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

Here's a summary of the acceptance criteria and the study details for the 3M ESPE Filtek™ Supreme Ultra Universal Restorative, based on the provided text:

Device: Filtek™ Supreme Ultra Universal Restorative

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state numerical acceptance criteria for each physical property. Instead, it indicates that the new device's performance was compared to a predicate device (3M™ ESPETM HAUR) to establish substantial equivalence. The "reported device performance" is essentially that the new device performed comparably or acceptably against the predicate in these properties.

Property Evaluated	Acceptance Criteria (Implied)	Reported Device Performance
Compressive strength	Substantially equivalent to predicate device 3M™ ESPETM HAUR.	Data from bench testing shows performance comparable to the predicate.
Diametral Tensile Strength	Substantially equivalent to predicate device 3M™ ESPETM HAUR.	Data from bench testing shows performance comparable to the predicate.
Flexural strength	Substantially equivalent to predicate device 3M™ ESPETM HAUR.	Data from bench testing shows performance comparable to the predicate.
Flexural Modulus	Substantially equivalent to predicate device 3M™ ESPETM HAUR.	Data from bench testing shows performance comparable to the predicate.
Surface hardness	Substantially equivalent to predicate device 3M™ ESPETM HAUR.	Data from bench testing shows performance comparable to the predicate.
Radio-opacity	Substantially equivalent to predicate device 3M™ ESPETM HAUR.	Data from bench testing shows performance comparable to the predicate.
Water Sorption	Substantially equivalent to predicate device 3M™ ESPETM HAUR.	Data from bench testing shows performance comparable to the predicate.
Water Solubility	Substantially equivalent to predicate device 3M™ ESPETM HAUR.	Data from bench testing shows performance comparable to the predicate.
Polish Retention	Substantially equivalent to predicate device 3M™ ESPETM HAUR.	Data from bench testing shows performance comparable to the predicate.
Fluorescence	Substantially equivalent to predicate device 3M™ ESPETM HAUR.	Data from bench testing shows performance comparable to the predicate.
Biocompatibility	Safe for intended use based on standard risk assessment techniques and FDA/international guidelines.	Concluded to be safe for its intended use.

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

The document states that data included "bench testing to evaluate the performance." However:

Sample Size: The specific sample sizes for each bench test are not mentioned in the provided text.
Data Provenance: The provenance is bench testing, which implies controlled laboratory conditions. There is no information regarding country of origin, nor whether it was retrospective or prospective, as these terms are generally not applicable to bench testing of material properties.

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

Number of Experts: This information is not applicable as the study described is bench testing of physical properties, not a clinical study involving human interpretation or expert ground truth for medical imaging/diagnosis.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable for this type of bench testing. Adjudication methods like 2+1 or 3+1 are used for clinical trials where multiple experts assess cases and resolve discrepancies.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices involving human interpretation (e.g., radiologists reading images with and without AI assistance). The provided study is bench testing of material properties.
Effect Size: Not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Standalone Study: Not applicable. This concept applies to AI algorithms operating independently to produce a diagnostic output. The described study evaluates the physical properties of a dental restorative material through bench testing.

7. Type of Ground Truth Used

Type of Ground Truth: The "ground truth" for this study comes from objective measurements of the physical properties (e.g., strength, hardness, radio-opacity) of the material as determined by standardized laboratory bench tests. The performance of the new device was compared against a legally marketed predicate device, implying that the predicate's established performance served as a benchmark for "acceptable" property values.

8. Sample Size for the Training Set

Sample Size: This information is not applicable. The device is a dental restorative material and its evaluation involved bench testing of its physical properties, not machine learning or AI models that require training sets.

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

Ground Truth Establishment: Not applicable as there is no training set for this type of device evaluation.

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.