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For in vitro diagnostic use in the quantitative determination of salicylate in human serum and plasma (lithium heparin) on the ADVIA 1650 Chemistry systems. Such measurements are used in the diagnosis of salicylate toxicity and overdose

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I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details, or ground truth establishment. The document is an FDA 510(k) clearance letter for the "ADVIA Chemistry Salicylate Reagent" and primarily discusses regulatory compliance and indications for use. No clinical study data or performance metrics are present in the provided pages.

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The Diagnostic Chemicals Limited's Salicylate method is an in vitro diagnostic device intended to measure salicylate levels in human serum or plasma (Lithium heparin). intended to modellio balleyfato to the diagnosis of salicylate toxicity and overdose.

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The provided text is a 510(k) clearance letter for a Salicylate test system. This type of document does not typically contain the detailed information requested regarding acceptance criteria, study design, or ground truth establishment relevant to AI/ML device performance.

The letter confirms that the device, Salicylate, Cat.Nos.511-20 and 511-40, is substantially equivalent to legally marketed predicate devices for measuring salicylate levels in human serum or plasma to aid in the diagnosis of salicylate toxicity and overdose.

Therefore, I cannot provide the requested information based on the input text. The information is pertaining to a traditional in vitro diagnostic device, not an AI/ML device which would involve specific performance metrics and validation studies against a ground truth as outlined in your request.

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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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Salicylate (SALY) Reagent, when used in conjunction with SYNCHRON® Systems Salicylate Calibrator, is intended for the quantitative determination of salicylate in serum and plasma on Beckman Coulter's SYNCHRON Systems by a colorimetric timed-endpoint method. Measurements obtained by this device are used in diagnosis and treatment of salicylate overdose and in monitoring salicylate levels to ensure appropriate therapy.

The SYNCHRON System Salicylate (SALY) Reagent is designed for optimal performance on the SYNCHRON CX and LX Systems. The assay is intended for use in the quantitative determination of salicylate concentration in serum or plasma by a colorimetric timed-endpoint method. The reagent kit contains two 45-test cartridges and is packaged with the single-level calibrator.

The document provided is a 510(k) summary for the SYNCHRON® Systems Salicylate Reagent, an in vitro diagnostic device used for quantitative determination of salicylate concentration in serum or plasma. It is not an AI/ML device, and therefore, many of the requested criteria (like sample size for test/training set, expert ground truth, adjudication methods, MRMC studies, standalone performance for AI, etc.) are not applicable.

However, based on the information available in the document, here's a description related to its performance validation:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes performance in terms of Method Comparison and Imprecision. While explicit acceptance criteria (e.g., "slope must be between X and Y") are not detailed as such, the results presented demonstrate performance compared to a predicate device and show reproducibility.

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

• Sample Size (Method Comparison): 75 serum patient specimens.
• Data Provenance: The specimens were "serum patient specimens." The country of origin is not specified, but the submission is from Beckman Coulter in Brea, CA, suggesting US-based data is likely. The study appears to be retrospective, using existing patient specimens.

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

• Not applicable. This is an in vitro diagnostic (IVD) device, not an AI/ML device that requires human expert review for image interpretation or similar. The "gold standard" or "ground truth" for the method comparison is the predicate device, the Abbott TDx Salicylate Assay. For imprecision, the ground truth is statistical reliability based on repeat measurements of control samples.

4. Adjudication Method for the Test Set:

• Not applicable. This concept relates to reconciling discrepancies between human readers or between AI and human readers, which is not relevant for an IVD device measuring analyte concentrations.

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. MRMC studies are for AI/ML devices involving human readers. This device is an automated reagent system.

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

• Yes, in spirit. The performance data presented (Method Comparison and Imprecision) are for the SYNCHRON® Systems Salicylate Reagent and system stand-alone, meaning its performance is evaluated based on its own measurements compared to a predicate or its own reproducibility, independent of human interpretive intervention. The device's output is a quantitative value, not an interpretation requiring human review. User input for sample loading and initiating tests is implied, but the core measurement and result generation are automated.

7. The type of ground truth used:

• For Method Comparison: A legally marketed predicate device (Abbott TDx Salicylate Assay) was used as the comparative "ground truth" to establish substantial equivalence.
• For Imprecision: Statistical measures of variability (Standard Deviation and % Coefficient of Variation) across repeated measurements of control samples served as the basis for assessing precision.

8. The sample size for the training set:

• Not applicable. This device is a reagent for a colorimetric timed-endpoint method, not an AI/ML algorithm that requires a training set. Its development would involve chemical and analytical optimization, not machine learning training.

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

• Not applicable. As stated above, there is no AI/ML training set for this type of IVD device.

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The Emit® tox™ Salicylic Acid Assay is a homogenous enzyme immunoassay intended for use in the quantitative analysis of salicylic acid in human serum or plasma. Measurements obtained from this device are used in the diagnosis and treatment of salicylic acid overdose or in monitoring levels of salicylic acid to ensure appropriate therapy.

