(56 days)
Glidewell™ Appliance Resin, Hard/Soft is indication of orthodontic and dental appliances such as bite planes, mouthguards, nightguards, splints and repositioners.
Glidewell™ Appliance Resin, Hard/Soft is a light-cured resin for fabrication of orthodontic and dental appliances such as bite planes, mouthguards, nightguards, splints and repositioners. The Glidewell™ Appliance Resin. Hard and the Glidewell Appliance Resin, Soft can be used in combination to create a dual layer device consisting of a 3D printed hard layer, made from Glidewell™ Appliance Resin, Hard, and a soft layer that is molded with Glidewell Appliance Resin, Soft. The Glidewell™ Appliance Resin, Hard can also be used alone to create a 3D printed single layer device. The Glidewell™ Appliance Resin, Hard is compatible with DLP printers utilizing a wavelength of 385nm.
This is a 510(k) summary for a dental resin, not an AI/ML device. Therefore, the requested information regarding AI/ML device acceptance criteria and study details (such as sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details) is not applicable to this document.
The document discusses the substantial equivalence of the Glidewell™ Appliance Resin, Hard/Soft to a predicate device (KeyPrint KeySplint Soft Resin). The "acceptance criteria" in this context refer to the performance thresholds for physical properties and biocompatibility tests, rather than diagnostic accuracy or AI model performance.
Here's a breakdown of the relevant information provided, adapted to the context of a dental material rather than an AI device:
1. Table of Acceptance Criteria and Reported Device Performance (Non-AI Context):
The document states that "All the testing results met the acceptance criteria" for the following tests, indicating the device performed satisfactorily according to established standards. Specific numerical acceptance criteria and reported numerical performance values are not provided in this summary, but the summary confirms successful adherence to them.
| Test Type | Standard Applied | Acceptance Criteria (Summary confirms met) | Reported Device Performance (Summary confirms met) |
|---|---|---|---|
| Physical Properties | |||
| Flexural Strength | ISO 20795-2 | Met predetermined criteria | Met predetermined criteria |
| Flexural Modulus | ISO 20795-2 | Met predetermined criteria | Met predetermined criteria |
| Water Sorption | ISO 20795-2 | Met predetermined criteria | Met predetermined criteria |
| Water Solubility | ISO 20795-2 | Met predetermined criteria | Met predetermined criteria |
| Tensile Strength | ASTM D638 | Met predetermined criteria | Met predetermined criteria |
| Tensile Modulus | ASTM D638 | Met predetermined criteria | Met predetermined criteria |
| Elongation | ASTM D638 | Met predetermined criteria | Met predetermined criteria |
| Printing Accuracy | Based on design input | Met pre-specified tolerance | Met pre-specified tolerance |
| Printing Orientation Validation | Based on performance criteria | Met same performance criteria | Met same performance criteria |
| Biocompatibility | ISO 10993-1 | No biocompatibility concern | No biocompatibility concern |
| Packaging Validation | ASTM D4169-14 | Suitable for use | Suitable for use |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in the summary for each specific test (e.g., how many specimens for flexural strength). It broadly states "All the testing results" met the criteria.
- Data Provenance: Not specified, but generally, such tests are conducted in a laboratory setting by the manufacturer or a contracted lab. The document does not mention country of origin or whether it's retrospective/prospective data, as these concepts are not typically relevant for material property testing in this context.
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 science and biocompatibility assessment, not a diagnostic device requiring expert interpretation of results to establish ground truth. Ground truth is established by standardized physical/chemical measurements and biological assays against defined limits.
4. Adjudication method for the test set:
- Not Applicable. No adjudication process is described as the tests are objective material property 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 not an AI device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an AI device.
7. The type of ground truth used:
- Objective Measurement against Standards: For physical properties, ground truth is established by precise laboratory measurements against the requirements and limits defined in standards like ISO 20795-2 and ASTM D638. For biocompatibility, ground truth is established by standardized biological tests (e.g., cytotoxicity, sensitization) according to ISO 10993-1, with results interpreted against established safety thresholds.
8. The sample size for the training set:
- Not Applicable. This is not an AI device, so there is no "training set."
9. How the ground truth for the training set was established:
- Not Applicable. As there is no training set for an AI device.
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