(56 days)
Flexo Dental Resin Material is used for the fabrication of partial or full removable dentures, as well as occlusal splints and night guards.
The Flexo Dental Resin Material is an injection moldable, flexible thermoplastics resin designed for fabricating removable dental appliances.
The provided text describes the Flexo Dental Resin Material, an injection moldable, flexible thermoplastic resin used for fabricating removable dental appliances. The submission focuses on demonstrating substantial equivalence to a predicate device, Lucitone FRS Flexibel Dental Resin, rather than providing a detailed study proving the device meets specific acceptance criteria through clinical or complex performance studies.
Therefore, many of the requested elements for a study design and acceptance criteria related to AI/algorithm performance are not applicable here.
Here's an analysis based on the provided information, addressing the relevant points and noting where information is not available or not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Physical properties equivalent to predicate device | "Physical property testing indicates that Flexo Dental Resin Material performs equal to the predicate device." |
| Biocompatibility (Non-cytotoxic) | "The cytotoxic and biocompatible test has been performed(Non-cytotoxic)." |
| Similarity in composition to predicate device | "similarity in composition of Flexo Dental Resin Material to the predicate device" |
| Suitable for intended use: fabrication of partial or full removable dentures, occlusal splints, and night guards | Implied by substantial equivalence to a legally marketed device for these uses. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This is not a study involving a test set of data for an AI/algorithm. The "testing" refers to physical property testing and biocompatibility testing of the material itself. The text does not provide specific sample sizes for these material tests, nor does it detail their provenance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is not a study requiring expert ground truth for a test set.
4. Adjudication Method for the Test Set
Not applicable.
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
Not applicable. This is a material science submission, not an AI/algorithm-based diagnostic or assistive device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The Type of Ground Truth Used
The "ground truth" in this context refers to established standards for material properties and biocompatibility.
- Physical Properties: Likely established through standardized ASTM or ISO testing methods for dental resins. The comparison is against the predicate device's known performance.
- Biocompatibility: Established through standardized in vitro (e.g., cytotoxicity) testing methods.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning model.
9. How the Ground Truth for the Training Set was Established
Not applicable.
Summary of the Study (Implied):
The "study" presented here is essentially a substantial equivalence demonstration based on in vitro material property testing and biocompatibility testing, compared against a predicate device.
- Acceptance Criteria Focus: The primary acceptance criterion is that the Flexo Dental Resin Material's physical properties and biocompatibility are equal or similar enough to the legally marketed predicate device (Lucitone FRS Flexibel Dental Resin) to demonstrate it is safe and effective for its intended uses. The composition is also a key factor in this comparison.
- Evidence Provided:
- Physical Property Testing: Stated that "Physical property testing indicates that Flexo Dental Resin Material performs equal to the predicate device." No specific measurements or methodology are detailed in this summary.
- Biocompatibility Testing: Stated that "The cytotoxic and biocompatible test has been performed (Non-cytotoxic)." Again, details of the test are not provided.
- Compositional Similarity: The submission highlights the "similarity in composition" to the predicate device.
- Conclusion: Based on these comparisons, the ACI Flexo Dental Resin Material is considered substantially equivalent to the Lucitone FRS Flexible Dental Resin in design, material, and function.
§ 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.