(117 days)
For in vitro diagnostic use with the CARESIDE Analyzer™ to measure prothrombin time from applied citrated whole blood or citrated plasma as a general screening procedure for the detection of possible clotting deficiencies in the extrinsic pathway or to monitor patients receiving anticoagulant therapy.
CARESIDE™ PT cartridges are used with the CARESIDE Analyzer™ to measure prothrombin time in citrated plasma with the sample applied either as citrated whole blood or citrated plasma. The CARESIDE™ PT cartridge, a single use disposable in vitro diagnostic test cartridge, aids in specimen separation and delivers a measured volume of plasma to a cartridge cuvette to initiate the measurement of prothrombin time. The cartridge (patent pending) contains all reagents necessary to measure prothrombin time.
Each CARESIDE™ PT cartridge consists of a cuvette with dried recombinant rabbit tissue factor with calcium ions mounted in a plastic cartridge with a hinged lid. The user opens the pouch, introduces the citrated whole blood or citrated plasma specimen into the cartridge Sample Well, closes the lid and inserts the cartridge into the CARESIDE Analyzer™.
Once loaded, the CARESIDE Analyzer™ scans the cartridge barcode, brings the cartridge and the contained specimen to 37℃, and spins the cartridge to move the sample from the Sample Well into the cartridge channels and chambers. As the cartridge continues to spin. the blood cells are separated from the plasma and the cells accumulate in the separation well. Forty microliters of citrated plasma remain in the metering passage. Any excess sample flows into an overflow well. Once the analyzer completes any other tests, the sample is added to begin the coagulation test. The metered volume of sample is dispensed into the cuvette by a plunger that displaces a flexible seal that covers the Sample Well while a second plunger seals the cartridge vent. As the flexible seal is displaced, air is forced through the metering passage, forcing the sample out and into the cuvette to mix with the reagent. The cuvette is then positioned over an LED and the coagulation event is optically monitored. An onboard timer measures the coagulation time.
Photodiodes monitor the amount of scattered light transmitted by a 570 nanometer light emitting diode to optically monitor the progress of the clot formation. The time at which a clot is detected is reported as the prothrombin time. The results are also reported as the prothrombin ratio (% PT/mean normal PT reference interval) or as the INR (International Normalized Ratio).
The provided text describes the CARESIDE™ PT device and its performance in comparison to a predicate device, Innovin on the MLA Electra 900C. However, it does not explicitly state acceptance criteria or a detailed study plan with statistical endpoints in the format typically used for AI/ML device evaluations. The document is primarily a 510(k) summary, focusing on substantial equivalence.
Based on the provided information, here's an attempt to extract the requested details, with several points marked as "Not Stated" where the information is absent from the text.
Acceptance Criteria and Device Performance
The document does not explicitly state pre-defined acceptance criteria in terms of statistical metrics (e.g., minimum sensitivity, specificity, or agreement thresholds) for regulatory approval. Instead, it relies on demonstrating substantial equivalence to a predicate device through comparative performance characteristics.
The "Accuracy via Method comparison" section provides the most direct performance comparison, which suggests implicit acceptance of performance equivalent to or better than the predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance (CARESIDE™ PT) |
|---|---|
| Detection Limit: Similar to or better than predicate (7 sec) | 9 sec |
| Reportable Range: Similar to or better than predicate | 9 to 75 sec |
| Precision: Acceptable (No predicate target given) | Total CV, 10.2 sec, 4.1% |
| Accuracy (Correlation with Predicate): Strong correlation | CARESIDE™ = 0.98 (Innovin on Electra 900C ) + 0.60 sec, |
| r = 0.98 (correlation coefficient) | |
| Interference: No significant interference | No significant interference observed at tested concentrations of: |
| Bilirubin 20 mg/dL | |
| Hemoglobin 500 mg/dL | |
| Triglyceride 300 mg/dL | |
| Safety and Effectiveness: As safe, effective, and performs as well as or better than the legally marketed predicate device. | "The nonclinical and clinical data provided demonstrate that the CARESIDE™ PT product is as safe, effective, and performs as well as or better than the legally marketed predicate device." |
Study Details
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The "Accuracy via Method comparison" implies a dataset was used for correlation, but the number of samples is not provided.
- Data Provenance: Not explicitly stated (e.g., country of origin). The study appears to be clinical performance data for device comparison. It does not mention if the data was retrospective or prospective.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Stated. The ground truth in this context is the actual prothrombin time measured by a reference method (the predicate device). There are no "experts" involved in establishing this type of ground truth; it's a quantitative measurement.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. This type of adjudication is typically used for subjective assessments or when reconciling disagreements among human readers, especially in image-based diagnostic AI. For a quantitative measurement device like this, the ground truth is established by the reference method (predicate device), and the CARESIDE™ PT measurements are compared to it.
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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:
- No. This is a comparison between two devices (CARESIDE™ PT vs. predicate device), not a study involving human readers with and without AI assistance for interpretation. The CARESIDE™ PT is a standalone diagnostic device.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone device comparison was done. The CARESIDE™ PT device, incorporating its own algorithm for clot detection, was compared against the predicate device (Innovin on Electra 900C) in a standalone manner to assess its measurement accuracy and other performance characteristics. The comparison is between the CARESIDE™ PT's measured coagulation time and the predicate device's measured coagulation time. The "Clot Detection Algorithm" for both devices is "Peak of second derivative of optical time course."
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for the "Accuracy via Method comparison" study effectively comes from the measurements provided by the predicate device (Innovin on Electra 900C). This is a form of reference standard measurement from an established, legally marketed device.
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The sample size for the training set:
- Not applicable / Not stated. This document describes a medical device, specifically a test cartridge and analyzer, not a machine learning model that undergoes a distinct "training" phase with a separate "training set" in the common AI/ML sense. The device has an algorithm for clot detection, but its development process (including any data used to refine that algorithm) is not detailed here.
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How the ground truth for the training set was established:
- Not applicable / Not stated. As above, the concept of a "training set" and its associated ground truth in the context of an AI/ML model is not directly addressed for this device.
§ 864.7750 Prothrombin time test.
(a)
Identification. A prothrombin time test is a device used as a general screening procedure for the detection of possible clotting factor deficiencies in the extrinsic coagulation pathway, which involves the reaction between coagulation factors III and VII, and to monitor patients receiving coumarin therapy (the administration of one of the coumarin anticoagulants in the treatment of venous thrombosis or pulmonary embolism).(b)
Classification. Class II (performance standards).