(46 days)
HemosIL Low Abnormal Control ASSAYED is intended for the quality control of coagulation assays in the low abnormal range on IL Coagulation and ELECTRA™ Systems. The Low Abnormal Control is prepared from human citrated plasma from healthy donors (not heparinized plasma or plasma samples under oral anticoagulant therapy) and modified to simulate an abnormal coagulation sample.
Values for all analytes are in the low abnormal range.
HemosIL Low Abnormal Control ASSAYED is intended for the quality control of coagulation assays in the low abnormal range on IL Coagulation and ELECTRA™ Systems. The Low Abnormal Control is prepared from human citrated plasma from healthy donors (not heparinized plasma or plasma samples under oral anticoagulant therapy) and modified to simulate an abnormal coagulation sample.
The provided text describes the performance of a medical device called "HemosIL Low Abnormal Control ASSAYED," a quality control product for coagulation assays. The study aims to demonstrate that this new device is substantially equivalent to existing predicate devices.
Acceptance Criteria and Reported Device Performance:
The acceptance criteria for this device are implicitly tied to the performance of predicate devices, which are already legally marketed. The study evaluates the precision of the HemosIL Low Abnormal Control ASSAYED. The reported device performance is presented in the table below:
| Analyte | Acceptance Criteria (Implied by equivalence to predicate devices) | Reported Device Performance (Within-Run %CV) |
|---|---|---|
| Activated Partial Thromboplastin (APTT) (Seconds) | Not explicitly stated, but expected to be comparable to or better than predicate devices | 1.84% |
| Antithrombin (% Activity) | Not explicitly stated, but expected to be comparable to or better than predicate devices | 5.60% |
| Protein C (% Activity) | Not explicitly stated, but expected to be comparable to or better than predicate devices | 5.96% |
| Protein S (% Activity) | Not explicitly stated, but expected to be comparable to or better than predicate devices | 2.31% |
| Prothrombin Time (PT)* (Seconds) | Not explicitly stated, but expected to be comparable to or better than predicate devices | 1.15% |
| Thrombin Time (Seconds) | Not explicitly stated, but expected to be comparable to or better than predicate devices | 4.00% |
Study Details:
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Sample sizes used for the test set and the data provenance:
- Sample Sizes:
- Activated Partial Thromboplastin (APTT): n=80
- Antithrombin: n=80
- Protein C: n=80
- Protein S: n=40
- Prothrombin Time (PT): n=80
- Thrombin Time: n=80
- Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective/prospective). The control itself is prepared from "human citrated plasma from healthy donors."
- Sample Sizes:
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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 study is a precision study for a quality control device, not a diagnostic device requiring expert interpretation of results. The "truth" is the expected performance of a control material.
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Adjudication method for the test set: Not applicable. This is a precision study for a quality control, not a diagnostic study requiring adjudication.
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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: Not applicable. This is a quality control device, not an AI-powered diagnostic tool involving human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The study evaluates the standalone performance of the HemosIL Low Abnormal Control as a product. There isn't an "algorithm" in the typical sense for this type of device; rather, it's about the analytical performance of the control material itself when used with "IL Coagulation and ELECTRA™ Systems."
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device is its expected value range for each analyte (i.e., its "low abnormal range") and its consistency (precision). This is established through laboratory measurement and characterization, not expert consensus, pathology, or outcomes data in the context of human diagnosis. The control is physically manufactured to simulate an abnormal sample.
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The sample size for the training set: Not applicable. This is not a machine learning model, so there is no training set. The device is a physical quality control material.
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How the ground truth for the training set was established: Not applicable, as there is no training set. The characteristics of the control material (mean and precision) are determined through experimental testing.
§ 864.5425 Multipurpose system for in vitro coagulation studies.
(a)
Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.(b)
Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.