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The microINR System measures prothrombin time (PT) expressed in International Normalized Ratio (INR), for monitoring oral anticoagulant therapy with warfarin.

The microINR System consists of a meter and chips (test strips) and uses fresh capillary whole blood from a fingerstick. The microINR System is intended for patient self-testing use as well as for healthcare professionals at Point of Care settings.

The microINR System is intended for use in patients 18 years old or older. Patients must be stable on warfarin medication for at least 6 weeks before starting to use the microINR System.

For self-testing use: The system is intended for properly trained users under specific prescription of a physician.

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 System is comprised of a portable measuring device (microINR, microINR Link and microINR Expert 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 meters measure 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.

The microINR System measures prothrombin time (PT) expressed in International Normalized Ratio (INR) for monitoring oral anticoagulant therapy with warfarin.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) clearance letter:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined "acceptance criteria" in terms of specific thresholds for slope, intercept, Pearson correlation, SD, or CV%. Instead, it presents the performance characteristics demonstrated by the studies. The comparison to predicate devices, and the conclusion of substantial equivalence, imply that these reported performance values were considered acceptable.

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The microINR System measures prothrombin time (PT) expressed in International Normalized Ratio (INR), for monitoring oral anticoagulant therapy with warfarin.

The microlNR System consists of a meter and chips (test strips) and uses fresh capillary whole blood from a fingerstick. The microlNR System is intended for patient self-testing use as well as for healthcare professionals at Point of Care settings.

The microlNR System is intended for use in patients 18 years old or older. Patients must be stable on warfarin medication for at least 6 weeks before starting to use the microINR System.

For Self-testing use: The System is intended for properly trained users under specific prescription of a physician. Caution: The microINR System is not in patients who are transitioning from heparin treatment to VKA therapy. The microINR System is not intended to be used for screening purposes.

The modified device microINR System containing the microINR Expert Meter is derived from the existing devices microINR Meter and microINR Link Meter. The change is for the incorporation of additional connectivity functions (Wi-Fi and Ethernet connectivity on top of the Bluetooth connectivity of the microINR Link), a touchscreen, a barcode scanner as well as other configurable settings and optional functions (such as the option of including operator and patient identification). All the actions related to the extra functionalities and configurable settings are set before or after performing the analytical test. The fundamental scientific technology of the modified device and its performance has not changed. No performance changes to the microINR System have been implemented since its initial clearance on K180780 and its home use clearance in K201185.

The provided text is a 510(k) summary for the microINR System, specifically addressing changes made to the device (the incorporation of the microINR Expert Meter). The key takeaway from the document is that the fundamental scientific technology and performance of the device have NOT changed. The modifications primarily involve connectivity, user interface, and optional features.

Therefore, the document does not present new performance data based on a new study for the microINR System's core functionality (measuring PT/INR). Instead, it relies on the performance previously cleared under K180780, K201185, and K231711. The testing described in section 7 ("Testing on the modified device was conducted as follows: Software verification and validation; testing for Radiofrequency, Electromagnetic Compatibility and Electrical Safety: Cybersecurity analysis and testing; and Usability testing.") relates to the new functionalities added to the expert meter, not the core PT/INR measurement.

Given this, I cannot extract numerical "acceptance criteria" and "reported device performance" directly from this document for the PT/INR measurement. The document states:

• "No performance changes to the microINR System have been implemented since its initial clearance on K180780 and its home use clearance in K201185."
• "The fundamental scientific technology of the modified device and its performance has not changed."
• "The performance characteristics of the microINR System remain the same."

Therefore, for the purpose of answering your request based solely on the provided text, the answer will reflect that the core performance information is not detailed here, as the submission focuses on documenting that the new components do not negatively impact the already cleared performance.

Here's the information based on the provided text, with explicit notes where information is not available or where the focus is on the new functionalities rather than the core PT/INR measurement:

Acceptance Criteria and Device Performance for microINR System (Focus on New Expert Meter Functionalities)

The provided 510(k) summary for the microINR System (K243543) primarily addresses changes related to the incorporation of the "microINR Expert Meter," which introduces additional connectivity, a touchscreen, barcode scanner, and other configurable settings. The document explicitly states that the fundamental scientific technology and the performance of the device related to its intended use (measuring Prothrombin Time/INR) have not changed from previous clearances (K180780, K201185, K231711).

Therefore, the "study" described in the document primarily focuses on verifying and validating these new functionalities to ensure they do not introduce new questions of safety or effectiveness, rather than re-evaluating the core PT/INR measurement accuracy.

1. Table of Acceptance Criteria and Reported Device Performance

As the core performance of the PT/INR measurement is stated to be unchanged and reliant on previous clearances, a specific table of numerical acceptance criteria and reported new performance for PT/INR is not present in this document. The testing detailed pertains to the new functionalities of the Expert Meter. The acceptance criteria for these new functionalities are broadly stated as:

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

The document does not specify quantified sample sizes for the testing of the new functionalities. It generally refers to "Software verification and validation; testing for Radiofrequency, Electromagnetic Compatibility and Electrical Safety: Cybersecurity analysis and testing; and Usability testing."

Data provenance (e.g., country of origin, retrospective/prospective) for these specific verification and validation activities is not detailed.

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

Given that the document focuses on technical verification (software, electrical, cybersecurity) and usability of new features (connectivity, touchscreen, barcode scanner), and not the diagnostic accuracy of PT/INR measurement, the concept of "experts establishing ground truth" in the clinical sense (e.g., radiologists for imaging) is not directly applicable here. The ground truth for these tests would be technical specifications and user expectations. The document does not specify the number or qualifications of personnel involved in these specific verification and validation activities.

4. Adjudication Method for the Test Set

Not applicable in the context of the described technical verification and validation of new functionalities. Adjudication methods like 2+1 or 3+1 are typical for clinical outcome or diagnostic accuracy studies involving human interpretation, which is not the focus of the testing described for this device's modifications.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No MRMC study was done or described in this document. This type of study is relevant for AI-assisted diagnostic tools where human reader performance is being evaluated, which is not the nature of the microINR System or the modifications herein.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The microINR System is a point-of-care device that requires human interaction (fingerstick, applying blood, reading results). Therefore, a purely "standalone" (algorithm only) performance is not a direct concept for this type of device. The document states that the "fundamental scientific technology... has not changed," implying that the core measurement algorithm's performance remains as previously cleared. The current submission focuses on added functionalities (connectivity, display) to an already cleared system.

7. The Type of Ground Truth Used

For the new functionalities tested: The ground truth would be based on engineering specifications, software requirements, cybersecurity standards, and usability design principles. The document does not specify the exact methods or "ground truth" for each of these technical tests, only that they met pre-determined acceptance criteria.

For the core PT/INR measurement: This information would reside in the previous 510(k) submissions (K180780, K201185, K231711). Typically, ground truth for INR devices is established against a reference laboratory method (e.g., plasma-based PT/INR using a validated coagulometer).

