(145 days)
Masky is indicated for use when patients require a partial denture prosthetic that has a substantial amount of exposed metal in the frame. Masky covers exposed metal areas to reduce visual impact of framework in the mouth. Can also cover wires used in orthodontic appliances to make appliances less visible.
Resin material that is biologically inert once cured on the metallic framework, similar to ArtGlass, with exception of curing methodology. ArtGlass cures by light; Masky by heat.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (Masky) |
|---|---|
| Biocompatibility: Absence of chromosomal aberrations induced in vitro. | Masky demonstrated no negative results in this test, indicating no chromosomal aberrations. |
| Biocompatibility: No adverse effect on cell viability using propidium iodide uptake. | Masky demonstrated no negative results in this test, meaning no adverse effect on cell viability. |
| Biocompatibility: Non-mutagenic in the Ames Salmonella/microsome test. | Masky demonstrated no negative results in this test, indicating it is non-mutagenic. |
| Biocompatibility: Absence of sister chromatid exchange in vitro. | Masky demonstrated no negative results in this test, indicating no sister chromatid exchange. |
| Similar in design, composition, and function to predicate device (ArtGlass). | Masky is a resin material that is biologically inert once cured, similar to ArtGlass, with the exception of curing methodology (ArtGlass cures by light, Masky by heat). |
| Intended Use: Cover exposed portions of metallic frameworks in partial denture prostheses for natural appearance. | Masky is indicated for this use and the biocompatibility tests support its safe application. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document refers to "tests as performed by the Istituti Ortopedici Rizzoli for Pressing Italy" but does not specify the number of samples or specimens used for each test.
- Data Provenance: The tests were performed in December 1996 by the Istituti Ortopedici Rizzoli for Pressing Italy. This indicates the data is retrospective (performed prior to the 510(k) submission) and originated from Italy.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This information is not provided in the document. The tests performed are laboratory-based biocompatibility assays, not studies requiring expert interpretation of clinical data in the same way, for example, a diagnostic imaging study would. The ground truth for these tests would be established by the scientific methodologies and controls inherent in each assay.
4. Adjudication Method for the Test Set
This information is not applicable/not provided in the document. The biocompatibility tests are objective laboratory assays with predetermined endpoints, rather than subjective assessments that would require an adjudication method.
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
No, an MRMC comparative effectiveness study was not conducted. This device is a material (tooth shade resin), not an AI-powered diagnostic or assistive tool for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. "Masky" is a material, not an algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant here.
7. The type of ground truth used
The ground truth used for "Masky" is based on the results of standardized laboratory biocompatibility tests. These included:
- Evaluation of chromosomal aberrations (in vitro)
- Evaluation of cell viability (using propidium iodide uptake)
- Mutagenicity in Ames Salmonella/microsome test
- Evaluation of sister chromatid exchange (in vitro)
8. The Sample Size for the Training Set
This information is not applicable/not provided. "Masky" is a material, not a machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. As stated above, "Masky" is a material, not an AI/ML algorithm requiring a training set. The "ground truth" related to its performance is established through the objective laboratory tests mentioned in point 7.
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.