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The CoaguChek Pro APTT test is for the quantitative determination of the activated partical thromboplastin time (APTT) of freshly drawn whole blood. It is intended for health care professional use only.

The APTT is used to evaluate intrinsic pathway function. The APTT is sensitive to deficiencies of factors VIII, IX, XI, and XII, prekallikrein, high molecular weight kinogen, as well as common pathway factors (II, V, X, and fibrinogen). The APTT is useful as a screening test for coagulation function, since it is sensitive to all coagulation factors except VII, platelet factor III and calcium. Additionally, the APTT is used to monitor the effectiveness of heparin therapy. Many diseases and drugs can prolong or prevent coagulation by altering the balance of clotting factors involved in coagulation. The APTT test is initiated by inserting a CoaguChek Pro APTT test cartridge into the instrument. The instrument reads a code on the test cartridge to determine test identity and lot number. The test cartridge contains a sample application well, a reagent chamber, and a reaction path. After the instrument heats the test cartridge, a drop of fresh, whole blood is placed on the test cartridge sample application well. Blood is drawn into the reagent chamber by capillary action, where it mixes with the reagent to initiate coagulation. The blood sample moves along the reaction path until a clot forms. The laser optical system detects the clot by monitoring blood flow; endpoint is reached when the blood stops moving. The time from sample application to clot detection is the APTT. The displayed result is equivalent to laboratory plasma APTT results. Because each newly-manufactured lot is calibrated to an internal reference lot, any lot-to-lot variability between reagents is corrected electronically using information coded on the lot-specific code key.

The medical device in question is the CoaguChek Pro System, APTT Test and Controls.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The provided document does not explicitly state "acceptance criteria" but rather presents a comparison of performance characteristics between the new device (CoaguChek Pro) and its predicate (CoaguChek Plus). The implication is that the CoaguChek Pro's performance characteristics demonstrate substantial equivalence to the predicate device, thereby meeting the necessary criteria for market entry. The study aims to show that the CoaguChek Pro's performance is comparable to or acceptable relative to the already marketed CoaguChek Plus system.

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

The sample sizes for the accuracy study (which serves as the "test set" for this type of device comparison) are:

• Site 1: n = 55
• Site 2: n = 54
• Site 3: n = 45

The total number of samples for the accuracy study in the CoaguChek Pro is 55 + 54 + 45 = 154 samples.

The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. However, given the nature of a 510(k) submission for a diagnostic device, these studies are typically prospective clinical performance evaluations conducted in a controlled environment, likely in the United States, by the manufacturer or affiliated research sites.

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

This type of in vitro diagnostic device (APTT test) typically uses a laboratory reference method or a legally marketed predicate device's results as the "ground truth" for comparison, rather than expert interpretation of images or clinical findings.

The document states: "The displayed result is equivalent to laboratory plasma APTT results." and "Test results for both methods were originally calibrated to laboratory plasma method." This indicates that the ground truth for the reported accuracy data would be a standard laboratory plasma APTT method.

Therefore, the concept of "experts" in the sense of clinicians or radiologists establishing ground truth is not directly applicable here. The ground truth is established by the highly controlled and validated laboratory reference methods for APTT, which are operated by trained laboratory professionals. The document does not specify the number or qualifications of the lab personnel operating the reference method.

4. Adjudication method for the test set

No adjudication method is mentioned. For an in vitro diagnostic device comparing its results to a laboratory reference method, an adjudication process involving multiple human readers or experts is generally not relevant. The comparison is typically a direct quantitative assessment (e.g., correlation and regression analysis) between the device's numerical output and the reference method's numerical output.

5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and 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 document describes an in vitro diagnostic device for measuring Activated Partial Thromboplastin Time (APTT) in whole blood, not an AI-assisted diagnostic imaging or clinical decision support system. Therefore, the concept of human readers improving with AI assistance is not applicable. The device provides a quantitative measurement directly.

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

Yes, the performance presented is standalone/algorithm-only.

