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The Hemochron™ Signature Elite Whole Blood Microcoagulation System is a battery-operated, hand-held instrument that performs individual point-of-care coagulation tests on fresh or citrated whole blood. These tests 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 the manufacturer.

For in vitro Diagnostic Use. For professional use. Rx only.

The Hemochron™ Signature Elite Whole Blood Microcoagulation System is a battery operated hand-held instrument. The system is intended for use in clinical settings requiring point of care testing. Whole blood test results are displayed as clotting times (in seconds). The instrument also displays correlated Celite® equivalent ACT values, APTT and PT plasma equivalent values, and the PT INR value.

The Hemochron™ Signature Elite Whole Blood Microcoagulation System contains a test chamber which warms a test cuvette to the required temperature, and it performs all operations to measure the clotting time of a whole blood sample after it is placed in the test cuvette and the test is started by the operator. The front panel contains a keypad with various action keys as well as a number pad. The operator uses the keypad to select a command or enter information. The instrument also includes a barcode scanner for reading of barcode identifications (IDs).

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 Operator PIN and printing of results

Here's an analysis of the provided text regarding the acceptance criteria and study for the Hemochron™ Signature Elite device.

This document describes a Special 510(k) submission for a software update (Version 2.3 to 2.4) to an already cleared device, the Hemochron™ Signature Elite (K050016). Special 510(k)s are used when the modifications do not significantly alter the device's fundamental scientific technology, indications for use, or safety and effectiveness, and when well-established methods are available to evaluate the change. This means that a full de novo study with extensive acceptance criteria and performance data is generally not required for such submissions. Instead, the focus is on demonstrating that the software change itself does not introduce new risks or affect the established performance of the device.

Therefore, the "acceptance criteria" here are primarily satisfied by demonstrating substantial equivalence to the predicate device, particularly by showing that the software update does not change the prior performance claims. The study is a comparison of the updated device to its predicate, confirming that critical specifications remain substantially equivalent.

1. Table of Acceptance Criteria and Reported Device Performance

For this Special 510(k) with a software update, the acceptance criteria are implicitly that the updated device performs equivalently to the predicate device across all listed operational and performance characteristics. The reported device performance is that these characteristics remain "Substantially Equivalent" after the software update.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a separate "test set" in the context of a new performance study. The submission is a Special 510(k) for a software update, claiming that "Performance data are unnecessary, or if performance data are necessary, well-established methods are available to evaluate the change." The comparison detailed is against the predicate device (K050016), implying that previously established performance characteristics of the predicate are used as the benchmark.

Therefore, no new sample size for a test set is explicitly provided or required in this summary for the software update. The data provenance is implicitly the performance data established for the predicate device (K050016) in its original clearance process.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Given that this is a Special 510(k) for a software update and does not describe a new clinical or analytical study requiring expert ground truth establishment for a novel test set, this information is not applicable and not provided in the document.

4. Adjudication Method for the Test Set

As no new test set is described or required for this type of submission, no adjudication method is mentioned. The evaluation is based on a comparison to the established specifications of the predicate device.

5. 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

The device, Hemochron™ Signature Elite, is a point-of-care coagulation system. It measures clotting times. There is no indication of AI or human reader interpretation involved in its operation. Therefore, an MRMC comparative effectiveness study is not applicable to this device, and no such study was done or reported here.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This device is not an AI-based algorithm for interpretation. It's an in-vitro diagnostic instrument that objectively measures clotting times. Therefore, a standalone algorithm performance study (in the context of AI) is not applicable and not mentioned. The device operates as a standalone instrument for its intended use.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)

For this type of device (a coagulation measurement system), the "ground truth" for its accuracy and precision would typically be established by comparing its measurements to a recognized reference method (e.g., a laboratory gold standard coagulation analyzer) or by using calibrated control materials with known values. This information would have been established during the original clearance of the predicate device (K050016). For this Special 510(k), the "ground truth" is that the updated software does not alter the device's ability to accurately perform these measurements as previously established.

8. The Sample Size for the Training Set

The document does not describe the development of a predictive model or an AI algorithm that would require a "training set." The submission pertains to a software update for a measurement device.

9. How the Ground Truth for the Training Set was Established

As there is no training set mentioned or implied for this device's function, this question is not applicable.

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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

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.

1. 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.

2. 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."

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

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