(15 days)
This is a dental amalgam for the filling of tooth cavities of Black's Classes I and II.
Bestaloy is used as a filling material for restoring function to teeth that have lost portions to caries.
The provided text describes a 510(k) premarket notification for a dental amalgam called "Bestaloy." It states that Bestaloy has undergone safety, performance, and product validations and that it has the same device characteristics as its predicate device (LUXALLOY™, DEGUSSA AG K902249). However, it does not provide specific details about acceptance criteria or a study proving that the device meets those criteria with quantitative performance metrics.
Therefore, I cannot extract the detailed information requested in your prompt regarding acceptance criteria, reported performance, sample sizes, ground truth establishment, expert qualifications, or MRMC studies. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed quantitative results.
Here's what can be inferred from the provided text, but it falls short of your specific requirements:
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Table of Acceptance Criteria and Reported Device Performance: Not available in the provided text. The submission states, "Bestaloy has been subjected to extensive safety, performance, and product validations prior to release. Safety tests have been performed to ensure the devices comply to applicable industry and US requiations." However, it does not list specific criteria or quantitative performance results.
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Sample Size Used for the Test Set and Data Provenance: Not mentioned in the provided text.
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Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications: Not mentioned in the provided text.
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Adjudication Method for the Test Set: Not mentioned in the provided text.
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If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size: Not mentioned in the provided text. This type of study is generally not typical for a dental amalgam 510(k) submission, which focuses on material equivalence.
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If a Standalone (algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a dental material, not an algorithm.
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The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.): Not mentioned in the provided text. The submission relies on "device characteristics" being the same as the predicate.
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The Sample Size for the Training Set: Not mentioned in the provided text. (Training sets are typically for AI/ML models, which this device is not).
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How the Ground Truth for the Training Set was Established: Not applicable as this is a dental material.
Summary of what is available from the text:
- Device Name: Bestaloy
- Predicate Device: LUXALLOY™, DEGUSSA AG K902249 (K902249)
- Basis for Equivalence: "Bestaloy has the same device characteristics as the predicate device. Material, design and use concept is similar."
- Testing Conducted: "extensive safety, performance, and product validations" and "Safety tests have been performed to ensure the devices comply to applicable industry and US requiations."
- Conclusion: The manufacturer concludes that Bestaloy is "safe and effective and substantially equivalent to predicate devices."
The document is a 510(k) clearance letter, which confirms that the FDA found the device substantially equivalent to a predicate. It does not contain the detailed performance study results that would be part of a submission to demonstrate performance against specific acceptance criteria.
§ 872.3070 Dental amalgam, mercury, and amalgam alloy.
(a)
Identification. Dental amalgam is a device that consists of a combination of elemental mercury, supplied as a liquid in bulk, sachet, or predosed capsule form, and amalgam alloy composed primarily of silver, tin, and copper, supplied as a powder in bulk, tablet, or predosed capsule form, for the direct filling of carious lesions or structural defects in teeth. This device also includes the individual component devices, mercury and amalgam alloy, when intended to be combined with each other to form dental amalgam.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Dental Amalgam, Mercury, and Amalgam Alloy.”See § 872.1(e) for the availability of this guidance document.