The CoaguChek Pro System provides a direct, quantitative measurement of APTT. The performance characteristics (Mean Normal, Assay Range, Factor Sensitivity, Hematocrit Range, Precision, Accuracy) describe the device's inherent analytical performance without direct human interpretation of the result in the clinical decision-making process for the purpose of the measurement itself. Healthcare professionals use the results provided by the device, but the device's detection of clot formation and calculation of APTT is an automated, standalone function.

7. The type of ground truth used

The ground truth used for performance validation is the laboratory plasma APTT method. The document explicitly states: "The displayed result is equivalent to laboratory plasma APTT results. Because each newly-manufactured lot is calibrated to an internal reference lot, any lot-to-lot variability between reagents is corrected electronically using information coded on the lot-specific code key." And "Test results for both methods [CoaguChek Pro and CoaguChek Plus] were originally calibrated to laboratory plasma method."

8. The sample size for the training set

The document does not explicitly specify a "training set" sample size. For an in vitro diagnostic device like this, the "training" equivalent would be the development and calibration of the instrument and reagents. While there's no mention of a traditional machine learning "training set," the device's internal reference lots and calibration processes are essentially what "train" the system to provide accurate results. The "Accuracy" and "Precision" data presented are considered the validation or test data, comparing the device's performance to the predicate and/or reference method.

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

As noted above, the concept of a "training set" in the context of this device is analogous to its development and calibration. The ground truth for this process, as indicated by the text, is the laboratory plasma APTT method. The device's results are intended to be "equivalent to laboratory plasma APTT results" and were "originally calibrated to laboratory plasma method." This implies that the standard laboratory method was used as the reference to establish the correct readings and ensure lot-to-lot variability is corrected electronically.

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The Elecsys® Red Blood Cell Folate Lysing Reagent is to be used in combination with the Elecsys® Folate Assay for the quantitation of folate in human red blood cells. The electrochemiluminescence assay "ECLIA" is intended for use on the Boehringer Mannheim Elecsys 2010 immunoassay analyzer.

The Elecsys® test principle is based on the competitive principle. Total duration of assay: 90 +- 15 minutes. Reconstitution Step: Add contents of the ascorbic acid packet to 100 mL distilled or deionized water. Pretreatment Step: By incubating the sample (15 μl) with the folate pretreatment 1 (15 μl) and pretreatment 2 (10 μl), bound folate is liberated into the serum. Proceed to conduct the Elecsys® Folate Assay (K973674) as per insert instructions.

The provided text does not contain detailed acceptance criteria or a study that explicitly proves the device meets specific performance criteria beyond general statements about evaluation of assay precision, demonstration of linearity, and correlation with a predicate device. The document primarily focuses on regulatory approval and equivalence to a predicate device.

However, based on the information provided, we can infer some details related to the study conducted.

Here's an attempt to structure the information based on your request, with significant caveats that much of the detailed information you asked for is not present in the provided text.

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

2. Sample sized used for the test set and the data provenance

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified (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

Not specified. The context suggests a laboratory assay, so "experts" in the clinical interpretation sense might not be directly applicable for establishing ground truth for the raw assay results themselves, but rather for clinical validation or interpretation of results.

4. Adjudication method for the test set

Not specified.

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 (IVD) assay, not an AI-assisted diagnostic imaging device requiring human reader comparison.

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

Yes, in a sense. This is an IVD assay. Its performance is evaluated as a standalone system (reagent + analyzer) that produces a quantitative result without a "human-in-the-loop" step in generating the primary measurement. The "study" here refers to the analytical performance of the assay itself.

7. The type of ground truth used

For an IVD assay like this, the "ground truth" for assay performance evaluation is typically established through:

• Reference Methods: Using established, highly accurate analytical methods to determine true folate concentrations in samples.
• Known Concentration Samples: Using samples with accurately known concentrations of the analyte (e.g., spiked samples, certified reference materials).
• Clinical Samples with Clinical Diagnosis: For correlation studies, comparing assay results to a clinical diagnosis (though the document only mentions correlation with the predicate device, not directly with patient outcomes).
• Predicate Device Comparison: The document explicitly mentions "correlation with the predicate device," implying the predicate device's results serve as a comparative "ground truth" or standard.

