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

The provided document is a 510(k) premarket notification for a dental composite restorative material named "Prestige." It does not describe an AI/ML-driven device or study. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert qualifications, and ground truth establishment for such a device is not applicable to this document.

The document discusses the "Prestige" dental composite restorative material and its substantial equivalence to a predicate device (Herculite XR & XRV). It focuses on non-clinical performance testing for material properties.

However, I can extract the relevant information from the document that pertains to the non-clinical performance testing conducted for the "Prestige" device to demonstrate substantial equivalence.

Here's the information that can be extracted, interpreted in the context of material performance rather than AI/ML algorithms:

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

The document states that the substantial equivalence is supported by "Physical and Mechanical Properties performance testing." While explicit acceptance criteria values are not given in this summary, the reported performance is that the Prestige™ device "has the same performance and technological characteristics" as the predicate device, and that bench testing indicates its suitability for the intended purpose. The overall acceptance criterion for the 510(k) submission is to demonstrate substantial equivalence to the predicate device.

Acceptance Criteria (Implied)	Reported Device Performance
Device performance is substantially equivalent to predicate.	"Results of our bench testing indicate that Prestige™ has the same performance and technological characteristics [as the predicate]." "The substantial equivalence or suitability to the intended purpose of Prestige™ has been demonstrated by a combination of in-house testing and side-by-side comparisons to predicate devices currently on the market." "The differences between the subject device and the predicate device do not affect substantial equivalence, or raise different questions of substantial equivalence."
Performance of specific physical and mechanical properties.	Testing was performed for: Flexural Strength, Depth of Cure, Sensitivity to Ambient Light, Diametral Strength, Water Sorption, Shade and Color Stability, Radiopacity. (Specific quantitative results or direct comparisons to predicate values are not provided in this summary, but the general conclusion is equivalence).
Functions of chemicals and components are identified and similar.	"Chemicals, function of each component of the product are identified." (Implied similarity to predicate)
Indications for Use are similar.	Stated as similar and shown in a table where both "Prestige™" and "Herculite XR & XRV" are described as "a dental composite restorative material designed to be used in all classes of cavities."

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

Sample Size: Not specified in the provided summary. The non-clinical testing refers to "in-house testing" and "side-by-side comparisons" but does not give specific numbers of samples or units tested for each property (e.g., number of specimens for flexural strength).
Data Provenance: The testing was conducted as "in-house testing" by Danville Materials LLC, located in San Ramon, California, USA. The data would be prospective in relation to the submission, as it was generated specifically to support the 510(k) application.

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)

This is not applicable as the document describes a dental restorative material, not an AI/ML device that requires expert-established ground truth for image interpretation or diagnosis. The "ground truth" for this device would be the objective measurements of its material properties.

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

This is not applicable as the document describes a dental restorative material, not an AI/ML device requiring adjudication of human interpretations.

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

This is not applicable as the document describes a dental restorative material, not an AI/ML device.

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

This is not applicable as the document describes a dental restorative material, not an AI/ML device. The "standalone" performance here would refer to the intrinsic material properties measured in a lab, which are described as being tested.

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

The "ground truth" for this device's performance would be the objective, empirically measured physical and mechanical properties of the material itself (e.g., actual flexural strength values, depth of cure measurements, radiopacity readings, etc.) using established testing standards and methodologies for dental materials.

8. The sample size for the training set

This is not applicable as the document describes a dental restorative material, not an AI/ML device that requires a training set.

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

This is not applicable as the document describes a dental restorative material, not an AI/ML device that requires a training set and associated ground truth.

Summary

Regulation Number and Section

§ 872.3690 Tooth shade resin material.

(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.