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The SOFRELINER TOUGH S denture relining, repairing, or rebasing resin device is for use as a denture reliner.

The SOFRELINER TOUGH S denture relining, repairing, or rebasing resin device is a prescription addition-cured silicone chairside soft lining material for removable dentures. It is indicated for use as a denture reliner.

The main components of the SOFRELINER TOUGH S device are:

• 1. A paste consisting of a base and catalyst;
• A primer packaged separate used for bonding to the acrylic surfaces; and 2)
• Various accessories, namely a spatula, brush, drip-cap, drip-cup, mixing 3) tip, coarse point, finish wheel, and washer

Nearly all ingredients used in the SOFRELINER TOUGH S denture relining, repairing, or rebasing device are either commonly used in similar dental devices or have been subjected to extensive biocompatibility testing. However, the paste of the SOFRELINER TOUGH S does contain one new ingredient and thus toxicity testing was performed, namely cytotoxicity, sensitization, irritation, subchronic systemic toxicity, and genotoxicity.

The SOFRELINER TOUGH S denture relining, repairing, or rebasing resin device does not come sterilized and is not intended to be sterilized prior to use.

The provided text describes the 510(k) summary for the Tokuyama Dental Corporation's SOFRELINER TOUGH S Denture Relining, Repairing, or Rebasing Resin Device. Below is an analysis of its acceptance criteria and the supporting study, structured according to your request.

1. Table of Acceptance Criteria and Reported Device Performance

The documentation does not explicitly define "acceptance criteria" with specific numerical targets. Instead, it states that the device was tested for various physical properties and compared to predicate devices for substantial equivalence. The "performance" reported is that the device meets the properties of the standards and is considered as safe and effective as the predicates.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the exact sample sizes used for the non-clinical physical properties testing or the biocompatibility testing. It only states that these tests "were conducted in accordance with ISO 10139-1: 1991 and ISO 10139-2: 1999" and that toxicity testing "was performed."

The data provenance is from Japan, as the submitter, Tokuyama Dental Corporation, is based in Tokyo, Japan. The study appears to be retrospective as it involves non-clinical testing of a developed product to demonstrate its properties.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The tests described are primarily physical and chemical property assessments according to international standards (ISO). These types of tests typically rely on standardized methods and laboratory technicians rather than clinical experts establishing "ground truth" in the same way it would be for diagnostic devices.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. The assessment involves laboratory testing against established standards, not interpretation by multiple experts that would require an adjudication method.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "There were no clinical tests performed for the SOFRELINER TOUGH S device." Therefore, there is no effect size of how much human readers improve with AI vs without AI assistance to report.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

No, a standalone study was not done. This device is a material for dental use, not a diagnostic algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for the physical properties and biocompatibility testing was based on:

• Adherence to International Standards: ISO 10139-1: 1991 and ISO 10139-2: 1999 for physical properties.
• Established Biocompatibility Testing Protocols: As implied by the common practice for cytotoxicity, sensitization, irritation, subchronic systemic toxicity, and genotoxicity tests.
• Comparison to Predicate Devices: The overall performance and safety were assessed in comparison to legally marketed predicate devices. This implies that the performance of the predicate devices served as a de facto "ground truth" for what constitutes acceptable performance for this type of device.

8. The Sample Size for the Training Set

This information is not applicable/not provided. The device is a material, not an AI or machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable/not provided for the same reason as above.

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