(150 days)
CAD/CAMouflage Milling Block is indicated as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces. The CAD/CAMouflage Milling Block is made for fabricating temporary and permanent restorations such as inlays, onlays, veneers and full crown restorations.
The CAD/CAMouflage Milling Block is a nanohybrid composite material that is designed as an indirect restorative for both anterior and posterior restorations including occlusal surfaces. The CAD/CAMouflage Milling Block is made for fabricating indirect restorations such as inlays, onlays, veneers and full crown restorations, including crowns. The mandrel is solely to aid in the manipulation of the material during processing (grinding, shaping, cutting, etc.). It is removed prior to the material (subject device) being put into final placement. As such, there are no implications for device performance or safety, since it is removed, and it has no patient contact.
The provided document is a 510(k) Summary for a dental device, the CAD/CAMouflage Milling Block. This type of submission focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing of material properties, rather than clinical efficacy studies often associated with AI/ML devices. Therefore, many of the requested points related to AI/ML device studies (like sample size for test set, number of experts for ground truth, adjudication methods, MRMC studies, and training set details) are not applicable or cannot be extracted from this document.
Here's the information that can be extracted, primarily focusing on the non-clinical testing for material properties:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that the device was evaluated using the relevant FDA recognized standard: ISO 4049: 2009 Dentistry - Polymer-based restorative materials, and ISO 10477:2004(E). It also mentions various tests performed: Flexural Strength, Water Sorption and Solubility, Radio Opacity, Shade Stability, Diametral Strength, and Compressive Strength. However, the specific acceptance criteria values from these ISO standards for each test, and the reported device performance values for the CAD/CAMouflage Milling Block, are not explicitly provided in this summary. The summary only states that the device meets the requirements.
A conceptual representation based on the text (actual values are missing):
| Test Name | Acceptance Criteria (from ISO 4049:2009, ISO 10477:2004(E)) | Reported Device Performance (CAD/CAMouflage Milling Block) |
|---|---|---|
| Flexural Strength | Specific value/range from ISO standard | Meets criteria (exact value not provided) |
| Water Sorption | Specific value/range from ISO standard | Meets criteria (exact value not provided) |
| Water Solubility | Specific value/range from ISO standard | Meets criteria (exact value not provided) |
| Radio Opacity | Specific value/range from ISO standard | Meets criteria (exact value not provided) |
| Shade Stability | Specific criteria from ISO standard | Meets criteria (details not provided) |
| Diametral Strength | Specific value/range from ISO standard | Meets criteria (exact value not provided) |
| Compressive Strength | Specific value/range from ISO standard | Meets criteria (exact value not provided) |
| Biocompatibility | Biocompatible (based on relevant standards) | Biocompatible |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified in the document. Non-clinical material testing typically uses a certain number of samples for each test type according to the relevant ISO standards, but the exact count is not given here.
- Data Provenance: The tests were performed by Prismatik Dentalcraft, Inc. The document implies these are internal laboratory tests. There is no information about country of origin of data, nor whether it is retrospective or prospective, as these terms are generally not applicable to laboratory material property testing in the same way they are for clinical studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable. The "ground truth" for material properties is established by objective physical and chemical measurements following standardized protocols (like ISO 4049). It does not involve expert interpretation or consensus in the context of this type of device and study.
4. Adjudication method for the test set
This is not applicable. As these are objective material property tests, there is no need for adjudication as one would find in a clinical or image-interpretation study.
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
This is not applicable. This is not an AI/ML device, nor is it a device that involves human readers or interpretation. It is a dental restorative material.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. This is not an AI/ML algorithm.
7. The type of ground truth used
The "ground truth" for this device's performance relies on objective physical and chemical measurements conducted according to recognized international standards (ISO 4049:2009 and ISO 10477:2004(E)) for dental polymer-based restorative materials. These standards define the methods and criteria for evaluating properties like flexural strength, water sorption, water solubility, radio opacity, shade stability, diametral strength, and compressive strength.
8. The sample size for the training set
This is not applicable. This device is a material, not an AI/ML algorithm that requires a "training set."
9. How the ground truth for the training set was established
This is not applicable. There is no training set for this device.
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.