8. The Sample Size for the Training Set

The document does not describe a "training set" in the context of machine learning model development. This device is an in-vitro diagnostic (IVD) device, not an AI/ML diagnostic tool that requires a training set for model development in the same way. The core measurement algorithm's development (if it had a "training" phase) would have occurred prior to the initial clearances.

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

Not applicable as this is not an AI/ML device that uses a "training set" in the described context.

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The Xprecia Prime™ Coagulation System, which includes the INR Coagulation Analyzer (Meter) and PT/INR Test Strips, is for the determinational Normalized Ratio (INR) for the monitoring of oral anticoagulation therapy with Warfarin (a vitamin K antagonist) in fresh capillary whole blood from a fingerstick. The results are reported in INR as well as in seconds. It is intended to be used to monitor patients 18 years of age or older who are stable on vitamin K antagonist therapy for at least six weeks and is not intended for use in patients who are transitioning from heparin treatment to vitamin K antagonist therapy. The Xprecia Prime™ Coagulation System is an in-vitro diagnostic device intended for multi-patient use in professional healthcare settings including CLIA Waived and Point of care settings.

The Xprecia Prime™ Coagulation System has been specifically designed to monitor INR of patients undergoing anticoagulation therapy with warfarin (Vitamin K antagonist). It consists of the Xprecia Prime " Coagulation Analyzer, Xprecia Prime™ PT/INR Test Strips and Xprecia " Systems PT Controls.

The Xprecia Prime™ Coagulation System analyses a blood sample taken from the patient by fingerstick. The sample is transferred from the patient's finger to a test strip that has been inserted in the Xprecia Prime™ Coagulation Analyzer. The blood is mixed with a reagent contained within the strip and the analyzer detects when clotting has occurred. The result is then displayed on the analyzer's screen in either units known as the International Normalized Ratio (INR) or in calibrated seconds.

The provided text describes the acceptance criteria and the study that proves the device meets those criteria for the Xprecia Prime Coagulation System.

1. Table of Acceptance Criteria and the Reported Device Performance:

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

• Precision/Reproducibility:
  • Intermediate Precision: Single site, 20 days, two runs/day, two replicates (total N for LQC is not explicitly stated but implied by the study design).
  • Reproducibility: 5-day study, multiple sites, untrained intended use operators (IUO), LQC material (total N for LQC not explicitly stated).
  • Capillary Repeatability: Enrolled subjects, duplicate results (total N not given, but mentioned as "all sites").
• Assay Reportable Range: Established through method comparison studies.
• Interference Limits: Whole blood from normal subjects and patients on VKA therapy, spiked separately with interferents (N not explicitly stated).
• Hematocrit Range: 371 patients across four intended use sites. Data collected included capillary blood samples for Xprecia Prime System INR, citrated plasma samples for central laboratory INR (Sysmex® CS-2500), and measured EDTA venous whole blood hematocrit.
• Method Comparison with Predicate Device: 401 capillary samples. (Provenance: Not explicitly stated, but often multi-site clinical studies occur in the US for FDA submissions, however, the location specified for the predicate device comparison is not mentioned).
• Method Comparison with Reference Device: 397 samples. Performed at 4 clinical sites in the US.
• Expected Values/Reference Range: 120 patients who were not on oral anticoagulant therapy. (Provenance: Not explicitly stated, but likely from clinical sites involved in other studies).

Data Provenance: The studies for "Method Comparison with Reference Device" were performed at 4 clinical sites in the US. Most other studies imply fresh patient samples or LQC material, suggesting prospective data collection for the specific studies. The general provenance for all studies aside from the one specified as US is not explicitly stated in the provided text.

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

This device is an in-vitro diagnostic (IVD) device for measuring Prothrombin Time (PT) and International Normalized Ratio (INR), which are quantitative measurements. The ground truth for this type of device is typically established against a recognized reference method (e.g., laboratory analyzer) or a predicate device, rather than through expert consensus on qualitative interpretation.

For the method comparison studies:

• Reference Method: Sysmex® CS 2500 laboratory analyzer using Dade® Innovin® reagent. This is an automated laboratory instrument, so it doesn't involve "experts" establishing ground truth in the traditional sense of medical image interpretation. The "ground truth" is the result provided by the established laboratory method.
• Predicate Device: CoaguChek® XS System. Similarly, the predicate device's results serve as a comparative standard.

Therefore, the concept of "number of experts" and their "qualifications" for establishing ground truth for this specific IVD device is not directly applicable in the way it would be for, say, an AI-powered diagnostic imaging tool. The accuracy is assessed by comparing quantitative results to established analytical methods.

4. Adjudication Method for the Test Set:

Not applicable in the context of quantitative IVD assays compared to a reference method or predicate device. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies where expert consensus is needed to establish a qualitative ground truth (e.g., presence or absence of a disease in imaging). For this device, the "ground truth" is the numerical reading from the reference or predicate device/method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:

Not applicable. This device is an in-vitro diagnostic (IVD) system, a standalone quantitative measurement device for INR. It does not involve human readers interpreting images or data with or without AI assistance. Therefore, an MRMC study is not relevant to its evaluation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Yes, the studies evaluate the standalone performance of the Xprecia Prime™ Coagulation System (meter and test strips). The system provides a direct INR or PT in seconds result. The "algorithm" or measurement principle of the device is evaluated directly against reference methods or predicate devices. There is no human interpretation step in the device's output itself; a healthcare professional uses the device to obtain a numerical result.

7. The Type of Ground Truth Used:

The ground truth used for performance evaluation (specifically for method comparison and reportable range) was:

• Results from a reference laboratory analyzer: Siemens Sysmex® CS-2500 using Dade® Innovin® reagent.
• Results from a predicate device: CoaguChek® XS System.
• Expected values/reference range was established by testing samples from healthy individuals not on anticoagulant therapy.

8. The Sample Size for the Training Set:

The provided document describes performance studies, which generally fall under verification and validation (V&V) testing. For IVD devices, a "training set" is more relevant for machine learning algorithms. While the device contains software, the nature of the electrochemical measurement and factory calibration suggests a traditional development process. The document does not explicitly mention a "training set" in the context of developing a machine learning model. Instead, it refers to:

• Factory calibration: "Each lot of Xprecia Prime™ PT/INR Test Strips is factory calibrated to a reference lot of human recombinant thromboplastin traceable to the World Health Organization International Reference Preparation." This calibration process uses reference materials to ensure accuracy, which is somewhat analogous to training but not typically quantified as a "sample size for a training set" in the ML sense.

9. How the Ground Truth for the Training Set Was Established:

As mentioned above, a "training set" in the machine learning sense is not explicitly detailed. The fundamental "ground truth" for the device's measurement integrity and accuracy is established through:

• Traceability to WHO International Reference Preparation: For the PT/INR Test Strips, ensuring that the thromboplastin reagent is standardized against accepted international references.
• Analytical methods and reference materials: The device's electrochemical detection method is designed to measure thrombin activity, correlated with accepted PT/INR values from established reference methods and predicate devices.

