(50 days)
PANAVIA F is indicated for the following applications:
Cementation of metal crowns and bridges, inlays and onlays.
Cementation of porcelain crowns, inlays and onlays.
Cementation of to composite resin crowns, inlays and onlays
Cementation of adhesion bridges and splints
Cementation of metal cores and prefabrication posts
Bonded amalgam restorations
PANAVIA F is classified into dental cement, CFR 21 Section 872.3275, because it is a device composed of materials such as dimethacrylate monomers and inorganic fillers intended to be used for cementation of dental devices such as crowns or bridges.
PANAVIA F is a resin based cement cured chemically and by visible light activation, and the improved device of PANAVIA 21. There are two major improvements; the curing method and introduction of the metal adhesion primer (ALLOY PRIMER, K974089).
This device consists of Paste (A and B pastes), ED Primer (Liquids A and B), ALLOY PRIMER, Oxyguard II, and accessories.
This is a 510(k) premarket notification for a dental adhesive device, not an AI/ML device. Therefore, the requested information about acceptance criteria, study details, and AI/ML specific metrics is not available in the provided text.
The document discusses the substantial equivalence of the "PANAVIA F" dental cement to predicate devices already on the market. The "acceptance criteria" in this context refer to the regulatory requirements for showing the new device is as safe and effective as existing ones, rather than performance metrics for an AI algorithm.
Specifically:
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A table of acceptance criteria and the reported device performance: Not applicable in the context of an AI/ML device. The document states "These modifications do not affect the safety and effectiveness" of PANAVIA F compared to PANAVIA 21. The "performance" is implicitly tied to its intended use for cementation of dental devices.
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Sample size used for the test set and the data provenance: Not applicable. This refers to a medical device's components and intended use, not a test set for an algorithm.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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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: Not applicable.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" here is the established safety and effectiveness of the predicate devices.
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The sample size for the training set: Not applicable.
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How the ground truth for the training set was established: Not applicable.
The core argument for the device's acceptance is its "substantial equivalence" to legally marketed predicate devices, meaning it shares similar design, composition, function, and intended use, and that any modifications do not negatively impact its safety and effectiveness.
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.