(134 days)
PULPDENT FLOW-RITE is a visible light cured flowable composite used as a Class II, III, IV and V restorative. It dispenses as a smooth paste with excellent working properties and translucency for matching, blending and depth of cure. It cures in 30-40 seconds, is color stable and polishes beautifully.
Pulpdent FLOW-RITE is a visible light cured flowable composite material. It dispenses as a smooth paste with excellent working properties and translucency for matching, blending and depth of cure. It cures in 30-40 seconds, is color stable and polishes beautifully.
The provided document describes a 510(k) submission for a dental device, "Pulpdent Flow-Rite," a visible light-cured flowable composite material. However, the document does not contain the specific information requested regarding acceptance criteria or a dedicated study proving the device meets those criteria.
Instead, the submission focuses on demonstrating substantial equivalence to predicate devices and referencing a general NIH Technology Assessment Conference on the safety of dental restorative materials.
Here's a breakdown of why I cannot provide the requested information from the given text:
- No specific acceptance criteria are listed.
- No detailed study protocol or results are presented. The document refers to general knowledge about dental restorative materials' safety but doesn't detail a study conducted specifically for Pulpdent Flow-Rite to prove its performance against quantifiable criteria.
Therefore, for each point you requested, the answer derived solely from this document is that the information is not provided:
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A table of acceptance criteria and the reported device performance:
- Information Not Provided: The document does not specify any quantifiable acceptance criteria (e.g., bond strength, wear resistance, dimensional stability thresholds) for Pulpdent Flow-Rite, nor does it present specific performance data from a dedicated study against such criteria.
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Information Not Provided: The document does not describe a test set, sample sizes, or data provenance for any specific study related to Pulpdent Flow-Rite's performance. The safety and effectiveness statement references a general NIH conference on dental materials, not a study performed for this specific device.
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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):
- Information Not Provided: Since no specific test set or study for performance is detailed, there's no mention of experts establishing ground truth for such a test.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Information Not Provided: No test set or adjudication method is described.
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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:
- Information Not Provided: This device is a dental restorative material, not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study with human readers and AI assistance is not applicable and not mentioned.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Information Not Provided: This device is a physical dental material, not an algorithm. Standalone algorithm performance is not applicable.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Information Not Provided: No specific study with ground truth establishment is described for Pulpdent Flow-Rite. The safety statement is based on general clinical usage of similar materials over time as discussed in an NIH conference.
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The sample size for the training set:
- Information Not Provided: No training set is applicable or described, as this is a physical medical device, not a machine learning model.
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How the ground truth for the training set was established:
- Information Not Provided: Not applicable, as there is no training set described.
Summary of Device Information Provided:
- Device Name: Pulpdent FLOW-RITE
- Intended Use: Class II, III, IV, and V restorations.
- Description: Visible light-cured flowable composite material, smooth paste, excellent working properties and translucency, cures in 30-40 seconds, color stable, polishes beautifully.
- Predicate Devices: Pulpdent Hybrid Anterior Composite, Bisco Aeliteflo, E&D / Kerr Revolution.
- Safety and Effectiveness Justification: Based on substantial equivalence to predicate devices and general consensus from an NIH Technology Assessment Conference on the high benefit-to-risk ratio and "relatively trouble free" nature of composites and glass ionomers over 20 years of general usage, with "no evidence of short or long term risk."
The 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive de novo clinical trials with predefined acceptance criteria for every new product. The provided document aligns with this regulatory pathway.
§ 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.