(35 days)
The intended use of the Sysmex® CA-500 is as a fully automated, computerized blood plasma coagulation analyzer for in vitro diagnostic use in clinical laboratories.
The instrument uses citrated human plasma to perform the following parameters and calculated parameters:
Clotting Analysis Parameters
-
Prothrombin Time (PT) ●
-
Activated Partial Thromboplastin Time (APTT) .
-
Fibrinogen (Clauss) .
-
Batroxobin .
-
Protein C .
Heparin
.
- · Thrombin Time
- Extrinsic Factors (II, V, VII, X) .
- Intrinsic Factors (VIII, IX, XI, XII) .
Chromogenic Analysis Parameters
- Antithrombin III .
- . Protein C
Calculated Parameters
- PT Ratio ●
- . PT INR
- . Derived Fibrinogen
- Factor Assays % Activity .
The Sysmex® CA-500 is intended for use as an automated blood plasma coagulation analyzer.
The Sysmex® Automated Coagulation Analyzer CA-500 is intended for use as an automated blood plasma coagulation analyzer. The device's performance was compared to a predicate device, the Behring Coagulation Timer (BCT).
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes "in-house correlation studies" to demonstrate that the performance claims of the proposed device are similar to the predicate device. The acceptance criteria can be inferred from the reported performance, which shows high correlation coefficients (r ≥ 0.960) between the CA-500 and the BCT for the measured coagulation factors.
| Test | Acceptance Criteria (Implied) | Reported Device Performance (Coefficient of Correlation (r)) | Regression Equation |
|---|---|---|---|
| Coagulation Factor VII | Sufficiently high correlation with predicate device (r > X) | 0.976 | Y = 0.97X – 1.55 |
| Coagulation Factor VIII | Sufficiently high correlation with predicate device (r > X) | 0.960 | Y = 1.00X + 3.71 |
Note: The specific numerical acceptance criteria (e.g., r > 0.95) are not explicitly stated in the provided text but are inferred from the reported strong correlations.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size (Test Set):
- Coagulation Factor VII: 80 specimens
- Coagulation Factor VIII: 94 specimens
- Data Provenance: The specimens were evaluated from "apparently healthy individuals and from patients with different pathological conditions which are expected to affect the results for a particular assay." The country of origin is not specified but the manufacturing site is Kobe, Japan, and the distributor is Dade Behring Inc. in Newark, DE, USA. The studies are described as "in-house correlation studies," suggesting they were conducted by the manufacturer or a contracted entity. The data is prospective, as samples were "evaluated" during these studies.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
The document does not mention the use of experts to establish ground truth in the context of the correlation studies. The ground truth for the device's performance is established by comparison to a predicate device, the Behring Coagulation Timer (BCT), rather than an independent expert consensus on patient conditions.
4. Adjudication Method for the Test Set:
Not applicable. The study is a method comparison study between the proposed device and a predicate device, not an assessment requiring expert adjudication of results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. The study focuses on the analytical performance of the device compared to a predicate device, not on human reader performance with or without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, the study describes the standalone performance of the Sysmex® Automated Coagulation Analyzer CA-500 in comparison to the predicate device. It evaluates the device's ability to measure coagulation factors.
7. The Type of Ground Truth Used:
The "ground truth" for this study is the measurements obtained from the predicate device, the Behring Coagulation Timer (BCT). The study assesses the correlation and agreement of the Sysmex CA-500 with a previously cleared device, not against absolute pathological or outcomes data independent of a measurement instrument.
8. The Sample Size for the Training Set:
The document does not mention a "training set" as this is not an AI/machine learning device that would typically undergo a training phase. It is an automated coagulation analyzer being evaluated for substantial equivalence to a predicate device based on its analytical performance.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no mention of a training set for this device in the provided text.
§ 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.