(56 days)
The MAX-ACT Activated Clotting Time test tubes are intended for use in the measurement of the activated clotting time test (ACT) on Actalyke Models A1, A1P, A2, A2P, and Hemochron® Models 400, 401, 800, 801 and 8000.
The MAX-ACT Activated Clotting Time test tubes utilize a "cocktail" of particulate activators (including celite, kaolin, and glass particles) and is intended for use in the measurement of the activated clotting time test (ACT) on Actalyke Models A1, A1P, A2, A2P, and Hemochron® Models 400, 401, 800, 801 and 8000.
Here's a breakdown of the acceptance criteria and study information for the MAX-ACT Activated Clotting Time Test Tube, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state pre-defined performance acceptance criteria. Instead, it demonstrates substantial equivalence to a legally marketed predicate device (Array Medical Actalyke C-ACT test tube, K964609) through correlation studies. The reported performance is presented as correlation coefficients.
| Study Type / Group | Performance Metric | Reported Device Performance | Acceptance Criteria (Implicit) |
|---|---|---|---|
| In-Vitro (Normal Donors) | Correlation with C-ACT/FTCA510 | r = 0.97, p = 0.0001 (n=72) | Strong positive correlation (demonstrating substantial equivalence) |
| Clinical - Bypass Patients | Correlation with C-ACT/FTCA510 | r² = 0.82 (all samples), r² = 0.87 (after omitting samples outside linear range) | Strong positive correlation (demonstrating substantial equivalence) |
| Clinical - Aprotinin Bypass Patients | Correlation with ACTII/K-ACT/FTKACT | r² = 0.89 | Strong positive correlation (demonstrating substantial equivalence) |
| Clinical - Pediatric Bypass | Correlation with FTCA510 | r² = 0.86 | Strong positive correlation (demonstrating substantial equivalence) |
| Clinical - Catheterization Patients | Correlation with FTCA510 | r² = 0.88 | Strong positive correlation (demonstrating substantial equivalence) |
2. Sample Size Used for the Test Set and Data Provenance
- In-vitro study:
- Sample Size: 72 samples (derived from 3 normal, healthy volunteers by adding increasing amounts of heparin).
- Data Provenance: In-house study, in-vitro heparinization of normal donor blood. The country of origin is not explicitly stated but can be inferred as the US given the submission to the FDA. Retrospective/Prospective: Not explicitly stated, but the description of generating samples suggests a controlled, prospective approach.
- Clinical studies:
- Total Sample Size: 330 paired blood samples.
- Breakdown by Study Group:
- Bypass Patients: 239 patient samples (from n=30 patients)
- Aprotinin Bypass Patients: 28 patient samples (from n=6 patients)
- Pediatric Bypass: 41 patient samples (from n=5 patients)
- Catheterization Patients: 22 patient samples (from n=10 patients)
- Data Provenance: Clinically collected samples from patients (adult bypass, pediatric bypass, cardiac catheterization) at "numerous institutions." The country of origin is not explicitly stated, but given FDA submission, it's likely primarily US data. Retrospective/Prospective: The description "collected... before, during, and following heparinization" suggests these were prospectively collected as part of the study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not provided in the given document. The "ground truth" in this context is the measurement provided by the legally marketed predicate devices (C-ACT, FTCA510, ACTII/K-ACT/FTKACT). These are established laboratory tests, and their results are considered the standard for comparison rather than requiring expert consensus on individual results.
4. Adjudication Method for the Test Set
This type of information is not applicable to this study. The study compares a new device's readings to those of a predicate device. There is no mention of human interpretation or a need for adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a MRMC comparative effectiveness study was not done. This study focuses on the analytical performance of a diagnostic device (activated clotting time measurement), not on the diagnostic accuracy of human readers with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the performance data presented is that of the device (MAX-ACT Activated Clotting Time Test Tube) in a standalone capacity, i.e., without a human-in-the-loop evaluating its output in a diagnostic context. It compares the MAX-ACT's readings directly to those of established ACT tests.
7. The Type of Ground Truth Used
The ground truth used for comparison was the readings obtained from legally marketed predicate Activated Clotting Time (ACT) tests. Specifically, these included:
- Array Medical Actalyke C-ACT
- HEMOCHRON CA510
- HEMOCHRON FTKACT
- ACTII/K-ACT
These predicate devices serve as the established standard for measuring ACT.
8. The Sample Size for the Training Set
This document does not mention a 'training set.' The MAX-ACT device is a physical test tube containing "a cocktail of particulate activators." It’s not an AI/ML algorithm that requires a training set in the conventional sense. The studies described are for validation and demonstration of equivalence, not for training an algorithm.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for this device, this question is not applicable.
§ 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).