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The Acetaminophen assay is used for the quantitative determinophen in human serum or plasma on the ARCHITECT c Systems.

The Acetaminophen assay is to be used as an aid in the diagnosis and treatment of acetaminophen overdose toxicity.

The Acetaminophen assay is an enzymatic, spectrophotometric assay for the measurement of acetaminophen concentration in human serum and plasma. The assay consists two working reagents, an enzyme reagent and a color reagent.

The enzyme reagent contains aryl acylamidase, which cleaves the amide bond of acetaminophen, forming p-aminophenol which then reacts with the 2,5-dimethylphenol (contained the color reagent) in the presence of manganese. The product of that reaction causes increased absorbance at 660 nm which is directly proportional to the acetaminophen concentration in the sample.

Testing is performed on the ARCHITECT c8000 clinical chemistry analyzers in conjunction with a calibrator (510(k) exempt) which is provided separately.

The provided text describes a 510(k) premarket notification for an Acetaminophen assay (K202644). The document details various performance studies conducted to demonstrate the device's substantial equivalence to a legally marketed predicate device.

Here's an analysis of the acceptance criteria and study details based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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Intended for the in vitro quantitative measurement of acetaminophen in serum, lithium heparin plasma. Measurement of acetaminophen is used in the diagnosis and treatment of acetaminophen overdose toxicity.

The SEKURE Acetaminophen L3K assay is an enzymatic, spectrophotometric assay for the measurement of acetaminophen concentration in serum, lithium heparin plasma and sodium heparin plasma. The assay consists two working reagents, an enzyme reagent and a color reagent. The enzyme reagent contains acyl amidohydrolase, which cleaves the amide bond of the acetaminophen, forming p-aminophenol which then reacts with the 2,5- dimethylphenol (contained the color reagent) in the presence of manganese. The product of that reaction causes increased absorbance at 605 nm which is directly proportional to the acetaminophen concentration in the sample. Testing is performed on open system clinical chemistry analyzers, such as the Hitachi 717 (K872494) in conjunction with a calibrator (510(k) exempt) which is included and controls which are provided separately.

The provided document is a 510(k) Pre-market Notification for a medical device called the "SEKURE Acetaminophen L3K Assay." This document describes the analytical studies conducted to demonstrate the device's performance and substantial equivalence to a predicate device, rather than a study involving human readers or AI assistance in image interpretation. Therefore, many of the requested points related to AI, human reader performance, expert consensus, and MRMC studies are not applicable to this type of device submission.

Here's an analysis based on the available information:

Device Type: In vitro diagnostic device (IVD) for quantitative measurement of acetaminophen in biological samples.

Focus of the Document: Analytical performance studies (precision, analytical sensitivity, linearity, interference, method comparison, matrix comparison) to demonstrate the assay's accuracy and reliability.

Information NOT Applicable to this Document Type:

• Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective) - Data provenance is typically not detailed for IVD analytical studies in this manner; samples are clinical specimens or prepared materials.
• 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) - Ground truth for IVDs is established by reference methods or gravimetric preparation, not expert review of images.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set - Not applicable for IVD analytical studies.
• 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 not an AI-assisted diagnostic imaging device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done - Not applicable; this is not an AI algorithm.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc) - Ground truth is established by reference methods, gravimetric preparation, or theoretical values.
• The sample size for the training set - Not applicable; this device does not use an AI training set.
• How the ground truth for the training set was established - Not applicable.

Acceptance Criteria and Reported Device Performance

The device is an in vitro diagnostic assay, and its performance is evaluated through various analytical studies. The acceptance criteria are therefore analytical performance specifications, not clinical outcomes directly.

Here's a table summarizing the acceptance criteria and a selection of reported performance data from the document:

Table of Acceptance Criteria and Reported Device Performance

Study that Proves the Device Meets the Acceptance Criteria

The study that proves the device meets the acceptance criteria is a series of Non-Clinical Performance Data studies, as detailed in the "510(k) Summary" document. These are analytical studies, typically following CLSI (Clinical and Laboratory Standards Institute) guidelines, to characterize the performance of the in vitro diagnostic assay.

