(97 days)
The ComfortSoft® Soft Denture Liner System is intended for use as a long-term soft liner for removable dentures.
ComfortSoft® is a high pressure cured, silicone-based soft lining material for long-term use in removable dentures. ComfortSoft® is suitable for all PMMA-based dentures. Meets ISO 10139-2 and is a Shors A hardness Type A material. It is a, translucent, non-flowing, long-term soft silicone based liner. Use to reline, rebase or line new or existing dentures. ComfortSoft® Soft Denture Liner provides a cushion between the denture and the mouth tissues to aid in reducing sore spots, and allows improved adaptation to tissue contours thereby aiding in a comfortable fit of the denture.
Here's a breakdown of the acceptance criteria and study information for the ComfortSoft® Soft Denture Liner System based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| MEM elution | Passed |
| Guinea Pig Maximization Sensitization | Passed |
| Intracutaneous Toxicity | Passed |
| Systemic Toxicity | Passed |
| Sub-Acute Toxicity | Passed |
| Ames test | Passed |
| Chromosomal Aberration | Passed |
| In vivo Mouse Micronucleus Extract | Passed |
| Material Properties: | |
| Meets ISO 10139-2:2009 | Passed |
| Shore A hardness Type A material | Confirmed (stated in description) |
| Bond strength | At least 1 MPa |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for the individual biocompatibility tests or the ISO 10139-2 testing. It only reports that these tests were "completed and passed."
The data provenance is not explicitly mentioned (e.g., country of origin). The studies appear to be pre-market bench and biological testing conducted by or for the manufacturer. No retrospective or prospective human clinical trial data is mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable. The evaluations conducted were physical and biological tests against established standards (ISO 10139-2) and biocompatibility guidelines, not subjective expert assessments of a test set. Ground truth was established by the specifications of the tests themselves.
4. Adjudication Method for the Test Set
This information is not applicable as the evaluations were objective tests against standards rather than subjective expert assessments requiring adjudication.
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 focuses on bench testing and biocompatibility.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable to a physical medical device like a denture liner. There is no algorithm involved.
7. The Type of Ground Truth Used
The ground truth used for performance validation was based on:
- International Standards: ISO 10139-2:2009 for material properties.
- Biocompatibility Guidelines: Established protocols for various toxicity and sensitization tests (e.g., MEM elution, Guinea Pig Maximization Sensitization).
- Manufacturer Specifications: For bond strength (at least 1 MPa).
8. The Sample Size for the Training Set
This information is not applicable. There is no machine learning "training set" for this type of device.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.