(33 days)
Coamatic® AT-400 is intended for the quantitative determination of the heparin cofactor activity of antithrombin (AT) in human citrated plasma.
Coamatic® AT-400 is intended for the quantitative determination of the heparin cofactor activity of antithrombin (AT) in human citrated plasma.
Antithrombin is the most important natural inhibitor of the coagulation cascade. Bv inhibiting the coagulation proteases, especially thrombin, factor Xa and factor IXa, antithrombin prevents uncontrolled coagulation and thrombosis. Plasma is incubated with an excess of Factor Xa (FXa) in the presence of heparin. The residual activity of FXa is determined by the rate of hydrolysis of the chromogenic substrate S-2772. The pNA release measured at 405 nm is inversely proportional to the AT level in the range 10-125% of normal plasma.
Here's an analysis of the Coamatic® AT-400 device's acceptance criteria and the supporting study, based on the provided text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Metric | Predicate Device Performance / Target | Coamatic® AT-400 Performance |
|---|---|---|---|
| Method Comparison | Slope | Not explicitly stated as a target, but predicate device served as comparison. | 0.9810 |
| Intercept | Not explicitly stated as a target, but predicate device served as comparison. | 4.9773 | |
| Correlation (r) | A high correlation (close to 1) indicates substantial equivalence. | 0.995 | |
| Precision | CV% (Within run) | No explicit target stated. | 1.80% (113% AT) |
| 2.64% (59% AT) | |||
| 4.52% (31% AT) | |||
| CV% (Total) | No explicit target stated. | 2.81% (113% AT) | |
| 3.23% (59% AT) | |||
| 4.76% (31% AT) |
Note: The document states that "Coamatic® AT-400 is substantially equivalent in performance to the predicate device: IL Test™ Antithrombin." While specific numerical acceptance targets are not explicitly listed for each metric, the reported performance (high correlation, low CV%) demonstrates this substantial equivalence.
Study Details
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Sample Size used for the test set and the data provenance:
- Sample Size: 61 citrated plasma samples.
- Data Provenance: Not specified (e.g., country of origin). The study involved "citrated plasma samples," which are human biological specimens. There is no indication of whether the data was retrospective or prospective.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable as the study involves a quantitative laboratory assay comparison, not an interpretative task requiring human expert adjudication for ground truth. The "ground truth" for the method comparison was established by the predicate device's measurement.
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Adjudication method for the test set:
- Not applicable for this type of quantitative assay comparison. The comparison was based on direct numerical results from two different devices/methods.
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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 conducted. This device is a quantitative in vitro diagnostic (IVD) assay, not an AI-assisted diagnostic imaging or interpretative tool that would involve human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, this study represents a standalone performance evaluation of the Coamatic® AT-400 device (an automated in vitro diagnostic assay). Its performance was compared directly against a predicate device without human interpretation or intervention in the measurement process beyond standard laboratory operating procedures.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the method comparison study was established by the results from the predicate device, IL Test™ Antithrombin on ACL 9000. For precision, the control plasma levels served as references.
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The sample size for the training set:
- Not applicable. This is a 510(k) summary for a traditional in vitro diagnostic device, not a machine learning or AI-driven algorithm. There is no concept of a "training set" in the context of this device's development as described.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.
§ 864.7060 Antithrombin III assay.
(a)
Identification. An antithrombin III assay is a device that is used to determine the plasma level of antithrombin III (a substance which acts with the anticoagulant heparin to prevent coagulation). This determination is used to monitor the administration of heparin in the treatment of thrombosis. The determination may also be used in the diagnosis of thrombophilia (a congenital deficiency of antithrombin III).(b)
Classification. Class II (performance standards).