(90 days)
BRIGHTGLASS Discs are milling blanks consisting of Polymethylmethacrylate (PMMA) and designed for the fabrication of long-term temporary crown and bridgework. They are machined with the CAD/CAM technique. BRIGHTGLASS Discs are recommended for manufacturing substructures of single tooth crowns and bridgework with up to two pontics.
BRIGHTGLASS discs are milling blanks composed of hot cured polymethymethacrylate (PMMA). They are intended to be used by dental professionals e.g. dental technicians for the fabrication of long-term temporary crowns and bridgeworks as custom-made restorations for the sole use of a particular patient. These restorations are designed virtually by dental technicians using the CAD technology on the basis of intraoral scans or scans from impressions and/or models. The designed restorations can thereafter be machined in all appropriate CAM Milling Centers out of BRIGHTGLASS Discs. In a further step the milled workpiece can be individually characterized with veneering materials and polished for to improve the aesthetic appearance of the finished restoration. BRIGHTGLASS discs are offered as monochromic disc (BRIGHT-GLASS) in six different shades and as multicolored disc (BRIGHT-GLASS M) in up to four shades, all discs in different thicknesses.
The medical device described, BRIGHTGLASS and BRIGHTGLASS M, is a Temporary Crown and Bridge Resin (PMMA). The submission is a Traditional 510(k) by KTK Medical Supplies GmbH.
Here's an analysis of the provided text regarding acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly define discrete "acceptance criteria" with numerical thresholds for each test, nor does it present the "reported device performance" in a structured table or quantitative manner for each criterion. Instead, it describes a comparative testing approach.
The closest equivalent to acceptance criteria is implied through the stated goal of demonstrating "compatibility" and "substantially equivalent" to the predicate device (ZENO PMMA Discs) in a series of tests. Therefore, the "acceptance criteria" can be inferred as achieving comparable results to the predicate device in the specified tests. The "reported device performance" is described qualitatively as being "comparable."
| Test Performed | Implied Acceptance Criteria (Goal) | Reported Device Performance (Qualitative) |
|---|---|---|
| Tensile Strength | Comparable to ZENO PMMA Discs | Comparable to the predicate device |
| Elastic Limit | Comparable to ZENO PMMA Discs | Comparable to the predicate device |
| Bending Strength | Comparable to ZENO PMMA Discs | Comparable to the predicate device (noted as "major bending strength" and "extreme high homogeneity") |
| E-Module | Comparable to ZENO PMMA Discs | Comparable to the predicate device |
| Water Solubility | Comparable to ZENO PMMA Discs | Comparable to the predicate device |
| Water Absorption | Comparable to ZENO PMMA Discs | Comparable to the predicate device |
| Homogeneity | Comparable to ZENO PMMA Discs | "extreme high homogeneity" |
| Surface Density | Comparable to ZENO PMMA Discs | "high surface density" |
| Breaking Resistance | Comparable to ZENO PMMA Discs | "major breaking resistance" |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the sample size used for the mechanical and physical tests performed (tensile strength, elastic limit, bending strength, e-module, water solubility, and water absorption). It only states "a series of testing was performed."
- Data Provenance: The document does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. Given the submitter's location (Germany) and the nature of physical/mechanical testing, it's highly probable the testing was conducted in a laboratory setting, likely in Germany, to generate prospective data. However, this is an inference.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This medical device is a material (PMMA) for dental fabrication, not an imaging or diagnostic device requiring expert interpretation of results for ground truth establishment in the traditional sense. The "ground truth" for the performance tests (tensile strength, etc.) is established through standardized physical and chemical measurement techniques and instruments, not human experts. There is no mention of experts establishing a "ground truth" for these measurements.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the "ground truth" for these material property tests is derived from standardized physical and chemical measurements, not from expert review or interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices where human readers interpret patient cases, comparing performance with and without AI assistance. The BRIGHTGLASS device is a dental material, not a diagnostic tool, so an MRMC study is not relevant here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
No, a standalone study in the context of an algorithm's performance was not done. This device is a material, not software or an algorithm. The "standalone" performance relates to the material's inherent physical and chemical properties as measured in a lab, which is what the comparative testing aimed to assess against the predicate device.
7. The Type of Ground Truth Used
The "ground truth" for the performance tests (tensile strength, elastic limit, bending strength, e-module, water solubility, and water absorption) is established through objective, quantifiable physical and chemical measurements obtained using standard laboratory methods and equipment, not expert consensus, pathology, or outcomes data. The "truth" is the measured value for each material property.
8. The Sample Size for the Training Set
Not applicable. This device is a manufactured material, not an AI or machine learning algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
§ 872.3770 Temporary crown and bridge resin.
(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.