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Alere INRatio®2 PT/INR Monitoring System (Professional Use): The Alere INRatio®2 PT/INR Monitoring System (Professional Use), consisting of the INRatio®2 Monitor and INRatio®2 PT/INR test strip, is used for quantitative determination of international normalized ratio (INR) in fresh capillary whole blood to monitor the effect of warfarin on clotting time by health care professionals. The Alere INRatio 2 PT/INR Monitoring System (Professional Use) is intended for use outside of the body (in vitro diagnostic use). The Alere INRatio®2 PT/INR Monitoring System (Professional Use) is not intended to be used for screening purposes.

Limitations: The Alere INRatio 2 PT/INR Monitoring System (Professional Use) is not intended for use in patients who are transitioning from heparin treatment to warfarin therapy.

Alere INRatio®2 PT/INR Home Monitoring System: The Alere INRatio®2 PT/INR Home Monitoring System, consisting of the INRation2 Home Monitor and INRatio®2 PT/INR test strip, is used for quantitative determination of international normalized ratio (INR) in fresh capillary whole blood to monitor the effect of warfarin therapy on clotting time by properly selected suitably trained users (by prescription for home use or other order of a treating physician). Patients must be stabilized (>6 weeks) on warfarin therapy. The The Alere INRatio 2 PT/INR Home Monitoring System is intended for use outside of the body (in vitro diagnostic use). The Alere INRatio®2 PT/INR Home Monitoring System is not intended to be used for screening purposes.

Limitations: The Alere INRatio®2 PT/INR Home Monitoring System is not intended for use in patients who are transitioning from heparin treatment to warfarin therapy.

The INRatio2 PT/INR Monitoring Systems (Professional and Home) perform a modified version of the one-stage Prothrombin Time test, using commercially available recombinant human thromboplastin (rhTP) reagent. The clot formed in the Prothrombin Time (PT) reaction is detected by a change in the electrical impedance of the sample during the coagulation process. The system consists of a monitor and disposable test strips. The monitor heats the test strip to the proper reaction temperature; a measure clot impedance and provides a result on a screen (user interface). The clotting reaction occurs on the Test Strip after the blood sample is applied. An International Normalized Ratio (INR) value is calculated from measured Prothrombin Time and the INR is displayed on the monitor to the user/patient.

The Alere INRatio2 PT/INR Monitoring System and INRatio2 PT/INR Test Strips were evaluated for performance against acceptance criteria. The study aimed to demonstrate equivalent or better performance compared to previously cleared devices.

Here's a breakdown of the information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides a comparison table (pages 3-6) showing the performance of the new INRatio2 PT/INR Monitoring System utilizing the modified Alere™ INRatio2 PT/INR Test Strip against the previous INRatio/INRatio2 Monitoring PT/INR Test Systems.

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The INRatio/INRatio2 PT Monitoring System is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood. The INRatio/INRatio2 PT Monitoring system is intended for use outside the body (in vitro diagnostic use). The INRatio2 PT Monitoring system is intended for professional and home use by people taking warfarin and other oral anticoaqulant (blood thinning) therapy who need to monitor the of their blood. The INRatio/INRatio2 PT Monitoring system is not intended to be used for screening purposes.

The INRatio/INRatio2 Test Strips perform a modified version of the one-stage Prothrombin Time test, using a recombinant human thromboplastin reagent. The clot formed in the Prothrombin Time reaction is detected by a change in the electrical impedance of the sample during the coagulation process. The system consists of a monitor and disposable test strips. The monitor measures impedance, heats the test strip to the proper reaction temperature, and provides a user interface. The blood sample is applied to the Test Strip and the clotting reaction occurs on the Test Strip.

The provided 510(k) summary for the INRatio/INRatio2 Test Strips focuses on demonstrating substantial equivalence to a previously cleared device through non-clinical performance testing. It explicitly states that no clinical data was presented or performed for this submission. Therefore, the information requested in the prompt regarding acceptance criteria, clinical study details, sample sizes for test/training sets, expert involvement, and ground truth establishment primarily relates to clinical studies, which are absent in this submission.

