FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The provided document is a 510(k) premarket notification for a dental device, "artegra® ImCrown," which is a preformed temporary crown. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove performance against specific acceptance criteria with quantifiable metrics.

Therefore, many of the requested elements for describing an acceptance criteria study (such as sample size for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, specific training set details) are not applicable or not explicitly stated in this type of regulatory submission.

Here's an analysis based on the information provided, highlighting what is (and isn't) present:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not provide a table of acceptance criteria with specific performance metrics for the device. Instead, the "device performance" is primarily demonstrated by compliance with established international standards and a statement of intended use, implying that if it meets these standards, it is suitable for its intended purpose.

Acceptance Criteria (Inferred)	Reported Device Performance
Compliance to ISO 3336	Tested for compliance
Compliance to ISO 10993	Tested for compliance
Suitable for intended use as provisional anterior crown when fitted with CEREC 3D and inLab Systems	artegral® ImCrown is indicated for use as a provisional anterior crown when fitted with the CEREC 3D and inLab Systems
Substantial equivalence to predicate devices (Temporary Crown and Bridge Resin)	Found substantially equivalent by FDA

Explanation:

ISO 3336: Specifies requirements for dental polymeric materials for crowns and bridges. Compliance implies the material properties (e.g., strength, durability, biocompatibility) meet a recognized standard. Without the full test report, specific acceptance values (e.g., flexural strength > X MPa) are not provided in this summary.
ISO 10993: Covers biological evaluation of medical devices. Compliance implies the device materials are biocompatible and do not pose unacceptable biological risks. Again, specific acceptance criteria (e.g., no cytotoxicity detected in X assay) are not detailed here.
Intended Use Statement: Demonstrating that the device can fulfill its intended purpose, which is to function as a provisional anterior crown when used with specified systems. The FDA clearance confirms its suitability for this indication.
Substantial Equivalence: This is the primary "performance metric" for a 510(k). The device performs "as well as" or "similarly to" a legally marketed predicate device.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not specified in the provided summary. Testing for ISO standards often involves a specific number of samples for each test (e.g., mechanical testing, biocompatibility). However, the exact numbers used for this device are not disclosed here.
Data Provenance: Not explicitly stated (e.g., retrospective/prospective). The testing would have been conducted by the manufacturer (Merz Dental GmbH) in Germany, or by a certified testing laboratory. It would be considered prospective testing for the purpose of demonstrating compliance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. For a device like a temporary crown, "ground truth" isn't established by expert consensus in the same way it would be for an AI diagnostic algorithm. Performance is typically assessed against physical and chemical specifications defined by the ISO standards and the material's intended function. The "experts" would be the engineers and scientists conducting the laboratory tests according to standard protocols.

4. Adjudication method for the test set

Not Applicable. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among human readers/experts when establishing ground truth for diagnostic accuracy studies. This is not relevant for the type of laboratory and biocompatibility testing described for this dental device.

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 a physical dental product (a preformed crown), not an AI diagnostic tool. Therefore, MRMC studies and AI assistance comparisons are not relevant.

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

Not Applicable. As this is a physical device and not an algorithm, standalone performance (in the context of AI) is not relevant. The "standalone" performance here would refer to the device's material properties and fit, which are covered by the ISO testing.

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

The "ground truth" for this device's performance would be compliance with the specifications outlined in ISO 3336 and ISO 10993 (e.g., specific thresholds for mechanical properties, absence of cytotoxic effects). These standards define acceptable performance based on scientific and clinical understanding of dental materials.

8. The sample size for the training set

Not Applicable. This is not an AI/machine learning device; therefore, there is no "training set." The device is manufactured based on established material science and engineering principles.

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

Not Applicable. See point 8.

Summary

Regulation Number and Section

§ 872.3770 Temporary crown and bridge resin.

(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.