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510(k) Data Aggregation
(442 days)
The Xprecia Stride™ Coagulation System, which includes the Xprecia Stride™ Coagulation Analyzer and the Xprecia™ System PT/INR Strips.is intended for use by professional healthcare provide an INR (International Normalized Ratio) based on a prothrombin time (PT) response for the monitoring of oral anticoagulation therapy with warfarin, a vitamin K antagonist. The Xprecia Stride™ Analyzer is intended to be used with only the Xprecia™ System PT/INR Strips and the Xprecia™ System PT Controls. The analyzer uses fresh capillary (fingerstick) whole blood applied to an Xprecia™ Strip. It is intended for in vitro diagnostic use at the point-of-care.
Xprecia™ System PT/INR Strips are for use with only the Xprecia Stride™ Coagulation Analyzer for PT/INR determinations by professional healthcare providers. This product is for in vitro diagnostic use.
Xprecia™ System PT Controls is a combination package containing lyophilized normal and therapeutic plasma controls for use with Xprecia™ Coagulation System for PT/INR determinations by professional healthcare providers. This product is for in vitro diagnostic use.
The Xprecia Stride™ Coagulation Systemis intended for use in patients 18 years of age and older. Patients must be stabilized (>6 weeks) on warfarin therapy. The Xprecia Stride™ Coagulation System is not intended for use in patients who are transitioning from heparin treatment to warfarin therapy.
The Xprecia Stride™ Coagulation System is an in vitro diagnostic medical device that is used to provide an INR (International Normalized Ratio) based on a prothrombin time (PT) response in whole blood and is intended for point of care professional use for the monitoring of warfarin (sold under Coumadin® and other brand names) therapy. The Xprecia Stride™ Coagulation System consists of a hand-held analyzer, Xprecia Stride™ Coagulation Analyzer, used in combination with single-use PT/INR test strips, Xprecia™ System PT/INR Strips, and Liquid Quality Controls (LQC), Xprecia™ System PT Controls.
The XpreciaT™ System PT/INR Strip contains the Dade® Innovin® reagent which is a preparation of purified recombinant human tissue factor combined with synthetic phospholipids, calcium chloride, and stabilizers. When a blood sample is applied to the test strip target area, the blood mixes with reagents and activates the coagulation cascade. The clot time is determined by an algorithm and the result is displayed as INR.
The XpreciaTM System PT Controls kit contains assayed Liquid Quality Controls for the assessment of precision and analytical bias in the normal (PT Control 1) and therapeutic (PT Control 2) ranges for the International Normalized Ratio (INR) to be used with the Xprecia™ System PT/INR Strips and Xprecia Stride™ Coagulation Analyzer. The controls consist of lyophilized human plasma, buffers and stabilizers. A Calcium Chloride diluent present in the kit is used to reconstitute the lyophilized control to activate the clotting process.
Here's a breakdown of the acceptance criteria and study details for the Xprecia Stride™ Coagulation System, based on the provided document:
1. Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implicit/Explicit) | Reported Device Performance |
|---|---|---|
| Precision / Repeatability (Whole Blood) | ≤10% CV across the measuring range | Combined Sites: - INR < 2.0: 5.8% CV - INR 2.0 to 3.0: 5.3% CV - INR 3.1 to 4.5: 4.5% CV |
| Reproducibility / Intermediate Precision (LQC - PT Control 1) | Not explicitly stated but implied by detailed reporting of SD and %CV. | Combined Sites (Total): 0.06 SD, 4.6% CV |
| Reproducibility / Intermediate Precision (LQC - PT Control 2) | Not explicitly stated but implied by detailed reporting of SD and %CV. | Combined Sites (Total): 0.16 SD, 5.0% CV |
| Linearity/Assay Reportable Range | Not applicable (calculated INR uses logarithmic clot times). Established by data from method comparison studies. | Measuring Range: 0.8 to 4.5 INR (Established by comparison studies) |
| Closed Vial Stability (Strips) | 24 months shelf life at 5-30°C up to 75% RH | 24 months shelf life at 5-30°C up to 75% RH |
| Open Vial Stability (Strips) | 2 months when stored between 5-30°C at up to 75% RH | 2 months when stored between 5-30°C at up to 75% RH |
| Out of Vial Stability (Strips) | 5 minutes | 5 minutes (substantiated at up to 12.5 minutes under extreme conditions) |
| Shelf Life (PT Controls) | 12 months from date of manufacture | 12 months from date of manufacture |
| Reconstituted Control Stability (2-8°C) | 60 minutes | 60 minutes |
| Reconstituted Control Stability (15-25°C) | 25 minutes | 25 minutes |
| Factor Sensitivity (Factor II) | <36% of normal factor level (in vitro) | Verified for Factor II <36% |
| Factor Sensitivity (Factor V) | <58% of normal factor level (in vitro) | Verified for Factor V <58% |
| Factor Sensitivity (Factor VII) | <52% of normal factor level (in vitro) | Verified for Factor VII <52% |
| Factor Sensitivity (Factor X) | <68% of normal factor level (in vitro) | Verified for Factor X <68% |
| Interference (Hematocrit) | Hematocrit range between 22 – 52% does not significantly affect test results. | Data analysis demonstrated that hematocrit range between 22 - 52% do not significantly affect test results. |
| Method Comparison (vs. Predicate) | Not explicitly stated, but implied by statistical measures (slope, intercept, r²) for demonstrating substantial equivalence. | All Sites Combined: - Slope (95% CI): 0.93 (0.91 - 1.00) - Intercept (95% CI): 0.0 (-0.1 - 0.1) - Coefficient of determination (r²): 0.93 |
| Method Comparison (vs. Lab Reference) | Not explicitly stated, but implied by statistical measures (slope, intercept, r²) for demonstrating substantial equivalence. | All Sites Combined: - Slope (95% CI): 1.00 (0.95 - 1.00) - Intercept (95% CI): 0.0 (0 - 0.1) - Coefficient of determination (r²): 0.89 |
| Normal Range | 95% of INRs ranged between 0.9 - 1.1 for healthy subjects. | 95% of the INRs ranged between 0.9 - 1.1. |
2. Sample Sizes Used for the Test Set and Data Provenance
- Precision/Repeatability (Whole Blood): 168 subjects across 4 sites.
