains a Polyethyl Methacrylate powder, a liquid Ethyl Alcohol, and a mixing stick. The material contains no Methyl Methacrylate Monomer, no Phtalate Plasticizer, no Bisphenol A, and no Cadmium colors.

The powder and the liquid are to be mixed together with the mixing stick to make the relining material. The relining material is then poured into the denture base and placed into the mouth to make the impression.

Once the impression has cured any excess material is trimmed with a sharp knife.

Can be easily removed with warm water or soaking in a solution of hydrogen peroxide and water overnight.

The provided text describes a 510(k) submission for a dental device, "ProSoft™ Denture Reliner." However, it does not include information about AI algorithms or studies that would typically relate to the acceptance criteria and performance metrics asked for in the prompt. The device is a physical product (denture reliner kit) and the evaluation focuses on substantial equivalence to predicate devices based on non-clinical bench testing, not AI performance.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, MRMC study, standalone performance, training set size) are not applicable to the provided document.

Here's an analysis of what is available in the document, framed as closely as possible to your request:

1. A table of acceptance criteria and the reported device performance

Explanation of "Acceptance Criteria": For a 510(k) submission of this type of device, the primary "acceptance criterion" from a regulatory perspective is demonstrating "substantial equivalence" to a legally marketed predicate device. This is achieved by showing that the new device is as safe and effective as the predicate. The document indicates that the device met this criterion through non-clinical bench testing and biocompatibility assessments.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test Set Sample Size: Not applicable. The "test set" in this context refers to the samples used in the non-clinical bench testing. The document states "Bench testing was performed" and "Comparative testing data was provided" but does not specify the sample size of the materials or tests conducted.
• Data Provenance: The testing was "performed by a third party laboratory." The country of origin and whether the data was retrospective or prospective are not mentioned, but given it's a 510(k) in the US, it's presumed to be for the US market. The testing is implied to be prospective for the purpose of the submission.

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 does not involve a diagnostic or interpretive function that would require "experts to establish ground truth" as it would for an AI-powered image analysis device. The "ground truth" for its performance is assessed via established physical and chemical test methods.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. Adjudication methods like 2+1 are relevant for discrepancies in expert interpretations, which is not pertinent to this device's evaluation.

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. An MRMC study was not done. This device is a physical denture reliner, not an AI-assisted diagnostic tool or an imaging device. Clinical testing was explicitly not conducted ("Clinical testing was not conducted").

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This device is a physical product and does not have an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Type of Ground Truth: For the functionality and biocompatibility, the "ground truth" would be established by established scientific and engineering principles, material science standards, and accepted testing protocols (e.g., for strength, adhesion, biocompatibility through ISO standards or similar). The FDA Guidance Document "OTC Denture Cushions, Pads, Reliners, Repair Kits, and Partially Fabricated Denture Kits" serves as a benchmark for what needs to be tested. The "ground truth" for showing substantial equivalence essentially means demonstrating that the new device's performance profiles, as measured by these tests, are comparable to those of the predicate device within acceptable limits.

8. The sample size for the training set

• Not applicable. This device is a physical product and does not involve AI/machine learning, therefore no training set is relevant.

9. How the ground truth for the training set was established

• Not applicable. See #8.

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