(142 days)
Rhondium One-Visit-Crown is intended for restoration of permanent teeth with a single unit crown.
Rhondium One-Visit-Crown (OVC) is a hybrid ceramic crown consisting of a fully-cured anatomical occlusal layer and an uncured sub-layer that allows customization of the OVC to the tooth preparation. When finished, the customized OVC is bonded to a prepared natural tooth. The OVC is for restoring structurally compromised posterior teeth in cases normally restored with an onlay or a partial crown in a single dental visit. The OVC is selected based on tooth location and size and therefore no impressions are necessary. The OVC is provided in designs for the upper and lower first and second premolars and the first and second molars, and each design is provided in six (6) sizes (extra-small (XS), small (S), medium (M), large (L), extra-large (XL), and extra-extra-large (XXL)). The OVC is made from a ceramic tooth shade resin material, and is provided nonsterile for single use only.
Accessories to the OVC Device include the OVC Replica, an exact replica of the cured (occlusal layer) portion of the OVC. The OVC Replica is used to confirm that sufficient occlusal clearance was obtained during tooth preparation and to provide direct visualization of the overall 3D position of the OVC on the prepared tooth and the relationship with adjacent and opposing dentition. The OVC Replica is manufactured from vinyl polysiloxane impression material. OVC Wedges are accessories provided in four configurations (small right, large left and large right), and are placed interproximally to create a working surface and to block out undercuts of the preparation. The Wedges are manufactured from polyacetal resin. The Selector Keys are accessories that allow the clinician to measure the mesial-distal distance in order to choose the appropriate size OVC for the restoration, and are used during the curing of the uncured resin to prevent disturbing the placement of the crown. The Selector Keys are manufactured from polycarbonate resin. All accessories are provided nonsterile for single use only.
The provided document describes a 510(k) premarket notification for a dental device, the Rhondium One-Visit-Crown (OVC). This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than de novo clinical studies with acceptance criteria in the context of diagnostic performance metrics like sensitivity and specificity.
Therefore, the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not directly applicable to this document. This submission focuses on non-clinical performance and a comparison of technological characteristics to establish equivalence.
Here's a breakdown of the performance data and equivalence demonstration, addressing the relevant points from your request:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission, there are no "acceptance criteria" in the sense of predefined diagnostic performance thresholds (e.g., sensitivity, specificity). Instead, the device demonstrates substantial equivalence through a series of non-clinical tests and a comparison of its technological characteristics to a predicate device.
The document lists the following performance tests and their purpose:
| Test | Purpose | Reported Performance |
|---|---|---|
| Product Shelf Life Testing | To ensure the device maintains its properties and safety over its intended shelf life. | Data submitted, referenced, or relied upon to demonstrate substantial equivalence (specific results not detailed in this summary, but implied to be acceptable for substantial equivalence). |
| Biocompatibility Testing (ISO 10993-1, ISO 10993-5) | To evaluate the biological response to the device materials, including cytotoxicity. | Data submitted, referenced, or relied upon to demonstrate substantial equivalence (specific results not detailed, but implied to be acceptable for substantial equivalence). |
| Flexural Strength Testing | To assess the material's resistance to bending or deformation. | Data submitted, referenced, or relied upon to demonstrate substantial equivalence (specific results not detailed, but implied to be acceptable for substantial equivalence). |
| Static Compressive Strength Testing | To assess the material's resistance to compression. | Data submitted, referenced, or relied upon to demonstrate substantial equivalence (specific results not detailed, but implied to be acceptable for substantial equivalence). |
| Resin Depth of Cure Testing | To measure how deeply the light-cured resin material hardens. This is crucial for the OVC's function, as it has an uncured sub-layer for customization that needs to cure properly upon placement. | Data submitted, referenced, or relied upon to demonstrate substantial equivalence (specific results not detailed, but implied to be acceptable for substantial equivalence). |
| Comparison of Technological Characteristics with Predicate Device (K072733) | To demonstrate that the subject device's design, material, intended use, and other features are sufficiently similar to a legally marketed device that it raises no new questions of safety or effectiveness. | "Any differences in the technological characteristics between the subject device and the predicate devices do not affect substantial equivalence." (Implies that the comparison was favorable) |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a "test set" in the context of diagnostic performance evaluation. The performance data discussed are from non-clinical laboratory tests. Therefore, information about sample sizes for a test set and data provenance (country of origin, retrospective/prospective) for clinical data is not applicable here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. The device is a physical dental restoration, not an AI/diagnostic tool requiring expert-established ground truth for a test set.
4. Adjudication Method for the Test Set
This information is not applicable, as there is no "test set" in the context of human interpretation requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done. This device is a physical dental material, not an AI-assisted diagnostic system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable, as the device is a physical dental restoration, not an algorithm.
7. The Type of Ground Truth Used
The concept of "ground truth" as typically used in AI/diagnostic studies (e.g., pathology, outcomes data) is not directly applicable here. For the non-clinical tests, the "ground truth" would be the scientifically established physical or biological properties of the materials as measured by standardized testing methods. For the substantial equivalence argument, the "ground truth" is the established safety and effectiveness of the predicate device (K072733).
8. The Sample Size for the Training Set
This is not applicable. The device is a manufactured product; it does not involve AI algorithms that require training sets.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the reasons mentioned above.
In summary:
The provided document is an FDA 510(k) summary for a dental restorative device. It establishes substantial equivalence through non-clinical performance testing of the device's material properties (shelf life, biocompatibility, mechanical strength, depth of cure) and a detailed comparison of its technological characteristics with a legally marketed predicate device. The performance data demonstrate that the device meets the necessary safety and effectiveness criteria for its intended use, analogous to how an AI device would meet acceptance criteria, but through different types of evidence.
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.