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AIGIS-A is intended for manufacturing

• Inlay / Onlays -
• Crowns -
• Short span bridges -
• Long span bridges -
• Removable partials -

AIGIS-A is an inlay, onlay, crown and bridge alloy. This device is dependable 48% gold alloy with a high gold appearance. AIGIS-A is excellent for inlays, threequarter crowns, long and short-span bridges.

The provided document describes a 510(k) premarket notification for a dental casting alloy named AIGIS-A. The submission focuses on demonstrating substantial equivalence to a predicate device (JENSEN'S JMC) rather than presenting a study with specific acceptance criteria related to AI or algorithmic performance. Therefore, many of the requested categories (e.g., sample size for test set, number of experts, MRMC study, training set details) are not applicable to this type of submission.

Here's a breakdown based on the information available:

Acceptance Criteria and Device Performance (AIGIS-A vs. JENSEN'S JMC)

The acceptance criteria for this device are implicitly tied to demonstrating substantial equivalence to the predicate device, JENSEN'S JMC, by showing comparable composition and physical/mechanical properties, and suitability for the same indications for use.

Study Information:

1. 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 material (dental casting alloy), not an AI/algorithm-driven device. Performance is demonstrated through material characterization tests (as per ANSI/ADA 5 and ISO 9693), not a clinical 'test set' in the context of AI. The data provenance would be from laboratory testing; specific details are not provided beyond the standards referenced.

2. 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. Ground truth for material properties is established through standardized laboratory testing, not expert consensus on interpretations.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • N/A. Adjudication methods are not relevant for material property testing.

4. 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-powered device.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • N/A. This is not an AI-powered device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • The "ground truth" for this device constitutes the established quantitative measurements of its physical and mechanical properties, obtained through standardized test methods (ANSI/ADA 5 and ISO 9693).

7. The sample size for the training set:

   • N/A. This is not an AI-powered device.

8. How the ground truth for the training set was established:

   • N/A. This is not an AI-powered device.

Summary of Acceptance:

The device, AIGIS-A, met the acceptance criteria by demonstrating substantial equivalence in composition, physical properties (melting point, hardness, elongation, density), and intended use to the legally marketed predicate device, JENSEN'S JMC. The minor differences in properties, such as a slightly lower yield strength, were deemed not to affect safety or effectiveness, as stated in the conclusion: "AIGIS-A is substantially equivalent to JENSEN'S JMC and the minor differences between them do not affect safety or effectiveness."

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