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ACTICHROME® Heparin (anti-fila) is a chromogenic assay intended for the quantitative determination of therapeutic heparin in human plasma by measurement of factor IIa (thrombin) inhibition. The Electra 900C® was used to determine performance data. This kit is for in vitro diagnostic use.

ACTICHROME® Heparin (anti-fIIa) Product No. 820

The provided text describes a 510(k) summary for the ACTICHROME® Heparin (anti-fIIa) assay. It focuses on demonstrating substantial equivalence to a predicate device, primarily through method comparison and precision studies.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a numerical or categorical format for demonstrating substantial equivalence. Instead, it relies on a strong "positive correlation" with the predicate device and acceptable precision (CV%).

Study Proving Device Meets Criteria:

The studies described in the "Summary of Performance Data" are intended to prove the device meets these (implied) substantial equivalence criteria. These include:

• Method Comparison Study: Compared the ACTICHROME Heparin (anti-fIIa) assay results against the predicate device (Spectrolyse® Heparin (anti-IIa)).
• Precision Studies: Evaluated intra-assay and inter-assay variability using control samples.

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

• Method Comparison Test Set:

  • Sample Sizes: 88 samples (first regression) and 32 samples (second regression). It's unclear if these are independent sets or subsets.
  • Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It refers to "human plasma," which implies the samples were derived from human subjects. The fact that the studies were performed as part of a 510(k) submission prior to market launch suggests they were prospective in nature for validation purposes.

• Precision Test Set:

  • Hepanorm Controls: N=80 per control (for intra-assay and inter-assay with 20 runs).
  • Spiked Plasma Controls: N=40 per control (for intra-assay and inter-assay with 10 runs).
  • Data Provenance: Not explicitly stated regarding country of origin or retrospective/prospective. Given the nature of precision studies for assay validation, these would typically be performed prospectively in a laboratory setting.

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

Not applicable. This device is an in vitro diagnostic (IVD) assay for quantitative determination. The "ground truth" for method comparison is the measurement obtained from the predicate device, and for precision, it's the statistical variation around the measured value of control samples. There are no human experts involved in establishing a "ground truth" in the way radiologists or pathologists establish it for imaging or histology.

4. Adjudication Method for the Test Set:

Not applicable. As noted above, this is an IVD assay, not a device requiring human interpretation adjudicated by experts. The "adjudication" is based on the comparison of quantitative results.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done:

No, an MRMC comparative effectiveness study was not done. This type of study is typically conducted for diagnostic imaging or screening devices where human readers interpret results, and the impact of an AI algorithm on their performance is evaluated. The ACTICHROME Heparin (anti-fIIa) assay is a laboratory-based quantitative measurement device.

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

Yes, the studies presented are essentially "standalone" performance evaluations of the ACTICHROME Heparin (anti-fIIa) assay. The performance data (method comparison, precision) reflects the assay's output directly, without a human in the loop interpreting the result to reach a diagnosis or making a decision. The Electra 900C® (an analyzer) was used to determine the performance data, indicating automated measurement.

7. The Type of Ground Truth Used:

• For Method Comparison: The "ground truth" for comparison was the results obtained from the predicate device, Spectrolyse® Heparin (anti-IIa). This is a form of reference method comparison.
• For Precision: The "ground truth" implicitly used for evaluating precision are the expected values and inherent variability of the control samples themselves.

8. The Sample Size for the Training Set:

Not applicable. This document describes an IVD assay that is likely based on established chromogenic assay principles, rather than a machine learning model that requires a "training set" in the computational sense. The "development" of the assay likely involved optimizing reagents and protocols, but not training an algorithm on a 'dataset'.

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

Not applicable, as there is no "training set" in the context of a machine learning algorithm. The development of the assay would have involved standard chemical and biological assay development practices, not machine learning ground truth establishment.

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