(205 days)
Additive production of temporary anterior and posterior restorations, e.g.
- Single tooth crowns.
- Bridges (max. six units, max. two consecutive pontics).
- Veneers, Inlays, Onlays.
P pro Crown & Bridge is a flowable, light-curing, acrylate-based composite material for the additive production of temporary anterior and posterior restorations.
It consists of multifunctional acrylic resins and fillers made of inorganic fillers ranging in size from 0.04 - 0.2 um. The raw materials used in the preparation have been used for many years in dental products.
Exposition: The temporary crown and bridge resin has an intended gingival, enamel/dentine contact for more than 30 days.
The provided text is a 510(k) Summary for a dental device called "P pro Crown & Bridge." This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to legally marketed predicate devices. It focuses on the chemical, physical, and biocompatibility properties of the material rather than a "device" in the sense of an AI or diagnostic tool that would typically involve a multi-reader, multi-case study or extensive clinical performance data with ground truth experts.
Therefore, many of the requested elements for an AI/diagnostic device study (like MRMC, human reader improvement, number of experts for ground truth, adjudication methods) are not applicable to this type of medical device submission.
However, I can extract the relevant information regarding acceptance criteria and the study proving the device meets those criteria, specifically concerning its physical, mechanical, and biocompatibility properties.
Here's a breakdown based on the provided text:
Acceptance Criteria and Device Performance
The acceptance criteria for "P pro Crown & Bridge" are primarily based on established ISO standards for dental materials (ISO 4049 and ISO 10477) and an internal DeltaMed standard for compressive strength. The device performance is then compared directly against these criteria and its predicate devices.
1. A table of acceptance criteria and the reported device performance:
| Property / Requirement | Acceptance Criteria | Reported Device Performance (P pro Crown & Bridge) | Passes/Fails |
|---|---|---|---|
| Mechanical Properties (ISO 4049 & ISO 10477) | |||
| Flexural strength (ISO 4049) | ≥ 100 MPa | 146 MPa | Pass |
| Flexural strength (ISO 10477) | ≥ 50 MPa | 146 MPa | Pass |
| Solubility (ISO 4049 & ISO 10477) | ≤ 7.5 µg/mm³ | 0.5 µg/mm³ | Pass |
| Water absorption (ISO 4049 & ISO 10477) | ≤ 40 µg/mm³ | 16 µg/mm³ | Pass |
| Color stability (ISO 4049 & ISO 10477) | Not explicitly quantified, "pass" | Pass | Pass |
| Mechanical Properties (DeltaMed internal standard) | |||
| Compressive Strength | > 300 MPa | 358 MPa | Pass |
| Modulus of elasticity | > 5000 MPa | 5988 MPa | Pass |
Biocompatibility (ISO 10993-1, -5, -10):
| Biocompatibility Test | Acceptance Criteria (Implied: "Pass") | Reported Device Performance (P pro Crown & Bridge) | Passes/Fails |
|---|---|---|---|
| Cytotoxicity (ISO 10993-5) | Compliant | Performed and substantiated safety | Pass |
| Sensitization (ISO 10993-10) | Compliant | Performed and substantiated safety | Pass |
| Irritation (ISO 10993-10) | Compliant | Performed and substantiated safety | Pass |
Study Details (as inferable from the document):
2. Sample size used for the test set and the data provenance:
- Sample size: Not explicitly stated in terms of the number of individual specimens tested for each property (e.g., how many samples for flexural strength). However, the results (e.g., "146 MPa") imply a quantitative measurement from a test set.
- Data provenance:
- Country of origin: The manufacturer, DeltaMed GmbH, is based in Friedberg, Germany. The testing would presumably be conducted in Germany or by certified labs adhering to international standards.
- Retrospective or Prospective: These are laboratory tests on material samples, not clinical studies involving patient data. Therefore, "retrospective" or "prospective" as typically applied to clinical data collection does not directly apply. The tests are conducted on manufactured material samples to demonstrate performance against specifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For a material device, "ground truth" is established by adherence to physical, chemical, and biological testing standards (e.g., ISO 4049, ISO 10477, ISO 10993 series). The "truth" is the measured property value compared to the standard's requirement, not an expert's interpretation of an image or clinical finding. These tests are performed by qualified laboratory technicians/scientists following validated protocols.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods are relevant for subjective assessments (e.g., consensus among radiologists). For objective material properties testing, results are quantitative and directly measured. Statistical analysis of multiple measurements would be performed to ensure reliability, but not "adjudication."
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 material device, not a diagnostic imaging device or AI software. There are no "human readers" or "AI assistance" in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a material device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Objective Laboratory Measurements against International Standards: The "ground truth" is derived from standardized laboratory testing procedures (e.g., measuring flexural strength, water absorption, cytotoxicity) as defined by ISO standards (ISO 4049, ISO 10477, ISO 10993). The "truth" is whether the measured physical/chemical property falls within the acceptable range specified by these standards.
8. The sample size for the training set:
- Not Applicable. This device is a material, not an AI/machine learning algorithm that requires a "training set." The characteristics of the material are inherent to its composition and manufacturing process, not learned from data. Extensive R&D and formulation development would have occurred, but not in the sense of "training data."
9. How the ground truth for the training set was established:
- Not Applicable. No "training set" as defined for AI/ML. The properties of the material (composition, etc.) are determined during the material science and engineering development process.
§ 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.