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• 1. Direct anterior and posterior restorations (including occlusal surfaces)
• 2. Direct veneers
• 3. Correction of tooth position and tooth shape
• 4. Indirect restorations including inlays, onlays and veneers
• 5. Intraoral repairs of fractured restorations
• 6. Core build-ups
• 7. Splinting

The subject devices (Medi galaxy Flow, Medi Classic, Medi Jupiter,Medi Opaque Plus, Medi Opaque Posterior.Medi White Pearl) are visible light-cure, radiopaque restorative material (Composite) with high polishingability, excellent physical properties and are designed for anterior and posterior restorations. The subject devices formulated from multifunctional methacrylate monomer-based resin, photo initiator, silanated inorganic filler and pigments. Available in multiple shades. These restoratives provides high strength and low wear for durability. They are packaged in traditional syringes and Pre-Loaded Tips.

The provided FDA 510(k) document (K170873) is for a dental restorative material, not an AI-powered diagnostic device. Therefore, the typical acceptance criteria and study designs relating to AI performance metrics (like sensitivity, specificity, F1-score, reader studies, etc.) are not applicable here.

Instead, this document focuses on demonstrating substantial equivalence to a predicate device based on physical and mechanical properties, chemical composition, and biocompatibility, as per the requirements for Class II medical devices like tooth shade resin materials.

Here's a breakdown of the relevant information provided, adapted to the context of a material rather than an AI device:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by compliance with ISO 4049:2009 for "Dentistry - Polymer-based restorative materials" and substantial equivalence to the predicate device (Clearfil Majesty ES-2) across various physical and performance properties. The "reported device performance" refers to the measured values for the subject devices and the predicate device.

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

• Sample Size: The document does not explicitly state the sample size (n-value) for each physical and mechanical property test. It provides mean values and standard deviations, which implies repeat measurements were taken, but the exact number of samples per test is not detailed.
• Data Provenance: The data is generated from non-clinical performance testing of the subject devices themselves, and for comparison, the predicate device. The country of origin for the data generation and whether it's retrospective or prospective is not specified, but it would typically be prospective laboratory testing conducted by the manufacturer or a contracted lab.

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

This question is not applicable. The "ground truth" for material properties is established through standardized laboratory testing methods (e.g., ISO 4049:2009), not through expert clinical consensus or interpretation in the way AI models are evaluated.

4. Adjudication Method for the Test Set

This question is not applicable as there is no expert adjudication for material properties. Compliance is determined by objective measurements against established international standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

This question is not applicable. MRMC studies are used for evaluating diagnostic accuracy with human readers, which is not relevant for a dental restorative material.

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

This question is not applicable. This is not an AI algorithm. The performance data presented are "standalone" in the sense that they describe the intrinsic physical and chemical properties of the material itself.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on objective measurements obtained through standardized laboratory testing protocols as defined by ISO 4049:2009 and comparison to the well-established performance of a legally marketed predicate device.

8. The Sample Size for the Training Set

This question is not applicable. There is no AI model, therefore, no training set.

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

This question is not applicable as there is no AI model or training set.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study proving the device meets acceptance criteria is a non-clinical performance testing program based on the international standard ISO 4049:2009 (Dentistry - Polymer-based restorative materials). The manufacturer tested the physical and mechanical properties of the subject devices (Medi Galaxy Flow, Medi Classic, Medi Pearl, Medi Jupiter, Medi Opaque Plus, Medi Opaque Posterior, Medi White Pearl) and compared them to a legally marketed predicate device, Clearfil Majesty ES-2, which also complies with ISO 4049:2009.

The study demonstrated that:

• The subject devices' measured physical properties (e.g., radiopacity, compressive strength, flexural strength, depth of cure, water sorption, water solubility) fall within very similar values to those of the predicate device.
• The chemical ingredients of the subject devices are all used in the predicate devices.
• The subject devices, like the predicate, comply with ISO 4049:2009.
• The biocompatibility is considered acceptable because the chemical ingredients are common to the predicate device, which has no reported post-market adverse events.

These findings support the conclusion that the subject devices are substantially equivalent in performance to the predicate device and thus meet the necessary acceptance criteria for marketing.

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