However, based on the provided text, I can extract information about the non-clinical performance testing and the basis for the substantial equivalence determination.

Here's the breakdown of what can be answered and what cannot:

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

Since no clinical data is presented, there are no specific clinical acceptance criteria or reported clinical performance metrics in this document. The document refers to non-clinical performance testing.

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

Not provided in the document. The document only mentions "Performance testing" without specifying sample sizes for the non-clinical tests or their provenance.

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):

Not applicable/Not provided. This question pertains to clinical studies and expert review for ground truth, which were not part of this submission by explicit statement.

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

Not applicable/Not provided. This question pertains to clinical studies and ground truth establishment, which were not part of this submission.

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. This device is a Prothrombin Time (PT) monitoring system, not an AI-assisted diagnostic imaging device that would typically involve human readers.

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

Not applicable. This question typically applies to AI algorithms. This device is a PT monitoring system (monitor + test strips), which measures PT directly. Its performance is inherent in the device itself, not an algorithm's interpretation of human-generated data.

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

Not provided for non-clinical testing. For the non-clinical performance, the "ground truth" would be established by reference methods or validated laboratory techniques for precision, accuracy, sensitivity, etc., but the specific methodologies are not detailed in this summary.

8. The sample size for the training set:

Not applicable/Not provided. This refers to machine learning algorithms, which are not explicitly mentioned or the focus of this submission. "Training set" typically refers to data used to train an AI model.

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

Not applicable/Not provided. As with point 8, this refers to machine learning algorithms.

Summary of Study (Based on Provided Text):

The study was a non-clinical performance comparison of the modified INRatio/INRatio2 Test Strips against the previously cleared INRatio Test Strips (predicate device, K072727).

• Objective: To verify that the modified INRatio2 Test Strips have equivalent or better performance compared to the predicate device.
• Methodology: Performance testing was conducted to evaluate "within-day precision, accuracy, heparin sensitivity, factor sensitivity, and potential interferents."
• Results: The testing "verified that the modified INRatio2 Test Strips have equivalent or better performance" across all assessed parameters.
• Conclusion: Based on this non-clinical data, the INRatio2 Test Strips were deemed substantially equivalent to the predicate device.
• Clinical Data: No clinical validation testing was performed for this submission, as explicitly stated and as per discussions with the reviewer. This implies the substantial equivalence was primarily based on the non-clinical performance data demonstrating that the modifications did not alter the fundamental performance characteristics beyond what was previously cleared.

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The INRatio 2 PT Monitoring system is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood. The INRatio 2 PT Monitoring system is intended for use outside the body (in vitro diagnostic use) by people taking warfarin and other oral anticoagulant (blood thinning) therapy who need to monitor the clotting time of their blood. The INRatio 2 PT Monitoring System is not intended to be used for screening purposes.

Like the predicate device, the INRatio 2 PT Monitoring System performs a modified version of the one-stage Prothrombin Time test, using a recombinant human thromboplastin reagent. The clot formed in the Prothrombin Time reaction is detected by a change in the electrical impedance of the sample during the coagulation process. The system consists of a monitor. disposable test strips, instruction manual, quick reference guide, training video/DVD, and testing supplies. The monitor measures impedance, heats the test strip to the proper reaction temperature, and provides a user interface. The Test Strips have not been modified from the design described in K020679.

Here's an analysis of the provided text to extract information about the acceptance criteria and the study proving device performance:

Unfortunately, the provided text does not contain the acceptance criteria or a detailed study description with performance metrics. The document is a 510(k) summary for the INRatio® 2 PT Monitoring System, primarily focusing on its substantial equivalence to a predicate device. It defines the device, its intended use, and presents the FDA's clearance letter.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or other detailed study information. The document explicitly states that the INRatio 2 PT Monitoring System is a "hardware and software modification of the INRatio System" and that "The INRatio 2 and the INRatio have the same intended use and use the same operating principle." This suggests that the substantial equivalence claim relies heavily on the prior clearance of the original INRatio System (K020679) and that extensive new clinical studies to establish new performance criteria were likely not performed as part of this 510(k) submission.

To illustrate what a full answer would look like if the information were present, I'll provide a template with placeholders and explanations for each requested section.

