(62 days)
IL Test™ APTT-SP is intended for the in vitro diagnostic determination of Activated Partial Thromboplastin Time (APTT) in citrated plasma on IL Coagulation Systems as a general screening procedure for the evaluation of the intrinsic coagulation pathway and to monitor patients receiving heparin anticoagulant therapy.
IL Test™ APTT-SP is intended for the in vitro diagnostic determination of Activated Partial Thromboplastin Time (APTT) in citrated plasma on IL Coagulation Systems.
Here's a breakdown of the acceptance criteria and study information for the IL Test™ APTT-SP device, based on the provided text:
Acceptance Criteria and Device Performance
| Metric | Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance |
|---|---|---|
| Correlation (r) | Substantially equivalent to predicate IL Test™ APTT-C | ACL 300: 0.915 vs. predicate |
| ACL Futura: 0.907 vs. predicate | ||
| Within-run Precision (CV) | Substantially equivalent to predicate IL Test™ APTT-C | ACL 300: 0.65% (mean 27.27s), 0.89% (mean 52.05s), 1.32% (mean 74.65s) |
| ACL Futura: 0.65% (mean 27.50s), 0.84% (mean 50.89s), 0.93% (mean 72.38s) |
Note: The text explicitly states that "IL Test™ APTT-SP...is substantially equivalent in performance, intended use, and safety and effectiveness" to the predicate device. Therefore, the acceptance criteria are implicitly defined by demonstrating this substantial equivalence through the reported performance metrics. No specific numerical thresholds for acceptance were provided in the document beyond achieving correlation and precision comparable to the predicate.
Study Details
2. Sample size used for the test set and the data provenance:
- Sample Size: 73 plasma samples (50 abnormal / 23 normal).
- Data Provenance: Not explicitly stated, but clinical samples are generally used for this type of test. Whether it was retrospective or prospective is not mentioned. Given the context of a 510(k) summary, it's highly likely to be retrospective analysis of existing samples. The country of origin is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. For in vitro diagnostic devices like APTT tests, the "ground truth" for the test set is typically established by the result from the predicate device (APTT-C in this case) or a reference method. It does not commonly involve human expert interpretation in the same way as, for example, image-based diagnostic AI.
4. Adjudication method for the test set:
- This information is not applicable/provided. The study described is a method comparison study between the new device and a predicate device. Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation or subjective assessment where consensus building is required, which is not the case for an automated diagnostic test like APTT.
5. 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 done. This type of study is specifically designed for AI systems that assist human readers in tasks like medical image interpretation. The IL Test™ APTT-SP is an in vitro diagnostic assay, not an AI-assisted human reading device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the performance reported is essentially a standalone performance. The IL Test™ APTT-SP is an automated diagnostic test run on coagulation systems (ACL 300 and ACL Futura). The reported correlation and precision values reflect the stand-alone performance of the device itself (reagent + instrument) in measuring APTT, without human interpretation influencing the result.
7. The type of ground truth used:
- Predicate device results: The ground truth for this method comparison study was established by the results obtained from the predicate device, IL Test™ APTT-C. The new device's performance was evaluated against the measurements of the established predicate.
8. The sample size for the training set:
- The document does not mention a training set. This type of 510(k) submission for a diagnostic assay typically focuses on validation data (the "test set" described), demonstrating equivalence to a predicate device. It's unlikely that a "training set" in the context of machine learning (where this term is often used) was part of this study for a traditional in vitro diagnostic reagent.
9. How the ground truth for the training set was established:
- Not applicable, as a training set is not mentioned/relevant in the context of this traditional diagnostic assay validation.
§ 864.7925 Partial thromboplastin time tests.
(a)
Identification. A partial thromboplastin time test is a device used for primary screening for coagulation abnormalities, for evaluation of the effect of therapy on procoagulant disorders, and as an assay for coagulation factor deficiencies of the intrinsic coagulation pathway.(b)
Classification. Class II (performance standards).