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510(k) Data Aggregation
(200 days)
The APVolution System is used to fabricate prostheses for missing/damaged teeth. The APVolution pressable ingots are pressed onto metal alloy (APVolution M) or zirconia (APVolution Z) frames by dental technicians to fabricate ceramic restorations. APVolution M and APVolution Z ceramic layering powders and/or pastes are used to layer or build up the pressed ceramic to final tooth morphology. APVolution S ceramic ingots are used to create all-ceramic restorations. AP Stains and Glaze are used during the fabrication process to achieve the correct shade.
The APVolution System consists of several silica glass ceramic materials used to create allceramic, ceramic-metal or ceramic-zirconia dental restorations. The APVolution System includes three ceramic ingots for use in the fabrication of all-ceramic (APVolution S), press-to-metal (APVolution M) or press-to-zirconia (APVolution Z) restorations. The system also includes powders and pastes for use in build-up and shaping of the final restoration, as well as shades and glazes for use in achieving acceptable aesthetics.
This document is a 510(k) premarket notification for the "APVolution System" and does not contain information about a study proving the device meets acceptance criteria in the manner requested (e.g., sample size, expert ground truth, MRMC study). Instead, it's a declaration of conformity to existing ISO standards.
However, I can extract the acceptance criteria and the type of "performance" or "testing" that was done to demonstrate conformity.
Here's a breakdown of the requested information based on the provided text, focusing on the available details:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard & Section) | Reported Device Performance |
|---|---|
| ISO 6872 Dentistry - Ceramic Materials | The APVolution System components met all requirements of the ISO 6872 standard. |
| Specific Inspections & Tests in ISO 6872: | |
| - Identification of Types & Classes of System Components | Tested to confirm compliance |
| - Uniformity | Tested to confirm compliance |
| - Freedom from Extraneous Materials | Tested to confirm compliance |
| - Mixing & Condensation Properties (Class I Ceramics) | Tested to confirm compliance |
| - Physical & Chemical Properties | Tested to confirm compliance |
| - Flexural Strength | Tested to confirm compliance |
| - Linear Thermal Expansion Coefficient | Tested to confirm compliance |
| - Glass Transition Temperature | Tested to confirm compliance |
| - Chemical Solubility | Tested to confirm compliance |
| - Radioactivity | Tested to confirm compliance |
| ISO 7405:2008 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry | The APVolution System components met the biocompatibility requirements described in ISO 7405. |
| Specific Test in ISO 7405: | |
| - ISO 10993-5 cytotoxicity test: L929 cell monolayer proliferation/inhibition during contact with extended (7 day) extraction using DMSO in complete cell culture medium | The APVolution components met all requirements of the ISO 7405 standard (referring to the cytotoxicity test results). Proliferation or inhibition of L929 cell monolayer was evaluated. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify sample sizes for the tests conducted under ISO 6872 or ISO 7405. It's common in these types of submissions to refer to the standard itself which defines the testing methods and sample sizes, rather than detailing them in the submission. The data provenance is not mentioned.
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)
This information is not applicable to the type of testing described (physical material properties and biocompatibility). Ground truth in this context is established by the standardized methods and acceptance limits defined in the ISO standards, not by expert interpretation of observational data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The tests are objective measurements of material properties and biological response according to defined standard protocols.
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 ceramic system, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study or AI-related effectiveness analysis was performed or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a material device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is derived from the acceptance criteria and test methods defined within the ISO 6872 (for ceramic materials) and ISO 7405 (for biocompatibility) international standards. These standards provide objective, measurable criteria for attributes like flexural strength, chemical solubility, and cytotoxicity.
8. The sample size for the training set
Not applicable. There is no "training set" as this is a material device being evaluated against predefined standards, not a machine learning model.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for a machine learning model, no ground truth was established in this context.
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