(140 days)
TempSpan Clear Matrix is indicated for:
- Use as a clear template for intra oral polymerization of light activated materials to create temporary restorations.
- Use as a general impression material for monophase impression techniques.
TempSpan Clear Matrix Material is a clear preoperative impression material that will reproduce the finest detail resulting in extremely accurate provisional restorations. Use as the preliminary impression material for intraoral and extra-oral polymerization of dual-cure provisional materials. Light curing dual-cure provisional materials may eliminate or drastically reduce the oxygen-inhibited smear layer. TempSpan Clear Matrix Material is a medium viscosity vinyl polysiloxane material. It is packaged in a 50ml auto-mix cartridge, with an oral set time of 2 minutes. TempSpan Clear Matrix Material enables provisional restorations fabricated with dual cure materials to be light cured intra-orally and extra-orally. This process shortens the provisional procedure, minimizing chair time and patient discomfort. Additional features include: clear formula for intra-oral light curing, auto-mix delivery, and a quick set time with a working time of 1 minute and an oral set time of 2 minutes.
Here's a breakdown of the acceptance criteria and the study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance (TempSpan Clear Matrix) | Predicate Device (Memosil 2) Performance (for comparison) | Predicate Device (Elite Glass) Performance (for comparison) | Predicate Device (Correct VPS) Performance (for comparison) |
|---|---|---|---|---|---|
| Biocompatibility (Cytotoxicity) | Non-cytotoxic | Non-cytotoxic (from ISO L929 MEM Elution Test) | Not explicitly stated but implied to be non-cytotoxic as a legally marketed device | Not explicitly stated but implied to be non-cytotoxic as a legally marketed device | Not explicitly stated but implied to be non-cytotoxic as a legally marketed device |
| Biocompatibility (Irritation) | Negligible irritant | Negligible irritant (from ISO Intramuscular Injection Test) | Not explicitly stated but implied to be negligible irritant as a legally marketed device | Not explicitly stated but implied to be negligible irritant as a legally marketed device | Not explicitly stated but implied to be negligible irritant as a legally marketed device |
| Work Time | Not explicitly stated, but expected to be comparable to predicate devices | Not explicitly stated, but evaluated and found comparable | Not explicitly stated | Not explicitly stated | Not explicitly stated |
| Oral Set Time | Not explicitly stated, but expected to be comparable to predicate devices | 2 minutes (also evaluated and found comparable) | Not explicitly stated | Not explicitly stated | Not explicitly stated |
| Shore A Hardness | Not explicitly stated, but expected to be comparable to predicate devices | Not explicitly stated, but evaluated and found comparable | Not explicitly stated | Not explicitly stated | Not explicitly stated |
Note: The document states that the performance characteristics (Work Time, Oral Set Time, and Shore A Hardness) were "evaluated" and provided data for comparison to predicate devices, but the specific numerical results for TempSpan Clear Matrix or the predicate devices, and thus explicit acceptance criteria values, are not included in the provided text. The conclusion of substantial equivalence implies that these characteristics were within acceptable ranges compared to the predicates.
2. Sample Size for the Test Set and Data Provenance:
- Sample Size for Test Set: Not explicitly stated. The document refers to "bench testing" without providing specific sample sizes for each test.
- Data Provenance: The studies were non-clinical (bench testing and biocompatibility). The country of origin of the data is not specified but is assumed to be from the manufacturer or accredited testing facilities. The data is retrospective in the sense that it supports a premarket notification for a new device, comparing it to existing ones.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Number of Experts: Not applicable. This was a non-clinical bench testing study. The "ground truth" was established by objective physical and chemical testing methods (e.g., ISO standards for biocompatibility and laboratory measurements for physical properties).
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. This was a non-clinical bench testing study. The results of the tests (biocompatibility, work time, set time, hardness) would be objectively measured and compared, not adjudicated.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
- MRMC Study: No. The document explicitly states: "Clinical testing has not been conducted on this product."
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was Done:
- Standalone Study: Yes, in the sense that the device's physical and biocompatibility properties were tested independently. This device is a dental impression material, not an algorithm, so the concept of "standalone performance" applies to its inherent material properties rather than an AI algorithm.
7. The Type of Ground Truth Used:
- Type of Ground Truth:
- For biocompatibility: Adherence to ISO standards (ISO Intramuscular Injection Test and ISO L929 MEM Elution Test) results (negligible irritant, non-cytotoxic).
- For performance characteristics (Work Time, Oral Set Time, Shore A Hardness): Objective physical measurements compared against the properties of legally marketed predicate devices. The "ground truth" here is the established performance of the predicate devices.
8. The Sample Size for the Training Set:
- Sample Size for Training Set: Not applicable. This is a physical medical device, not an AI/machine learning algorithm. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set was Established:
- How Ground Truth for Training Set was Established: Not applicable, as there is no training set for this device.
§ 872.3660 Impression material.
(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).