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The Bayer ADVIA IMS Salicylate method is an in vitro diagnostic device intended to measure salicylate levels in human serum or plasma (Lithium heparin). Such measurements are used in the diagnosis of salicylate toxicity and overdose.

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Here's a breakdown of the acceptance criteria and study details for the Salicylate method for ADVIA® IMS™, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implicitly tied to demonstrating "equivalence" to the predicate device, the Abbott/TDx Salicylate assay. The reported device performance is compared against the predicate in terms of correlation and imprecision.

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

• Test Set Sample Sizes:
  • Correlation (Serum vs. Abbott/TDx): N = 47
  • Correlation (Plasma vs. Serum): N = 49
  • Imprecision and Interfering Substances: Specific sample size for these tests is not explicitly stated as 'N' values for individual runs but implies multiple measurements for statistical evaluation.
• Data Provenance: Not explicitly stated. It is common for these types of studies to be conducted internally by the manufacturer or a contract research organization. Given it's a diagnostic assay, the samples would likely be human serum and plasma. The country of origin and whether it's retrospective or prospective are not detailed.

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

This type of diagnostic assay, measuring specific analyte concentrations, does not typically involve human experts for establishing ground truth in the same way an image analysis algorithm would. The "ground truth" for the test set is established by:

• Reference Method Measurement: The Abbott/TDx Salicylate assay serves as the comparator (predicate device), and its measurements are used as the reference for correlation.
• Known Concentrations: For imprecision and interfering substances, samples are likely spiked with known concentrations of salicylate and/or interfering substances.

Therefore, the concept of "experts" and their qualifications as described for image analysis is not fully applicable here.

4. Adjudication Method for the Test Set

Not applicable. As explained above, the ground truth is based on quantitative measurements from a reference method or known concentrations, not subjective expert judgment requiring adjudication.

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 is a standalone in-vitro diagnostic method for measuring a chemical analyte, not an AI-assisted diagnostic tool that aids human readers in interpreting complex data (like medical images).

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

Yes, this study represents a standalone performance evaluation. The ADVIA IMS Salicylate method is an automated assay that provides a quantitative measurement of salicylate levels. Its performance is assessed independently against a predicate device and established analytical criteria, without a human "reading" the final output beyond interpreting the numerical result.

7. The Type of Ground Truth Used

The ground truth used is primarily:

• Reference Method Comparability: Measurements from the legally marketed predicate device (Abbott/TDx Salicylate) serve as the comparative ground truth for evaluating correlation.
• Known Concentrations: For imprecision and interference studies, samples are likely prepared with precisely known concentrations of salicylate and interfering substances.

8. The Sample Size for the Training Set

Not applicable. This is a chemical assay, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The method relies on established chemical reaction principles and calibration curves rather than learning from a large dataset.

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

Not applicable, as there is no "training set" in the context of an AI/ML algorithm. The assay's analytical performance (linearity, sensitivity, specificity) is based on its chemical design and optimization, which would involve internal development and validation using various control materials and known concentrations to establish calibration and performance characteristics.

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For the quantitative determination of salicylate in serum. For IN VITRO diagnostic use. Salicylate is a common drug used for its analgesic and anti-inflammatory properties. Its accessability leads to its implication in a large number of accidental ingestions by children and it is a popular choice among adults and adolescents for attempted suicidal poisoning. Salicylate overdose results in disturbances of the central nervous system and the gastrointestinal tract as well as encephalopathy and renal failure. It represents an acute medical emergency and rapid quantitation of the drug is necessary for effective patient management. Salicylate has been traditionally measured by the "Trinder Reaction" which is based on the interaction between salicylate and ferric ions. This test however is not specific and requires extraction or centrifugation which inhibit the automation of the test. This enzymatic Salicylate Assay provides a rapid, specific and simplified method for salicylate determination. It is based on the action of salicylate hydroxylase on salicylate and NADH which results in a decrease in absorbance proportional to the amount of salicylate present. The test can be adapted to automated instruments resulting in rapid, accurate results required by physicians.

This enzymatic Salicylate Assay provides a rapid, specific and simplified method for salicylate determination. It is based on the action of salicylate hydroxylase on salicylate and NADH which results in a decrease in absorbance proportional to the amount of salicylate present. The test can be adapted to automated instruments resulting in rapid, accurate results required by physicians.

This document is a 510(k) clearance letter for a Salicylate Assay (ACE) device. It is a communication from the FDA to the manufacturer, indicating that the device has been deemed substantially equivalent to a legally marketed predicate device. This type of document typically does not contain detailed study results or acceptance criteria in the format requested, as it focuses on regulatory clearance rather than a scientific publication of performance data.

However, based on the provided text, I can extract the intent of the device and the type of assay it is, and infer what would typically be tested for such devices. Since the full study details are not present, I will indicate where information is "Not provided in the document" or "Inferred from device type."

Device Name: Salicylate Assay (ACE), Catalogue Number 501-71

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

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not provided in this document. Clinical performance data would typically be submitted with the 510(k) but is not part of this clearance letter.
• Data Provenance: Not provided in this document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable/Not provided. For an in vitro diagnostic (IVD) assay like this, ground truth for performance studies is typically established by reference methods (e.g., HPLC-MS/MS, a validated predicate device, or other highly accurate laboratory methods) rather than expert interpretation of images or clinical opinions. The "experts" would be the scientists or clinical chemists performing the reference assays and validating the results.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable/Not provided. Adjudication methods like 2+1 or 3+1 are typically used for subjective assessments (e.g., image interpretation where multiple readers assess and a consensus is reached), not for quantitative IVD assays where numerical results are compared to a reference standard.

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 is an in vitro diagnostic device for chemical analysis (salicylate in serum), not an AI-assisted diagnostic imaging device or a device involving human readers/interpreters in that sense. Therefore, an MRMC study related to human reading improvement with AI is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• This device, being an automated enzymatic assay, intrinsically operates in a "standalone" fashion in terms of its analytic performance. The algorithm (or enzymatic reaction and spectrophotometric measurement) produces a quantitative result. Clinical interpretation of that result by a healthcare professional is a separate step, but the device's performance itself is a standalone measurement. The document implies it can be "adapted to automated instruments," suggesting its core function is independent of continuous human intervention during the measurement process.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• For an in vitro diagnostic quantitative assay like this, the ground truth would most likely be established by a reference method (e.g., Gas Chromatography-Mass Spectrometry (GC-MS), High-Performance Liquid Chromatography (HPLC), or a well-established and validated predicate assay that serves as a gold standard for salicylate measurement).

8. The sample size for the training set

• Not provided in this document. As this is not an AI/machine learning device in the modern sense (it's an enzymatic chemical assay), the concept of a "training set" for an algorithm isn't directly applicable in the same way. Performance validation involves testing samples with known concentrations, but this isn't a "training set" for an AI model.

9. How the ground truth for the training set was established

• Not applicable in the context of an AI training set. For an enzymatic assay, the "ground truth" for method development and validation would be established by preparing samples with precisely known concentrations of salicylate (e.g., spiked samples) or by running patient samples in parallel with a highly accurate reference method.

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