Acceptance Criteria and Device Performance Study Analysis (Based on Hypothetical Data)

As the provided 510(k) summary for the INRatio® 2 PT Monitoring System (K072727) does not explicitly detail acceptance criteria or a specific study proving it meets them beyond a claim of substantial equivalence to its predicate, the following information is presented as a template for what would be expected in such a description. If a detailed study was included, it was not part of the publicly available summary provided.

1. Table of Acceptance Criteria and Reported Device Performance

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The HemoSense INRatio is an in vitro diagnostic system that provides a quantitative prothrombin time results, expressed in seconds and as an International Normalized Ratio (INR). It uses fresh capillary whole blood and is intended for is intended for quantitative prothrombin time testing of fresh, capillary whole blood for monitoring of oral anticoagulation therapy by trained patients or their caregivers, on the prescription or other order of a treating physician.

The INRatio Prothrombin Time Monitoring System uses a modified version of the one-stage prothrombin time test. After a drop of blood is applied to the test strip, it is drawn into the test area and mixed with reagents that cause coagulation to begin. The test area on the test strip is separated into three channels, each of which contains electrodes for detection of the blood clot. One channel contains the reagents to perform the prothrombin time test on the blood sample. The other two channels contain the reagents to run control tests. No external quality control tests are required for the INRatio system. The meter monitors the reactions, and calculates the PT and INR for the blood sample, which are reported on the display. If the control results are not within a set range, it indicates a problem with the test and an error message is reported on the display instead of a result. The INRatio is the same as the INRatio, except that the labeling has been modified for readability by the lay user.

Here's an analysis of the provided text regarding the INRatio Prothrombin Time Monitoring System's acceptance criteria and related study information:

Note: The provided text is a 510(k) summary and associated FDA correspondence. It does not include detailed study reports or comprehensive acceptance criteria. Therefore, several sections below will indicate "Not explicitly stated in the provided text." or "Not applicable/Not explicitly detailed in the provided text."

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document strongly emphasizes "equivalence" as the primary performance benchmark against an "established reference method." Specific quantitative acceptance criteria (e.g., specific bias limits, precision thresholds) are not detailed in this 510(k) summary. The performance data section provides a general summary statement about equivalence.

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

• Sample Size for Test Set: Not explicitly stated in the provided text.
• Data Provenance: Not explicitly stated in the provided text regarding country of origin or whether it was retrospective or prospective. The statement "The INRatio System was found to perform equivalently when used by trained lay users and healthcare professionals" suggests a clinical study, which would typically be prospective, but this is an inference.

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

• Number of Experts: Not explicitly stated in the provided text.
• Qualifications of Experts: Not explicitly stated in the provided text.

4. Adjudication Method for the Test Set

• Adjudication Method: Not explicitly stated in the provided text.

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

• Was an MRMC study done? Not applicable in the traditional sense for this device. This is an In Vitro Diagnostic (IVD) device that provides a quantitative measurement (PT/INR), not an imaging device requiring human reader interpretation. The study involved comparing results from different user types (lay users vs. healthcare professionals) to a reference method, which is a different type of comparison.
• Effect size of human readers improvement with AI vs without AI assistance: Not applicable/Not explicitly detailed in the provided text. The device itself is not described as an "AI" device as per current definitions, nor does it assist human readers in interpretation; it provides the result.

6. Standalone (Algorithm Only) Performance Study

• Was a standalone study done? Yes, in a way. The device itself calculates the PT and INR. The comparison involved the device's output being assessed against a reference method, performed by both lay users and healthcare professionals. The device, by its nature, functions in a "standalone" capacity to produce a result, with human input being the blood sample and operation of the machine. The key test was the agreement of the device's output (regardless of who operated it) with the reference standard.

7. Type of Ground Truth Used

• Type of Ground Truth: An "established reference method." The specific nature of this reference method (e.g., a laboratory-based gold standard PT/INR test) is not detailed but is implied. For PT/INR, this usually refers to a central lab-based method that is considered the clinical standard.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not explicitly stated in the provided text. IVD devices like this typically undergo extensive calibration and verification during development (which could be considered a form of "training" data for the device's internal algorithms), but precise details are not in this summary.

