(156 days)
The intended use of the Sysmex® CA-500 Series is as a compact, 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) .
- Thrombin Time .
Chromogenic Analysis Parameters
- Antithrombin III ●
Calculated Parameters - PT Ratio .
- PT INR .
- Derived Fibrinogen .
The CA-500 is substantially equivalent in intended use and technological characteristics to its predecessor, the CA-6000 analyzer. Both instruments are manufactured by TOA Medical Electronics, CO, Ltd., Kobe, Japan. The CA-6000 analyzer was described in details under Document Control No. K964139. The Sysmex® CA-500 is intended for use as an automated blood plasma coagulation analyzer.
Here's a summary of the acceptance criteria and study details for the Sysmex® Automated Coagulation Analyzer CA-500, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state pre-defined acceptance criteria (e.g., target ranges for coefficient of correlation or regression coefficients). Instead, it presents the results of a correlation study between the proposed device (CA-500) and its predicate device (CA-6000) as evidence of substantial equivalence. The reported device performance is indicated by the Coefficient of Correlation (r) and the Regression Equation (Y = mX + c) for various coagulation tests. High correlation coefficients and regression equations close to Y=X (slope near 1, intercept near 0) indicate good agreement.
| Test | Sample Number (n) | Coefficient of Correlation (r) | Regression Equation |
|---|---|---|---|
| Prothrombin Time (Dade® Innovin®, seconds) | 111 | 0.991 | Y = 0.98X + 0.3 |
| Prothrombin Time (Dade® Innovin®, INR) | 111 | 0.991 | Y = 0.99X + 0.03 |
| Derived Fibrinogen (Dade® Innovin®) | 104 | 0.983 | Y = 0.78X + 31.2 |
| Prothrombin Time (Dade® Thromboplastin C Plus, seconds) | 131 | 0.997 | Y = 1.00X + 0.02 |
| Prothrombin Time (Dade® Thromboplastin C Plus, INR) | 131 | 0.997 | Y = 1.00X + 0.01 |
| Derived Fibrinogen (Dade® Thromboplastin C Plus) | 131 | 0.979 | Y = 0.92X + 20.2 |
| Prothrombin Time (Thromborel® S, seconds) | 119 | 0.990 | Y = 0.99X + 0.2 |
| Prothrombin Time (Thromborel® S, INR) | 119 | 0.989 | Y = 1.00X + 0.01 |
| Derived Fibrinogen (Thromborel® S) | 115 | 0.985 | Y = 0.86X + 29.2 |
| Activated Partial Thromboplastin Time (Dade® Actin®) | 114 | 0.997 | Y = 1.00X - 0.3 |
| Activated Partial Thromboplastin Time (Dade® Actin® FSL) | 116 | 0.997 | Y = 1.01 X - 0.01 |
| Activated Partial Thromboplastin Time (Pathromtin® SL) | 114 | 0.996 | Y = 0.98X + 1.0 |
| Fibrinogen (Clauss) | 119 | 0.989 | Y = 0.95X + 20.3 |
| Thrombin Time | 128 | 0.806 | Y = 0.54X + 9.8 |
| Antithrombin III | 109 | 0.927 | Y = 0.91X + 10.8 |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Varies by assay, ranging from 104 to 131 samples (as shown in the table above under "Sample Number (n)").
- Data Provenance: The studies were performed "in house" by Dade Behring Inc. The samples included "apparently healthy individuals and from patients with different pathological conditions." The country of origin for the data is not explicitly stated, but Dade Behring Inc. is located in Miami, FL, USA. The study is retrospective in the sense that the data was collected and then analyzed to compare the two devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The study compares the performance of a new automated analyzer (CA-500) against a predicate automated analyzer (CA-6000), rather than against a human expert or gold standard like pathology in the context of image analysis. Therefore, the concept of "experts establishing ground truth" as it would apply to diagnostic imaging, for instance, isn't directly relevant here. The predicate device's results are considered the "truth" for comparison.
4. Adjudication method for the test set
This information is not provided and is not applicable in this type of device comparison study. Adjudication methods are typically used when human interpretation is involved and discrepancies need to be resolved. Here, the comparison is between two automated instruments.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
There was no MRMC comparative effectiveness study and no human readers or AI assistance are mentioned. This study is focused on the analytical performance of an automated coagulation analyzer compared to another automated analyzer, not the impact on human clinicians' diagnostic abilities.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the study is essentially a standalone performance study of the Sysmex® Automated Coagulation Analyzer CA-500. It measures the device's output against the predicate device's output, without human intervention in the result generation or interpretation process of the devices themselves.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context is the results obtained from the predicate device, the Sysmex® CA-6000 analyzer. The study aims to demonstrate substantial equivalence by showing a strong correlation between the measurements of the proposed device and the predicate device.
8. The sample size for the training set
This information is not provided and is not applicable for this type of medical device submission. The CA-500 is an automated analyzer, and the results presented are from a validation study comparing its performance to a predicate device, not from an AI model that requires a training set.
9. How the ground truth for the training set was established
This information is not provided and is not applicable, as there is no mention of a "training set" for an AI model.
§ 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.