(65 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. 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 text describes a 510(k) summary for a dental device, the CAD/CAMouflage Milling Block, which is a nanohybrid composite material for indirect dental restorations. The core of the submission is to demonstrate substantial equivalence to a previously cleared predicate device (K160425).
Here's an analysis of the provided information concerning acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" against "reported device performance" in a quantitative sense as might be seen for diagnostic accuracy or clinical outcomes. Instead, it demonstrates substantial equivalence to a predicate device based on technological characteristics and non-clinical testing against recognized standards.
The closest representation of "acceptance criteria" are the parameters for which the proposed device must be "Same" as the predicate or meet specific ISO standards for mechanical and chemical properties.
| Characteristic / Acceptance Criteria | Reported Device Performance (Proposed Device) | Comparison to Predicate Device (K160425) |
|---|---|---|
| FDA Classification Name: Tooth shade resin material | Tooth shade resin material | Same |
| FDA Product Code: EBF | EBF | Same |
| FDA Device Classification: Class II per 21 CFR 872.3690 | Class II per 21 CFR 872.3690 | Same |
| Chemical Composition: Composite Restorative Material | Composite Restorative Material | Same |
| Intended Use: Intended to restore carious lesions or structural defects in teeth | Intended to restore carious lesions or structural defects in teeth | Same |
| Indications: CAD/CAMouflage Milling Block is indicated as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces. Made for fabricating temporary and permanent restorations such as inlays, onlays, veneers and full crown restorations. | CAD/CAMouflage Milling Block is indicated as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces. Made for fabricating temporary and permanent restorations such as inlays, onlays, veneers and full crown restorations. | Same |
| Biocompatibility: Biocompatible | Biocompatible | Same |
| Sterility: Non-Sterile | Non-Sterile | Same |
| Single or Multiple Use: Single use | Single use | Same |
| Prescription/OTC Use: Prescription | Prescription | Same |
| Final Vita Shades: A2 LT (Predicate) | A1 HT, A2 HT, A3 HT, A3.5 HT, B1 HT, A1 LT, BL LT, A3 LT, A3.5 LT, B1 LT, C2 LT, D2 LT | Different (Proposed device has additional shades) |
| Mechanical Properties (e.g., Flexural Strength, Diametral Strength, Compressive Strength): Meets relevant FDA recognized standards (ISO 4049:2009, ISO 10477:2004(E)) | Tested against these standards | Demonstrated to meet standards |
| Chemical Properties (e.g., Water Sorption and Solubility, Radio Opacity, Shade Stability): Meets relevant FDA recognized standards (ISO 4049:2009, ISO 10477:2004(E)) | Tested against these standards | Demonstrated to meet standards |
Study Proving Acceptance Criteria:
The study proving the device meets the "acceptance criteria" is a non-clinical testing study designed to demonstrate substantial equivalence to the predicate device and compliance with relevant international standards.
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes (e.g., number of blocks tested for each property) used for the non-clinical testing. It broadly states that "Prismatik performed various tests including the Flexural Strength, Water Sorption and Solubility, Radio Opacity, Shade Stability, Diametral Strength, Compressive Strength."
The data provenance is not explicitly stated in terms of country of origin or whether it's retrospective/prospective, but it's generated by the manufacturer (Prismatik Dentalcraft, Inc.) for the purpose of this 510(k) submission, implying it's a prospective internal company study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the evaluation is based on non-clinical, physical, and chemical property testing against international standards, not on expert adjudication of clinical outcomes or images. The "ground truth" here refers to the quantitative values defined by the ISO standards.
4. Adjudication method for the test set
This information is not applicable for the same reason as point 3. The assessment is objective, based on material property measurements.
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 information is not applicable. This device is a dental material (milling block), not an AI-powered diagnostic or assistive technology for human readers. Therefore, no MRMC study or AI assistance evaluation would be relevant or performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical dental material, not an algorithm.
7. The type of ground truth used
The "ground truth" for the non-clinical testing is defined by international consensus standards for dental materials:
- ISO 4049: 2009 Dentistry - Polymer-based restorative materials
- ISO 10477:2004(E) Dentistry - Polymer-based crown and veneering materials
These standards specify the acceptable ranges for various physical and chemical properties of dental restorative materials.
8. The sample size for the training set
This information is not applicable. This is a material science product, not a machine learning model. There is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as point 8.
§ 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.