(86 days)
PRO-V is line of provisional restorative materials designed to address the differing requirements for creating or placing any provisional restoration. The PRO-V System consists of PRO-V FLO, PRO-V FILL, and PRO-V COAT which offers a complete solution to create an effective inlay or onlay provisional.
Indications for Use:
- Temporary fillings
- Provisional Inlays
- Provisional Onlays
PRO-V is line of provisional restorative materials designed to address the differing requirements for creating or placing any provisional restoration. The PMO-V System consists of PRO-V FLO, PRO-V FII.1, and PRO-V COAT. PRO-V FLO™ is a flowable composite for use as a provisional for inlay restorations. PRO-V FILL™ is a packable composit: for use as a provisional for onlay restorations. PRO-V COATTM is a separating agent.
The provided text describes the PRO-V Temporary/Provisional Filling Material, a dental cement, and its substantial equivalence to a predicate device (E-Z Temp). However, the document does not contain a study that proves the device meets specific acceptance criteria in terms of performance metrics.
Instead, the document details a 510(k) premarket notification for the PRO-V device, indicating that it has been deemed "substantially equivalent" to a legally marketed predicate device (E-Z Temp). This substantial equivalence is based on comparisons of intended use, chemical composition, and mechanical/physical properties, along with biocompatibility testing.
Therefore, many of the requested details about acceptance criteria, study methodologies, and performance metrics are not present in this submission.
Here's a breakdown of what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative "acceptance criteria" or provide "reported device performance" against specific thresholds. Instead, it presents a comparative table between the applicant device (PRO-V) and the predicate device (E-Z Temp) to establish substantial equivalence.
| Characteristic | Predicate Device (E-Z Temp) | Applicant Device (PRO-V) |
|---|---|---|
| Intended Use | Provisional Inlay and Onlay Restorative | Provisional Inlay and Onlay Restorative |
| Chemical Composition | Light-cured, glass filled, resin based inlay and onlay composite supplied with a water-soluble separating agent | Light-cured, glass filled, resin based inlay and onlay composite supplied with a water-soluble separating agent |
| Mechanical / Physical Properties | E-Z Temp Inlay: Low viscosity dispensable composite | |
| E-Z Temp Onlay: High viscosity sculptable composite | ||
| E-Z Temp Separating Agent: Water-soluble separating agent | PRO-V FLO: Low viscosity, dispensable composite | |
| PRO-V FILL: High viscosity sculptable composite | ||
| PRO-V COAT: Water-soluble separating agent | ||
| Biocompatibility | Not explicitly stated for E-Z Temp in this table, but assumed to be acceptable as a legally marketed predicate. | Tested and found to be non-toxic. |
"Acceptance Criteria" for Substantial Equivalence: The implicit acceptance criterion here is that PRO-V's characteristics (intended use, chemical composition, and physical/mechanical properties) are sufficiently similar to those of E-Z Temp, and that PRO-V is found to be non-toxic, such that it poses no new or different questions of safety and effectiveness.
2. Sample size 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 only mentions that "PRO-V was tested for biocompatibility." No details on the sample size for this testing are provided. The broader comparison is conceptual and based on product descriptions, not a specific clinical or performance test set.
- Data Provenance: Not specified. It's implied the biocompatibility testing was conducted by or for Bisco, Inc. (USA), but no country of origin for the data is explicitly stated. The nature of the comparison is based on product specifications rather than observational data.
- Retrospective or Prospective: Not applicable as no specific study involving a test set is detailed. The substantial equivalence argument is based on product descriptions and documented biocompatibility.
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)
Not applicable. No "ground truth" establishment by experts for a test set is described. The comparison is based on technical specifications and biocompatibility testing report reviewed by the FDA.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No adjudication method described as no specific test set requiring such expert review is mentioned.
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 device is a dental material, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a dental material, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable in the conventional sense of establishing ground truth for diagnostic performance. The "truth" for substantial equivalence is based on the characteristics of the predicate device and the new device's compliance with these characteristics (e.g., chemical composition, physical properties, non-toxicity).
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/machine learning 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.