(315 days)
The JUVORA™ Dental Disc is a thermoplastic dental disc. They are intended to be used for the manufacture of:
i) full and partial removable dentures and implant overdentures.
ii) copings, substructures (cemented), frameworks for permanent and transitional anterior or posterior crowns and bridgework.
JUVORA™ Dental Discs are cylindrical, puck-shaped discs made from the polymer, PEEK-OPTIMA™ LT1, that are used in the CAD/CAM manufacture of removable dental prostheses. The disc is provided non-sterile, without any accessories, and are single use.
The JUVORA™ Dental Discs are provided in a variety of sizes:
Ø 95 x 16 mm Ø 95 x 20 mm Ø 98 x 16 mm Ø 98 x 18 mm Ø 98 x 20 mm Ø 98 x 22 mm Ø 98 x 25 mm Ø 98 x 30 mm Ø 101 x 13 mm
Ø 101 x 20 mm
The provided text describes a 510(k) premarket notification for the Juvora Dental Disc, and evaluates its substantial equivalence to a predicate device. This document is a regulatory submission for a medical device and therefore primarily focuses on demonstrating that the new device is as safe and effective as a legally marketed device.
Unfortunately, this type of regulatory document does not typically include the detailed information required to answer your questions about acceptance criteria, specific study results, sample sizes, ground truth establishment, or expert-driven studies (like MRMC or standalone AI performance). These elements are much more common in publications and regulatory filings for AI/ML-driven diagnostic devices, especially those that provide clinical insights or automate diagnostic tasks.
The Juvora Dental Disc is a physical dental material (a thermoplastic disc) used for manufacturing dental prostheses (dentures, crowns, bridgework). The "performance" in this context refers to its physical and biocompatibility properties, not the performance of an AI algorithm.
However, I can extract the information that is present and explain why other information is not available in this document.
1. A table of acceptance criteria and the reported device performance
The document compares the new device (K160918) to its predicate device (K132725) and a reference device (K133608) based on various material properties. While explicit "acceptance criteria" for each parameter aren't stated as numeric thresholds (e.g., "must be > X MPa"), the implicitly accepted performance is "substantially equivalent" to (or matching) the predicate device, or meeting relevant ISO standards.
| Characteristic | Acceptance/Comparison Basis | Reported Device Performance (JUVORA™ Dental Disc K160918) | Predicate Device Performance (JUVORA™ Dental Disc K132725) | Reference Device Performance (TRINIA K133608) |
|---|---|---|---|---|
| Flexural Strength | Comparison to predicate and reference devices; ISO 10477, ISO 20795, ISO 6872 standards. Implied acceptance is substantial equivalence to predicate. | 192 MPa (ISO 10477) | ||
| 165 MPa (ISO 20795) | ||||
| 194 MPa (ISO 6872) | 192 MPa (ISO 10477) | |||
| 165 MPa (ISO 20795) | ||||
| 194 MPa (ISO 6872) | 393 MPa (ISO 14125) | |||
| Flexural Modulus | Comparison to predicate and reference devices; ISO 20795 standard. Implied acceptance is substantial equivalence to predicate. | 3995 MPa (ISO 20795) | 3995 MPa (ISO 20795) | 18.8 GPa (ISO 14125) |
| Water Absorption | Comparison to predicate and reference devices; ISO 20795, ISO 10477, ISO 62 standards. Implied acceptance is substantial equivalence to predicate. | 5 (µg/mm³) (ISO 20795) | ||
| 5.0 (µg/mm³) (ISO 10477) | ||||
| 0.5% (wt) (ISO 62) | 5 (µg/mm³) (ISO 20795) | |||
| 5.0 (µg/mm³) (ISO 10477) | ||||
| 0.5% (wt) (ISO 62) | 0.03% | |||
| Shear Bond Test | Comparison to predicate device; ISO TR 11405 standard. Implied acceptance is substantial equivalence to predicate. | Dental composite veneer system (GC Gradia, GC): 27.3 MPa (ISO TR 11405) | ||
| Dental cement system (RelyXUltimate, 3M ESPE): 21.2 MPa (ISO TR 11405) | Dental composite veneer system (GC Gradia, GC): 27.3 MPa (ISO TR 11405) | |||
| Dental cement system (RelyXUltimate, 3M ESPE): 21.2 MPa (ISO TR 11405) | - | |||
| Biocompatibility | Compliance with ISO 10993 for PEEK-OPTIMA™ material composition. Implicit acceptance is meeting the standard. | "Biocompatibility for material composition of PEEK-OPTIMA™ per ISO 10993." (Stated as having been tested and results contributing to substantial equivalence conclusion). | "Biocompatibility for material composition of PEEK-OPTIMA™ per ISO 10993." (Implicitly accepted as compliant, as it's the predicate device.) | Not applicable/provided. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the document. The physical and mechanical testing (e.g., flexural strength, water absorption, shear bond) would have involved multiple samples, but the exact number for each test is not provided in this regulatory summary.
- Data Provenance: The tests were conducted to international ISO standards (e.g., ISO 10477, ISO 20795, ISO 6872, ISO TR 11405, ISO 62, ISO 10993). This implies standard laboratory testing, likely by the manufacturer or a contracted lab. The country of origin of the data is not specified, but the manufacturer is Juvora, Ltd. based in the UK. The studies are prospective in nature, as they involve testing newly manufactured materials according to established protocols.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This question is not applicable to this device submission. This is a material science and biocompatibility submission, not an AI/ML diagnostic device. "Ground truth" in this context refers to the measured physical and chemical properties of the material, not expert clinical diagnoses. The "truth" is established by adhering to the specified ISO testing standards and methodologies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 refer to consensus-building among multiple human reviewers for tasks like image interpretation or clinical diagnosis. This document pertains to material property testing, where the "truth" is derived from standardized physical measurements, not human interpretation.
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. MRMC studies are specific to evaluating AI/ML systems in diagnostic imaging or similar contexts where human readers interact with AI assistance. This device is a dental material, not an AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This question relates to the performance of an AI algorithm. The device is a physical dental material.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's evaluation is primarily:
- Physical and Mechanical Properties: Measured values obtained through standardized laboratory testing following ISO (International Organization for Standardization) standards (e.g., flexural strength, flexural modulus, water absorption, shear bond strength). These are objective measurements.
- Biocompatibility: Established by testing the material's composition (PEEK-OPTIMA™) against ISO 10993 standards, which define biological evaluation of medical devices.
8. The sample size for the training set
Not applicable. This device is not an AI/ML algorithm that requires a "training set." It's a manufactured material, and its properties are inherent to its composition and manufacturing process, not learned from data.
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.