(62 days)
Direct anterior restorations including: Class III, IV, V and VI Veneers Incisal edge repair - Direct posterior restorations including: Class I or II or V Sandwich technique with glass ionomer resin material Cusp buildups - Core buildups - Splinting . - Indirect anterior and posterior restorations including: . Inlays Onlays Veneers
Hermes is a one component dental filling composite. Hermes uses different monomer chemistry and a different polymerization mechanism than most filling composites which are currently commercially available. Based on its particular chemistry, Hermes reveals considerably low shrinkage properties.
The provided document is a 510(k) Summary of Safety and Effectiveness for a dental device called "Hermes," a tooth shade resin material. It is a premarket notification for a Class II device. The document states that the device is substantially equivalent to predicate devices based on performance data and indications for use.
However, the document does not contain any information about acceptance criteria or a specific study proving the device meets acceptance criteria in the format of a clinical study assessing algorithm performance, which is what your query implies.
Instead, it's a regulatory submission demonstrating substantial equivalence to already approved predicate devices. It states that "Biocompatibility testing for Hermes provides evidence that the device is safe for its intended use." And "In summary, it can be concluded that safety and effectiveness requirements for Hermes are completely met."
Therefore, based on the provided text:
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A table of acceptance criteria and the reported device performance: Not provided in the context of an algorithm's performance. The document focuses on demonstrating substantial equivalence to predicate dental restorative materials, implying that "acceptance criteria" are met if it performs similarly or equivalently to established devices for its intended use.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for this type of regulatory submission. There is no "test set" in the context of validating 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 (e.g. radiologist with 10 years of experience): Not applicable. There is no ground truth established by experts for a test set in this document.
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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. This document is about a dental restorative material, not an AI or imaging device with human readers.
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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 concensus, pathology, outcomes data, etc): Not applicable in the context of an algorithm's performance. The "ground truth" for this device's performance is likely measured against established standards for dental materials (e.g., shrinkage, strength, wear resistance), usually through laboratory or in-vitro tests, and clinical performance as observed over time, but these details are not provided here.
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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.
In conclusion, the provided 510(k) summary is for a dental restorative material and does not describe a study involving acceptance criteria and performance metrics for an AI/algorithm-based device as implied by your detailed request. It confirms that the device meets safety and effectiveness requirements, primarily through biocompatibility testing and comparison to predicate devices, rather than through an algorithm performance study.
§ 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.