(114 days)
The Sysmex® CA-6000 is substantially equivalent in intended use and technological characteristics to the Electra 1000C™ Automatic Coagulation Timer, manufactured by Medical Laboratory Automation, Inc., Pleasntville, NY, previously cleared under Document Control No., K894052. Sysmex® CA-6000 is intended for use as an automated blood plasma coagulation analyzer.
Automated blood plasma coagulation analyzer
The provided text describes a 510(k) summary for the Sysmex® Automated Coagulation Analyzer CA-6000, comparing its performance to a predicate device, the Electra 1000C™.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are implied by the comparison to the predicate device, meaning the new device's performance should be "similar" to the predicate. The performance is reported in correlation studies, showing a high coefficient of variation and regression equations close to ideal (Y=X).
| Assay | Acceptance Criteria (Implied) | Reported Device Performance (Coefficient of Variation) | Reported Device Performance (Regression Equation) |
|---|---|---|---|
| Prothrombin Time (Dade® Innovin®, seconds) | Similar to predicate | 0.997 | Y= 1.02X + 0.4 |
| Prothrombin Time (Dade® Innovin®, INR) | Similar to predicate | 0.997 | Y= 1.07X - 0.1 |
| Derived Fibrinogen (Dade® Innovin®) | Similar to predicate | 0.988 | Y= 1.03X - 6.2 |
| Prothrombin Time (Dade® Thromboplastin C Plus, seconds) | Similar to predicate | 0.983 | Y= 1.02X - 0.1 |
| Prothrombin Time (Dade® Thromboplastin C Plus, INR) | Similar to predicate | 0.984 | Y= 1.02X - 0.1 |
| Derived Fibrinogen (Dade® Thromboplastin C Plus) | Similar to predicate | 0.992 | Y=0.76X +63.9 |
| Activated Partial Thromboplastin Time | Similar to predicate | 0.971 | Y= 1.00X + 1.7 |
| Fibrinogen (Clauss) | Similar to predicate | 0.984 | Y=0.98X -15.0 |
| Thrombin Time | Similar to predicate | 0.888 | Y= 1.98X - 5.0 |
| Factor VII (Dade® Innovin®) | Similar to predicate | 0.987 | Y=0.97X - 2.2 |
| Factor VII (Dade® Thromboplastin C Plus) | Similar to predicate | 0.979 | Y=0.94X - 4.4 |
| Factor VIII | Similar to predicate | 0.973 | Y= 1.04X - 2.2 |
| Antithrombin III | Similar to predicate | 0.980 | Y=0.98X + 0.6 |
| Plasminogen | Similar to predicate | 0.999 | Y=1.03X-0.7 |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample sizes for the test set:
- Prothrombin Time (Dade® Innovin®): 119
- Derived Fibrinogen (Dade® Innovin®): 139
- Prothrombin Time (Dade® Thromboplastin C Plus): 133
- Derived Fibrinogen (Dade® Thromboplastin C Plus): 126
- Activated Partial Thromboplastin Time: 128
- Fibrinogen (Clauss): 230
- Thrombin Time: 148
- Factor VII (Dade® Innovin®): 130
- Factor VII (Dade® Thromboplastin C Plus): 131
- Factor VIII: 118
- Antithrombin III: 132
- Plasminogen: 158
- Data provenance: The studies were "in-house correlation studies." Specimens were evaluated from "apparently healthy individuals and from patients with different pathological conditions." No specific country of origin is mentioned, but the manufacturing site is Kobe, Japan, and the importer is in Long Grove, IL, USA. It's likely these were prospective studies as they involved evaluating specimens for comparison.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the text. The study describes a comparison between two automated instruments, not the establishment of a ground truth by human experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the text, as it's a comparison between automated devices, not human-read interpretations.
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
- Was an MRMC study done? No. The study compares the performance of a new automated device (Sysmex® CA-6000) to a predicate automated device (Electra 1000C™). It does not involve human readers or AI assistance.
- Therefore, the effect size of human readers improving with/without AI assistance is not applicable and not provided.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, a standalone study was done. The entire study analyzes the performance of the Sysmex® Automated Coagulation Analyzer CA-6000 (an algorithm-driven device) in comparison to another automated coagulation analyzer (predicate device), without human intervention in the result generation or analysis from the device itself.
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 (Electra 1000C™). The new device's performance is assessed by how closely its results correlate with those of the established predicate device.
8. The sample size for the training set
This information is not provided in the text. This is a 510(k) summary for a medical device that performs laboratory tests, not a machine learning algorithm that requires a dedicated training set in the typical sense of AI development. The device's internal algorithms would have been developed and validated, but the text focuses on its clinical performance comparison.
9. How the ground truth for the training set was established
This information is not provided in the text, as there is no mention of a traditional "training set" or "ground truth" establishment in the context of machine learning for this type of device. The development of the device's measurement algorithms would have relied on established coagulation science and laboratory standards, but details on that process are not included in this regulatory summary.
§ 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.