The Emit® tox™ Salicylic Acid Assay is a homogenous enzyme assay intended for use in quantitative analysis of Salicylic Acid in human serum or plasma.

The Emit® tox™ Salicylic Acid Assay is intended for the quantitative analysis of salicylic acid in human serum or plasma to diagnose and treat salicylic acid overdose or monitor therapeutic levels.

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

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For the quantitative determination of salicylate in serum. For IN VITRO diagnostic use.

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.

The provided document is a 510(k) premarket notification letter for the Salicylate-SL Assay. It confirms the device's substantial equivalence to a predicate device and allows it to be marketed. However, this document does not contain the detailed acceptance criteria or the study data that would demonstrate the device meets those criteria.

A 510(k) clearance primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical efficacy studies akin to PMA (Premarket Approval) applications. While "performance" might be mentioned in the context of the device's mechanism, the letter does not include a table of acceptance criteria or reported device performance in the way a study report would.

Therefore, for your request, I can only extract limited information based on what is provided:

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

• Not provided in this document. The letter refers to the device being "substantially equivalent," which implies its performance is comparable to the predicate device, but specific metrics and acceptance criteria for that equivalence are not detailed here.

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

• Not provided in this document. The letter does not detail any specific test set or study design.

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 provided in this document.

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

• Not provided in this document.

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 an in vitro diagnostic assay, not an imaging AI device that would involve human readers interpreting images.

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

• Not applicable in the typical sense for AI algorithms. This is a laboratory assay. The "algorithm" here is the enzymatic reaction and measurement. The letter mentions it "can be adapted to automated instruments," implying standalone operation as a lab test, but no separate "standalone performance study" in the context of AI is discussed.

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

• Not explicitly stated in this document. For an in vitro diagnostic device like this, ground truth would typically be established through a reference method or validated gold standard test for salicylate concentration in serum. The document mentions "Salicylate has been traditionally measured by the 'Trinder Reaction'," suggesting this might be the comparator for method development, but it doesn't specify how ground truth was established for the specific testing of this device.

8. The sample size for the training set:

• Not provided in this document.

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

• Not provided in this document.

Summary of Device and Indications:

• Device Name: Salicylate-SL Assay
• Indications for Use: For the quantitative determination of salicylate in serum. For IN VITRO diagnostic use.
• Mechanism: Enzymatic assay based on the action of salicylate hydroxylase on salicylate and NADH, resulting in a decrease in absorbance proportional to the amount of salicylate present. This is designed to be more rapid, specific, and simplified than the traditional Trinder Reaction and adaptable to automated instruments.
• Purpose: Rapid quantitation of salicylate is necessary for effective patient management in cases of salicylate overdose (due to accidental ingestion or attempted suicidal poisoning), which can lead to central nervous system disturbances, gastrointestinal tract issues, encephalopathy, and renal failure.

To obtain the detailed information about acceptance criteria and study data, one would typically need to review the full 510(k) submission, including the specific performance data sections, which are not part of this FDA clearance letter.

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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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The Paramax® Salicylate Reagent is intended for use as quantitative determination of salicylate in plasma and serum.

The Paramax® Salicylate Reagent is based on colormetric methodology.

{
  "acceptance_criteria_and_performance": {
    "table": [
      {
        "criterion": "Correlation with predicate device",
        "acceptance_level": "High correlation coefficient",
        "reported_performance": "Correlation coefficient = 0.999"
      },
      {
        "criterion": "Regression equation",
        "acceptance_level": "Regression equation indicating substantial equivalence",
        "reported_performance": "Paramax® value = (1.16 x aca value) - 1.8 mg/dL"
      }
    ],
    "study_summary": "The study demonstrated substantial equivalence between the Paramax® Salicylate Reagent and the DuPont aca Salicylate Reagent based on the high correlation coefficient (0.999) and a regression equation of Paramax® value = (1.16 x aca value) - 1.8 mg/dL."
  },
  "sample_size_test_set": 49,
  "data_provenance": "Not specified (likely clinical samples, but country/retrospective/prospective not mentioned in snippet).",
  "number_of_experts_ground_truth": "Not applicable; the ground truth for this comparison study was established by the predicate device (DuPont aca Salicylate Reagent).",
  "qualifications_of_experts": "Not applicable",
  "adjudication_method": "Not applicable",
  "mrmc_comparative_effectiveness_study": "No, this was a device-to-device correlation study, not an MRMC study involving human readers.",
  "standalone_performance_study": "Yes, the study evaluated the standalone performance of the Paramax® Salicylate Reagent by comparing its results to a predicate device's results on the same samples.",
  "type_of_ground_truth": "Predicate device's results (DuPont aca Salicylate Reagent). The predicate device's measurements are considered the reference for establishing substantial equivalence.",
  "sample_size_training_set": "Not applicable; this is a device validation study, not a machine learning model training.",
  "how_ground_truth_for_training_set_established": "Not applicable"
}

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