(256 days)
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.
| Acceptance Criteria (Non-Clinical) | Reported Device Performance (Non-Clinical) |
|---|---|
| Equivalent or better performance compared to previously cleared INRatio Test Strips for: | Modified INRatio2 Test Strips have equivalent or better performance compared to the previously cleared INRatio Test Strips for: |
| - Within-day precision | - Within-day precision |
| - Accuracy | - Accuracy |
| - Heparin sensitivity | - Heparin sensitivity |
| - Factor sensitivity | - Factor sensitivity |
| - Potential interferents | - Potential interferents |
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.
§ 864.7750 Prothrombin time test.
(a)
Identification. A prothrombin time test is a device used as a general screening procedure for the detection of possible clotting factor deficiencies in the extrinsic coagulation pathway, which involves the reaction between coagulation factors III and VII, and to monitor patients receiving coumarin therapy (the administration of one of the coumarin anticoagulants in the treatment of venous thrombosis or pulmonary embolism).(b)
Classification. Class II (performance standards).