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510(k) Data Aggregation
(224 days)
PT S TEST STRIPS AND CONTROLS FOR THE COAGUCHEK S SYSTEM, MODELS 2032422 AND 3271404
The PT•S test strip is intended for quantitative prothrombin time (PT) testing for monitoring of warfarin therapy, using fresh capillary or non-anticoagulated venous whole blood with the CoaguChek S System by professional health care providers.
The PT•S test strip, used as directed with the CoaguChek S monitor, will accurately measure blood PT values. After placing a drop of fresh whole blood on the test strip, the blood is drawn into the reaction chamber and mixed with reagents that cause coagulation to begin. In the test strip, tiny iron particles are mixed with the sample. Alternating magnetic fields cause the iron particles to move within the sample. The endpoint is reached when the blood clot stops the iron particles from moving. The PT result is then displayed by the monitor.
Here's a breakdown of the acceptance criteria and study details for the PT•S Test Strips and Controls for the CoaguChek S System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text compares the PT•S Test Strips and Controls for the CoaguChek S System to a predicate device, the ProTime Microcoagulation System (K010599). While explicit "acceptance criteria" for the PT•S device are not listed as pass/fail thresholds, the document presents performance characteristics of the PT•S system. For the purpose of this response, I will consider the reported performance of the PT•S system as meeting its intended design requirements, as the device received 510(k) clearance implying substantial equivalence.
| Acceptance Criteria (Performance Claim) | Reported Device Performance (PT•S Test Strips) |
|---|---|
| Normal Range | When performed on 122 normal, healthy, warfarin-free individuals (venous and capillary samples), 99% of venous and capillary INRs ranged from 0.8 to 1.1. |
| Reportable Range | Has a PT reportable range of 0.8 - 6.0 INR. |
| Factor Sensitivity | Internal studies utilizing four replicates of each Factor Level (II, V, VII, and X) showed sensitivity. Samples were assayed on CoaguChek S and Ortho Recombiplastin on the MLA 900 Analyzer. Results are shown as graphs in the test strip insert. (Specific quantitative results not provided in this summary). |
| Hematocrit Range | Hematocrit ranges between 32-52% do not significantly affect test results. |
| Heparin Levels | Results are unaffected by heparin concentrations up to 2.0 U/mL. Insensitive to low molecular weight heparins up to 1 IU anti-factor Xa activity/mL. |
| Precision with Controls (Level 1) | Mean INR 1.2. Total SD: 0.06, Total %CV: 4.57 (combining lot-to-lot, monitor-to-monitor, strip-to-strip variability). |
| Precision with Controls (Level 2) | Mean INR 3.0. Total SD: 0.17, Total %CV: 5.76 (combining lot-to-lot, monitor-to-monitor, strip-to-strip variability). |
| Precision with Blood | Whole blood precision for venous samples determined from sample duplicates at three external sites. Whole blood capillary data collected from sample duplicates at two external sites. (Bland Altman plots in insert, specific numerical results not provided in this summary). |
| Accuracy (Venous Samples vs. Lab Plasma) | 506 venous samples from 255 outpatients. Compared to MLA 900 analyzer with Ortho Recombiplastin. Regression: y = 1.049x - 0.08. Correlation = 0.975. Slope 95% CI: (1.028, 1.070), Intercept 95% CI: (-0.13, -0.03). |
| Accuracy (Capillary Samples vs. Lab Plasma) | 294 capillary samples from 147 outpatients. Compared to MLA 900 analyzer with Ortho Recombiplastin. Regression: y = 1.048x - 0.10. Correlation = 0.969. Slope 95% CI: (1.017, 1.079), Intercept 95% CI: (-0.17, -0.02). |
2. Sample Size Used for the Test Set and Data Provenance
- Normal Range Study: 122 individuals.
- Accuracy Study (Venous): 506 venous samples from 255 outpatients.
- Accuracy Study (Capillary): 294 capillary samples from 147 outpatients.
- Precision with Blood: Not explicitly stated as a count, but involved sample duplicates at "three external sites" for venous and "two external sites" for capillary.
- Data Provenance: The accuracy studies mention "outpatients at three external sites" and "outpatients at two external sites," implying a prospective collection of patient samples within a clinical setting. The country of origin is not specified but is implicitly the location of these "external sites."
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. This device is a quantitative diagnostic test for Prothrombin Time (PT), where the "ground truth" is a laboratory reference method, not subjective expert interpretation of an image or signal.
4. Adjudication Method for the Test Set
Not applicable. For this type of quantitative diagnostic device, adjudication by experts for ground truth is not typically performed. The gold standard (MLA 900 analyzer with Ortho Recombiplastin) provides the comparative "ground truth."
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for medical devices that assist human readers in interpreting clinical data (e.g., radiologists reading images). The PT•S System is a standalone diagnostic test performed by professional healthcare providers, not an AI assistance tool for human interpretation.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done
Yes, the performance characteristics provided are for the standalone performance of the PT•S Test Strips used with the CoaguChek S monitor. The results reported (e.g., accuracy, precision, reportable range) reflect the device's inherent measurement capabilities without direct human interpretive input being part of the primary measurement. The healthcare provider acts as the operator, not as an interpreter whose performance is being assisted.
7. The Type of Ground Truth Used
The ground truth for the accuracy studies was established by comparing the PT•S System measurements to laboratory plasma PT methods performed on an MLA 900 analyzer using Ortho Recombiplastin. This is a well-established and recognized reference method for Prothrombin Time testing in a clinical laboratory setting.
8. The Sample Size for the Training Set
The document does not explicitly state the sample size for a "training set." This type of diagnostic device development often involves internal development and validation, but the term "training set" is more commonly associated with machine learning algorithms. The reported "internal studies" for precision and factor sensitivity likely represent a portion of the development and validation work.
9. How the Ground Truth for the Training Set was Established
Given that "training set" is not explicitly mentioned and the device is a chemical-mechanical diagnostic system rather than an AI algorithm requiring iterative training data, information on how a "training set ground truth" was established is not provided. The development process would have involved calibrating the device and reagents against known standards and reference methods, similar to the "ground truth" used for the performance evaluation, but this isn't framed as a distinct "training set" in the context of machine learning.
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