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Coamatic® Heparin is an in vitro diagnostic test for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human citrated plasma using automated and microplate methods. The amount of UFH or LMWH is determined from the anti-FXa activity expressed by the [AT*Heparin] complex formed in plasma.

Device Description

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Coamatic® Heparin device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical targets in the provided document. Instead, the study aims to demonstrate "substantial equivalence in its performance" to the predicate device (IL Test™ Heparin). This is primarily assessed through correlation studies, where a slope close to 1, an intercept close to 0, and a high correlation coefficient (r) indicate substantial equivalence. Precision is also evaluated using %CV.

Therefore, the acceptance criteria are inferred from what constitutes "substantially equivalent performance" in such comparative studies.

Performance Metric	Acceptance Criteria (Inferred)	Reported Device Performance
Comparative Studies (vs. Predicate IL Test™ Heparin)
Slope	Close to 1.00 (e.g., 0.90 to 1.10)	Range: 0.91 to 1.04
Intercept	Close to 0.00 (e.g., -0.10 to 0.10)	Range: -0.01 to 0.06
Correlation (r)	High (e.g., ≥ 0.95)	Range: 0.97 to 0.99
Precision (Microplate Method)
Within Run %CV (UFH)	Low (e.g., < 5%)	2.8%, 3.4%
Between Run %CV (UFH)	Low (e.g., < 5%)	1.2%, 1.5%
Total %CV (UFH)	Low (e.g., < 5%)	2.8%, 3.7%
Within Run %CV (LMWH)	Low (e.g., < 5%)	3.6%, 2.4%
Between Run %CV (LMWH)	Low (e.g., < 5%)	2.8%, 2.3%
Total %CV (LMWH)	Low (e.g., < 5%)	4.4%, 3.2%

Note: The exact numerical acceptance criteria (e.g., specific ranges for slope, intercept, and r) are not explicitly stated but are common expectations for demonstrating substantial equivalence for such devices. The reported performance consistently falls within generally accepted ranges for good correlation and precision in clinical assays.

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

The "test set" in this context refers to the samples used in the comparative studies against the predicate device and the precision studies.

Comparative Studies (against IL Test™ Heparin):
- Patient Samples (UFH and LMWH treated):
  - Cobas Mira: 87 samples
  - Microplate: 70 samples
  - ACL 300: 62 samples
  - ACL Futura: 113 samples
  - MLA Electra: 80 samples
- Normal Plasmas and Pooled Plasmas Spiked with UFH:
  - Sysmex 6000: 30 samples
  - AMAX: 30 samples
  - Hitachi 911: 30 samples
  - Hitachi 917: 30 samples
Precision Data (Microplate Method):
- The sample size for the precision studies is not explicitly stated as a number of individual patient samples. The %CVs are reported at specific mean concentrations (0.7 IU/mL UFH, 0.4 IU/mL UFH, 0.7 IU/mL LMWH, 0.4 IU/mL LMWH), implying replicate measurements were performed to determine within-run, between-run, and total precision. The "n" in the comparative table refers to the number of samples compared across methods, not necessarily the number of replicates for precision.
Data Provenance: The document does not specify the country of origin of the data. It states samples were from "patients treated with UFH and LMWH" and "normal plasmas and pooled plasmas spiked with UHF heparin," implying these were likely clinical or laboratory samples. The study appears to be retrospective in the sense that existing samples (from patients or prepared in a lab) were used, rather than prospectively enrolling and following patients solely for this study.

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

This type of device (in vitro diagnostic for quantitative determination of substances) does not typically involve human expert "ground truth" establishment in the same way an image analysis AI might.

Number of Experts: Not applicable.
Qualifications of Experts: Not applicable.

For quantitative assays like this, the "ground truth" is established by a reference method or a predicate device. In this study, the predicate device, IL Test™ Heparin, run on an ACL 300, served as the de facto reference standard against which the new Coamatic® Heparin device was compared. The performance of the predicate device itself would have been validated against an even more fundamental reference method or through extensive clinical use.

4. Adjudication Method for the Test Set

Not applicable. This is a quantitative laboratory assay for which adjudication by experts is not a standard practice. The "result" is the numerical concentration reported by the instrument. Discrepancies would be resolved through re-testing, calibration checks, or investigation of assay interference, not through expert consensus.

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

No, an MRMC comparative effectiveness study was not done. These studies are typically relevant for diagnostic imaging or pathology, where human readers interpret and classify cases. This device is an in vitro diagnostic assay that produces a quantitative numerical output, not an image or case requiring human interpretation in the same way.

6. Standalone (Algorithm Only) Performance

Yes, the studies presented in the "Summary of Performance Data" are essentially standalone performance studies for the Coamatic® Heparin device. The device is a laboratory assay kit which, when run on various automated analyzers (e.g., Cobas Mira, Microplate, ACL 300, ACL Futura, MLA Electra, Sysmex 6000, AMAX, Hitachi 911, Hitachi 917), produces quantitative results. The performance metrics (slope, intercept, correlation against the predicate, and precision) represent the device's inherent capability to measure heparin directly. There is no human-in-the-loop component being evaluated in these specific performance summaries.

7. Type of Ground Truth Used

The ground truth used for the comparative studies was the measurements obtained from the predicate device, IL Test™ Heparin, particularly when run on an ACL 300. This approach is standard for demonstrating substantial equivalence for new in vitro diagnostic devices against already-cleared predicate devices. For precision, the ground truth is statistical variation around a known concentration of analyte.

8. Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning or algorithm development. This device is a biochemical assay kit, not an AI/ML algorithm that requires training data in that sense. The methods are established based on known chemical reactions and principles.

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

Not applicable, as there is no mention of a machine learning "training set" for this device. The principles of the assay are based on established scientific understanding of Factor Xa inactivation using a synthetic chromogenic substrate.

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