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All temporary fillings and temporary restorations using inlay and onlay restorations.

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I apologize, but the provided text does not contain detailed information about acceptance criteria, device performance results, study design, or expert qualifications for a medical device. The document is primarily a letter from the FDA regarding a 510(k) premarket notification for a device called "PreVision Fill."

The letter confirms that the device is substantially equivalent to legally marketed predicate devices and outlines the regulatory framework for marketing it. It mentions the product's trade name, regulatory class, and product code, but does not include:

• A table of acceptance criteria or reported device performance.
• Details about sample sizes, data provenance, ground truth establishment methods, or whether the study was retrospective or prospective.
• Information on the number or qualifications of experts used for ground truth.
• Adjudication methods.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was conducted or its effect size.
• If a standalone (algorithm-only) performance study was done.
• The type of ground truth used (e.g., pathology, outcomes data).
• The sample size for the training set or how its ground truth was established.

The "Indications For Use" section on page 2 states that the device is for "All temporary fillings and temporary restorations using inlay and onlay restorations," but this is an intended use, not performance criteria or study results.

Therefore, I cannot provide the requested information based on the text provided.

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