(91 days)
The Triage D-Dimer Calibration Verification Controls are to be used with the The Thage D-Dimer Test and Triage MeterPlus to verify the calibration of the Triage D-Dimor Test throughout the measurable range.
The Triage D-Dimer Controls are assayed materials to be used with the The Thage D-Dimer Test and Triage MeterPlus to assist the laboratory in monitoring test performance.
The Triage D-Dimer Calibration Controls are to be used with the Triage D-Dimer Test and Triage MeterPlus to verify the calibration of the Triage D-Dimer Test throughout the measurable range.
The Triage D-Dimer Controls are assayed materials to be used with the Triage D-Dimer Test and Triage MeterPlus to assist the laboratory in monitoring test performance.
The provided text is a 510(k) summary for Triage D-Dimer Calibration Verification Controls / Triage D-Dimer Controls. This document is a regulatory submission demonstrating substantial equivalence to a predicate device, not a study evaluating the performance of a medical device in terms of diagnostic accuracy against clinical outcomes.
Therefore, many of the requested criteria regarding device performance, sample sizes for test/training sets, ground truth establishment, expert involvement, and MRMC studies are not applicable or cannot be extracted from this type of document.
The document primarily focuses on the intended use and classification of the control materials.
Here's an analysis based on the provided text, highlighting what is not applicable:
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A table of acceptance criteria and the reported device performance:
- N/A. This document describes "Calibration Verification Controls" and "D-Dimer Controls," which are materials used to verify the calibration and monitor the performance of a diagnostic test (the Triage D-Dimer Test), not a diagnostic device itself that has performance metrics like sensitivity, specificity, etc. As such, there are no acceptance criteria and reported device performance in the typical sense for a diagnostic algorithm. The document states the controls are "safe and effective for their intended use," which is their primary claim.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- N/A. There is no "test set" in the context of device performance evaluation described here, as this is a submission for control materials.
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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):
- N/A. As no test set for diagnostic performance is described, there's no mention of experts establishing ground truth for such a set.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. No test set for diagnostic performance is described.
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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:
- N/A. This device is control material, not an AI-assisted diagnostic tool or a device requiring human reader interpretation, so MRMC studies are not relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is control material, not a standalone diagnostic algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- N/A. Ground truth for diagnostic performance is not relevant to this submission for control materials. The "truth" for these controls would be their assigned D-Dimer concentration values, which are established as part of their manufacturing and assay process.
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The sample size for the training set:
- N/A. This is control material, not a machine learning model, so there is no training set mentioned.
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How the ground truth for the training set was established:
- N/A. This is control material, not a machine learning model, so there is no training set or associated ground truth establishment described.
§ 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.