1. Sample Sized Used for the Test Set and Data Provenance:

• Precision: 80 measurements per sample/control per lot (assayed in duplicate twice a day for 20 days). This included two unaltered patient serum samples, two spiked patient serum samples, and three levels of controls. Data is likely from laboratory samples, not specified by country.
• Analytical Sensitivity (LoB/LoD): 60 measurements per lot (five blank samples and five low concentration samples in quadruplicate over three operating days).
• Analytical Sensitivity (LoQ): 40 replicates per low concentration sample per lot (five low concentration samples tested in 40 replicates over five runs across three operating days).
• Linearity/Assay Reportable Range: 4 replicates per sample per lot (nine internally prepared samples across the measuring range).
• Analytical Specificity (Interference): 5 replicates per interferent concentration per acetaminophen concentration (tested at 3-4 acetaminophen concentrations).
• Method Comparison: 105 patient specimens, tested in duplicate, over seven operating days. Samples were distributed evenly throughout the assay range.
• Matrix Comparison: 40 matched sets of patient specimens.

Data Provenance: The document does not explicitly state the country of origin for patient samples or whether they were retrospective or prospective. However, for analytical performance, samples are typically collected from a pool of patient samples or are internally prepared clinical matrix materials.

2. Number of Experts and Qualifications:

• Not applicable. This device is an analytical chemistry assay, not one that relies on human experts for interpretation or ground truth establishment. The performance is assessed against quantitative analytical standards and a predicate device.

3. Adjudication Method:

• None. Not applicable for analytical performance studies of an IVD assay.

4. MRMC Comparative Effectiveness Study:

• No. Not applicable as this is not an imaging device or an AI-assisted diagnostic device.

5. Standalone Performance:

• Yes (in the context of an IVD). The performance data presented (e.g., precision, analytical sensitivity, linearity, interference) represent the standalone performance of the SEKURE Acetaminophen L3K Assay itself, without a "human-in-the-loop" in the artificial intelligence sense. The assay quantitatively measures acetaminophen concentration.

6. Type of Ground Truth Used:

• Reference Methods / Gravimetric Preparation / Theoretical Values / Predicate Device Comparison.
  • Precision: Relative to the mean of repeat measurements.
  • Analytical Sensitivity: Derived statistically from blank and low-level samples.
  • Linearity: Compared to theoretical concentrations of gravimetrically prepared standards.
  • Interference: Compared to control samples without interferent.
  • Method Comparison: Compared to measurements obtained using a legally marketed predicate device (SEKURE Acetaminophen L3K Assay, K081938). This is a common form of "ground truth" for demonstrating substantial equivalence for IVDs.
  • Matrix Comparison: Compared to serum samples (considered the reference matrix).

7. Sample Size for the Training Set:

• Not applicable. This device is an in vitro diagnostic assay, not an AI algorithm that requires a training set.

8. How the Ground Truth for the Training Set Was Established:

• Not applicable. See above.

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cobas c Acetaminophen Gen.2 assay:
The cobas c Acetaminophen Gen.2 assay is an in vitro diagnostic test for the quantitative determination of acetaminophen in serum and plasma for use in the diagnosis of acetaminophen overdose in serum and plasma on Roche/Hitachi cobas c systems.

ACET2 calibrator:
The ACET2 calibrator is for use in the calibration of the Acetaminophen Gen.2 Roche assay.

The cobas c Acetaminophen Gen.2 assay is based on a homogeneous enzyme immunoassay technique used for the quantitative analysis of acetaminophen in human serum and plasma.
Reagents are packaged in a cassette labeled with their instrument positioning R1 (Reagent 1) and R2 (Reagent 2).
R1 contains anti-acetaminophen antibody (sheep polyclonal), G6P, NAD, bovine serum albumin, preservatives and stabilizers.
R2 contains acetaminophen labeled with bacterial G6PDH, Tris buffer, preservatives, bovine serum albumin, and stabilizers.
The ACET2 calibrator contains a known quantity of acetaminophen. The cobas c 501 analyzer dilutes the ACET2 calibrator on-board the analyzer with NaCl diluent, in order to create five concentration levels, and level 1 is water. This results in a six-level calibrator set, and the calibrator set is then used to establish a standard curve. The ACET2 calibrator contains acetaminophen, phosphate buffer, and preservatives.

