(63 days)
Variflex™ is intended for the laboratory fabrication of dental appliances such as interocclusal splints and night guards.
Variflex 100 is a chemically cured soft dental acrylic. All components have been used in legally marketed devices or have been found to be safe for dental use.
This is a 510(k) premarket notification for a dental material (Variflex™ heat-softening acrylic), not a medical device software or AI algorithm. Therefore, many of the requested criteria such as "effect size of how much human readers improve with AI vs without AI assistance," "standalone performance," "training set size," and "ground truth establishment for training set," are not applicable.
Here's the information gleaned from the document regarding the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Test/Attribute | Acceptance Criteria (Implicit) | Reported Device Performance (Variflex™) | Predicate Device (Clearsplint™) |
|---|---|---|---|---|
| Technological Characteristics | Mechanical properties | Performance comparable to predicate device for indicated use. | Not explicitly stated, but implied to be sufficient for indicated use. | Not explicitly stated. |
| Hardness | Performance comparable to predicate device. | Not explicitly stated, but implied to be sufficient. | Not explicitly stated. | |
| Water absorption | Performance comparable to predicate device. | Not explicitly stated, but implied to be sufficient. | Not explicitly stated. | |
| Discoloration | Performance comparable to predicate device. | Not explicitly stated, but implied to be sufficient. | Not explicitly stated. | |
| Physical properties variation with temperature | Performance comparable to predicate device. | Not explicitly stated, but implied to be sufficient. | Not explicitly stated. | |
| Biocompatibility | MEM Elution Test | Non-cytotoxic | Non-cytotoxic | Not explicitly stated for predicate in this document. |
| Mucous membrane irritation | Non-irritant | Non-irritant | Not explicitly stated for predicate in this document. | |
| Kligman Maximization Test (NaCI) | Non-sensitizer | Non-sensitizer | Not explicitly stated for predicate in this document. |
Note: The document states that "We conclude that the similarity in composition between Variflex™ and the predicate device, as well as the performance data and biocompatibility results, supports the safety and effectiveness of Variflex™ for the indicated uses." This implies that the acceptance criteria for the mechanical and physical properties were met if they were comparable or equivalent in performance to the predicate device, as the 510(k) process is about demonstrating substantial equivalence. Exact numerical acceptance criteria are not provided in this summary.
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the provided text for any of the tests (mechanical, physical, or biocompatibility).
- Data Provenance: Not specified. It's standard for such tests to be laboratory-based.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a material testing for a physical device, not an AI or diagnostic imaging device requiring expert ground truth for interpretation.
4. Adjudication method for the test set
Not applicable. No "adjudication" in the sense of expert consensus on interpretations is relevant here. The tests are objective laboratory measurements.
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 test, not a diagnostic imaging device with human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a material test.
7. The type of ground truth used
For the biocompatibility tests (MEM Elution Test, Mucous membrane irritation, Kligman Maximization Test), the "ground truth" is established by standard biological assays and their predefined thresholds for cytotoxicity, irritation, and sensitization. For the mechanical and physical properties, the "ground truth" would be the standard measurement techniques and reference values for similar dental materials, with the predicate device serving as a comparative benchmark.
8. The sample size for the training set
Not applicable. This device is not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This device is not an AI algorithm.
§ 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.