(98 days)
Sysmex® CA-1000 & CA-5000 are intended for use as automated blood plasma coagulation analyzers.
Automated blood plasma coagulation analyzers. The systems were described in details in premarket notifications, document control numbers: K931149/A, K933886, K942096/S1 and K942097/S1. The devices belong to the same family of instruments and they are equivalent in their technological features and performance.
The acceptance criteria and device performance information for the Sysmex® Automated Coagulation Analyzer CA-1000 and CA-5000 are detailed below, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes a comparison between new software versions (24 for CA-1000, 13 for CA-5000) and previous software versions or predicate devices. The acceptance criteria are implicitly good correlation and agreement between the new and predicate devices/software, indicated by high correlation coefficients and regression equations close to Y=X.
| Test | Acceptance Criteria (implicit) | Reported Device Performance (r) | Regression Equation |
|---|---|---|---|
| Prothrombin Time (PT), seconds | High correlation (e.g., r > 0.95) | 0.999 | Y = 0.97X + 0.1 |
| Activated Partial Thromboplastin Time (APTT), seconds | High correlation (e.g., r > 0.95) | 0.978 | Y = 0.99X + 0.7 |
| Fibrinogen (Clauss), mg/dL | High correlation (e.g., r > 0.95) | 0.995 | Y = 0.96X + 10.4 |
| Derived Fibrinogen | High correlation (e.g., r > 0.95) | 0.951 | Y = 1.02X - 9.8 |
| Factor VII Assay | High correlation (e.g., r > 0.95) | 0.996 | Y = 0.95X + 1.0 |
| Factor VIII Assay | High correlation (e.g., r > 0.95) | 0.995 | Y = 0.92X + 0.6 |
| Thrombin Time | High correlation (e.g., r > 0.95) | 0.951 | Y = 1.00X - 0.3 |
The acceptance criteria are inferred based on the strong correlations and regression equations presented, indicating that the new software versions perform comparably to the established predicate devices/software.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The sample sizes for each test ranged from 19 to 49 samples, as reported in the "Sample Number (n)" column of the table. Specifically:
- PT: 39 samples
- APTT: 37 samples
- Fibrinogen (Clauss): 41 samples
- Derived Fibrinogen: 19 samples
- Factor VII Assay: 49 samples
- Factor VIII Assay: 38 samples
- Thrombin Time: 42 samples
- Data Provenance: The samples consisted of "plasma samples with each representative analyte of the core coagulation assays." This group "represented approximately even numbers of males and females, consisted of approximately 40 samples." The study evaluated specimens from "apparently healthy individuals and from patients with different pathological conditions." The document does not specify the country of origin or whether the data was retrospective or prospective, only that it was a "clinical study."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This type of device is an automated coagulation analyzer. Ground truth is established by comparing the results of the new device/software against the results of a predicate device or established laboratory methods. Therefore, the concept of "experts" establishing ground truth in the traditional sense (e.g., radiologists interpreting images) is not directly applicable. The "ground truth" here is the measurement obtained by the predicate device or a recognized standard method.
4. Adjudication Method for the Test Set
Adjudication methods (e.g., 2+1, 3+1) are typically used for subjective assessments where multiple human interpreters might disagree. For an automated coagulation analyzer, the "ground truth" (or reference standard) is typically derived from laboratory measurements using an established method or a predicate device. Therefore, no multi-expert adjudication method is relevant or described for this type of test.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This study focuses on the performance comparison between the proposed device/software and a predicate device/software, not on the improvement of human readers with AI assistance. The device is an automated analyzer, not an AI-assisted diagnostic tool for human interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, this study represents a standalone (algorithm only) performance evaluation. The coagulation analyzer is an automated system, and the study compares its measurements generated by different software versions to each other, without human interpretation being part of the primary measurement process.
7. The Type of Ground Truth Used
The ground truth for this comparison was the measurements obtained from the predicate device or the current software versions of the Sysmex® Automated Coagulation Analyzers. The studies were "method comparison evaluations" comparing "Software Version 21 versus Software Version 24" for the CA-1000 and CA-5000 systems. This indicates that the results of the established, previously cleared software/device served as the reference for evaluating the new software/device.
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" for the software. This is common for traditional laboratory instruments where the software's algorithms are based on established biochemical principles and calibrated during development rather than "trained" on a large dataset in the machine learning sense. The clinical study described evaluates the performance of the already developed software.
9. How the Ground Truth for the Training Set Was Established
As noted above, a "training set" in the context of machine learning is not applicable here. The algorithms within the coagulation analyzer software are developed based on known coagulation assay principles and calibrated using standard reference materials and methods, not by establishing ground truth from a large, labeled training dataset in the same way an AI model would be.
§ 864.5425 Multipurpose system for in vitro coagulation studies.
(a)
Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.(b)
Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.