The provided document describes the analytical performance of the cobas c Acetaminophen Gen.2 assay and ACET2 Calibrator. It outlines various studies conducted to demonstrate the device's characteristics, which can serve as acceptance criteria.

Here's the requested information:

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

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

• Precision (Repeatability and Intermediate Precision): The study was conducted according to CLSI EP5-A2 requirements using human samples and controls. "n = 84" is mentioned for repeatability. "2 aliquots per run, 2 runs per day, 21 days" for intermediate precision. The document does not specify the country of origin or whether the data was retrospective or prospective.
• Method Comparison to Predicate: Sample size (n) = 105 human serum samples. The document does not specify the country of origin or whether the data was retrospective or prospective.
• Linearity: One batch of reagent, one run, samples measured in triplicate. Two separate dilution series (serum and Li-Heparin plasma) with thirteen levels each. The document does not specify the country of origin or whether the data was retrospective or prospective.
• Detection Limits (LoB, LoD, LoQ):
  • LoB: One analyte-free sample tested in n=5 on two analyzers with three reagent batches for six runs per day across three days.
  • LoD: Five low-analyte samples spiked with acetaminophen measured in singlicate on two analyzers with three reagent batches for six runs per day across three days.
  • LoQ: A low-level sample set of six measured in two aliquots using three reagent batches on one analyzer over at least six days.
    The document does not specify the country of origin or whether the data was retrospective or prospective.
• Analytical Specificity (Cross-Reactivity, Endogenous Substances, Common Drugs): Tested using sample pools (at two target concentrations of acetaminophen) and spiked samples. The specific number of individual samples for each compound/substance is not given, but refers to "two sample pools" or "serum sample pools". The document does not specify the country of origin or whether the data was retrospective or prospective.
• Matrix Comparison: 60 tubes collected per anticoagulant (Lithium-heparin, K2-EDTA, K3-EDTA). This suggests 60 samples for each, so 180 total samples. The document does not specify the country of origin or whether the data was retrospective or prospective.

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)

This product is an in vitro diagnostic test for the quantitative determination of acetaminophen. The "ground truth" for such assays is typically established by reference methods or spiking known concentrations of analyte into samples. The document does not mention the involvement of medical experts (like radiologists) for ground truth establishment, as it's a quantitative chemical assay, not an image-based diagnostic. It uses USP reference standards for traceability, which represents a highly controlled and recognized standard for chemical concentration.

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

Not applicable. Adjudication methods like "2+1" are typically used in studies involving human interpretation (e.g., radiology for diagnostic accuracy) where there might be disagreement among readers, and a third reader is brought in to resolve discrepancies. This document describes the performance of a quantitative chemical assay, where the output is a numerical value.

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 not an AI-assisted diagnostic device, nor does it involve human readers interpreting cases. It is a standalone in vitro diagnostic assay.

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

Yes, this is a standalone device. The entire document describes the performance of the assay itself (cobas c Acetaminophen Gen.2 assay and ACET2 calibrator) on the Roche/Hitachi cobas c 501 analyzer, which processes samples and provides quantitative results without human interpretation or algorithm assistance as part of the primary diagnostic function.

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

The ground truth for this chemical assay is primarily based on:

• Known concentrations of analyte: For linearity, detection limits (LoD, LoQ), cross-reactivity, and interference studies, samples were spiked with known concentrations of acetaminophen or interfering substances.
• Reference Methods / Standards: For traceability, the method has been standardized against USP reference standards.
• Comparative Method: The performance was compared to a legally marketed predicate device (Siemens Emit® tox™ Acetaminophen Assay).

8. The sample size for the training set

This document describes the analytical validation of a chemical assay. The concept of a "training set" is typically associated with machine learning or AI models, where data is used to train an algorithm. This document details the performance testing of the device, not the development of a machine learning model. Therefore, a "training set" in the context of an AI algorithm is not applicable here.

