(63 days)
Dental Mercury is elemental mercury, supplied as a liquid packaged in sachets, intended to be combined with amalgam alloy for the direct filling of carious lesions or structural defects in teeth.
Dental Mercury is elemental mercury, supplied as a liquid packaged in sachets.
The provided document (K093587) describes a 510(k) submission for "Dental Mercury," an elemental mercury product used in dental amalgam. This submission is an Abbreviated 510(k), which means it demonstrates substantial equivalence to a predicate device by showing conformity to recognized consensus standards and FDA guidance documents, rather than through a traditional clinical study with detailed performance metrics.
Therefore, the information requested in the prompt, which typically pertains to the performance evaluation of a device through a study with specific acceptance criteria, test sets, ground truth establishment, and statistical analysis, is not explicitly available or applicable in the provided document for "Dental Mercury" in the same way it would be for a diagnostic or AI-driven device.
Here's an attempt to address each point based on the information provided, highlighting the limitations due to the nature of an Abbreviated 510(k) for a material like elemental mercury:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria for "Dental Mercury" are based on compliance with established standards and FDA guidance for this type of material, rather than performance metrics from a specific study.
| Acceptance Criteria (from recognized standards/guidance) | Reported Device Performance |
|---|---|
| ISO 24234:2004(E) Dentistry Mercury and alloys for dental amalgam First edition: Defines requirements for dental mercury and amalgam alloys. | The device meets the requirements included in ISO 24234:2004(E). This implies the elemental mercury supplied is of the quality, purity, and other specifications outlined in this standard for dental use. |
| Class II Special Controls Guidance Document: Dental Amalgam, Mercury, and Amalgam Alloy - Guidance for Industry and FDA Staff (July 28, 2009): Outlines specific controls to enhance the safety and effectiveness of dental amalgam, mercury, and amalgam alloy. | The device conforms to FDA's guidance document. This suggests compliance with recommended practices concerning manufacturing, labeling, biocompatibility considerations, and other aspects for dental mercury. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This was an Abbreviated 510(k) based on compliance with existing standards and guidance, not a study involving a "test set" of patient data or clinical samples. The "device performance" is demonstrated through adherence to material specifications and regulatory controls.
3. 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. As noted above, there was no "test set" requiring ground truth established by experts in the context of a clinical performance study. The "ground truth" for the acceptance of dental mercury is the established scientific and regulatory consensus on its material properties and safety when used as intended, as codified in ISO standards and FDA guidance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There was no test set or adjudication method for clinical performance. The "adjudication" in this context is the FDA's regulatory review process to confirm that the manufacturer's claims of conformity to the referenced standards and guidance are valid.
5. 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 device is elemental mercury for dental fillings, not an AI-driven or diagnostic device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is elemental mercury, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth"
for this submission is the expert consensus and scientific understanding formalized in the referenced consensus standard (ISO 24234:2004(E)) and FDA guidance document ("Class II Special Controls Guidance Document: Dental Amalgam, Mercury, and Amalgam Alloy"), which define the acceptable characteristics and safe use of elemental mercury in dentistry.
8. The sample size for the training set
Not applicable. This submission is about a material (elemental mercury), not a machine learning algorithm.
9. How the ground truth for the training set was established
Not applicable. There is no training set as this is not an AI/ML device.
§ 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.