- Reproducibility/Intermediate Precision (LQCs): 320 total runs (80 per site) for each control level over 20 operational days.
- Hematocrit Range Evaluation: 282 patients across 4 intended use sites.
- Method Comparison with Predicate Device: 365 test subjects.
- Method Comparison with Lab Reference Device: 364 subjects.
- Normal Range Study: 120 healthy subjects.
- Data Provenance: The studies were conducted across multiple "intended use sites" (4 sites) and involved "fresh capillary (fingerstick) whole blood" samples and "fresh citrated venous whole blood" for interference studies. This suggests prospective human subject studies, likely within the USA given the FDA submission. The document doesn't explicitly state the country of origin but implies clinical study conduct.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- The document describes the device as a "Prothrombin time test" and a "System PT Controls" which provides an INR (International Normalized Ratio) based on a PT response.
- Ground Truth for Method Comparison Studies:
- Predicate Device: Roche CoaguChek® XS System (another point-of-care PT/INR device). The "ground truth" here is the result from an already cleared device.
- Lab Reference Device: Siemens BCS XP laboratory analyzer using Dade® Innovin® recombinant human tissue thromboplastin reagent. This is a recognized laboratory standard.
- No "experts" in the sense of human readers/adjudicators are mentioned as establishing ground truth. The ground truth is established by a comparison to established, legally marketed, and validated devices/methods, which are considered objective measurements in this context.
4. Adjudication Method for the Test Set
- Not applicable. This is a diagnostic device measuring a quantitative value (INR). Adjudication, typically involving expert consensus on subjective findings (e.g., image interpretation), is not relevant here. The comparison is against objective measurements from other devices.
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 is not an AI/medical imaging device requiring human reader interpretation. It's a point-of-care coagulation analyzer providing a direct quantitative result.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, this is a standalone device. The "Xprecia Stride™ Coagulation System" (analyzer and strips) directly provides the INR result. Its performance is evaluated on its own ("algorithm only") against reference methods. Human involvement is in operating the device and applying the sample, but not in interpreting the raw data to derive the INR.
7. The Type of Ground Truth Used
- The ground truth for the test set was established by comparison to predicate and lab reference devices.
- For the method comparison studies, the "ground truth" for evaluating the Xprecia Stride™ System's accuracy was the INR values obtained from:
- The Roche CoaguChek® XS System (predicate device).
- The Siemens BCS XP laboratory analyzer using Dade® Innovin® recombinant human tissue thromboplastin reagent (lab reference device, considered the "gold standard" for this type of test).
- For the normal range study, the ground truth was the expected range observed in healthy individuals not on anticoagulant therapy.
- For the method comparison studies, the "ground truth" for evaluating the Xprecia Stride™ System's accuracy was the INR values obtained from:
8. The Sample Size for the Training Set
- The document does not explicitly describe a separate "training set" for an algorithm in the traditional sense of machine learning.
- Instead, the device's algorithms are built upon established scientific principles of coagulation and electrochemistry.
- The calibration uses "a reference lot of human recombinant thromboplastin traceable to the World Health Organization International Reference Preparation."
- "An International Sensitivity Index (ISI) and Mean Normal Prothrombin Time (MNPT) values are assigned by calibration for each lot and embedded on the barcode label on the test strip vial along with the lot number and expiration date." This suggests a robust, standardized calibration process rather than an iterative machine learning training phase with a distinct dataset.
9. How the Ground Truth for the Training Set Was Established
- As noted above, there isn't a traditional "training set" and associated ground truth in the machine learning sense.
- The "ground truth" for the device's fundamental operational parameters and calibration is based on traceability to the World Health Organization International Reference Preparation for thromboplastin and established scientific principles for measuring prothrombin time. This ensures standardization and accuracy of the device's underlying calculations for INR.
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