(105 days)
IL Test™ Plasmin Inhibitor is an in vitro diagnostic test for the quantitative determination of plasmin inhibitor in human citrated plasma based on a synthetic chromogenic substrate and plasma inactivation. Plasmin inhibitor, the major fast acting inhibitor of the fibrinolytic system, also known as a -- antiplasmin is an important regulator of the fibrinolytic system. Congenital deficiencies are associated with haemorragic problems. Decreased levels of plasmin inhibitor are observed in liver diseases and DIC. Increased levels have been reported during post-operative episodes.
IL Test™ Plasmin Inhibitor is an in vitro diagnostic test for the quantitative determination of plasmin inhibitor in human citrated plasma based on a synthetic chromogenic substrate and plasma inactivation. Plasmin inhibitor, the major fast acting inhibitor of the fibrinolytic system, also known as a -- antiplasmin is an important regulator of the fibrinolytic system. Congenital deficiencies are associated with haemorragic problems. Decreased levels of plasmin inhibitor are observed in liver diseases and DIC. Increased levels have been reported during post-operative episodes.
Here's an analysis of the provided text regarding the IL Test™ Plasmin Inhibitor, focusing on the acceptance criteria and study details:
This document is a 510(k) summary for a new in vitro diagnostic device, the IL Test™ Plasmin Inhibitor, seeking substantial equivalence to a predicate device. The primary study described is a method comparison study.
Acceptance Criteria and Device Performance
Based on the provided text, the acceptance criteria are implicitly derived from the comparison to the predicate device. The performance is assessed by correlation and precision.
| Acceptance Criteria Category | Specific Metric | Acceptance Threshold (Implicit) | Reported Device Performance |
|---|---|---|---|
| Method Comparison | Correlation (r) | High correlation to predicate | ACL 300: 0.987 (n=46) |
| ACL Futura: 0.996 (n=51) | |||
| Precision (Within-Run) | CV (%) | Low CV | ACL 300: 2.7% (46.6% mean) |
| ACL 300: 1.3% (95.4% mean) | |||
| ACL Futura: 4.4% (51.9% mean) | |||
| ACL Futura: 2.7% (96.8% mean) |
Note on Acceptance Thresholds: The document states that the new device "is substantially equivalent in performance" to the predicate. Therefore, the reported high correlation values (0.987 and 0.996) and the low CVs are considered to meet this implicit acceptance criterion of comparable performance. There are no explicit numerical thresholds given as "acceptance criteria" in this summary.
Study Details
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Sample sizes used for the test set and the data provenance:
- ACL 300 comparison: n = 46 plasma samples (normal and abnormal)
- ACL Futura comparison: n = 51 plasma samples
- Precision (ACL 300): Not explicitly stated, but "2 levels of plasma" were used over "multiple runs."
- Precision (ACL Futura): Not explicitly stated, but "2 levels of plasma" were used over "multiple runs."
- Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective/prospective). It mentions "normal and abnormal plasma samples," implying collection from human subjects.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is an in vitro diagnostic test for quantitative determination, and the study involves method comparison against a predicate device and precision assessment. Ground truth in the sense of expert consensus on qualitative interpretation is not relevant here. The "ground truth" for the method comparison is effectively the results generated by the predicate device.
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Adjudication method for the test set:
- Not applicable. See point 2. No adjudication process for expert opinions or interpretations is mentioned or required for this type of quantitative comparison study.
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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. This is not an MRMC study. This device is an automated in vitro diagnostic test, not an AI-assisted diagnostic tool for human readers.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in essence. The performance data presented for correlation and precision are purely instrumental/algorithm-based, comparing the new device's output to the predicate device's output, and assessing its internal consistency. There is no human intervention in the result generation itself, beyond operating the instrument.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the method comparison study is the results obtained from the predicate device (IL Test™ α2-Antiplasmin K920012/B). For the precision study, the ground truth is statistical consistency over repeated measurements. There is no external "gold standard" pathology or outcomes data mentioned for establishing truth in these particular performance studies.
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The sample size for the training set:
- Not applicable / Not specified. This document describes a traditional in vitro diagnostic device, not one based on machine learning or AI that would typically involve a separate "training set." The study focuses on validation using test samples.
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How the ground truth for the training set was established:
- Not applicable. No training set, as per point 7.
§ 864.7290 Factor deficiency test.
(a)
Identification. A factor deficiency test is a device used to diagnose specific coagulation defects, to monitor certain types of therapy, to detect coagulation inhibitors, and to detect a carrier state (a person carrying both a recessive gene for a coagulation factor deficiency such as hemophilia and the corresponding normal gene).(b)
Classification. Class II (performance standards).