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The i-STAT PTP45 cartridge is intended for use in the in vitro quantitative measurement of the extrinsic coagulation pathway when activated by thromboplastin in non-anticoagulated whole blood (venous or capillary), using the i-STAT 1 System. Measurements of prothrombin time are used to aid in the monitoring of patients receiving anticoagulant therapy with coumarin derivatives. The i-STAT PT246 Prothrombin Time test result is reported in seconds and as an International Normalized Ratio (INR). The test is intended for point of care use and is for prescription use only.

The i-STAT 1 System consists of the i-STAT 1 analyzer and the i-STAT cartridges. Other components of the i-STAT 1 System are the Electronic Simulator, the i-STAT 1 Downloader/Recharger and the i-STAT Printer. The i-STAT 1 analyzer is a handheld, in vitro diagnostic analytical device designed to run only i-STAT test cartridges. The system is designed for use by trained medical professionals at the patient point of care or in the clinical laboratory and is for prescription use only.

The i-STAT PTPlus cartridge is a coagulation cartridge for determining the time required for complete activation of the extrinsic coagulation cascade. The cartridge contains electrochemical sensors and test reagents that must be mixed with the sample. The reagents include the reactive ingredient to activate the coagulation cascade as well as electrochemical markers that generate a sensor signal when the cascade is fully activated.

The analysis time of the i-STAT PT2405 cartridge is up to 300 seconds (5 minutes). The sample volume required for the i-STAT PT2105 cartridge is approximately 20 ul of whole blood (venous or capillary) without added anticoagulant. The i-STAT PTplus cartridge is a single-use disposable unit that is self-contained. The test reagents and sample fluids do not contact the instrument or user. All the test steps and fluid movements occur within the cartridge.

The i-STAT 1 System has an internal quality control (internal simulator) and an external quality control (Electronic Simulator). The internal and external simulators are used to check the instrument signal-reading function. In addition to the quality controls within the i-STAT 1 System, liquid quality controls are available as an optional quality control methodology to meet the regulatory compliance requirements applicable to the facility where they are to be used.

The liquid quality controls are the i-STAT PT2008 Control Levels 1 and 2 and can be used for the quality control of the i-STAT PT2005 cartridge. The coagulation controls consist of lyophilized citrated human plasma and calcium chloride fluid for reconstitution.

i-STAT PT2145 Control Level 1 has been formulated to produce a normal prothrombin time. Level 2 has been formulated to produce an extended prothrombin time.

Each level of control is packaged as a box of 5 vials containing 1 mL of lyophilized citrated human plasma and 5 vials of 1.5 mL of calcium chloride diluent.

The i-STAT PT2"45 controls are intended for use with the i-STAT PTP"46 cartridge on the i-STAT System, and values assigned to these controls may not be commutable with other commercial methods.

Here's an analysis of the provided FDA 510(k) summary for the i-STAT PTplus Cartridge with the i-STAT 1 System, structured to address your request about acceptance criteria and study proof.

Device: i-STAT PTplus Cartridge with the i-STAT 1 System
Device Name: Prothrombin Time Test
Regulation Number: 21 CFR 864.7750
Regulatory Class: Class II

This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device, rather than defining specific pre-defined acceptance criteria in the same way one might for a novel high-risk device or an AI/ML product where clinical endpoints are primary. For an IVD like a PT test, the "acceptance criteria" are generally established through analytical performance metrics that demonstrate equivalence or non-inferiority to a legally marketed predicate and established scientific principles for laboratory tests. The studies predominantly prove analytical performance.

1. Table of Acceptance Criteria and Reported Device Performance

Given this is a 510(k) for an In Vitro Diagnostic (IVD) device, the "acceptance criteria" aren't explicitly stated as pass/fail thresholds against specific performance numbers in the summary. Instead, they are implicitly defined by robust analytical performance demonstrating precision, linearity, traceability, and method comparison with a predicate and a reference method. The goal is to show the new device performs comparably and acceptably for its intended use.

Here, I've interpreted "acceptance criteria" as ranges or levels of performance that are considered acceptable for a prothrombin time test, and then listed the reported device performance.

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

• Precision/Reproducibility (Liquid Controls): N=104-120 per fluid level per cartridge lot (total of 9 measurements * ~115 samples = ~1035 data points). Data provenance implied as internal laboratory study.
• Precision (Whole Blood):
  • Capillary: N=58 (non-therapeutic), N=119 (therapeutic), N=9 (very high therapeutic).
  • Venous: N=65 (non-therapeutic), N=131 (therapeutic), N=13 (very high therapeutic).
  • Data provenance: Samples collected from "three (3) point of care sites" for repeatability analysis. Implied retrospective or prospective collection based on CLSI guidelines.
• Method Comparison (vs. Predicate):
  • Venous: N=191* (samples with outliers included)
  • Capillary: N=153* (samples with outliers included)
  • Data provenance: "prospectively collected from subjects undergoing anticoagulant therapy with coumarin derivates and from subjects who were not on anticoagulant therapy at three (3) clinical sites." (Prospective)
• Method Comparison (vs. Reference):
  • Venous: N=211* (samples with outliers included)
  • Capillary: N=203* (samples with outliers included)
  • Data provenance: "prospectively collected from subjects undergoing anticoagulant therapy with coumarin derivates and from subjects who were not on anticoagulant therapy at three (3) clinical sites." (Prospective)
• Interference: Not explicitly stated N, but implied adequate for the substances tested.
• Factor Sensitivity: Not explicitly stated N.
• Fibrinogen, Platelet, Hematocrit, Heparin Sensitivity, Lupus Anticoagulant: Not explicitly stated N.
• Reference Range:
  • Capillary: N=146
  • Venous: N=154
  • Data provenance: "apparently healthy adult subjects" from "three (3) clinical sites." (Likely Prospective)

Country of Origin: Not explicitly stated, but "CLSI guidelines" are US-based and "FDA" approval implies US studies or studies compliant with US standards. Assuming US/North American origin.

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

This section is not applicable in the context of this device. This is an In Vitro Diagnostic (IVD) device for measuring a quantitative biomarker (prothrombin time). The "ground truth" for these studies is typically established by:

• Reference Methods: Such as the Sysmex CS-2500 instrument in this case, which is a laboratory instrument considered a more definitive measurement.
• Predicate Devices: The CoaguChek® XS Plus System, which is a legally marketed device used for comparison to demonstrate equivalence.
• Assigned Values for Controls/Calibrators: For analytical precision and linearity.
• Clinical Outcomes/Pathology: Not used directly for establishing "ground truth" for the PT measurement itself, but the PT values might be correlated with outcomes in broader clinical studies (which are not detailed here as part of the 510k).

There are no human "experts" rating images or making diagnoses that would require adjudication; the measurements are quantitative.

4. Adjudication Method for the Test Set

Not applicable. As a quantitative IVD, there is no subjective rating or interpretation by multiple readers that would require an adjudication method (like 2+1, 3+1 consensus for imaging studies). Measurements from instruments are taken as-is for statistical analysis.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is an In Vitro Diagnostic (IVD) device, not an AI/ML imaging device that assists human readers. Therefore, an MRMC study and analysis of human reader improvement with AI assistance are not relevant to this submission.

