(81 days)
The aiACT Kit is an in vitro diagnostic test for use with the Sonoclot® Coagulation & Platelet Function Analyzer System. The aiACT test is an activated whole blood clotting time test which uses a blend of celite and clay for contact activation. It may also be used with citrated whole blood.
The aiACT Kit is intended only for high dose heparin anticoagulation management (ACT ≥ 400 seconds on Sonoclot Analyzer) as typically encountered during cardiopulmonary bypass surgery. The aiACT test provides ACT results that are substantially unaffected by aprotinin. When used with the Sonoclot Analyzer System, the aiACT test provides quantitative Onset/ACT and Clot Rate results. Do not use the aiACT test for platelet function assessment.
The aiACT Kit is an in vitro diagnostic test for use with the Sonoclot® Coagulation & Platelet Function Analyzer System. The aiACT test is an activated whole blood clotting time test which uses a blend of celite and clay for contact activation. It may also be used with citrated whole blood.
The aiACT Kit is a yellow plastic lidded cuvette containing contact activator and magnetic stir bar.
Here's an analysis of the provided text, focusing on the acceptance criteria and study information for the aiACT Kit.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" for the aiACT Kit as specific thresholds for regulatory approval. However, it presents "Normal Ranges" for the aiACT test. While this isn't framed as a pass/fail criteria, it serves as a performance benchmark against healthy individuals without heparin.
| Result | Acceptance Criteria (Normal Range, No Heparin) | Reported Device Performance (Native Whole Blood - Normal Population, No Heparin) |
|---|---|---|
| ACT/Onset | 62-93 seconds | 62-93 seconds |
| Clot RATE | 22-41 Clot Signal Units / minute | 22-41 Clot Signal Units / minute |
Note: The document only provides the normal range itself as the "reported device performance." It doesn't present a separate study cohort demonstrating the aiACT kit's performance relative to these ranges from an external dataset. It's implied that the observed normal range is the performance of the device in a normal, unheparinized population.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used to establish the "Normal Range" for the aiACT Kit. It only refers to a "Normal Population, No Heparin" for "Native Whole Blood."
- Sample Size: Not explicitly stated.
- Data Provenance: Not explicitly stated (e.g., country of origin). It can be inferred that it is retrospective or prospective data collected to establish the normal range, but the methodology is not detailed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable as the document does not describe the use of experts to establish a "ground truth" for the test set in the context of diagnostic accuracy. The ground truth, in this case, is simply the observed range of ACT/Onset and Clot Rate results from a presumably healthy, unheparinized population. There's no mention of a diagnostic task requiring expert interpretation.
4. Adjudication Method for the Test Set
This section is not applicable as the document does not describe a scenario requiring adjudication, such as conflicting expert interpretations or complex diagnostic judgments. The "ground truth" is based on direct measurement of clotting parameters in a normal population.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
This section is not applicable. The document describes a comparison of the aiACT Kit with the SonACT Kit, but it is a comparison of technological characteristics and expected performance, not an MRMC study assessing human reader improvement with or without AI assistance. The aiACT Kit is an in vitro diagnostic test, not an AI-assisted diagnostic tool for Human Readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, implicit in the document, a standalone performance of the device (aiACT Kit with Sonoclot Analyzer) was assessed. The "Normal Range" values (ACT/Onset and Clot RATE) are the direct output of the device itself without human interpretation in a diagnostic loop.
7. The Type of Ground Truth Used
The ground truth used for establishing the normal ranges is based on direct physiological measurement of Activated Clotting Time (ACT/Onset) and Clot Rate from a "Normal Population" with "Native Whole Blood" (i.e., not heparanized). It's an empirical observation of typical values in a healthy state.
8. The Sample Size for the Training Set
The document does not explicitly mention a training set or its sample size. This is common for in vitro diagnostic devices where "training" in the machine learning sense is not typically applicable for establishing performance characteristics like normal ranges. The normal ranges are typically derived from a studied population.
9. How the Ground Truth for the Training Set Was Established
As no explicit "training set" is mentioned in the context of machine learning, this question doesn't entirely apply. However, if we consider the data used to define the "Normal Range" as the equivalent of data used to establish expected performance, the ground truth (the observed ACT/Onset and Clot RATE values) was established by direct measurement using the aiACT Kit on native whole blood samples from a "Normal Population" without heparin. The methodology of this measurement (e.g., number of subjects, how "normal" was defined, protocol for measurement) is not detailed in this summary.
§ 864.7140 Activated whole blood clotting time tests.
(a)
Identification. An activated whole blood clotting time tests is a device, used to monitor heparin therapy for the treatment of venous thrombosis or pulmonary embolism by measuring the coagulation time of whole blood.(b)
Classification. Class II (performance standards).