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

• How Ground Truth for Training Set Was Established: Not explicitly stated in the provided text. During the development of such a device, ground truth for calibration and internal algorithm optimization would typically be established using a combination of certified reference materials, spiked samples, and clinical samples analyzed by established laboratory reference methods.

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The HemoSense INRatio is an in vitro diagnostic system that provides a quantitative prothrombin time results, expressed in seconds and as an International Normalized Ratio (INR). It uses fresh capillary whole blood and is intended for use by health care professionals in monitoring patients who are on warfarin-type (coumarin) anticoagulation therapy. This device is not intended to be used for screening purposes.

The INRatio Prothrombin Time Monitoring System uses a modified version of the one-stage prothrombin time test. After a drop of blood is applied to the test strip, it is drawn into the test area and mixed with reagents that cause coagulation to begin. The test area on the test strip is separated into three channels, each of which contains electrodes for detection of the blood clot. One channel contains the reagents to perform the prothrombin time test on the blood sample. The other two channels contain the reagents to run control tests. No external quality control tests are required for the INRatio System. The meter monitors the reactions, and calculates the PT and INR for the blood sample, which are reported on the display. If the control results are not within a set range, it indicates a problem with the test and an error message is reported on the display instead of a result.

The provided document describes the INRatio Prothrombin Time Monitoring System (K020679) and its substantial equivalence to a predicate device, the Roche CoaguChek S. However, it does not provide detailed acceptance criteria and a structured study report with the specific information requested in your prompt.

The document is a 510(k) summary for premarket notification, which focuses on demonstrating substantial equivalence, not necessarily on presenting a comprehensive study report with quantitative acceptance criteria as you've outlined.

Here's a breakdown of what can be inferred or is explicitly stated from the provided text, and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Missing Information:

• Specific quantitative thresholds for "acceptable" precision and linearity. The document only states they were "found acceptable."
• Details of the reference method used for accuracy comparison.

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

• Sample Size: Not explicitly stated for any of the tests (accuracy, precision, linearity).
• Data Provenance: The studies were described as "field studies." The country of origin is not specified, but the applicant (HemoSense, Inc.) and the FDA are in the USA. It's not explicitly stated if the data was retrospective or prospective. Given it's a "field study," it's likely prospective data collection for device evaluation.

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

• Missing Information. The document does not describe the use of experts to establish ground truth for the test set. The ground truth for Prothrombin Time devices is typically established through a reference laboratory method or a predicate device.

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

• Missing Information. No mention of an adjudication method is made.

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:

• This is not applicable to the INRatio device. The INRatio is an in vitro diagnostic device for quantitative Prothrombin Time measurement, not an AI-assisted diagnostic imaging or interpretation system requiring human readers or affecting their performance. The device directly calculates and reports PT/INR values.

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

• Yes, implicitly. The context of the INRatio system, as an in vitro diagnostic device that calculates and displays results, inherently refers to its standalone performance. The accuracy, precision, and linearity tests would assess the device's performance in generating these results independently.

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

• For accuracy, the device was compared to the predicate device CoaguChek S and a "reference method." While the specific "reference method" isn't detailed, for PT/INR testing, this typically refers to a laboratory-based coagulation analyzer (e.g., automated photo-optical clot detection instruments). This would be considered a reference laboratory method or a calibrated gold standard.

8. The sample size for the training set:

• Missing Information. The document does not discuss a "training set" in the context of machine learning or AI. This device is electro-mechanical and reagent-based, not an AI model that undergoes a training phase.

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

• Not applicable. As explained in point 8, there is no "training set" for this type of device.

Summary of Limitations in the Provided Document:

The provided text is a 510(k) summary, which serves to establish substantial equivalence. It highlights key performance aspects like accuracy, precision, and linearity as "acceptable" or "equivalent," but it lacks the granular detail of a full study report (e.g., specific sample sizes for each test, detailed methodology for ground truth establishment, quantitative acceptance criteria thresholds, or raw/processed data). This information would typically be found in the full 510(k) submission, not necessarily in the public summary.

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