(51 days)
ENA HFO is a composite system for direct and indirect aesthetic restorations in anterior and posterior sectors.
ENA HFO is a system for direct and indirect aesthetic restorations in anterior and posterior sectors, composed by a light curing radiopaque composite, available in different colors, with accessories for application and polishing. The accessories contact tissue for less than 1 hour and therefore are exempt from 510(k) requirements and are described only generally.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the K062906 device:
It is important to note that the provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It does not contain detailed information about specific acceptance criteria, performance studies with sample sizes, expert involvement, or statistical analyses typically found in a full study report or technical documentation. The summary primarily lists the device's properties and claims similarity to existing products.
Acceptance Criteria and Reported Device Performance
The 510(k) summary does not explicitly list quantitative acceptance criteria for device performance. Instead, it states that the device has "similar technological characteristics" and "similar physical data" to predicate devices. The "Risk to Health" section implicitly defines areas where the device should not fail, which could be interpreted as a form of acceptance criteria in terms of safety.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety: No allergies or hypersensitivities. | Cytotoxicity tests performed (appears in Appendix V) - implies acceptable |
| Adhesion: Complete adhesion on teeth. | Not explicitly stated as a performance metric, only as a potential adverse effect if not met. |
| Curing: Complete and correct curing. | Not explicitly stated as a performance metric, only as a potential adverse effect if not met. |
| Polymerization: No or minimal polymerization gap/shrinkage. | Not explicitly stated as a performance metric, only as a potential adverse effect if not met. |
| Filling: Complete filling of the cavity. | Not explicitly stated as a performance metric, only as a potential adverse effect if not met. |
| General Performance: Similar to predicate devices in composition and physical data. | "They have similar composition (bis-GMA resin and glass filler) and similar physical data." |
Study Information
Based on the provided 510(k) summary, the following study information is available:
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided summary.
- Data Provenance: Not specified. The summary mentions "cytotoxicity tests" (in Appendix V, which is not provided), but no details on the data origin (e.g., country) or whether it was retrospective or prospective.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the 510(k) summary. The summary does not describe a clinical study or a study involving expert assessment to establish ground truth for performance metrics.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not provided as there is no mention of a test set with human adjudication in the summary.
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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:
- No MRMC study was conducted or reported. This device is a dental composite material, not an AI-assisted diagnostic tool, so such a study would not be applicable.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This device is a physical material, not an algorithm. Therefore, a standalone algorithm performance study is not applicable and was not performed.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The summary implies that performance (e.g., cytotoxicity, physical data) was assessed against standard laboratory tests and material specifications, likely comparing to predicate devices or industry standards like ISO 4049:2000. It does not refer to clinical outcomes, expert consensus, or pathology for establishing ground truth of inherent device performance.
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The sample size for the training set:
- Not applicable/Not provided. The summary refers to a manufactured product and its testing, not a machine learning model requiring a training set.
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How the ground truth for the training set was established:
- Not applicable/Not provided, as there is no training set for a machine learning model.
In summary, the provided K062906 510(k) summary is a regulatory document focused on demonstrating substantial equivalence. It highlights the device's intended use, composition, and similarity to existing products, along with general safety considerations (like cytotoxicity tests). It does not offer the detailed efficacy study data, expert involvement, or statistical results that would typically answer many of the questions asked.
§ 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.