(48 days)
The intended use of the Sysmex® CA-6000 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) .
- Thrombin Time .
- Extrinsic Factors (II, V, VII, X) ●
- Intrinsic Factors (VIII, IX, XI, XII) ●
- Batroxobin .
- . Protein C
Chromogenic Analysis Parameters
- Antithrombin III .
- . Plasminogen
- Factor VIII .
Calculated Parameters
- PT Ratio .
- PT INR .
- Protein C .
- Heparin ●
- a2-Antiplasmin .
- Derived Fibrinogen .
- Factor Assays % Activity .
The Sysmex® CA-6000 is intended for use as an automated citrated human plasma coagulation analyzer.
Here's a breakdown of the acceptance criteria and study information for the Sysmex® Automated Coagulation Analyzer CA-6000 based on the provided text:
1. Table of Acceptance Criteria (Implicit) and Reported Device Performance
The acceptance criteria for this device are implicitly tied to its substantial equivalence to a predicate device, the Behring Coagulation Timer (BCT). This means the performance of the CA-6000 is deemed acceptable if it demonstrates similar performance to the BCT.
| Test | Acceptance Criteria (Implied - Similar to Predicate) | Reported Device Performance (Correlation with BCT) | Assay Precision (Total %CV) |
|---|---|---|---|
| Factor VIII Chromogenic Assay | Coefficient of Correlation (r) close to 1 | r = 0.931 | 4.4% (for CPN and CPP) |
| α2-Antiplasmin Chromogenic Assay | Coefficient of Correlation (r) close to 1 | r = 0.990 | 2.3% (CPN), 7.9% (CPP) |
Note: The document focuses primarily on correlation with the predicate device and precision, rather than specific numeric thresholds for accuracy. The "acceptance criteria" here are implied to be achieving strong correlation and acceptable precision, demonstrating similar performance to the established predicate.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size:
- Factor VIII Chromogenic Assay: n = 92
- α2-Antiplasmin Chromogenic Assay: n = 128
- Precision Studies: 40 samples for each control level (CPN and CPP) for both Factor VIII and α2-Antiplasmin.
- Data Provenance: Retrospective and prospective. The studies "evaluated specimens from apparently healthy individuals and from patients with different pathological conditions which are expected to affect the results for a particular assay." The location of these individuals and patients is not explicitly stated (e.g., country of origin), but given the applicant is Dade Behring Inc. Miami, FL, and Sysmex Corp. Japan, it's likely a mix, potentially with US-based clinical samples. The "in-house correlation studies" suggest internal testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. For diagnostic devices like this, patient samples with known clinical conditions (pathological conditions) serve as the "ground truth" for evaluating accuracy and correlation. However, the specific process for establishing these "known clinical conditions" or whether expert review was involved is not detailed.
4. Adjudication Method for the Test Set
This information is not provided. As the study focuses on quantitative correlation with a predicate device and precision, inter-rater adjudication of results is not typically a direct component. The predicate device's results serve as the reference for comparison.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study assesses how human readers' performance (e.g., diagnostic accuracy) changes with and without AI assistance. The Sysmex CA-6000 is an automated analyzer, not an AI-assisted diagnostic tool for human readers. Its primary function is to perform tests and output quantitative results, rather than to aid human interpretation of complex images or data in an MRMC setting.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the provided studies essentially represent standalone performance. The Sysmex® CA-6000 is an "Automated Coagulation Analyzer." The studies described (method comparison and precision) evaluate the device's performance in generating results directly from samples, independent of human interpretation or intervention in the measurement process itself. The "algorithm" here refers to the device's internal methods for assay execution and result calculation.
7. Type of Ground Truth Used
The ground truth used for the method comparison studies was derived from the predicate device's measurements (Behring Coagulation Timer - BCT) and from patient specimens with "different pathological conditions" and "apparently healthy individuals". The BCT's results served as the reference for determining the CA-6000's correlation. For the precision studies, the "ground truth" is the inherent variability of the assay on control materials and patient samples under repeated measurements.
8. Sample Size for the Training Set
The document does not provide information on a "training set". This type of device (automated analyzer) is typically developed and validated using engineering principles, analytical studies, and comparison to existing, cleared devices, rather than machine learning models that require distinct training sets.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned or applicable in the context of this device's development as described, this information is not applicable.
§ 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.