(68 days)
This product is intended to verify the performance of the ACT instrument and the Heparinase (HR HTC) cartridges.
The CLOTtrac® HTC Control is an in vitro diagnostic device. This control is intended to TIC CEO Fudos TF C Collier CT instrument and the Heparinase (HR HTC) cartridges. The cartridge is for use in the ACT (Automated Coagulation Timer) instrument.
Here's a breakdown of the acceptance criteria and study information for the CLOTtrac® HTC Control, based on the provided text:
Acceptance Criteria and Reported Device Performance
The provided document, a 510(k) Summary for the CLOTtrac® HTC Control, is a pre-market notification to establish substantial equivalence to a predicate device. It does not explicitly state numerical "acceptance criteria" in the format of a table with specific thresholds. Instead, the "acceptance criteria" are implied by the claim of substantial equivalence to the predicate device.
The "reported device performance" is also not presented with specific quantitative metrics. The document states:
"Validation testing was used to establish the performance characteristic of the modifications of this device from the previously marketed device."
This implies that the device performed equivalently to the predicate device during the validation testing. Without the actual test results or the criteria for "performance characteristic," a specific table of acceptance criteria and reported device performance cannot be generated from the given text.
Detailed Study Information:
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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)
- Sample Size: Not specified in the provided document.
- Data Provenance: Not specified in the provided document. The exact nature of the "validation testing" (e.g., in-house, multi-center, clinical trial) is not detailed.
- Retrospective or Prospective: Not specified.
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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)
- Not applicable/Not specified. This device is an in vitro diagnostic control for an instrument, not a device that requires expert interpretation for "ground truth" in the same way an imaging or diagnostic AI would. The "ground truth" for a control device would be its known chemical properties and its ability to produce expected results on the instrument.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified. Adjudication methods are typically used in studies involving human interpretation or clinical outcomes where there might be disagreement in assessment. This is a quality control device.
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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 MRMC study was done. This is not an AI-assisted diagnostic device, but a control for an Automated Coagulation Timer.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable in the typical sense. The device itself (CLOTtrac® HTC Control) is a "control" material used to verify the performance of an instrument (ACT instrument) and its cartridges. It does not perform an algorithm standalone; rather, it is used by the instrument, and its performance is assessed by how well the instrument produces expected results when tested with the control.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For a control material, the "ground truth" would be its precisely manufactured, known concentration or activity levels. The device (control) itself is the standard against which the instrument's performance is measured. The study aimed to demonstrate that the modified control maintains the performance characteristics of the previously marketed control (which implicitly had a known 'truth').
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The sample size for the training set
- Not applicable. This is not an AI/machine learning device that requires a training set.
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How the ground truth for the training set was established
- Not applicable for the same reason as above.
§ 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.