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everX Flow is a reinforcing dentin replacement material suitable for:

• 1. All direct composite restorations including large posterior cavities.
• 2. Deep cavities and endo-treated teeth.
• 3. Cavities with missing cusps or after amalgam removal and cavities where inlays would also be recommended.
• 4. Core build-up

everX Flow is a light cured, short-fiber-reinforced composite for dentin replacement for the restoration of posterior and anterior teeth. EverX Flow is filled in a syringe. The material is available in two shades, Bulk shade and Dentin shade.

The provided document pertains to a 510(k) premarket notification for a dental device named "everX Flow," a tooth shade resin material. This document focuses on demonstrating substantial equivalence to legally marketed predicate devices, primarily through bench testing (performance testing) and biocompatibility assessment, rather than clinical performance testing involving human subjects or AI-assisted diagnostic studies.

Therefore, many of the requested details regarding acceptance criteria, study methodologies (like sample size for test sets, number of experts, adjudication, MRMC studies, standalone AI performance), and ground truth establishment for a diagnostic AI device are not applicable to this submission. This is a material science and dental product regulatory submission, not a medical AI/software as a medical device (SaMD) submission.

However, I can extract and present the acceptance criteria and performance data that are relevant to this type of device, which is primarily laboratory bench testing.

Acceptance Criteria and Reported Device Performance for everX Flow (Dental Resin Material)

This device, "everX Flow," is a dental restorative material, not an AI or diagnostic device. Therefore, the "acceptance criteria" refer to the physical, chemical, and biological properties of the material itself, as tested in a laboratory setting according to international standards (ISO 4049:2009 and ISO 10993-1:2009 for biocompatibility).

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is a series of non-clinical performance bench tests and biocompatibility assessments.

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

• Sample Size for Test Set: The document does not specify exact sample sizes for each bench test (e.g., how many specimens were tested for flexural strength). It broadly states that "Performance testing includes" a list of properties and that the device "complies with all the requirements of ISO 4049: 2009." ISO standards typically define the minimum number of samples for each test, and the claim of compliance implies these were followed.
• Data Provenance: The tests were conducted internally by the manufacturer (GC Corporation) or a contracted lab. The data is prospective, generated specifically for this regulatory submission. The country of origin of the data is not explicitly stated but is implicitly Japan, as GC Corporation is the manufacturer.

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

• Not Applicable. This is a material properties test, not a diagnostic study requiring expert human interpretation. The "ground truth" is defined by established international standards (ISO 4049:2009) and the results are quantifiable physical/chemical measurements.

4. Adjudication Method for the Test Set

• Not Applicable. As this involves objective laboratory measurements against defined standards, there is no human interpretation or adjudication process required for the primary test results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

• Not Applicable. This is a dental material, not a diagnostic AI system or medical imaging device. No MRMC study was conducted. The relevant comparison in this submission is the "substantial equivalence" of the material's properties (composition, curing mechanism, performance characteristics) to existing predicate devices.

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

• Not Applicable. This product is a physical dental material; it does not contain or rely on an algorithm or AI.

7. The type of ground truth used

• Defined Standards and Objective Measurements: The "ground truth" for the performance tests is established by the specified requirements in ISO 4049:2009 for dental polymer-based restorative materials. The measurements (e.g., depth in mm, strength in MPa, mass change in µg/mm³) are objective and quantitative. For biocompatibility, the ground truth is established by the guidelines of ISO 10993-5 (in vitro cytotoxicity).

8. The sample size for the training set

• Not Applicable. This product is a physical dental material, not an AI model that requires a training set.

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

• Not Applicable. As there is no training set, there is no ground truth establishment for one. The development of the material itself would involve R&D and quality control processes, but not "ground truth establishment" in the AI/diagnostic sense.

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