(57 days)
Starflow HV is intended for use for the restoration of Class III, Class IV, and Class V cavities, small Class I cavities not in occlusion, repair of enamel defects, repair of porcelain restorations, minor occusal build-ups in non-stress bearing areas, pit and fissure sealant, cement for seramic/composite veneers, incisal abrasions, and core build-ups.
Starflow HV is a light-cured, hybrid dental retorative which incorporates BIS/GMA resin along with Barium aluminosilicate glass filler (64% by wt) to yield a flowable dental restorative.
The provided text is a 510(k) summary for the Starflow HV device, which is a dental restorative material. This type of regulatory submission focuses on demonstrating substantial equivalence to pre-existing devices rather than independent clinical studies with specific acceptance criteria and detailed performance metrics.
Therefore, the document does not contain the information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.
The 510(k) summary describes the device, its intended use, and identifies predicate devices (Revolution by Sybron Dental Specialties (K013647), StarFlow by Danville Materials Inc (K990108), and Tetric Flow (K 993783) by Ivoclar Vivadent) to which it claims substantial equivalence. The primary difference noted is "very minor changes to the material composition."
To address the specific points of your request:
- A table of acceptance criteria and the reported device performance: Not present. The submission focuses on substantial equivalence based on material composition and intended use, not on specific performance metrics with predefined acceptance criteria.
- Sample size used for the test set and the data provenance: Not present. No test set or associated data is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present. No ground truth establishment for a test set is mentioned.
- Adjudication method: Not present.
- 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 restorative material, not an AI-powered diagnostic or assistive tool.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithmic device.
- The type of ground truth used: Not applicable for a performance study. For regulatory purposes, the "ground truth" for substantial equivalence is demonstrating that the new device is as safe and effective as a legally marketed predecessor.
- The sample size for the training set: Not applicable. No training set for an algorithm is mentioned.
- How the ground truth for the training set was established: Not applicable.
In conclusion, this 510(k) submission does not provide the kind of detailed study information (acceptance criteria, performance data, specific study design, expert involvement) that would be found in a clinical trial report or a submission for a novel, high-risk device. The regulatory pathway chosen for Starflow HV relies on demonstrating that it is fundamentally similar to existing, legally marketed dental restorative materials.
§ 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.