(14 days)
ULTRACROWN 75 ALLOY is indicated for the fabrication of porcelain-fused-to metal single-unit and multiple-unit restorations. / Fabrication of porcelain-fused-to-metal single-unit and multiple-unit restorations
ULTRACROWN 75 ALLOY is a gold-based dental alloy. It is highly biocompatible; does not contain nickel, beryllium, cadmium, or cobalt. The alloy is tarnish and corrosion resistant.
This document is a 510(k) summary for a dental alloy, ULTRACROWN 75 ALLOY. It is a premarket notification for a Class II medical device, indicating that its substantial equivalence to a legally marketed predicate device (Degudent LS Alloy, K960256) is being claimed based on similarities in formulation and components, rather than extensive new studies proving novel performance.
Therefore, many of the typical acceptance criteria and study details related to AI/software performance metrics (like sensitivity, specificity, F1-score, reader studies, etc.) are not applicable to this type of submission. This 510(k) focuses on material composition and biocompatibility as the primary areas of concern.
Here's an attempt to answer the questions based on the provided text, acknowledging the nature of this submission:
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A table of acceptance criteria and the reported device performance
Given that this is a material modification submission and not a performance-based AI/software device, the "acceptance criteria" revolve around demonstrating substantial equivalence to the predicate device, primarily through compositional similarity and prior use of components. The document does not list quantitative performance metrics in the traditional sense for medical device efficacy.
Acceptance Criteria (Inferred from submission) Reported Device Performance (as stated in the document) Biocompatibility "highly biocompatible; does not contain nickel, beryllium, cadmium, or cobalt." "ULTRACROWN 75 ALLOY's formulation is very similar to the predicate device and was not changed in any way that would adversely affect its biocompatibility. Therefore, it was determined that no biocompatibility testing was necessary." Tarnish and Corrosion Resistance "The alloy is tarnish and corrosion resistant." (Implicitly, at least as good as the predicate based on compositional similarity) Suitability for intended use Indicated for "fabrication of porcelain-fused-to metal single-unit and multiple-unit restorations." (Implicitly, suitable due to compositional similarity to predicate). Compositional Similarity to Predicate "Quantitative changes have been made to the device's formulation. All of the components have been used in legally marketed devices." "ULTRACROWN 75 ALLOY represents a modification to DENTSPLY's Degudent LS (K960256)." -
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
N/A. This submission is for a dental alloy, not a device evaluated through traditional test sets. The "test" here refers to a comparison of its chemical composition against a predicate device and known biocompatibility standards for its constituent materials. No patient data or image data (test set) was used.
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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)
N/A. No ground truth established by experts for a test set in the context of device performance. The evaluation is based on material science principles and regulatory compliance.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
N/A. No test set or related adjudication method in this submission.
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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
N/A. This is not an AI-assisted device. Therefore, no MRMC study was conducted.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done
N/A. This is not an algorithm or software device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context is based on:
- Material composition analysis: Chemical assays for the alloy's constituents.
- Established scientific principles: Regarding biocompatibility, tarnish, and corrosion resistance of specific elements and their combinations in dental alloys.
- Regulatory precedent: The substantial equivalence to the predicate device, Degudent LS Alloy (K960256), which itself would have met certain standards.
- Prior use of components: The components have a history of use in legally marketed devices.
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The sample size for the training set
N/A. This device does not involve machine learning or AI, and therefore has no "training set."
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How the ground truth for the training set was established
N/A. Similarly, this is not applicable for a dental alloy submission.
§ 872.3060 Noble metal alloy.
(a)
Identification. A noble metal alloy is a device composed primarily of noble metals, such as gold, palladium, platinum, or silver, that is intended for use in the fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.(b)
Classification. Class II (special controls). The special control for these devices is FDA's “Class II Special Controls Guidance Document: Dental Noble Metal Alloys.” The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. See § 872.1(e) for availability of guidance information.