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microINR System:

The microlNR System (consisting of the microINR Chip) is intended for multiple-patient use by professional healthcare providers for the determination of International Normalized Ratio (INR) to monitor Oral Anticoagulation Therapy (OAT) warfarin. The microINR System uses fresh capillary whole blood. The microNR System is intended for in vitro diagnostic use at the point-of-care.

The microlNR System is intended for use in patients 18 years of age and older. Patients must be stabilized (≥ 6 weeks) on warfarin.

Caution: The microINR System is not intended for use in patients who are transitioning from heparin treatment to warfarin therapy. The microINR System is not intended to be used for screening purposes.

The microINR chips are only intended to be used with the microINR meter.

microINR Control Level A / microINR Control Level B:

The microlNR Control is intended for quality control performed on the microINR Meter when used with the disposable microINR Chips.

iLine Microsystems has available two microNR Control Levels (A and B) to perform quality control checks in the therapeutic range on the microINR System.

The microINR Control is intended for professional use only.

The microINR® System is comprised of a portable measuring device (microINR® Meter) and test strips (microINR® Chips) in which the capillary blood sample flows through capillary action.

The microINR® Chip contains a reagent in dried form which consists of thromboplastin, and contains two symmetrical regions, the measuring channel and a control channel. The microINR® Meter measures International Normalized Ratio (INR) based on a Prothrombin Time (PT) assay carried out in the microINR® Chip based on microfluidic technology with machine vision detection.

The microINR® System has a multi-level On-board Quality Control. Multiple key functions and elements of the system are checked and if deviations are detected, error messages are displayed and test results are not reported.

In addition to the microINR® On-Board Controls, the microINR® Control has been developed as an optional liquid quality control solution. The microINR® Control must be used only by healthcare professionals in order to meet the regulatory compliance requirements applicable to the facility where they are to be used.

The microINR® Control contains lyophilized human citrated plasma from healthy donors (not heparinized plasma or plasma samples under oral anticoagulant therapy) modified by means of a dedicated process to simulate an abnormal coagulation sample and a calcium chloride solution. Before use, the lyophilized plasma must be reconstituted with the calcium chloride solution.

Here's an analysis of the provided text to extract information about the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" for accuracy in a tabulated format that is distinct from the reported performance. The "Performance Characteristics" section outlines various analytical performance aspects, and the "Method comparison with Laboratory Reference device" section provides data related to accuracy. We can infer the performance metrics from this section.

2. Sample size used for the test set and the data provenance:

• Accuracy Study (Method Comparison):
  • Sample Size: 260 capillary samples from patients (assumed to be from patients on warfarin therapy, based on the study's purpose).
  • Data Provenance: The document does not explicitly state the country of origin. It indicates that the study was performed at "three clinical sites" for the repeatability study which is likely part of the overall clinical evaluation. It is a prospective study as fresh capillary samples were tested.
• Repeatability Study:
  • Sample Size: 269 paired tests (meaning 269 subjects, with two fingersticks each)
  • Data Provenance: Performed at "three clinical sites". Subjects included "normal subjects and patients on warfarin therapy." Likely prospective.
• Reproducibility Study:
  • Sample Size: 90 (N=90 for each plasma level, though the number of individual devices/runs contributes to this count).
  • Data Provenance: Performed using "two levels of plasma samples". No country of origin mentioned. Likely prospective laboratory study.
• Reference Range Study:
  • Sample Size: 134 healthy subjects.
  • Data Provenance: Conducted across "three sites." Likely prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

The document does not mention the use of experts to establish ground truth for the test set in the context of diagnostic interpretation.

For the Accuracy Study (Method Comparison), the "ground truth" (reference method) was established by the Instrumentation Laboratory ACL TOP® 500 laboratory analyzer using HemosIL® RecombiPlasTin 2G recombinant human tissue thromboplastin reagent. This is a recognized laboratory method, not human expert consensus.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

No adjudication method for human interpretation is mentioned, as the primary comparison is against a reference laboratory instrument, not human readers.

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:

No MRMC study was performed or described. This device is an in-vitro diagnostic system that directly measures INR, not an AI-assisted diagnostic imaging or interpretation tool for human readers.

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

Yes, the studies described are of the device in a standalone capacity. The microINR® System itself performs the measurement and displays the INR result. The "Performance Characteristics" and "Comparison Studies" sections detail the analytical performance of the device without human intervention impacting the measurement itself, other than proper sample application.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The ground truth used for the accuracy study was the measurement from a validated laboratory reference device:

• Instrumentation Laboratory ACL TOP® 500 laboratory analyzer using HemosIL® RecombiPlasTin 2G recombinant human tissue thromboplastin reagent.

For other analytical studies like precision and reproducibility, the ground truth is often inherent in the repeatability/reproducibility metrics themselves (i.e., how consistently the device measures its own result) or against certified control materials.

8. The sample size for the training set:

The document does not explicitly describe a separate "training set" in the context of algorithm development. In IVD devices like this, the device is typically developed and validated using a structured R&D process, and these performance studies represent the final validation. If any internal algorithm development or calibration involved data, it's not disclosed as a distinct "training set" in the submission summary.

9. How the ground truth for the training set was established:

As no explicit training set is detailed, information on how its ground truth was established is not available in the provided text. The calibration of the microINR® Chips is done against a reference lot of human recombinant thromboplastin traceable to the World Health Organization International Reference Preparation. This could be considered part of the "ground truth" establishment for the device's inherent measurement capability.

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