(46 days)
Flowable composite restorative material for: Minimally-invasive fillings Restorations of type III and V cavities (according to Black) Liner for restorations of type I and II cavities Small restorations of type I and II cavities Deciduous tooth fillings Fissure sealing Extended fissure sealing Tunnel preparation Repair of composite fillings and ceramic veneers Filling of defects and undercuts in crowns, inlays, and onlays Cementing porcelain veneers, crowns, inlays, and onlays Refacing acrylic temporaries Blockouts
PROMPTFLOW® is classified as tooth shade resin material (21 C.F.R. § 872.3660) because it is a device composed of methacrylates intended to restore carious lesions or structural defects in teeth. PROMPTFLOW® is a flowable composite restorative material.
The provided text is a 510(k) summary for the dental device PROMPTFLOW®, a flowable composite restorative material. It largely focuses on establishing substantial equivalence to predicate devices (REFERENCE® and DYRACT® FLOW) based on chemical composition, physical/mechanical properties, and intended use.
Crucially, the document does NOT contain information about specific acceptance criteria (numerical thresholds for performance) or an explicit study describing how PROMPTFLOW® met these criteria.
It is a regulatory submission for a device modification (Special 510(k)) where the manufacturer asserts that due to its fundamental similarity and comparative performance to existing devices, it is safe and effective for its stated indications for use. The approach is to compare the modified device (PROMPTFLOW®) to the unmodified predicate (REFERENCE®) and another similar flowable material (DYRACT® FLOW) to demonstrate suitability.
Therefore, many of the requested sections regarding specific study details cannot be filled from the provided text.
Here's an attempt to answer based on the available information, noting where data is missing:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria. Instead, it relies on demonstrating that PROMPTFLOW® has "the same fundamental scientific technology and the same intended use as REFERENCE®" and that its properties, while slightly reduced in some mechanical characteristics due to flowability, are comparable to another predicate flowable material, DYRACT® FLOW.
| Acceptance Criteria Category (Implied) | Reported Device Performance (Summary from text) |
|---|---|
| Intended Use | PROMPTFLOW® has in general the same intended use as REFERENCE®. |
| Operating Principle | PROMPTFLOW® is used by the same operating principle as REFERENCE®. |
| Basic Chemical Design | PROMPTFLOW® incorporates the same basic chemical design as REFERENCE®. Reduced filler content was made to achieve flowability. |
| Shelf Life | PROMPTFLOW® has the same shelf life as REFERENCE®. |
| Manufacturing | PROMPTFLOW® is manufactured using the same materials and processes as REFERENCE®. |
| Physical and Mechanical Properties | Due to reduced filler content to achieve flowability, some mechanical strength characteristics decreased compared to REFERENCE®. However, "comparison with another flowable restorative material, DYRACT® FLOW by Dentsply, shows, that PROMPTFLOW® is a suitable material for the claimed indications for use." (Specific quantitative comparisons are not provided in this summary). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. The document describes a comparison between the modified and unmodified devices and a predicate flowable device, but does not detail the specific test sample sizes, study design (retrospective/prospective), or data provenance.
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 provided. Ground truth establishment by experts is not described in this regulatory submission for a dental material.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. Adjudication methods are not applicable nor described for this type of submission for a dental composite material.
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
A Multi-Reader, Multi-Case (MRMC) comparative effectiveness study is not mentioned as this device is a dental material and not an AI-powered diagnostic system. Therefore, AI assistance and effect size on human readers are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable, as PROMPTFLOW® is a dental restorative material, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a dental restorative material, "ground truth" would typically refer to established standards for material properties (e.g., ISO standards for dental materials), chemical composition, and performance in standardized physical and mechanical tests. While the document mentions "physical and mechanical properties," it does not detail the specific "ground truth" methodology beyond implying comparison to predicate devices and established suitability for indications. There's no mention of expert consensus, pathology, or outcomes data in the context of establishing "ground truth" for the material's properties in this summary.
8. The sample size for the training set
This information is not provided. As this is not an AI/ML device, a "training set" in that context is not relevant. If referring to material development, information on the sample sizes used in R&D for formulation and initial testing is not present in this 510(k) summary.
9. How the ground truth for the training set was established
This information is not provided, and the concept of a "training set" with established ground truth, as typically understood for AI/ML devices, is not applicable here.
§ 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.