(50 days)
Intended for use as a long-term resilient lining material for removable dentures, to reline, repair, or rebase dentures.
Not Found
The provided text is a 510(k) summary for the "Mucoderm™ soft reliner system" and primarily focuses on establishing substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study data typical of a clinical trial or performance study for a novel device.
Therefore, many of the requested information points (like specific acceptance criteria, detailed performance data, sample sizes for test/training sets, expert qualifications, and comparison studies) are not present in this document. This is common for 510(k) submissions where the device is considered substantially equivalent to already marketed devices, and thus extensive de novo studies may not be required to demonstrate safety and effectiveness.
However, based on the available information, here's what can be extracted:
Acceptance Criteria and Study for Mucoderm™ Soft Reliner System
The provided document describes a 510(k) submission for the Mucoderm™ soft reliner system, focusing on its substantial equivalence to predicate devices (K964040, K953589, K963736, and K954810). The primary "study" supporting its acceptance is the demonstration of substantial equivalence through comparison of intended use, technological characteristics, and material composition, along with biocompatibility testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied/Stated) | Reported Device Performance and Evidence |
|---|---|
| Intended Use: Long-term resilient lining material for removable dentures (reline, repair, rebase). | Meets: "These products have the same intended use, as a long-term resilient lining material for removable dentures, as the classified device and many cleared by the 510(k) process under K-964040 (Dentsply), K953589 (Tokuyama), K963736 (Sybron) and K954810 (Austenal)." |
| Technological Characteristics: Similar to predicate devices. | Meets: "The technological characteristics for this product are the same as those for the predicate devices and those currently on the market except for differences in methods of cure." (Acknowledges variation in cure methods across equivalent products). |
| Material Composition: Substantially equivalent to predicate devices. | Meets: "Descriptive information provided shows that the materials from which Mucopren™ is made are substantially equivalent to (nearly identical with some) those of similar products, used for identical purposes, currently on the market." (Note: Document uses both Mucoderm and Mucopren). |
| Biocompatibility: Safe for prolonged contact with mucosal membrane. | Meets: "Test data for biocompatibility of Mucopren was supplied in accordance with ODE General Program Memorandum #G95-1, using International Standard ISO 10993 for surface devices having prolonged contact with mucosal membrane. Less formal biocompatibility tests from Europe also were made. These data are supplied in Appendix III." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in the provided document for any specific clinical or performance test set. The submission relies on comparison to predicate devices and general biocompatibility testing.
- Data Provenance:
- Biocompatibility tests followed International Standard ISO 10993.
- "Less formal biocompatibility tests from Europe" were also made.
- The primary evidence is a comparison of characteristics to existing US-marketed predicate devices cleared via 510(k). The data underlying the safety and effectiveness of the predicate devices would be US-based, but not explicitly stated for this particular submission's "test set."
- Retrospective/Prospective: Not applicable to the primary substantial equivalence argument in this document. Biocompatibility testing would have been prospective for this device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable / Not specified. The document does not describe a clinical "test set" that required expert establishment of ground truth in the context of device performance metrics. The ground truth for biocompatibility would be established by laboratory testing against ISO standards.
4. Adjudication Method for the Test Set
- Not applicable / Not specified. No explicit clinical test set requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. This type of study is not mentioned or implied in the document, as the submission focuses on substantial equivalence rather than comparative effectiveness with human readers/users.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This document describes a dental relining material, not an algorithm or AI system.
7. The Type of Ground Truth Used
- The "ground truth" for this submission is primarily the established safety and effectiveness of the predicate devices and compliance with biocompatibility standards (ISO 10993). There is no mention of "expert consensus," "pathology," or specific "outcomes data" in the context of a de novo clinical study for this device here.
8. The Sample Size for the Training Set
- Not applicable / Not specified. This document describes a dental material, not a machine learning algorithm.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As above, this is not an AI/ML submission.
§ 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.