(61 days)
The Coag-A-Mate MAX is a fully automated hemostasis instrument capable of performing coagulation assays that utilize photo-optical detection end point methodology.
The Coag-A-Mate MAX is a fully automated coagulation system with the capability of performing coagulation assays that utilize photo-optical end point detection methodology. These assays include Screening Assays such as PT, APTT, and TT; Quantitative Clot Based Assays such as Factor VIII and Factor X, Clauss Fibrinogen and Derived PT Fibrinogen; and Colorimetric Assay such as ATIII and Heparin Xa.
The Coag-A-Mate MAX is a fully automated hemostasis instrument capable of performing coagulation assays that utilize photo-optical detection end point methodology.
Here's a breakdown of the acceptance criteria and study information for the Organon Teknika Corporation Coag-A-Mate MAX Coagulation System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the demonstration of "substantial equivalence" to predicate devices, specifically the Organon Teknika MDA-180 and/or Coag-A-Mate MTX. The key metric for acceptance is a high correlation coefficient (r-value) and minimal bias in method comparison studies.
| Acceptance Criteria (Implicit) | Reported Device Performance (Coag-A-Mate MAX) |
|---|---|
| Clot Based Assays (Screening: PT, APTT, TT): Substantially equivalent to predicate device (MDA 180) with high correlation and minimal bias. | Comparisons were highly correlated (r values of 0.978 to 0.994) in the presence of minimal bias. |
| Clot Based Assays (Quantitative: Fibrinogen, PT Derived Fibrinogen, Factor X, Factor VIII): Substantially equivalent to predicate device (MDA 180 and/or CAM MTX) with high correlation and minimal bias. | Comparisons were highly correlated (r values of 0.976 to 0.993) in the presence of minimal bias. |
| Reportable Ranges Established: |
- PT Factor X Assay: 4.39% - 158% (values above 93% extrapolated)
- APTT Factor VIII Assay: 7.8% - 23.1.1% (values above 87% extrapolated)
- Fibrinogen Assay: 110.1 mg/dl - 759.15 mg/dl (values above 494 mg/dl extrapolated – note: original text has a typo, likely meant to say "values above 494 mg/dl were extrapolated for PT Derived Fibrinogen")
- PT Derived Fibrinogen Assay: 131.3 mg/dl (values above 494 mg/dl extrapolated) |
| Colorimetric Assays (Chromogenic: Heparin Anti Xa, ATIII): Substantially equivalent to predicate device (MDA 180) with high correlation and minimal bias. | Method comparisons were highly correlated (r value of 0.979 and 0.992) in the presence of minimal bias. |
| Overall Comparison: Performance comparable to predicate devices and typical of photo-optical coagulation systems. | For clotting assays correlation coefficients ranged from 0.978 to 0.994, for Factor Assays correlation coefficients ranged from 0.976 to 0.993, and for chromogenic assays correlation coefficients were 0.979 to 0.992. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set. It also does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. It only refers to "comparison data" for establishing reportable ranges.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The studies described are method comparison studies comparing the new device against existing predicate devices, which act as the reference method rather than expert-established ground truth in a diagnostic sense.
4. Adjudication Method for the Test Set
This information is not applicable or provided. The studies are described as method comparisons, not requiring expert adjudication of results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not conducted or described. This type of study is more relevant for imaging or interpretative diagnostics where human readers evaluate cases with and without AI assistance. This device is a coagulation system, which performs automated measurements.
6. Standalone (Algorithm Only) Performance Study
Yes, the studies described are standalone performance studies of the Coag-A-Mate MAX system. The device's performance (measurements of coagulation assays) is compared directly to predicate devices (MDA-180 and Coag-A-Mate MTX) without human interaction influencing the measurement results beyond sample handling.
7. Type of Ground Truth Used
The "ground truth" for these studies is the results obtained from the predicate devices (Organon Teknika MDA-180 and Coag-A-Mate MTX). The studies are essentially method comparison studies, where the new device's measurements are correlated with those of the established, legally marketed predicate devices.
8. Sample Size for the Training Set
This information is not provided in the document. The filing describes performance studies for regulatory approval, not the internal development or training of an AI algorithm. If this device did incorporate AI (which is not explicitly stated but could be inferred from "automated hemostasis instrument" and "photo-optical detection"), the training data details are not included. However, given the date (1999) and nature of the device (coagulation system), it's more likely to rely on rule-based algorithms or calibrated physical principles rather than machine learning models requiring large training sets in the modern sense.
9. How the Ground Truth for the Training Set Was Established
This information is not provided, and as noted above, a "training set" in the context of modern AI/ML might not be applicable here. If calibration data was used for the device's internal algorithms, the method for establishing that calibration or "ground truth" is not detailed.
§ 864.5400 Coagulation instrument.
(a)
Identification. A coagulation instrument is an automated or semiautomated device used to determine the onset of clot formation for in vitro coagulation studies.(b)
Classification. Class II (special controls). A fibrometer or coagulation timer intended for use with a coagulation instrument is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.