Search Results

StarBright™ 5% Sodium Fluoride Varnish is a fluoride containing preparation for use as a cavity varnish and for the treatment of dentin hypersensitivity.

StarBright™ 5% Sodium Fluoride Varnish is a rosin based 5% sodium fluoride varnish. This device is available in tray form unit doses of 0.25 and 0.40 mL. Fluoride ions within StarBright™ 5% Sodium Fluoride Varnish may react with calcium and phosphate ions in saliva to form crystals in exposed dentin tubules, such as in exposed root surfaces, leading to protection by blocking external stimuli thereby reducing hypersensitivity.

The provided document is a 510(k) premarket notification for a medical device called "StarBright™ 5% Sodium Fluoride Varnish." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific acceptance criteria based on its performance against quantitative metrics in a clinical study.

Therefore, the document does not contain the information requested regarding acceptance criteria tables, sample sizes for test/training sets, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or detailed ground truth types.

Here's why the information is not present and what the document does contain:

• Type of Device: The device is a "Cavity Varnish" (Product Code: LBH), regulated as Class II. This is a dental material, not an AI/ML-based diagnostic or imaging device.
• Regulatory Pathway (510(k)): The 510(k) pathway for medical devices largely relies on showing that the new device is "substantially equivalent" to a legally marketed predicate device. This typically involves demonstrating similar technological characteristics, intended use, and performance, often through bench testing and biocompatibility. It does not generally require large-scale clinical trials or detailed performance metrics against ground truth, especially for a well-established device type like a fluoride varnish.
• Lack of AI/ML Component: The device is a chemical preparation. It does not involve any artificial intelligence, machine learning, image analysis, or diagnostic algorithms. Therefore, concepts like "test set," "training set," "ground truth experts," "adjudication," "MRMC study," and "standalone algorithm performance" are not applicable to this product.

What the document does include relevant to its regulatory pathway:

• Identified Predicate Devices: The submission identifies several predicate devices (e.g., Duraflor ®, 3M Vanish, Nupro Model 13016901, Enamelast) to which StarBright™ 5% Sodium Fluoride Varnish is considered substantially equivalent.
• Technological Characteristics and Intended Use: It states that the device has the same intended use (cavity varnish, treatment of dentin hypersensitivity) and similar technological characteristics (rosin-based 5% sodium fluoride varnish, paste formulation, unit dose packaging, applied with a brush) as the predicate devices.
• Non-clinical Performance Testing: It mentions that non-clinical performance testing (fluoride release, tubule occlusion, cytotoxicity, sensitization, irritation) was conducted to support substantial equivalence. The document states these tests "demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed predicate devices." This is the closest it comes to performance, but it's not quantitative "acceptance criteria" on a diagnostic metric.
• No Clinical Performance Testing: The document explicitly states, "Clinical performance data was not included." This further supports that the type of study design you're asking about (which often involves clinical endpoints or diagnostic accuracy) was not a requirement for this specific 510(k) submission.

In summary, as the input document describes a chemical dental product undergoing a 510(k) review based on substantial equivalence, the requested information pertaining to AI/ML device performance and clinical studies (e.g., MRMC, standalone algorithm performance, expert ground truth) is not applicable or present in this document.

Ask a specific question about this device