(60 days)
Provisional or temporary restorative materials are used in dentistry for treatment procedures not intended to be permanent or final. The purpose of the temporary material is to protect a prepared tooth surface during the interim period until the permanent restoration is available. An example of this interim beriod is the time that passes while porcelain or metal prosthetic devices are being fabricated in a dental laboratory. Another purpose of a temporary restoration is to provide an esthetically pleasing appearance for the patient during this interim period.
TempFil C&B is supplied in a double barreled cartridge container which can be used with any of the currently available cartridge dispensers ( i.e. Kerr's Extrude mixer/extruder dispenser ) that will accept 1:1 mix ratio plungers. This allows the dentist to simultaneously mix and dispense the material directly into the impression or crown form.
The provided text describes a medical device, "Kerr TempFil C&B Temporary Restorative Material," and its safety and efficacy. However, it does not contain the specific information required to complete the table and answer all the questions. The document is a 510(k) summary from 1997 for a dental temporary restorative material.
Here's an analysis of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Ease of placement | Supplied in a double-barreled cartridge for direct dispensing; eliminates need for spatulae, mixing pads, and placement instruments. |
| Convenience | Automatic mixing tips eliminate the need for spatulae, mixing pads, and placement instruments. |
| Biocompatibility (Safety) | Demonstrated positive results in: |
- Ames Mutagenicity Assay
- Cytotoxicity Study (Agarose Overlay)
- Kligman Maximization Study (Tissue Sensitization) |
| Efficacy/Suitability | Performed "as well or better than three predicate devices currently on the market" through in-house and side-by-side bench testing. |
Missing Information:
The document lists acceptance criteria for "ease of placement" and "convenience" by describing how the device meets them through its design. For "safety" and "efficacy," it states that tests were conducted and the device performed well or met standards, but does not provide specific quantitative acceptance criteria or detailed numerical performance results for these criteria. For example, it doesn't state "mutagenicity rate Y MPa."
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 for Test Set: Not specified. The document mentions "cured samples" for biocompatibility tests and "bench testing" but does not give sample numbers.
- Data Provenance (Country of Origin): Not specified.
- Retrospective or Prospective: Not applicable, as the tests described are bench (laboratory) tests and biocompatibility studies, not clinical studies involving patients over time.
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)
- Number of Experts: Not applicable. The "ground truth" here is established by standardized laboratory assays (biocompatibility) and direct physical/chemical measurements (bench testing for efficacy) against predicate devices, not by expert interpretation of patient data in the context of clinical imagery or pathology.
- Qualifications of Experts: The biocompatibility tests were "conducted by an independent laboratory which specializes in safety and toxicity evaluation." Specific qualifications of personnel are not given.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. This concept typically applies to clinical studies where human readers/experts independently assess cases and discrepancies need resolution (e.g., in radiological reads). The tests described are laboratory-based.
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
- MRMC Study: No, an MRMC study was not done. This device is a dental material, not an AI-powered diagnostic or assistive tool, and the studies described are bench and biocompatibility tests.
- Effect Size of AI Improvement: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Study: Not applicable. This device is a physical dental material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: For biocompatibility, the ground truth is established by the results of standardized biological assays (Ames, Cytotoxicity, Kligman) against pre-defined safety thresholds. For efficacy, the ground truth is established by direct physical/mechanical measurements and comparative performance against predicate devices in bench tests, presumably meeting certain performance specifications.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This device does not involve a "training set" in the context of machine learning or AI. The development process would involve formulation, iterative testing, and optimization, but not a distinct "training set" in the AI sense.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable, as there is no training set in the AI sense.
§ 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.