(268 days)
Harvest Printable Resin is indicated for the fabrication of dental bases for full removable dentures, artificial teeth, dental bite splints and guards and try-in devices, i.e., denture base and teeth. The material is an alternative to traditional heat-curable and auto-polymerizing resins and is intended for professional dental work only. This material is intended to be used by dental lab technicians and approved by licensed practitioners before being provided to the patient.
Harvest Printable Resin is a light-cured resin developed for additive manufacturing (3D printing) of individual full denture bases, artificial teeth, bite splints and guards and try-in devices, i.e., denture base and teeth. After being utilized in a 3D stereolithographic printer to generate a dental device based on a solid model, the device is placed in a UV light curing unit for final polymerization. Fabrication using Harvest Printable Resin requires an appropriate computer-aided Design and Manufacturing (CAD/CAM) system, a digital light processing (DLP) printer, and post-processing light curing equipment. It has been optimized for use with Asiga (Max UV, Pro 4K65 and Pro 4K80) and Sprintray (Pro95 S and Pro55 S) printers and, therefore, may only be used in conjunction with these printers and their associated software systems. It is also only to be used in conjunction with Asiga (Max UV, Pro 4K65 and Pro 4K80) and Sprintray (Procure and Procure 2) curing units for post-processing. The 3D printer is not included with the device.
The provided document describes a medical device, "Harvest Printable Resin," and its substantial equivalence to predicate devices based on technological characteristics and performance data, primarily through biocompatibility testing and ISO 20795-1 & -2 testing.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard Reference) | Reported Device Performance (Harvest Printable Resin) | Predicate Device 1 (NextDent Denture/E-Denture) Performance | Predicate Device 2 (E-Guard) Performance | Comparison to Criteria |
|---|---|---|---|---|
| Ultimate Flexural Strength (ISO 20795-1) | ≥ 65 MPa (reported: 81.6 MPa) | ≥ 65 MPa (reported: 84 MPa) | N/A | Passed |
| Ultimate Flexural Strength (ISO 20795-2) | ≥ 50 MPa (reported: 81.6 MPa) | N/A | ≥ 50 MPa (reported: 79.4 - 85.1 MPa) | Passed |
| Flexural Modulus (ISO 20795-1) | ≥ 2,000 MPa (reported: 2,339 MPa) | ≥ 2,000 MPa (reported: 2,383 MPa) | N/A | Passed |
| Flexural Modulus (ISO 20795-2) | ≥ 1,500 MPa (reported: 2,339 MPa) | N/A | ≥ 1,500 MPa (reported: 2050-2130 MPa) | Passed |
| Water Sorption (ISO 20795-1) | ≤ 32 µg/mm³ (reported: 24.3 µg/mm³) | ≤ 32 µg/mm³ (reported: 28 µg/mm³) | N/A | Passed |
| Water Sorption (ISO 20795-2) | ≤ 32 µg/mm³ (reported: 24.3 µg/mm³) | N/A | ≤ 32 µg/mm³ (reported: 30-32 µg/mm³) | Passed |
| Water Solubility (ISO 20795-1) | ≤ 1.6 µg/mm³ (reported: 1.1 µg/mm³) | ≤ 1.6 µg/mm³ (reported: 0.1 µg/mm³) | N/A | Passed |
| Water Solubility (ISO 20795-2) | ≤ 5 µg/mm³ (reported: 1.1 µg/mm³) | N/A | ≤ 5 µg/mm³ (reported: 0.5 µg/mm³) | Passed |
| Residual Monomer | None (no MMA monomers used for production) | ≤ 0.1% (w/w) (for some MMA) / ≤ 2.2% (w/w) | Unknown | Improved |
| Biocompatibility | Adequate biocompatibility | N/A (implied by predicate status) | N/A (implied by predicate status) | Passed |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample sizes used for the ISO 20795-1 & -2 tests or the biocompatibility tests. It also does not specify the provenance (e.g., country of origin, retrospective or prospective) of the data. These tests are typically conducted in a laboratory setting on standardized test specimens.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and not provided in the document. The "ground truth" for material property testing (like ISO 20795-1 & -2) and biocompatibility is established by adherence to recognized international standards and laboratory measurements, not by expert consensus on clinical cases. No human-in-the-loop performance is being evaluated here.
4. Adjudication method for the test set
Not applicable. As noted above, this is material property and biocompatibility testing, not a clinical assessment requiring adjudication of human expert opinions.
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
No MRMC comparative effectiveness study was done. The document explicitly states: "No human clinical testing was conducted to support substantial equivalence." This device is a material, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, "standalone" performance was effectively done in the form of laboratory testing of the material properties described in section 1 and biocompatibility. The performance evaluation focuses solely on the inherent characteristics of the Harvest Printable Resin itself, without any human intervention in its measurement or any AI algorithms.
7. The type of ground truth used
The ground truth for the performance evaluation relies on:
- Established International Standards: ISO 20795-1:2013 and ISO 20795-2:2013 for physical/mechanical properties. These standards define the methodology and acceptance criteria.
- Recognized Biocompatibility Standards: ISO 7405:2018 and ISO 10993-1 as recognized by the FDA for biocompatibility. These standards outline tests to ensure the material is safe for biological contact.
8. The sample size for the training set
Not applicable. This device is a material, not an AI model, 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 this type of device.
§ 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.