(37 days)
The HEMOCHRON® Signature Elite™ is a battery operated, hand-held instrument that performs individual point-of-care coagulation tests on fresh or citrated whole blood. The system is intended Incilitiation point coughtton toots of mare coagulation testing. Whole blood test results are displayed as clotting times (in seconds). The HEMOCHRON® Signature Elite™ also displays ulsplayed as clouing times (in socondo). The Hame equivalent values, and the PT INR value.
For in vitro Diagnostic Use Only
The HEMOCHRON® Signature Elite™ Whole Blood Microcoagulation System is a batteryr ne real over to re in the nement that performs individual point-of-care coagulation tests on fresh or operated, norial morantents include: Activated Clotting Time (ACT+ and ACT-LR), Activated Partial Thromboplastin Time (APTT and APTT Citrate), and Prothrombin Time (PT and PT Citrate). The system is intended to be used with test cuvettes that are available from ITC.
Data management capabilities are included with the instrument. These capabilities include Storage of up to 600 patient results and 600 quality control results, designation of quality control levels, tagging of test results with date and time, entry of Patient ID and/or Operator ID or levers, tagging of toot room and bate HEMOCHRON® Configuration Manager software is included with the instrument. This software allows the user to connect a personal computer to the included with the instrument. This octtivation functions using a Microsoft Windows® user interface. HEMOCHRON® ReportMaker" and idms " software which are provided separately, allow the user to connect a personal computer to the instrument and perform various data management and data reporting functions.
For in vitro Diagnostic Use
Here's a breakdown of the acceptance criteria and study information based on the provided text:
Acceptance Criteria and Device Performance
The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than explicitly stating quantitative acceptance criteria for a new device. However, the core implication is that the HEMOCHRON® Signature Elite™ must perform equivalently to the HEMOCHRON® Jr. Signature+ in terms of coagulation test results.
Table 1: Implied Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Coagulation test results are substantially equivalent to the predicate device. | "All clinical and laboratory data demonstrate the substantial equivalence of the HEMOCHRON® Signature Elite™ instrument system to the predicate HEMOCHRON® Jr. Signature+ instrument system." This implies that the measurements (Activated Clotting Time (ACT+ and ACT-LR), Activated Partial Thromboplastin Time (APTT and APTT Citrate), and Prothrombin Time (PT and PT Citrate)) taken by the new device were comparable to those taken by the predicate device. |
| User interface, data storage, and data manipulation functions are updated and improved. | The document explicitly states: "The submitted instrument design upgrades the user interface, data storage and data manipulation functions. The instrument provides a secondary information input pathway using a barcode/scanner in addition to manual keypad entry, and offers a larger capacity to store data." |
| User utility and ease of use are acceptable compared to the predicate device. | A "user-based evaluation of the clinical utility and ease of use of the instructional format displayed on the HEMOCHRON® Signature Elite™ instrument system when compared to the predicate HEMOCHRON® Jr. Signature+ instrument system was performed." The overall conclusion of substantial equivalence suggests this evaluation was favorable. |
| Technological aspects (reagent system, clot detection algorithms) are the same as predicate. | "It utilizes the same reagent system, the same closed end method and clot detection algorithms as the predicate device." This is a foundational aspect of claiming substantial equivalence. |
Study Details for Substantial Equivalence:
The provided text describes studies conducted to demonstrate substantial equivalence, rather than a single study designed to meet specific new performance acceptance criteria.
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Sample sizes used for the test set and the data provenance:
- Laboratory Comparison: "ITC whole blood control products for each currently 510(k) cleared assay for the HEMOCHRON® Jr. Signature+ instrument (predicate)." The exact number of samples or runs is not specified.
- Clinical Comparison: "split patient blood samples on the two instrument systems using each currently 510(k) cleared assay for the HEMOCHRON® Jr. Signature+ instrument system." The exact number of patient samples is not specified.
- Data Provenance: The studies appear to be internal laboratory and clinical comparisons to the predicate device, implying a retrospective (or at minimum, comparative) structure based on existing assays and clinical samples, likely conducted within the United States where ITC is based. No specific country of origin for the data is mentioned outside of the company's US location.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The studies are comparisons to a predicate device, and the "ground truth" for the predicate device's measurements would have been established during its own validation. For this submission, the predicate device itself serves as the reference point for "truth."
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not provided in the document. Given it's a comparative study of a diagnostic instrument rather than interpretation of images or complex clinical scenarios, a formal adjudication method by experts is unlikely to have been part of the primary data comparison. The comparison would involve statistical analysis of the numerical results from both devices.
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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, an MRMC comparative effectiveness study was not done. This document describes a medical device (a microcoagulation system) that performs automated tests. It is not an AI-assisted diagnostic tool for human interpretation, thus, MRMC studies and "human readers" are not applicable in this context.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This device, the HEMOCHRON® Signature Elite™, is an automated diagnostic instrument. Its performance is inherently standalone in terms of generating coagulation test results. The studies compared its results directly to the predicate device's results. There isn't a separate "algorithm only" performance reported as distinct from the device's operational performance, as the device is the implementation of the algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the laboratory comparison, "whole blood control products" were used. These controls have known or expected values, serving as a form of reference standard.
- For the clinical comparison, "split patient blood samples" were used. In this case, the "ground truth" for each sample was implicitly the result obtained from the predicate device (HEMOCHRON® Jr. Signature+), as the study aimed to demonstrate equivalence to it.
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The sample size for the training set:
- This information is not provided. The device utilizes "the same reagent system, the same closed end method and clot detection algorithms as the predicate device." This suggests the core algorithms were already established and validated with the predicate device. This submission focuses on hardware and software interface upgrades, therefore, a new "training set" for the coagulation algorithms is unlikely to have been part of this 510(k) submission.
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How the ground truth for the training set was established:
- This information is not provided. As mentioned above, the underlying coagulation algorithms are stated to be the same as the predicate device. The ground truth for those original algorithms would have been established during the development and validation of the HEMOCHRON® Jr. Signature+ system, likely through comparison with reference laboratory methods and clinical correlation, but details are not in this document.
§ 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.