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AIGIS-PT is intended for manufacturing

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

AIGIS-PT is an inlay, onlay, crown and bridge alloy. This device is dependable 77% gold alloy with a high gold appearance. AIGIS-PT is excellent for inlays, three-quarter crowns, long and short-span bridges.

Here's a summary of the acceptance criteria and the study for the AIGIS-PT device, based on the provided text.

Based on the provided 510(k) summary, AIGIS-PT is a dental casting alloy, and its acceptance criteria and study are based on demonstrating substantial equivalence to a legally marketed predicate device (AUROFLUID 2PF) through comparisons of chemical composition and physical/mechanical properties, according to established standards. This is not a study of an AI-based medical device, but rather a traditional materials science regulatory submission. Therefore, many of the requested fields related to AI device performance (like sample sizes for test sets, expert ground truth, MRMC studies, standalone performance) are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the comparison to the predicate device and the adherence to industry standards. The reported device performance is presented in comparison to the predicate.

Conclusion from data: The submission concludes that "AIGIS-PT is substantially equivalent to AUROFLUID 2PF and the minor differences between them do not affect safety or effectiveness."

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not applicable. This is a material characterization rather than a clinical study involving a "test set" in the context of AI. The properties are inherent to the material formulation.
• Data Provenance: Not specified, but likely from laboratory testing conducted by the manufacturer, SB Lucius, Inc.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Number of Experts: Not applicable. Ground truth for material properties is established through standardized laboratory testing, not expert consensus.
• Qualifications of Experts: N/A

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Material properties are measured objectively.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• MRMC Study: No. This is not a study assessing reader performance with or without AI.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

• Standalone Study: No. This is not an AI device.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for the device's properties is established through standardized laboratory testing as per ANSI/ADA 5 and ISO 9693 standards. These standards define the methods for measuring properties like melting point, hardness, yield strength, elongation, and density.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is not an AI device that requires a "training set."

9. How the Ground Truth for the Training Set was Established

• How Ground Truth was Established: Not applicable.

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