Search Results

This is a yellow casting alloy for inlay / onlays, crowns, short span bridges, long span bridges, removable partials.

LUCIUS 76 is a platinum-free crown and bridge alloy. This device is dependable 76% gold alloy with a high gold appearance. LUCIUS 76 is an excellent for inlays, three-quarter crowns, long and short-span bridges.

The provided document is a 510(k) summary for a dental casting alloy, not an AI/ML medical device. Therefore, many of the requested details about acceptance criteria and study design for an AI/ML device are not applicable or cannot be extracted from this particular document.

However, I can provide the information that is present in the document related to the device's characteristics and its comparison to a predicate device, which serves as its "acceptance criteria" and "study" for substantial equivalence.

1. A table of acceptance criteria and the reported device performance

For a traditional medical device like a dental alloy, "acceptance criteria" for 510(k) clearance are primarily about demonstrating substantial equivalence to a legally marketed predicate device. This is typically done by comparing characteristics like composition and physical/mechanical properties. The "reported device performance" is the measured values for the new device and the predicate.

Discussion of Acceptance Criteria Approach for this Device:
The "acceptance criteria" here is that the LUCIUS 76 device must be sufficiently similar in composition and performance to the predicate device (Argenco 77**) to ensure comparable safety and effectiveness, as per the 510(k) pathway. The document explicitly states: "The main elements and their concentration are almost identical. LUCIUS 76 is a platinum-free crown and bridge alloy... LUCIUS 76 is a substantially equivalent to Argen's Argenco 77**, and the minor differences between them do not affect safety or effectiveness."

The following points are not applicable to this 510(k) submission for a dental alloy, as they relate specifically to AI/ML device evaluations. The document does not contain any information regarding these aspects.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• N/A - This is a material science comparison, not software/AI model testing. The "test set" would refer to the samples of the alloys themselves that were tested in a laboratory. The document mentions "Test methods applied: as in ANSI/ADA 5 and ISO 9693" but does not specify sample sizes or data provenance beyond standard material testing protocols.

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)

• N/A - This is a material science comparison, not software/AI model testing requiring expert ground truth for classification. The "ground truth" for material properties is established by standardized laboratory testing methods, not expert consensus in the diagnostic sense.

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

• N/A - This is a material science comparison. Adjudication methods are relevant for subjective interpretations, not objective material property measurements.

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

• N/A - This is a dental alloy, not an AI/ML device. No human readers or AI assistance are involved in the direct "use" being evaluated here.

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

• N/A - This is a dental alloy, not an algorithm.

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

• The "ground truth" for the material properties (melting point, hardness, yield strength, elongation, composition) is based on standardized physico-chemical and mechanical testing methods (referenced as ANSI/ADA 5 and ISO 9693).

8. The sample size for the training set

• N/A - This is a dental alloy. There is no "training set" in the AI/ML sense.

9. How the ground truth for the training set was established

• N/A - This is a dental alloy. No "training set" or "ground truth for training set" in the AI/ML sense.

Ask a specific question about this device