6. Standalone (Algorithm Only) Performance

The device itself (i-STAT PTplus Cartridge with the i-STAT 1 System) is the "standalone" diagnostic method. Its performance is measured directly by comparing its results to a predicate device and a laboratory reference instrument (Sysmex CS-2500). There isn't a separate "algorithm" that generates interpretations for human-in-the-loop use. The reported analytical performance (precision, correlation, etc.) reflects its standalone performance.

7. The Type of Ground Truth Used

The ground truth for evaluating the i-STAT PTplus cartridge performance was established primarily through:

• Validated Reference Method: The Sysmex CS-2500 (using Dade Innovin reagent) for venous plasma measurements, considered a reliable laboratory method for PT.
• Legally Marketed Predicate Device: The CoaguChek® XS Plus System, used for direct comparison to demonstrate substantial equivalence.
• Internal Control Fluids/Levels: For precision studies against known or assigned values.
• Clinical Samples: From patients on and not on anticoagulant therapy, characterized by their clinical status.

8. The Sample Size for the Training Set

Not applicable. This device does not use machine learning or AI that requires a "training set" in the traditional sense. It's a chemical and electrochemical analysis system. The development and internal validation of the cartridge's reagents and measurement principles would involve extensive R&D and analytical testing, but this isn't structured as a conventional ML training set.

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

Not applicable. As stated above, there is no AI/ML training set for this device. The "ground truth" for development and validation would involve standard analytical chemistry and medical device engineering practices, using reference materials, spiked samples, and clinical samples analyzed by established laboratory methods.

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The microINR System measures prothrombin time (PT) expressed in International Normalized Ratio (INR), for monitoring oral anticoagulant therapy with warfarin.

The microlNR System consists of a meter and chips (test strips) and uses fresh capillary whole blood from a fingerstick. The microlNR System is intended for patient self-testing use as well as for healthcare professionals at Point of Care settings.

The microlNR System is intended for use in patients 18 years old or older. Patients must be stable on warfarin medication for at least 6 weeks before starting to use the microINR System.

For Self-testing use: The System is intended for properly trained users under specific prescription of a physician. Caution: The microINR System is not in patients who are transitioning from heparin treatment to VKA therapy. The microINR System is not intended to be used for screening purposes.

The modified device microINR System containing the microINR Link Meter is derived from the existing device microINR Meter. The change is for the addition of Bluetooth connectivity to the meter. Bluetooth functionality stays inactive during the testing/measuring process. All the actions related to Bluetooth functionality are set before or after performing the analytical test. The fundamental scientific technology of the modified device and its performance has not changed. No performance changes to the microINR System have been implemented since its clearance on K201185.

This document (K231711) describes a Special 510(k) submission for the microINR System. This type of submission is used when changes are made to a previously cleared device, and it aims to demonstrate that the modified device remains substantially equivalent to the original cleared device. In this specific case, the change introduced is the addition of Bluetooth connectivity to the meter.

Because this is a Special 510(k), the focus of the testing is to demonstrate that the new functionality (Bluetooth) does not adversely affect the device's original performance and does not raise new questions of safety or effectiveness. Therefore, the acceptance criteria and study described are not for the primary device performance (e.g., accuracy of INR measurement), but rather for the impact of the newly added feature.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a specific table detailing acceptance criteria and reported device performance for the primary function of the microINR System (PT/INR measurement accuracy). This is because the original performance was established in the predicate K201185, and this submission focuses on the new Bluetooth functionality.

However, it does state general acceptance regarding the performed testing:

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

The document does not explicitly state the sample size used for the test set in the context of clinical performance or the data provenance (country of origin, retrospective/prospective). This is because the core analytical performance related to measuring INR was established with the predicate device (K201185). The testing for this Special 510(k) focused on the new Bluetooth functionality, which typically involves engineering or software testing, not patient-based clinical trials for accuracy.

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

Not applicable. The testing described for the Bluetooth feature (Radiofrequency, EMC, Electrical Safety, Cybersecurity, Usability, Software V&V) does not typically involve expert clinical ground truth establishment in the same way that a diagnostic accuracy study would.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the testing is for the impact of the new Bluetooth feature, not for diagnostic accuracy, and therefore does not rely on clinical adjudication of results.

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

Not applicable. The microINR System is a prothrombin time test device, not an AI-assisted diagnostic imaging device, and therefore MRMC studies or AI assistance effect sizes are not relevant to this submission.

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

The device is a system (meter and test strips) for measuring PT/INR. While the new Bluetooth functionality itself operates without direct human intervention once initiated, the overall device includes human interaction. The "standalone" performance here refers to the device functions for Radiofrequency, EMC, Electrical Safety, Cybersecurity, Usability, and Software verification and validation, all of which were tested without requiring a human operator to compensate for potential deficiencies in the Bluetooth module itself. The document states "Bluetooth functionality stays inactive during the testing/measuring process. All the actions related to Bluetooth functionality are set before or after performing the analytical test." This indicates the Bluetooth module's performance was assessed without interfering with the core measurement, and implicitly, its standalone function (transferring data) was verified.

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

For the testing related to the Bluetooth functionality:

• Radiofrequency, Electromagnetic Compatibility, Electrical Safety: Ground truth would be defined by relevant international and national standards and regulations (e.g., ISO, IEC standards for medical devices and radio equipment).
• Cybersecurity Analysis: Ground truth is established by recognized cybersecurity standards, best practices, and vulnerability assessment methodologies.
• Usability Testing: Ground truth is established by user feedback and observation against established usability heuristics and design principles for medical devices, potentially defined by standards like IEC 62366.
• Software Verification and Validation: Ground truth is established by the software requirements specification, design documents, and coding standards, ensuring the software performs as intended according to its formal definition.

For the primary device function (PT/INR measurement accuracy) which was established with the predicate, the ground truth would typically be a laboratory reference method for PT/INR.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/machine learning device that requires a "training set" in the conventional sense. The testing performed here (Radiofrequency, EMC, Electrical Safety, Cybersecurity, Usability, Software V&V) involves engineering and software validation, not the development of a predictive model.

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

Not applicable, as there is no "training set" for this type of device and submission.

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The STA- NeoPTimal kits provide thromboplastin reagents from rabbit brain extract, for the quantitative determination, in human citrated plasma (3.2% sodium citrate), of Prothrombin Time (PT) on STA-R family, STA Compact family and STA Satellite family instruments. STA- NeoPTimal is a coagulation screening test intended to be used by professional laboratory personnel for the evaluation of the extrinsic coagulation pathway and the monitoring of oral vitamin K antagonist therapy using the International Normalized Ratio (INR).

