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• All Futar bite registration materials (Futar, Futar D, Futar D Fast, Futar D Slow, . Futar Scan) can be used for making accurate occlusal registrations.
• Futar D materials (Futar D, Futar D Fast, Futar D Slow) can be used for . applications, which require a hard bite registration silicone.
• Futar D Fast can be used for "small applications" because of its shorter working . time.
• Futar D Slow can be used for time-consuming bite registrations because of its . longer working time.
• Futar Scan can also be used for an optical registration of occlusal data for CAD/CAM/CIM systems without using powder.

Futar®, Futar® D, Futar® D Fast, Futar® D Slow, and Futar® Scan are syringeable, addition-curing, elastomeric bite registration materials which differ in their final hardnesses, curing times, and linear dimensional changes.

The provided text is a 510(k) summary for the Futar® Bite Registration Materials. It describes the device and its intended use but does not contain a study that performs a direct comparison against a specific set of acceptance criteria in the manner requested (i.e., a table of acceptance criteria and reported device performance, information on sample size, expert ground truth establishment, MRMC studies, or standalone performance).

Instead, the submission demonstrates substantial equivalence to predicate devices by stating that the Futar® materials were evaluated in accordance with applicable criteria established by:

• Guidance for Industry and FDA Staff: Dental Impression Materials – Premarket Notification (FOD#2203, 8/17/1998)
• ISO 4823 (Dentistry – Elastomeric impression materials):2000/Cor 1:2004/Amd 1:2007
• DIN 13903:2005 (Dentistry-Bite registration material)

The document asserts that "The results of device performance testing demonstrated that Futar (Futar, Futar D, Futar D Fast, Futar D Slow, Futar Scan) are suitable for use as bite registration materials" and "perform in a manner substantially equivalent to that of the predicate devices."

Therefore, based solely on the provided text, I cannot complete the table or answer all specific questions as a detailed study report is not included. The FDA's 510(k) clearance letter (K081120) confirms that the device was found substantially equivalent based on the submitted information, which implies that the performance data, while not detailed here, met the necessary thresholds for substantial equivalence.

Here's what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance: This information is not explicitly detailed in the provided 510(k) summary. The summary only generally states that the device was "evaluated in accordance with the applicable criteria established in [various standards]" and that "results of device performance testing demonstrated that Futar... are suitable for use as bite registration materials." No specific pass/fail criteria or numerical performance metrics are given.

2. Sample size used for the test set and the data provenance: Not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned. This type of detail is generally not included in a 510(k) summary for a material device unless a specific clinical study with expert evaluation was a critical component of demonstrating equivalence, which does not appear to be the case here.

4. Adjudication method: Not mentioned.

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 dental material, not an AI-powered diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a dental material.

7. The type of ground truth used: Not explicitly stated in terms of a "ground truth" for a diagnostic algorithm. The "performance data" refers to the physical and chemical properties and functional suitability of the material as assessed against the specified industry standards (ISO 4823, DIN 13903). These standards themselves define the "ground truth" for material properties like linear dimensional change, curing times, hardness, etc.

8. The sample size for the training set: Not applicable. This is a material, not a machine learning algorithm requiring a "training set."

9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a regulatory submission for a dental material, not a clinical study report for a diagnostic device or AI algorithm. Therefore, many of the requested details about "acceptance criteria" and "study" as they relate to diagnostic accuracy, expert review, or AI performance are not present. The "study" referenced is the performance testing of the material against established standards for dental impression materials to demonstrate substantial equivalence to predicate devices.

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