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510(k) Data Aggregation
(169 days)
Whip Mix VeriSplint is a light-cured resin. It is a polymer used to create removable structures for therapeutic restorations i.e., bite guards/splints and occlusal night guards/splints using the Additive Manufacturing process. The resin in combination with a scanner, printer, and curing unit make up the system.
The VeriSplint ®OS system is a combination of a scanner, resin, 3D printer, and curing unit. The system components work together to manufacture a splint/bite guard. The additive manufactured appliance is part of a photo-cured product family that is a combination of methacrylate resins. In general, the products in this family are composed of a 3-component methacrylic system, polymerized via photo initiators in a 3D printer setting. The material is an alternative to traditional heat cured and auto polymerizing resins.
The provided text describes the Whip Mix VeriSplint device and its performance testing to demonstrate substantial equivalence to predicate devices, primarily for its physical and chemical properties as a dental material. It does not describe a study involving human-in-the-loop performance, expert ground truth establishment for a test set, or MRMC studies, as would be common for AI/ML-based medical devices.
Therefore, many of the requested elements for the acceptance criteria and study proving device performance (specifically those related to AI/ML and human reading studies) are not applicable to the information provided in this document.
Here's the information that can be extracted from the provided text, focusing on the material characteristics and the regulatory review process for VeriSplint:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria here are based on the requirements of ISO 20795-2:2013, Dentistry – Base Polymers – Part 2: Orthodontic base polymers, and comparison to predicate devices.
| Requirement | Acceptance Criteria (from ISO 20795-2:2013 or inferred from predicate) | Reported VeriSplint Performance | Primary Predicate Performance (K150432) | Reference Predicate Performance (K162572) |
|---|---|---|---|---|
| Flexural Strength | ≥ 50 MPa | > 100 MPa | 90 MPa | Not provided |
| Flexural Modulus | ≥ 1500 MPa | > 2500 MPa | Not provided | Not provided |
| Water Solubility | ≤ 5µg/mm³ | < 1 µg/mm³ | 0.0000 mg/mm³ | Not provided |
| Water Sorption | ≤ 32µg/mm³ | 29 µg/mm³ | 0.023 mg/mm³ | Not provided |
| Residual Monomer Content | ≤ 5% | ≤ 0.10 % | 1.4% | Not provided |
| Biocompatibility | Biocompatible | Biocompatible | Biocompatible | Biocompatible |
2. Sample size used for the test set and the data provenance
The document does not specify sample sizes for mechanical or chemical testing. It only states that tests were performed and results are reported. Data provenance is implied to be from laboratory testing conducted by Whip Mix Corporation. (e.g., this is likely physical material testing, not clinical data or image data).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a material, not an AI/ML diagnostic or image analysis device that would require expert ground truth for a test set in the conventional sense. The "ground truth" here is established via adherence to international standards for dental materials (ISO 20795-2:2013).
4. Adjudication method for the test set
Not applicable. This is not a study requiring adjudication of expert readings/interpretations.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, an MRMC study was not done, as this is a dental material, not a diagnostic imaging device.
6. If a standalone (i.g., algorithm-only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm. The performance described relates to the physical and chemical properties of the resin itself.
7. The type of ground truth used
The ground truth for the performance claims (Flexural Strength, Flexural Modulus, Water Solubility, Water Sorption, Residual monomer content, Biocompatibility) is established by the international standard ISO 20795-2:2013, Dentistry – Base Polymers – Part 2: Orthodontic base polymers. Biocompatibility would also rely on other relevant ISO standards (e.g., ISO 10993 series).
8. The sample size for the training set
Not applicable. This is a material, not a machine learning model; therefore, there is no "training set" in the context of AI/ML.
9. How the ground truth for the training set was established
Not applicable. See point 8.
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