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

As explained above, there is no "training set" in the AI/machine learning sense for this type of in vitro diagnostic device. The analytical characteristics are established through various experiments using samples with known properties or references.

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The Roche Acetaminophen assay is an in vitro test for the quantitative determination of toxic levels of acetaminophen in serum and plasma on Roche COBAS Integra, Roche/ Hitachi and cobas c system analyzers.

The Roche Diagnostics Acetaminophen assays under consideration in this submission are the same assays as were cleared on the COBAS Integra in K991598, Hitachi 917 in K013757 and cobas c501 in K060373 for the quantitative determination of toxic levels of Acetaminophen in human serum and plasma on automated clinical chemistry analyzers. The same reagents are used on all three systems. Acetaminophen is hydrolyzed by an arylacylamidase to yield p-aminophenol and acetate. Subsequently, the p-aminophenol is converted to an indophenol in the presence of o-cresol and a periodate catalyst. The production of indophenol is followed colorimetrically. The change in absorbance is directly proportional to the quantitative drug concentration in the sample.

The acceptance criteria for the Roche Acetaminophen assay are based on demonstrating substantial equivalence to previously cleared predicate devices: Roche COBAS Integra Acetaminophen assay (K991598), Roche/Hitachi Acetaminophen assay (K013757), and cobas c501 Acetaminophen assay (K060373). The study performed by Roche Diagnostics focused on validating the performance of the new Roche Acetaminophen assays on the cobas 8000 Modular Analyzer Series, specifically on the cobas c501 and Hitachi 917 platforms, and confirming similar performance on the COBAS Integra platform.

The study did not explicitly state "acceptance criteria" in terms of numerical thresholds for performance metrics. Instead, it demonstrated equivalence by comparing the analytical characteristics of the new assays with those of the predicate devices. The key performance aspects compared include:

1. Table of Acceptance Criteria (Implied) and Reported Device Performance:

Important Note on Measuring Range and Sensitivity: While the new device's LoB is 1.2 µg/ml for all platforms, the "Measuring range" starts at 15 µg/ml. This is a key difference from the predicate devices which had measuring ranges starting at their respective LDLs (1.2 µg/ml or 0.7 µg/ml). The LoQ (Limit of Quantitation) of 15 µg/ml seems to define the lower end of the measuring range for the new device. Additionally, the new assays performed more extensive bilirubin interference testing (at 15, 30, and 50 µg/ml) compared to the predicates (only at 50 µg/ml).

2. Sample size used for the test set and the data provenance:

• The document does not explicitly state the sample sizes used for the analytical performance studies (e.g., for LoB, LoD, LoQ, measuring range, specificity, or interference testing).
• The document does not specify the data provenance (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This information is not applicable to this type of submission. This is a 510(k) for an in vitro diagnostic (IVD) assay based on chemical/enzymatic reactions. The "ground truth" for an IVD assay's analytical performance (e.g., concentration of acetaminophen) is established through reference methods, certified reference materials, and robust analytical chemistry techniques, not through expert consensus on images or clinical outcomes.

4. Adjudication method for the test set:

• This information is not applicable as it pertains to expert reviews of data, which is not how analytical performance of IVD assays is typically established.

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:

• No, an MRMC comparative effectiveness study was not done. This is an IVD device, not an AI-powered diagnostic system that assists human readers.

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

• Yes, the performance described is the standalone performance of the analytical assay (the "algorithm" here is the chemical reaction and measurement system). There is no "human-in-the-loop" performance being evaluated in the context of this device's function.

7. The type of ground truth used:

• The "ground truth" for the analytical performance of this assay would be established using reference methods (e.g., gas chromatography-mass spectrometry (GC-MS) or high-performance liquid chromatography (HPLC) for acetaminophen quantification) and certified reference materials with known concentrations of acetaminophen. The document doesn't explicitly detail the reference methods used but implies the use of quantitative standards for calibration and evaluation.

