(83 days)
Pulpdent Temporary Crown and Bridge Material is used by the dental professional to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.
Pulpdent Temporary Crown and Bridge Material is a dual-cure, glass-filled, resin composite used by the dental professional to make a temporary prosthesis, such as a crown or bridge, to be used until a permanent restoration can be fabricated.
The provided document is a 510(k) Premarket Notification for the Pulpdent Temporary Crown and Bridge Material. It does not contain a study with acceptance criteria and device performance metrics in the format requested.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices already on the market, which is a different regulatory pathway than providing specific performance metrics against pre-defined acceptance criteria from a clinical or technical study.
Here's why the requested information cannot be fully extracted from this document:
- No specific acceptance criteria: The document doesn't list quantitative or qualitative acceptance criteria that the device had to meet through a dedicated study. Its primary claim is substantial equivalence to existing devices.
- No reported device performance data from a specific study: The document states that the device is "substantially equivalent in design, composition, performance, intended use, safety and effectiveness to the predicate products." It also references general usage over 20 years for similar materials. However, it does not present new performance data from a study conducted specifically for the Pulpdent Temporary Crown and Bridge Material against pre-defined criteria.
- No information on sample size, ground truth establishment, expert qualifications, or adjudication methods: Since no specific performance study is detailed, these related parameters are not present.
- No mention of AI assistance or MRMC studies: The device is a dental material, and the document predates the widespread regulatory consideration of AI in medical devices, so these are not applicable.
Summary of what can be inferred or directly stated from the document regarding "acceptance" for regulatory purposes:
The "acceptance" in this context refers to the FDA's determination of substantial equivalence to legally marketed predicate devices, which allows the device to be marketed.
Acceptance Criteria for Regulatory Approval (Substantial Equivalence):
| Acceptance Criteria (Implied for 510(k) Substantial Equivalence) | Reported Device "Performance" (as per document) |
|---|---|
| Intended Use: Device must have the same intended use as predicate devices. | Met: "Pulpdent Temporary Crown and Bridge Material is a dual-cure, glass-filled, resin composite used by the dental professional to make a temporary prosthesis, such as a crown or bridge, to be used until a permanent restoration can be fabricated." (Matches the general intended use of the listed predicate devices like Luxatemp, Sci-Span, Integrity, and CosmeTemp). |
| Design/Technology Characteristics: Device must have similar technological characteristics or demonstrate that differences do not raise new questions of safety or effectiveness. | Met: "Pulpdent Temporary Crown and Bridge Material is substantially equivalent in design, composition, performance, intended use, safety and effectiveness to the predicate products listed above." It is "fabricated from materials that have been used in the dental industry for many years." |
| Safety and Effectiveness: Device must be as safe and effective as predicate devices. | Met: "Pulpdent Temporary Crown and Bridge Material is substantially equivalent in design, composition, performance, intended use, safety and effectiveness to the predicate products listed above that have been on the market and used by dental professionals for more than 15 years with no serious safety or effectiveness problems." The document also cites a "NIN Technology Assessment Conference on Effects and Side-Effects of Dental Restorative Materials" stating, "General usage of these materials over about 20 years indicates a high benefit-to-risk ratio...There is no evidence of short-term or long-term risk...There is no suspicion of any problems after virtually billions of procedures in the United States." This refers to general composite and glass ionomer materials, not specifically the Pulpdent product. |
Information Not Found / Not Applicable (based on the provided document):
- Sample size used for the test set and the data provenance: Not applicable as a specific performance study with a test set is not detailed. The substantiation relies on equivalence to existing devices and broad general usage data for similar materials.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- 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. The device is a dental material, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: For the purposes of substantial equivalence, the "ground truth" is largely assumed by the historical safety and effectiveness of the predicate devices and the general class of materials. No specific new ground truth for this device is established in this document.
- The sample size for the training set: Not applicable. The device is a material, not a machine learning algorithm.
- How the ground truth for the training set was established: Not applicable.
In conclusion, the document serves as a regulatory submission (510(k)) demonstrating substantial equivalence, not as a detailed technical report of a performance study against specific acceptance criteria.
§ 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.