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For the quantitative determination of acetaminophen in serum. For IN VITRO diagnostic use. Acetaminophen (paracetamol) is used as an analgesic in many different formulations (1). While therapeutic doses rarely cause adverse side effects, the effect of long term treatment with acetaminophen is unclear. Cases have been reported where chronic excessive use of acetaminophen has led to hepatotoxicity and nephrotoxicity (2,3). In cases of acute overdosage, acetaminophen can cause severe hepatic damage leading to hepatic failure if untreated (4,5,6). The management of acetaminophen overdose requires early recognition of the drug in the bloodstream. Toxicity is generally reported at concentrations over 20 mg/dL. N-acetylcysteine has been used as an antidote in conjunction with intensive support care. Early diagnosis of acetaminophen-induced hepatotoxicity is important since initiation of therapy within 8 hours of ingestion lessens the potential for hepatic injury, and decreases the mortality rate (7). The majority of methods for measuring acetaminophen are based on spectrophotometric or chromatographic principles. Chromatographic methods are specific for the parent compound, however, they are not well suited to emergency laboratories. Spectrophotometric methods are simpler and more rapid, but do not always offer the desired specificity. This spectrophotometric method is rapid, reliable, convenient, and specific for acetaminophen.

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This is a 510(k) premarket notification for an Acetaminophen Assay. As such, it does not describe a study involving an "AI device" or its "acceptance criteria" in the way that current AI/ML medical devices do. The document pertains to a traditional in vitro diagnostic device, and the evaluation is for substantial equivalence to a legally marketed predicate device rather than a performance study against specific acceptance criteria.

Therefore, most of the requested information regarding AI device performance, sample sizes, expert ground truth, MRMC studies, training sets, etc., is not applicable to this document.

However, I can extract information related to the device and its intended use:

Device Name: Acetaminophen Assay (ACE)

Indications for Use: For the quantitative determination of acetaminophen in serum. For IN VITRO diagnostic use.

The document discusses the clinical relevance of measuring acetaminophen levels due to its use as an analgesic and the potential for hepatotoxicity and nephrotoxicity in cases of chronic excessive use or acute overdosage. It highlights the importance of early diagnosis for managing acetaminophen overdose, with toxicity generally reported at concentrations over 20 mg/dL.

The method used by the device is described as a "spectrophotometric method" which is "rapid, reliable, convenient, and specific for acetaminophen."

Regarding acceptance criteria and study data:

Traditional 510(k) submissions for in vitro diagnostic assays typically demonstrate substantial equivalence through analytical and sometimes clinical performance studies. These studies would define performance characteristics such as:

• Accuracy: Comparison to a reference method or known concentrations.
• Precision: Repeatability and reproducibility.
• Linearity/Measuring Range: The range over which the assay provides accurate results.
• Interference: Evaluation of substances that might falsely elevate or depress results.
• Specificity: How well the assay distinguishes acetaminophen from other compounds.

The document does not provide the detailed results of these studies or explicit "acceptance criteria" in the format of a table as requested for an AI device. Instead, the FDA's "substantial equivalence" determination implies that the device's performance is comparable to a predicate device, which would have met its own established performance specifications.

Therefore, I cannot fulfill your request in full for an "AI device" using this document. The information you're asking for is specific to AI/ML device evaluations, which involve different types of studies and reporting. This document is a regulatory approval letter for a chemical assay, not an AI product.

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