8. The sample size for the training set:

• This information is not explicitly stated as it's an analytical assay and not a machine learning algorithm that typically requires a distinct "training set." The development of such assays involves extensive R&D, method optimization, and analytical validation which uses various samples and experiments, but these are not typically referred to as a "training set" in the context of AI/ML.

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

• As above, the concept of a "training set" with established ground truth in the AI/ML sense is not applicable here. The analytical accuracy and precision are established through internal validation studies using known concentrations of analytes and comparison to reference methods, not through human-adjudicated ground truth.

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

Not Found

This document is a 510(k) premarket notification decision letter from the FDA for the ADVIA® Chemistry Acetaminophen Reagent. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way a medical imaging AI device submission would.

Medical device submissions for invitro diagnostic devices like this one focus on demonstrating substantial equivalence to a predicate device, and performance is typically evaluated through analytical validation studies (e.g., accuracy, precision, linearity, interference) rather than clinical studies with "test sets," "ground truth," or "expert readers" as you might find for an imaging AI.

Therefore, I cannot extract the requested information from the provided text because it describes a different type of medical device and regulatory submission.

Specifically, the information you requested would not typically be found in this type of document:

1. A table of acceptance criteria and the reported device performance: This document is the FDA's decision letter, not the submission itself which would contain such tables. Furthermore, for IVD devices, these criteria relate to analytical performance characteristics rather than diagnostic performance metrics like sensitivity/specificity derived from expert readings.
2. Sample size used for the test set and the data provenance: Not applicable in the context of this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a reagent for an automated chemistry analyzer, not an AI algorithm in the sense of imaging analysis.
7. The type of ground truth used: For an acetaminophen assay, "ground truth" would generally be established by highly accurate reference methods or known spiked concentrations, not expert consensus or pathology in this context.
8. The sample size for the training set: Not applicable as it's not an AI/machine learning model in the typical sense that requires a "training set."
9. How the ground truth for the training set was established: Not applicable.

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For the quantitative measurement of acetaminophen in serum and plasma. Measurement of acetaminophen is used in the diagnosis and treatment of acetaminophen overdose toxicity.

For the quantitative measurement of acetaminophen in serum and plasma. Measurement of acetaminophen is used in the diagnosis and treatment of acetaminophen overdose toxicity. Excessive amounts of acetaminophen leads to hepatotoxicity and nephrotoxicity. In acute overdosage, acetaminophen can cause severe hepatic damage leading to hepatic failure if untreated. Reagent is a two-part liquid in plastic bottles packaged in the appropriate box.

Here's a breakdown of the acceptance criteria and study details for the Acetaminophen L3K® Assay, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria are "implied" because the document states "Testing results demonstrate that the Acetaminophen L3K® Assay is equivalent to the predicate device" and focuses on the high correlation coefficients and favorable regression results as proof of this equivalence, rather than explicitly listing numerical thresholds for acceptance. The core of the acceptance criteria for a 510(k) often revolves around demonstrating substantial equivalence to a predicate device, meaning the new device is as safe and effective as a legally marketed device.

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

• Serum Test Set Sample Size: 100 samples
• Plasma Test Set Sample Size: 25 samples
• Data Provenance: Not explicitly stated regarding the country of origin. The submission is from Genzyme Diagnostics P.E.I. Inc. in Canada, so it's likely the data originated there or in a region where they conducted their studies. The data is retrospective as it involves comparing the new device's measurements against an existing "reference method" (presumably the predicate device or a clinical laboratory's established method).

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

• This information is not provided in the given document. For an in vitro diagnostic (IVD) like this, "ground truth" would typically be established by comparing the device's results to a recognized reference method or a method already validated for clinical use, rather than expert consensus on individual cases. The "reference method" is the de facto "ground truth" here.

4. Adjudication Method for the Test Set

• This information is not applicable for this type of IVD performance study. Adjudication methods (like 2+1, 3+1) are typically used in imaging studies or clinical trials where human interpretation or endpoint determination requires consensus among multiple experts. For a quantitative assay, the comparison is directly numerical against a reference method.

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

• No, this was not done. The Acetaminophen L3K® Assay is an in vitro diagnostic device for quantitative measurement, not an AI-assisted diagnostic imaging or interpretation tool. Therefore, MRMC studies and concepts of human reader improvement with AI assistance are not relevant to this submission.

