(68 days)
The new Rapidpoint Coaq HMP controls are intended to be used exclusively with the Rapidpoint Coag Analyzer and the Rapidpoint Coag Heparin Management Test (HMT), Heparin Titration Test (HTT), and Protamine Response Test (PRT) cards to provide a method for quality control of the system. The controls produce clotting times that must be within accepted, standard ranges, when tested at CVDI before release of product for sale, to indicate that the analyzer and test cards are functioning properly and thereby help assure the accuracy of HMT. HTT. and PRT card results.
Not Found
The provided documentation [0-3] is a 510(k) summary for a medical device called "Rapidpoint™ Coag Heparin Management Panel Controls (HMP Controls)" and its marketing authorization. This document outlines the regulatory process and approval of the device but does not contain information about the acceptance criteria or a study proving that the device meets those criteria, nor does it provide details about algorithm performance.
The document states, "The controls produce clotting times that must be within accepted, standard ranges, when tested at CVDI before release of product for sale, to indicate that the analyzer and test cards are functioning properly and thereby help assure the accuracy of HMT. HTT. and PRT card results" [3]. However, it does not specify what those "accepted, standard ranges" are, nor does it detail any specific clinical study data to demonstrate the device's performance against defined acceptance criteria.
Therefore, I cannot provide the requested information based on the given input. The categories below are left blank as the information is not present in the provided text.
| Criterium | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Specific Performance Metrics | Not specified in the provided document. | Not specified in the provided document. |
| Statistical Thresholds | Not specified in the provided document. | Not specified in the provided document. |
Study Details:
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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):
- Not specified in the provided document. The document describes controls for a system, not a diagnostic or AI algorithm with a test set of patient data.
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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 document pertains to the regulatory approval of quality control materials, not an AI algorithm requiring expert ground truth for a test set.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not specified.
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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:
- Not applicable. This document is for quality control materials for a coagulation system, not an AI-assisted diagnostic device.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This document does not describe an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable/Not specified.
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The sample size for the training set:
- Not applicable/Not specified.
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How the ground truth for the training set was established:
- Not applicable/Not specified.
§ 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.