(96 days)
cryocheck Clot APCR is a clotting assay intended to screen for resistance to activated protein C in citrated human plasma from individuals with the factor V Leiden mutation.
cryocheck Clot APCR consists of:
- 5 x 2.0 mL Activator Reagent (APC-AR) .
- 5 x 4.0 mL Russell's Viper Venom Reagent (APC-RV)
Here's a breakdown of the acceptance criteria and study information for the cryocheck™ Clot APCR™ device, based on the provided 510(k) summary:
1. Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria in terms of numerical thresholds for sensitivity, specificity, or correlation. Instead, it frames the acceptance criteria implicitly as "comparable precision," "identical results when challenged with interfering substances and factor deficiencies," and "identical sensitivity and specificity" when compared to the predicate device. The primary performance metric reported is a correlation coefficient.
| Acceptance Criteria (Implicit) | Reported Device Performance (cryocheck Clot APCR) |
|---|---|
| Comparable precision to predicate device (GradiLeiden V) | Showed comparable precision to GradiLeiden V. |
| Identical results with interfering substances/factor deficiencies as predicate | Demonstrated identical results when challenged with interfering substances and factor deficiencies. |
| Identical sensitivity to predicate device (GradiLeiden V) | Exhibited identical sensitivity to GradiLeiden V. |
| Identical specificity to predicate device (GradiLeiden V) | Exhibited identical specificity to GradiLeiden V. |
| Strong correlation with predicate device | A correlation of R = 0.960 was obtained (with GradiLeiden V). |
2. Sample Size and Data Provenance
- Sample Size for Test Set: 207 clinical samples.
- Data Provenance: The document states that clinical tests were performed "at Precision BioLogic and a US university hospital-based clinical coagulation laboratory." This indicates the data is prospective clinical data collected from human subjects (patients). The clinical samples were from "the target population for the assay."
3. Number of Experts and Their Qualifications for Ground Truth
The document does not specify the number of experts used to establish ground truth or their qualifications. The comparison is made against a predicate device, implies that the predicate device's results are considered the reference standard, rather than independently established expert ground truth.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method for the test set. The comparison appears to be a direct one-to-one comparison of results between the new device and the predicate device for each sample.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. The study focuses on comparing the new device's performance to a predicate device, not on assessing human reader performance with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study
Yes, the study is a standalone performance study. The device itself is an in vitro diagnostic (IVD) assay that provides a result (clotting time ratio). The "performance" being evaluated is the accuracy and reliability of this assay in classifying samples compared to the predicate device. There is no human-in-the-loop component described for the operation of this specific device or its interpretation in the context of the study.
7. Type of Ground Truth Used
The "ground truth" for the test set was essentially the results obtained from the predicate device (GradiLeiden V). The study compared the cryocheck Clot APCR's performance to the GradiLeiden V results across the 207 clinical samples.
8. Sample Size for the Training Set
The document does not explicitly mention a "training set" or its size. Since this is an in vitro diagnostic assay rather than an AI/machine learning algorithm, the concept of a distinct training set in the typical machine learning sense does not apply. The development of the assay would involve R&D and validation, but not a "training set" in the computational context.
9. How Ground Truth for Training Set Was Established
As noted above, the concept of a training set as it applies to AI/ML is not relevant here. The "ground truth" for the development and validation of such an assay would typically be established through robust laboratory methods, perhaps using known Factor V Leiden positive and negative samples, and comparison to established clinical diagnostic methods, but specific details of this process for assay development are not provided in the 510(k) summary.
§ 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).