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

• Yes, this was a standalone performance study. The Acetaminophen L3K® Assay is a laboratory assay that produces quantitative results directly. Its performance was evaluated purely on its analytical capabilities (accuracy, correlation) when measuring acetaminophen in samples, without any human-in-the-loop interpretation beyond standard laboratory procedures and result reporting.

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

• The ground truth was established by a "similar acetaminophen method" referred to as the "reference method" in the serum comparison and the "This method (serum)" in the plasma comparison. This implies an existing, validated laboratory method. For IVDs, this is often a widely accepted and validated analytical method or the predicate device itself.

8. The sample size for the training set

• This information is not provided as this is not an AI/ML device that requires a distinct "training set" in the conventional sense. The studies described are validation (test) studies to demonstrate performance. The "training" for such an assay would be its initial development and optimization, which isn't typically detailed in a 510(k) summary for a chemical assay.

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

• This information is not applicable as there is no mention of a "training set" in the context of an AI/ML device. For the development of the assay, standard analytical chemistry principles, method development, and optimization techniques would have been employed to ensure accuracy, but this is distinct from establishing ground truth for machine learning.

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The Diagnostic Chemicals Limited's Acetaminophen-SL Assay is an in vitro diagnostic device intended to measure acetaminophen levels in human serum or plasma (Lithium heparin). Such measurements are used in the diagnosis of acetaminophen toxicity and overdose. This assay consists of two reagents and a calibrator.

This assay consists of two reagents and a calibrator.

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a device called "Acetaminophen-SL Assay". This document primarily focuses on the regulatory approval process, stating that the device is substantially equivalent to legally marketed predicate devices.

The information required to answer your request, such as detailed acceptance criteria, specific study designs, sample sizes for test and training sets, expert qualifications, and detailed performance metrics, is not present within this regulatory letter.

Therefore, I cannot extract the requested information from the provided text.

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

This in-vitro diagnostic method is intended to measure acetaminophen in human serum and plasma using lithium heparin as the anticoagulant on ADVIA® IMS™. Acetaminophen (Tylenol, paracetamol, p-hydroxyacetanilide) is used in many formulations as an analgesic, generally with no adverse effects. Measurement of acetaminophen is used in the diagnosis and treatment of severe liver damage caused by overdose through chronic usage, accident or self-infliction.

Here's an analysis of the provided text to extract the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a formal, enumerated list. However, based on the performance data presented and the conclusion of equivalence to a predicate device, we can infer the implied acceptance criteria were met by showing comparable or better performance in the following areas:

2. Sample Sizes and Data Provenance

• Test Set Sample Sizes:
  • Imprecision (Serum): Not explicitly stated how many samples per level were used for CV calculation, but generally, this involves replicate measurements on multiple samples.
  • Correlation (Serum vs Abbott/TDx): 46 specimens
  • Correlation (Plasma vs Serum on ADVIA IMS): 50 specimens
  • Interfering Substances: A single Acetaminophen concentration was tested for each interferent, but the number of unique samples is not specified.
• Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It implies the studies were conducted by Bayer Corporation for regulatory submission.

3. Number of Experts and Qualifications for Ground Truth

This type of in-vitro diagnostic device (an assay for a chemical compound) typically does not rely on human experts to establish "ground truth" for the test set in the same way imaging devices do. The ground truth for such assays is established through:

• Reference Methods: Highly accurate and precise analytical methods (e.g., GC-MS, HPLC) or certified reference materials are used to assign true values to samples.
• Predicate Device Measurements: For comparison studies, the predicate device itself serves as a "ground truth" for the new device, assuming the predicate device is already validated and accepted.

The document does not mention any human experts or their qualifications for establishing ground truth.

4. Adjudication Method for the Test Set

Not applicable. As described in point 3, this device's performance evaluation does not involve subjective interpretations requiring adjudication by experts. The ground truth for quantitative assays is based on analytical measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This is an in-vitro diagnostic assay for measuring acetaminophen concentrations, not an imaging device or a device requiring human interpretation of results in a diagnostic imaging workflow. Therefore, an MRMC study is not relevant or performed for this type of device.