8. The sample size for the training set

Not applicable in the context of traditional machine learning "training sets" as this is a chemical assay, not an AI algorithm. The assay itself doesn't have a "training set" in that sense. However, the development and optimization of the assay would involve various experiments and sample analyses, but these are not referred to as a "training set."

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

Not applicable.

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The Roche Diagnostics, Boehringer Mannheim Liquid Total Bilirubin reagent is intended for use for the quantitative determination of total bilirubin in serum and plasma of adults and neonates. It is for use on automated clinical chemistry analyzers.

According to the Code of Federal Regulations, Title 21 (Food and Drugs), Part 862.1110, a bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasma or serum. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal distruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder block.

Total bilirubin, in the presence of a suitable solubilizing agent, is coupled with a diazonium ion in a strongly acid medium (ph 1 - 2).

Bilirubin + diazonium ion acid -> Azobilirubin

The intensity of the color of the azobilirubin formed is proportional to the total bilirubin concentration and can be measured photometrically.

The provided document describes a 510(k) premarket notification for the "Roche Diagnostics, Boehringer Mannheim Liquid Total Bilirubin Reagent." This is an in vitro diagnostic device, and the evaluation focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel AI algorithm. Therefore, many of the typical acceptance criteria and study aspects related to AI/ML devices do not directly apply.

However, I can extract the relevant performance characteristics and details provided for this type of device:

1. Table of Acceptance Criteria and Reported Device Performance

For an in vitro diagnostic such as a reagent, "acceptance criteria" are typically related to analytical performance characteristics like accuracy, precision, linearity, and correlation with a predicate device. The document primarily focuses on demonstrating that the new liquid reagent performs similarly to the predicate device.

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

The 510(k) Summary document does not explicitly state the sample size used for performance testing (e.g., patient samples for method comparison or clinical studies) nor the data provenance (e.g., country of origin, retrospective/prospective). It refers to "Specific data on the performance of the system [that have] been incorporated into the draft labeling in Section V of this submission," which is not included in the provided text.

For this type of IVD, performance data would typically involve:

• Method comparison studies: Comparing results from the new device to the predicate device using a range of patient samples.
• Precision studies: Assessing within-run, between-run, and total precision.
• Linearity studies: Verifying the analytical measurement range.
• Interference studies: Testing for substances that might affect results.

Without the "Section V" labeling, these specific details are unavailable.

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

This document describes a diagnostic reagent, not an AI/ML algorithm. Therefore, "ground truth" for the test set is established through analytical methods and comparison to a legally marketed predicate device (and often to reference methods if available), not by human expert opinion or consensus in the context of imaging or clinical interpretation.

4. Adjudication Method for the Test Set

Not applicable in the context of an IVD reagent's analytical performance.

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 IVD reagent, not an AI-assisted diagnostic tool for human readers.

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

This refers to an IVD reagent, which inherently operates "standalone" in the sense that it measures a specific analyte. Its performance is evaluated against analytical standards and predicate devices, not as an "algorithm only" in the AI sense.

7. The Type of Ground Truth Used

For this IVD reagent, the "ground truth" for its performance evaluation would primarily be:

• Results from the legally marketed predicate device: The new device's measurements are compared to those obtained from the predicate to demonstrate substantial equivalence.
• Reference methods (if applicable and used in internal studies): Highly accurate, often more complex, methods used to determine true analyte concentrations.
• Known concentrations in control materials: Used for precision, linearity, and calibration verification.

8. The Sample Size for the Training Set

Not applicable in the context of a chemical reagent and its analytical evaluation. This is not an AI/ML device that uses a "training set."

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

Not applicable, as there is no "training set" for an AI/ML algorithm in this submission.

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