The in-vitro diagnostic STA® - NeoPTimal kits are available in two sizes and contains:
STA® - NeoPTimal 5: 6 x 5 ml vials of Reagent 1, 6 x 5 ml vials of Reagent 2
STA® - NeoPTimal 10: 12 x 10 ml vials of Reagent 1, 12 x 10 ml vials of Reagent 2
Reagent 1 is STA® - NeoPTimal, lyophilized thromboplastin prepared from rabbit brain extract. The STA® - NeoPTimal reagent contains a specific heparin inhibitor. Any prolongation of the prothrombin time is, therefore, related to a real deficiency of factor II, V, VII, X and/or fibrinogen.
Reagent 2 is a solvent containing calcium.
The test consists of the use of calcium thromboplastin to measure the clotting time of the patient's plasma and to compare it with that of a normal standard. The test measures, as a whole, the activities of the coagulation factor II (prothrombin), factor V (proaccelerin), factor VII (proconvertin), factor X (Stuart factor) and factor I (fibrinogen).
The PT value is expressed in seconds or INR. The result has to be interpreted according to the patient's clinical and biological states. The INR value corresponds to the ratio of the patient's PT to that of the standard PT raised to the ISI (International Sensitivity Index) power of the thromboplastin used:
INR = ( Patient's PT / Mean Normal PT ) * ISI
The ISI value of a given thromboplastin is determined by testing normal plasma and VKA (vitamin K antagonist)-treated patient plasma with that thromboplastin and with the International Reference preparation (RBT) for thromboplastin.

The provided text is a 510(k) summary for a medical device called STA-NeoPTimal, which is a Prothrombin Time (PT) test. The document primarily focuses on the device's performance characteristics, stability, and comparison to a predicate device. It does not describe a study involving human readers or AI assistance. Therefore, I cannot extract information related to MRMC studies, the number of experts for ground truth, or the sample size of a training set for an AI model from this document.

However, I can provide information based on the performance criteria and studies detailed in the document for the STA-NeoPTimal device itself.

Here's the information extracted and organized as requested, with details that are present in the document:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" values in a table for each performance characteristic but rather describes that "acceptance criteria were met for all samples in the studies." The tables provided show the reported device performance.

Table of Performance Characteristics (Reported Device Performance)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Precision/Reproducibility (Single-site): Each sample type (11 samples for seconds, 7 for INR) was tested with N=240 replicates (2 replicates/day over 20 days) on each of three instruments (STA R Max, STA Compact Max, STA Satellite). Data provenance is "one external site" for single-site testing.
• Precision/Reproducibility (Multi-site): Each sample type (11 samples for seconds, 7 for INR) was tested with N=270 replicates (2 runs/day over 5 days at 3 sites per analyzer). Data provenance is "three external sites" per analyzer.
• Extrinsic Factor Sensitivity: Not explicitly stated, but implies the use of contrived samples with known factor levels.
• Interferences: Four samples were used: 1 normal, 2 VKA patient samples (INR 2.0-3.0 and 3.1-4.5), and 1 Deficient V patient sample.
• Sample Stability (Room Temperature): Four normal samples and eight VKA samples (INR 1.5 to 5.5).
• Sample Stability (Long-term Frozen): 53 samples stored at ≤ -70°C (Normal and VKA patient samples with INR between 1.5 and 5.0).
• Shelf-life Stability: 10 samples (Normal, VKA patient samples with INR 2-4.5, Deficient V, Quality controls).
• In-Use Stability: Six samples (Normal, VKA 2-3, VKA 3-4.5, Deficient V, Two controls).
• Method Comparison: Not explicitly stated, but it was an "external method comparison study" involving "four sites" comparing STA NeoPTimal with Thromborel S.
• Reference Interval: 137 patients. Data provenance is "across three external sites."

The document does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective, but as performance validation studies for a device, they are typically prospective.

3. 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)

This is not applicable as the device is an in-vitro diagnostic test for Prothrombin Time, and the "ground truth" (or reference values) is established through laboratory methods and reference standards, not expert interpretation of qualitative data like images.

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

Not applicable for this type of in-vitro diagnostic device performance study.

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

Not applicable. The document describes a laboratory diagnostic device, not an AI-assisted diagnostic tool that would involve human readers interpreting results.

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

The device is a standalone in-vitro diagnostic reagent kit used on automated instruments (STA-R family, STA Compact family, STA Satellite family). Its performance is evaluated directly (algorithm-like in terms of automated measurement) without direct human interpretation in the loop of the measurement itself, though human professionals use the results.

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

The "ground truth" for this in-vitro diagnostic device is established by:

• Reference Intervals: Determined using a population of 137 patients according to CLSI guideline EP28-A3c.
• Comparison to Predicate Device: Performance is compared to an existing, legally marketed predicate device (Thromborel® S) using a method comparison study.
• Known Concentrations/Levels: For intrinsic validity testing like Extrinsic Factor Sensitivity and Interference studies, controlled samples with known concentrations of factors or interfering substances are used.
• Standardized Prothrombin Time Measurement: The core measurement (PT) itself is a standardized laboratory test.

8. The sample size for the training set

Not applicable. This document describes a new in-vitro diagnostic reagent, not a machine learning model. There is no concept of a "training set" in this context.

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

Not applicable.

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The Coag-Sense Prothrombin Time (PT) / INR Monitoring System for Patient Self-Testing is an in vitro diagnostic device that provides quantitative prothrombin time (PT) results, expressed in INR units. It uses fresh capillary whole blood.

The Coag-Sense Prothrombin Time (PT) / INR Monitoring System for Patient Self-Testing is intended for use by properly selected and suitably trained patients or the order of the treating physician to monitor patients who are on anticoagulation therapy. Patients should be stabilized on warfarin-type (coumarin) anticoagulation therapy prior to self-testing.

The Coag-Sense Prothrombin Time (PT)/INR Monitoring System for Patient Self-Testing is not intended to be used for screening purposes.

The Coag-Sense Prothrombin Time (PT)/INR Monitoring System for Patient Self-Testing is intended to be used by a single person and should not be shared.

The Coaq-Sense Prothrombin Time (PT)/INR Monitoring System for Patient Self-Testing is a portable medical device for the measurement of the Prothrombin Time (PT) using fresh capillary whole blood obtained from a finger stick. The Coag-Sense Prothrombin Time (PT)/INR Monitoring System for Patient Self-Testing is a handheld device that directly detects clot formation. The System measures the PT of fresh capillary whole blood using micromechanical end point detection. The test is performed by inserting a test strip into the meter and applying a drop of blood to the sample receptacle of the disposable test strip. The test strip contains a rotating, spoked wheel that draws the sample into the reaction well after it is applied to the sample receptacle. The spokes rotate across the path of an infrared light beam and mix the liquid sample with the thromboplastin which is dried in the reaction well. When the sample clots, the clot is picked up by the spokes, interrupting the path of the infrared light beam that is detected by the meter.

The PT test and the result is displayed as International Normalized Ratio (INR). The result is date/time stamped and stored in the memory of the meter.

The device is powered by 4 AA batteries. This Coag-Sense Prothrombin Time (PT)//NR Monitoring System for Patient Self-Testing uses the exact same test and control strip as the predicate devices.

The information provided describes a Special 510(k) submission for the Coag-Sense Prothrombin Time (PT) / INR Monitoring System for Patient Self-Testing (K212779). This submission focuses on modifications to the user interface (from touchscreen to button navigation) and power source, asserting substantial equivalence to its predicate device (K183255).