6. Standalone Performance

Yes, the studies presented (Imprecision, Correlation, Interfering Substances, Analytical Range) represent the standalone performance of the ADVIA IMS Acetaminophen method. The "Correlation" section specifically compares the new device's measurements (Y) against a known comparison system (X), which serves as a benchmark for its standalone accuracy.

7. Type of Ground Truth Used

The ground truth used for this device's evaluation is primarily comparison to a legally marketed predicate device (Abbott/TDx) and likely reference methods or certified materials for establishing the validity of the predicate device and the new device's calibration and analytical range. For the interference study, the "true" acetaminophen concentration would have been precisely known when the interfering substance was added.

8. Sample Size for the Training Set

The document does not provide information about a "training set" or its sample size. For an in-vitro diagnostic assay of this nature, the development process typically involves:

• Method development and optimization.
• Calibration using a set of calibrators (the calibrator part number 04919015 is mentioned).
• Verification and validation studies using various types of samples to assess precision, accuracy, linearity, interference, etc.

There typically isn't a "training set" in the machine learning sense, as this is a chemical assay, not an AI/ML algorithm.

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

Not applicable, as there is no mention of a "training set" in the context of an AI/ML algorithm. The calibration process for the assay would establish its measurement curve, and this would be based on precisely known concentrations of acetaminophen.

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For the quantitative determination of toxic levels of acetaminophen in human serum or plasma on automated clinical chemistry analyzers. Measurements obtained by this device are used in the diagnosis and treatment of acctaminophen overdose.

The Roche Acetaminophen assay contains an in vitro diagnostic reagent system indicated for the quantitative determination of toxic levels of acetaminophen in human serum or plasma on automated clinical chemistry analyzers. The proposed labeling indicates the Roche/Hitachi 911, 912, 917, and Modular P analyzers can be used with the Roche Acetaminophen reagent kits.

Here's an analysis of the provided text regarding the Roche Acetaminophen Assay, focusing on acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for the Roche Acetaminophen Assay. However, it does present performance characteristics for comparison to the predicate device. For the purpose of this response, I will infer the acceptance criteria are implicitly defined by the acceptable performance compared to the predicate and the general requirements for such assays (e.g., adequate precision and method correlation).

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

• Test Set Sample Size:
  • For comparison against the Roche COBAS INTEGRA Acetaminophen assay on the COBAS Integra 700: N = 150
  • For comparison of the predicate device (Roche COBAS INTEGRA Acetaminophen) against the Abbott TDx Acetaminophen assay: N = 87 (This refers to data for the predicate, not the new device's primary test set)
• Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).

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

This information is not applicable to this type of device. The Roche Acetaminophen Assay is an in vitro diagnostic (IVD) quantitative assay. Its "truth" is established by comparing its measurements to a reference method (the predicate device) or a gold standard method, not by expert interpretation.

4. Adjudication Method for the Test Set

This is not applicable as there is no human interpretation or subjective assessment involved that would require adjudication for this IVD assay. The comparison is based on quantitative analytical results.

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

This is not applicable. The Roche Acetaminophen Assay is an IVD device for quantitative chemical analysis, not an AI-assisted diagnostic imaging or classification tool that would involve human "readers."

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

The performance of the Roche Acetaminophen Assay, as described, is inherently a "standalone" performance in the context of an IVD. It generates a quantitative result without human intervention in the analytical process. The study described (method comparison) assesses this standalone analytical performance against a known method.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluation was established by comparing the results of the new Roche Acetaminophen Assay against a predicate device (Roche COBAS INTEGRA Acetaminophen Assay), which is itself an already validated and legally marketed device. In essence, the predicate serves as the reference method or "gold standard" for this comparative study.

8. The Sample Size for the Training Set

This information is not provided as there is no mention of a "training set" in the context of this chemical assay. Chemical assays are developed and validated through analytical studies, not typically machine learning training protocols.

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

This is not applicable as there is no training set described for this type of device.

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