(265 days)
FREEPRINT denture is a light-cured resin indicated for the fabrication of all types of denture bases, for instance full and partial removable dentures. FREEPRINT denture is intended for continuous use in the oral environment, exclusively for professional dental work. FREEPRINT denture can be used in combination with a stereolithographic 3D printer using a 3D-printer is not part of the device.
FREEPRINT denture is a light-cured one-component materials for the Digital Light Processing (DLP)-printing of denture base products. It is stored in 500 and 1000ml HDPE bottles. This Product is a liquid photo-curable material that is polymerized, by the photo-initiator contained in the resin. This device can be manufactured with 3D stereolithographic printer with 385nm wavelength light source. Curing in a 3D printer is related to the conditions of the printer equipment and is typically 100µm in thickness. FREEPRINT denture products are post cured with a xenon flashlight, in a nitrogen atmosphere.
The provided text describes a 510(k) premarket notification for a dental device called "FREEPRINT denture." It focuses on bench testing and biocompatibility studies to demonstrate substantial equivalence to a predicate device, rather than the performance of an AI/ML-based device that would typically involve a test set, ground truth experts, and MRMC studies.
Therefore, the requested information regarding acceptance criteria and a study proving an AI device meets these criteria cannot be fully extracted or answered from the provided document. The document describes a physical medical device (denture resin), not an AI/ML system.
However, I can extract the details about the performance testing and acceptance criteria as described for this physical device.
Here's an interpretation based on the provided text, acknowledging it's for a physical product and not an AI/ML device:
Device: FREEPRINT denture (light-cured resin for denture bases)
Type of Study: Bench testing and biocompatibility testing to demonstrate substantial equivalence to a predicate device. No clinical tests were performed.
1. A table of acceptance criteria and the reported device performance
For a physical material like dental resin, acceptance criteria are typically defined by recognized standards (like ISO) and relate to physical, chemical, and biological properties.
| Acceptance Criteria Category (Referenced Standard) | Reported Device Performance (Summary) |
|---|---|
| Physical/Mechanical Properties | |
| Strength, Resistance to Compressive & Tensile Loads | Sufficient strengths and performances in all intraoral conditions. |
| Hardness | Sufficient hardness. |
| Water Sorption | Sufficient resistance to water sorption. |
| Solubility | Sufficient resistance to solubility. |
| Biocompatibility (ISO 10993-3, -5, -10, -11, -17; ISO 7405) | Insolubility is in compliance with requirements. No evidence of hazardous effects from leachable ingredients/contaminants. |
| Printer Compatibility | Four specified 3D printers are validated for processing FREEPRINT denture. |
Proof of Meeting Acceptance Criteria:
"Performance testing confirmed the FREEPRINT denture demonstrated performance to the acceptance criteria referred to ISO 20795-1."
"Biocompatibility testing...The results showed that the insolubility is in compliance with the requirements of the standard. There is no evidence that hazardous effects will arise by leachable ingredients/contaminants."
2. Sample sized used for the test set and the data provenance
- Sample Size: Not explicitly stated for each specific test (e.g., how many samples were tested for water sorption). The document generally states "Bench testing was carried out."
- Data Provenance: Not explicitly stated for test samples (e.g., country of origin). The device manufacturer is DETAX GmbH & Co.KG. in Germany, implying testing likely occurred in a similar region. The studies are retrospective in the sense that they are conducted on manufactured samples of the device and its components, not involving patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable as the document describes a physical dental material, not an AI/ML device requiring expert interpretation of images or data to establish ground truth. "Ground truth" in this context refers to measurements against established standards for material science.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not Applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus in interpreting medical images for AI/ML development. For material performance testing, results are typically objective measurements against a standard.
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 physical device, not an AI/ML system. No human readers or interpretations of results in the context of an MRMC study are mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance relies on established international standards (e.g., ISO 20795-1 for dental base polymers, ISO 10993 series for biocompatibility), and the objective measurements of the material's properties against the specifications within these standards.
8. The sample size for the training set
Not Applicable. This is a physical dental material, not an AI/ML device that requires a training set. The material is manufactured and tested according to specified processes and properties.
9. How the ground truth for the training set was established
Not Applicable. As there is no training set for an AI/ML model, this question does not apply.
§ 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.