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

Acceptance Criteria and Reported Device Performance

The document states that "All testing results met the pre-determined acceptance criteria that were established in the test protocols." However, the specific quantitative acceptance criteria for each test and the corresponding reported performance values are not explicitly listed in a detailed table format within the provided text. The text generally states that the device "demonstrated that it met the predetermined acceptance criteria and design specifications."

Based on the available text, a table can be constructed to show the types of tests performed and the general statement about meeting criteria, rather than specific numerical acceptance criteria and performance data.

Study Details:

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

   • Test Set Sample Size: The document does not specify a numerical sample size for the test set used in the functional bench testing, electrical safety/EMC testing, or software V&V. For the usability study, it mentions "All users" and "100% of professional and self-test users," but does not provide the number of users involved. For the side-by-side performance comparison, it mentions "identical test samples" but does not specify the number of samples.
   • Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be prospective in nature, as they were conducted specifically for this 510(k) submission to verify the modified device's performance.

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. The testing described (functional, electrical, software V&V, usability, and side-by-side performance) does not typically involve "experts" establishing a "ground truth" in the same way clinical diagnostic studies might (e.g., radiologists interpreting images). Instead, performance is assessed against established engineering specifications, regulatory standards, or predicate device results. For the usability study, users evaluated the device, but they are not described as "experts" establishing a "ground truth."

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

   • This information is not provided and is generally not applicable to the types of engineering and performance verification tests described for this device. Adjudication methods are typically associated with clinical studies involving interpretation of results by multiple human readers.

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 MRMC study was done. This device is a Prothrombin Time (PT) / INR Monitoring System, which measures a physiological parameter. It is an in vitro diagnostic device, not an AI-assisted diagnostic tool that would typically involve human readers interpreting results with or without AI assistance. The study described focuses on device performance and usability, not on improving human reader effectiveness.

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

   • The core of the described studies focuses on the standalone performance of the modified device. The functional bench testing, electrical safety/EMC testing, and software verification/validation are all evaluations of the device itself (algorithm and hardware) without human interpretation affecting the primary measurement. The side-by-side comparison also assesses the device's measurement accuracy against a predicate. While there is a human user interface, the primary measurement output (PT/INR) is generated by the device's mechanism and algorithm. Therefore, yes, standalone performance was assessed in the sense that the device's ability to generate accurate PT/INR results was verified independently.

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

   • The "ground truth" for the various performance tests seems to be based on:
     • Predetermined acceptance criteria and design specifications: For functional, electrical safety, and software V&V.
     • Applicable electrical safety standards (e.g., IEC 61010-1): For electrical safety and EMC.
     • Predicate device results: For the side-by-side performance comparison, where the predicate device served as the established reference for "no difference" in results.
     • User feedback: For the usability study.

7. The sample size for the training set:

   • Not applicable / Not explicitly provided. This submission is for modifications to an existing device and focuses on verification and validation of those changes. There is no mention of a "training set" in the context of machine learning model development. The device's underlying algorithm for detecting clot formation (micromechanical end point detection) is established and not part of a machine learning paradigm that would typically involve training sets.

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

   • Not applicable. As a traditional in vitro diagnostic device, the concept of a "training set" and "ground truth establishment" for it as it relates to machine learning is not relevant to this submission.

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HemosIL ReadiPlasTin is an in vitro diagnostic thromboplastin reagent, based on recombinant human tissue factor, for the quantitative determination, in human citrated plasma, of Prothrombin Time (PT) and Fibrinogen, on the ACL TOP Family and ACL TOP Family 50 Series of analyzers. The product is intended to be used for the extrinsic coagulation pathway and the monitoring of Oral Vitamin K Antagonist Therapy.

The thromboplastin reagent included in the ReadiPlasTin kit, after mixing with the ReadiPlasTin Diluent, is a liposomal preparation that contains recombinant human tissue factor (RTF), re-lipidated in a synthetic phospholipid blend. In the PT test, the addition of the tissue thromboplastin (ReadiPlasTin reagent) to the patient plasma in the presence of calcium ions initiates the activation of the extrinsic pathway. This results ultimately in the conversion of fibrin, with formation of a solid gel. The fibrinogen is quantitated (PT-based method) by relating the absorbance or light-scatter during clotting to a calibrator.

The provided text is a 510(k) Summary for a medical device called "HemosIL ReadiPlasTin." This document doesn't describe an AI/ML-based device, but rather an in vitro diagnostic (IVD) reagent used for Prothrombin Time (PT) and Fibrinogen determination. Therefore, many of the requested categories related to AI/ML device testing (e.g., number of experts for ground truth, adjudication method, MRMC study, training set information) are not applicable to this type of submission.

However, I can extract the relevant information regarding acceptance criteria and performance studies for this IVD device.

Here's a breakdown of the requested information, adapted for an IVD reagent:

Device: HemosIL ReadiPlasTin (In vitro diagnostic thromboplastin reagent)
Purpose: Quantitative determination of Prothrombin Time (PT) and Fibrinogen in human citrated plasma.
Reason for Submission (K213426): Reformulation of the existing HemosIL ReadiPlasTin by adding EDTA as a stabilizer and removing unnecessary fillers.

1. Table of Acceptance Criteria and Reported Device Performance

For this IVD, "acceptance criteria" are typically defined by the method validation standards (e.g., CLSI guidelines) and the equivalence to the predicate device. The performance data presented are the results of meeting these criteria.

• PT: UFH (1.0 IU/mL), LMWH (1.4 IU/mL), Hemoglobin (500 mg/dL), Triglycerides (1000 mg/dL), Bilirubin (Conjugated & Unconjugated) (50 mg/dL), Daptomycin (100 µg/mL)
• Fibrinogen: UFH (1.5 IU/mL), LMWH (1.7 IU/mL), Hemoglobin (500 mg/dL), Triglycerides (600 mg/dL), Bilirubin (Conjugated & Unconjugated) (50 mg/dL), Daptomycin (200 µg/mL) | New claims for daptomycin and conjugated bilirubin interference were added. The study used 2 clinical sample levels for both PT and Fibrinogen. |
  | Method Comparison | Strong correlation and agreement between the subject device and the predicate device (HemosIL RecombiPlasTin 2G). Slope should be near 1, intercept near 0, and correlation coefficient (r) close to 1. | ACL TOP Family:
• PT (INR): Slope 1.031 (95% CI 1.009, 1.053), Intercept -0.043 (-0.068, -0.018), r 0.997
• Fibrinogen (mg/dL): Slope 0.975 (95% CI 0.963, 0.986), Intercept 7.171 (3.842, 10.50), r 0.995
  ACL TOP Family 50 Series:
• PT (INR): Slope 1.021 (95% CI 0.999, 1.043), Intercept -0.034 (-0.060, -0.009), r 0.996
• Fibrinogen (mg/dL): Slope 1.015 (95% CI 1.003, 1.027), Intercept -0.811 (-4.148, 2.527), r 0.994 | All method comparison results demonstrated excellent correlation and agreement, supporting substantial equivalence. |
  | Open Vial Stability | Maintain performance for 10 days at 2-8°C in closed original vial after preparation. | "The results support the following labeled open vial stability claim: Once prepared for use, 10 days at 2-8℃ in closed original vial" | Tested across 3 lots per CLSI EP25-A. |
  | On-board Instrument Stability | Maintain performance for 10 days at 15°C on the ACL TOP Family and ACL TOP Family 50 Series after preparation. | "The results support the following labeled on-board instrument stability claim: Once prepared for use, 10 days at 15°C on the ACL TOP Family and ACL TOP Family 50 Series" | Tested across 3 lots per CLSI EP25-A. |
  | Real-time Shelf-life Stability | Device maintains stated performance throughout its claimed shelf-life. | "The study will continue to a point past final claim." (Ongoing assessment to support shelf-life). | Tested across 3 lots per CLSI EP25-A. |

