(35 days)
Point 4 Flowable is a low viscosity light cure hybrid resin restorative suitable for Class III, Class IV, and Class V restorations. Additional functions include: repair of enamel defects, repair of porcelain restorations, minor occlusal build-ups in non-stress bearing areas, pit and fissure sealant, cement for ceramic/composite veneers, incisal abrasions, and core build-ups.
Point 4 Flowable is a low viscosity light cure hybrid resin restorative suitable for Class III, Class IV, and Class V restorations. Additional functions include: repair of enamel defects, repair of porcelain restorations, minor occlusal build-ups in non-stress bearing areas, pit and fissure sealant, cement for ceramic/composite veneers, incisal abrasions, and core build-ups.
I am able to extract the requested information and have provided it below. Please note that the document provided is a 510(k) summary for a dental restorative material, which primarily focuses on demonstrating substantial equivalence to a predicate device based on material properties, mechanical testing, and intended use, rather than clinical performance data typical for AI/ML-driven devices. Therefore, many of the requested fields related to clinical study design, ground truth, and reader studies are not applicable or cannot be found in this type of document.
1. Table of Acceptance Criteria and Reported Device Performance & 6. Standalone Performance:
Based on the provided document, the "acceptance criteria" for Point 4 Flowable are primarily established by demonstrating substantial equivalence to a legally marketed predicate device (Kerr Corporation, Revolution Formula 2). The "device performance" is described through its physical and chemical properties and intended use, aligning with the predicate. Specific quantitative acceptance criteria with reported performance values in the context of clinical efficacy or diagnostic accuracy, as would be expected for a software device, are not present in this 510(k) summary. This document does not describe a "standalone" performance evaluation in the context of an AI algorithm's diagnostic accuracy.
| Acceptance Criteria Category | Acceptance Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Substantial Equivalence | Device functions in a manner similar to and is intended for the same use as the predicate device. | "Point 4 Flowable is substantially equivalent to other legally marketed devices in the United States. The composite restorative marketed by Kerr Corporation functions in a manner similar to and is intended for the same use as the product manufactured by Kerr Dental Materials Center." |
| Intended Use Safety & Efficacy | Suitable for specified dental restorations and functions. | "Point 4 Flowable is a low viscosity light cure hybrid resin restorative suitable for Class III, Class IV, and Class V restorations. Additional functions include: repair of enamel defects, repair of porcelain restorations, minor occlusal build-ups in non-stress bearing areas, pit and fissure sealant, cement for ceramic/composite veneers, incisal abrasions, and core build-ups." |
| Material Classification | Meets classification for Tooth Shade Resin Material. | Classified as "Tooth Shade Resin Material, per 21 CFR § 872.3690." |
2. Sample Size Used for the Test Set and Data Provenance:
Not applicable in this document. The 510(k) summary for "Point 4 Flowable" describes a conventional dental restorative material, not a device that underwent testing with a "test set" of patient data in the typical sense for an AI/ML device. The determination of substantial equivalence is based on material properties, physical testing, and intended use, not clinical trial data with a 'test set' of patient images or diagnostic outcomes.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. As described above, this document does not refer to a test set requiring ground truth established by experts for diagnostic or performance evaluation in the context of an AI/ML device.
4. Adjudication Method for the Test Set:
Not applicable. No "test set" requiring adjudication is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is a 510(k) for a dental material, not an AI/ML diagnostic aid that would typically undergo an MRMC study to evaluate human reader improvement with AI assistance.
7. Type of Ground Truth Used:
Not applicable for a device of this type in the context of clinical diagnostic accuracy. "Ground truth" for this device would refer to its material properties and chemical composition meeting specifications, rather than clinical outcomes or expert consensus on diagnostic interpretations.
8. Sample Size for the Training Set:
Not applicable. This document pertains to a physical dental material, not an AI/ML device that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As this is not an AI/ML device, there is no "training set" or establishment of ground truth in that context.
§ 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.