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

• Precision:

  • Sample Size: 80 measurements per instrument per lot (n=80/instrument/lot) for PT (controls + 6 native patient samples) and Fibrinogen (controls + 6 fibrinogen sample pools at 3 levels). Tested across 3 lots and representative members of both ACL TOP Family and ACL TOP Family 50 Series.
  • Data Provenance: Not explicitly stated, but "native (unadulterated) patient samples" and "fibrinogen sample pools" suggest human biological samples. Typically, these studies are conducted in a controlled laboratory setting (Likely within the manufacturer's R&D facilities or a contract research organization). The document is submitted to the US FDA, implying relevance to the US market. The retrospective/prospective nature is generally prospective for these types of validation studies.

• Interference:

  • Sample Size: Two clinical sample levels each for PT (normal pooled plasma and a high INR clinical sample) and Fibrinogen (normal pooled plasma and a low fibrinogen sample). Specific "n" per concentration/sample type is not given, but refers to CLSI EP07, 3rd Ed and CLSI EP37, 1st Ed which define the study design.
  • Data Provenance: Not explicitly stated, but "clinical sample levels" implies human biological samples.

• Method Comparison:

  • Sample Size:
    • PT (INR): 160 samples (normal and abnormal) for both ACL TOP Family and ACL TOP Family 50 Series.
    • Fibrinogen (mg/dL): 135 samples for ACL TOP Family, 134 samples for ACL TOP Family 50 Series.
  • Data Provenance: Not explicitly stated, but "normal and abnormal samples" implies human biological samples. The study was "in-house."

• Open Vial and On-board Instrument Stability:

  • Sample Size: For PT, controls and four native (unadulterated) patient samples were tested in eight replicates at each time interval. For Fibrinogen, controls and six fibrinogen sample pools at three levels were tested in eight replicates at each time interval.
  • Data Provenance: Not explicitly stated, but "native (unadulterated) patient samples" and "fibrinogen sample pools" imply human biological samples.

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

This is not applicable for this type of IVD device. The ground truth for chemical assays like PT and Fibrinogen is established through precise measurement methods and reference materials, not through expert consensus of visual or diagnostic interpretations. The "truth" is the quantitative value derived from the reference method or calibrator.

4. Adjudication Method for the Test Set

Not applicable, as this is an IVD reagent and not an AI/ML-based diagnostic system requiring human interpretation or adjudication.

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

Not applicable, as this is an IVD reagent and not an AI/ML-based diagnostic system involving human interpretation.

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

Not applicable, as this is an IVD reagent. Its performance is inherent to the chemical reaction and the analytical instrument it is used with.

7. The Type of Ground Truth Used

The "ground truth" for this IVD is established by:

• Reference Methods/Materials: For PT and Fibrinogen, this would rely on internationally recognized standards and calibrators, and the values obtained from a validated reference method (or the predicate device in method comparison studies).
• Known Concentrations: For linearity and interference studies, samples are often spiked with known concentrations of analytes or interfering substances.
• Validated Predicate Device: In the method comparison study, the predicate device (HemosIL RecombiPlasTin 2G) serves as the comparator for verifying the new formulation's performance.

8. The Sample Size for the Training Set

Not applicable. This is an IVD reagent, not an AI/ML model that requires a "training set." The development of the reagent involves chemical formulation and optimization, not data-driven machine learning.

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

Not applicable, as there is no "training set" for an IVD reagent.

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The microlNR System measures prothrombin time (PT) expressed in International Normalized Ratio (INR), for monitoring oral anticoagulant therapy with warfarin.

The microINR System consists of a microINR Meter and microINR Chip and uses fresh capillary whole blood from a fingerstick.

The microINR System is intended for patient self-testing use as well as for healthcare professionals at Point of Care settings.

The microlNR System is intended for use in patients 18 years old or older. Patients must be stable on warfarin medication for at least 6 weeks before starting to use the microINR System.

For Self-testing use: The System is intended for properly trained users under specific prescription of a physician. Caution: The microINR System is not in patients who are transitioning from heparin treatment to VKA therapy. The microINR System is not intended to be used for screening purposes.

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.

Here's a summary of the acceptance criteria and study detailed in the provided document for the microINR System:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary does not explicitly list "acceptance criteria" for the self-testing use case in a table format with pass/fail thresholds. Instead, it describes clinical studies and their outcomes designed to demonstrate that the device performs equivalently for patient self-testers as for healthcare professionals, particularly in terms of accuracy and precision. The success of the study itself serves as the demonstration of meeting the required performance for the new intended use.

Here's a breakdown of the key performance metrics reported, framed against the implicit acceptance criterion of equivalence to healthcare professional (HCP) results and a laboratory reference:

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

• Accuracy (PST vs. HCP): N = 225 patients. The study was conducted at "four clinical sites" and involved patients self-testing in a "home setting for up to 2 weeks" with "2 scheduled visits to their study site." This indicates a prospective study design. The country of origin of the data is not specified.
• Accuracy (PST vs. Laboratory System): N = 112 patients. Data collected at the second visit by PSTs was compared to a laboratory system. As part of the same study as above, this is also prospective, and the country of origin is not specified.
• Precision (PST): N = 110 patients (paired results). Data collected by patient self-testers at the second visit to the clinical sites. This is also prospective, and the country of origin is not specified.

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

For the ground truth comparison:

• Healthcare Professionals (HCPs): The study compares patient self-tester results to "healthcare professionals using the microINR® System." While the exact number of HCPs is not stated, it implies multiple professionals across the four clinical sites. Their specific qualifications (e.g., radiologist with 10 years of experience) are not provided, beyond being "healthcare professionals."
• Laboratory System: The "ACL TOP 500" is cited as the reference laboratory system. This is an automated coagulation analyzer, implying the ground truth was established by a validated laboratory method rather than individual expert consensus.

4. Adjudication Method for the Test Set

The document does not describe an explicit adjudication method (like 2+1 or 3+1) for resolving discrepancies in the test set. Instead, it's a direct comparison of the microINR results from patient self-testers against the microINR results from healthcare professionals and against a reference laboratory system.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This is not applicable. The microINR System is a diagnostic medical device for measuring prothrombin time (PT) expressed as INR, not an AI-assisted diagnostic tool for interpretation by human readers. Therefore, an MRMC comparative effectiveness study where human readers improve with AI assistance is not relevant to this device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in a way. The device itself, the microINR System, is the "standalone algorithm" that measures INR. The studies evaluate its performance (accuracy, precision) in the hands of two different user groups (patient self-testers and healthcare professionals) and against a laboratory reference, effectively assessing its standalone performance for each user group.

7. The Type of Ground Truth Used

The ground truth used for the clinical studies was a combination of:

• Clinical Reference (HCP results): INR results obtained by trained healthcare professionals using the microINR System. This serves as a "human expert" benchmark for the device's performance when operated by trained professionals.
• Laboratory Reference Method: INR results obtained from a standard "laboratory system (ACL TOP 500)." This is an established independent gold standard for PT/INR measurement.

8. The Sample Size for the Training Set

The document does not explicitly state a "training set" sample size for the new intended use (patient self-testing). The microINR System was previously cleared, meaning its core algorithm for INR measurement was already established. The studies for this 510(k) are focused on validating its performance in the hands of self-testers, rather than "training" a new algorithm. The document mentions that "following training, the patients self-tested." This implies the patients themselves received training on how to use the device, not that their data was used to train the device's internal algorithm.

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

Given that this 510(k) primarily addresses a new user population for an already cleared device, there isn't a "training set" in the sense of machine learning algorithm development. The core measurement principle and validation were established under the previous clearance (K180780), which would have involved its own validation studies against established reference methods. For the current submission, the focus is on demonstrating that trained patients can achieve equivalent results, with ground truth established as described in point 7.

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The Coag-Sense® Prothrombin Time (PT) / INR Monitoring System (Self-Test) is an in vitro diagnostic device that provides quantitative prothrombin time (PT) results, expressed in seconds and INR units. It uses fresh capillary whole blood.

It is intended for use by properly selected and suitably trained patients or their caregivers on the order of the treating physician to monitor patients who are on anticoagulation therapy. Patients should be stabilized on warfarin-type (coumarin) anticoagulation therapy prior to self-testing.

The device is not intended to be used for screening purposes.

For professional users, the Coag-Sense® Prothrombin Time (PT) / INR Monitoring System is an in vitro diagnostic device that provides quantitative prothrombin time (PT) results, expressed in seconds and INR units. It uses fresh capillary whole blood. It is intended for use by health care professional at the point of care to monitor patients who are on warfarin-type (coumarin) anticoagulation therapy.

The device is not intended to be used for screening purposes.

For self-test users, the Coag-Sense® Prothrombin Time (PT) / INR Monitoring System is an in vitro diagnostic device that provides quantitative prothrombin time (PT) results, expressed in seconds and INR units. It uses fresh capillary whole blood.

The device is intended for use by properly selected and suitably trained patients or their caregivers on the order of the treating physician to monitor patients who are on anticoagulation therapy. Patients should be stabilized on warfarin-type (coumarin) anticoagulation therapy prior to self- testing.

The device is not intended to be used for screening purposes.

The Coaq-Sense Prothrombin Time (PT)/INR Monitoring System is a portable medical device for the measurement of the Prothrombin Time (PT) using fresh capillary whole blood obtained from a finger stick. The Coag-Sense Prothrombin Time (PT)/INR Monitoring System is a hand held device and directly detects clot formation. The System measures the PT of fresh capillary whole blood using micro-mechanical end point detection. The test is performed by inserting a test strip into the meter and applying a drop of blood to the sample receptacle of the disposable test strip. The test strip contains a rotating, spoked wheel that draws the sample into the reaction well after it is applied to the sample receptacle. The spokes rotate across the path of an infrared light beam and mix the liquid sample with the thromboplastin which is dried in the reaction well. When the sample clots, the clot is picked up by the spokes, interrupting the path of the infrared light beam that is detected by the meter.

The PT test and the result is displayed as International Normalized Ratio (INR) and seconds (PT). The result is date/time stamped and stored in the memory of the meter.

The device is powered by batteries and/or AC adapter. This PT/INR System uses the exact same test and control strip as the predicate devices.

This document describes the Coag-Sense Prothrombin Time (PT)/INR Monitoring System, a medical device for measuring PT/INR using fresh capillary whole blood. The submission aims to establish substantial equivalence to previously cleared predicate devices (K050243 and K093243) for both professional and self-testing use.

Here's an analysis of 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 present a specific table of numerical acceptance criteria with corresponding performance metrics for clinical accuracy or diagnostic performance (like sensitivity, specificity, or agreement with a gold standard). Instead, it discusses the successful completion of various tests against pre-determined acceptance criteria and design specifications.

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

The document does not explicitly state the sample sizes for the "test set" in the context of clinical performance or accuracy. The tests mentioned (bench, electrical safety, software V&V, usability) are primarily engineering and human factors validations, not clinical trials with patient samples.

• Data Provenance: The document does not specify the country of origin for any data or whether the studies were retrospective or prospective. Given the nature of a 510(k) submission for an in vitro diagnostic device, it's highly likely that the "comparison of strip lots" and "comparison to predicate device" studies involved prospective testing of patient or quality control samples.

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

This information is not provided in the document. For an in vitro diagnostic device like a PT/INR monitor, "ground truth" would typically be established by:

• For strip lot comparisons: Reference laboratory methods (e.g., automated coagulometers, specific plasma-based PT assays).
• For predicate device comparisons: The results from the predicate device itself, or potentially a gold-standard laboratory method the predicate device correlates with.

4. Adjudication Method for the Test Set

This information is not mentioned. Given that this is an IVD device measuring a quantitative value (PT/INR), "adjudication" in the traditional sense (multiple readers reviewing images) would not be directly applicable to the device's output. The "ground truth" would be the reference measurement.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

An MRMC study is not applicable here because the device is an in vitro diagnostic (IVD) measurement device, not an image interpretation AI tool. There's no "human reader" component in using the device that requires assistance from AI; it provides a direct quantitative measurement. Therefore, no effect size of human improvement with AI assistance is reported.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device itself is a standalone measurement system. The "algorithm" is inherent in its electromechanical design to detect clot formation and calculate PT/INR. The performance studies described (comparison of strip lots, comparison to predicate) are effectively standalone performance evaluations. The device provides a direct result without human interpretation of raw data.

7. The Type of Ground Truth Used

The document implicitly refers to the following as ground truth/reference for comparative testing:

• Standard laboratory tests: Used for calibrating Coag-Sense strip lots and confirming correlation. This implies a highly accurate and established method for measuring PT/INR.
• The predicate device: Used as the comparator for the modified Coag-Sense PT/INR meter to demonstrate equivalent or better performance.

This is best characterized as Reference Method Comparison / Comparative Performance Study rather than expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

This information is not specified. The document describes verification and validation studies but does not detail the development process of the device's internal algorithms or any machine learning components that would necessitate a "training set" in the modern AI sense. It's a bio-mechanical and electromechanical system.

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

As no "training set" (in the context of AI/ML) is explicitly mentioned, the method for establishing its ground truth is also not described. The device's operation is based on physical principles of clot detection rather than learning from a vast dataset.

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