Search Results
Found 1 results
510(k) Data Aggregation
(13 days)
Pacific Hemostasis Coagulation Control Level 2 is intended for use as a control to monitor the performance of Prothrombin Time (PT) and Activated Partial Time (APTT) testing. It will yield PT and APTT values in the moderately abnormal range.
Pacific Hemostasis Coagulation Control Level 2 (Abnormal) is a lyophilized preparation of citrated plasma obtained from healthy donors, which has been adjusted to yield prolonged Prothrombin Time and Activated Partial Time values. Stabilizers and buffers have been added to the plasma prior to lyophilization. Each unit of source material used in the preparation of the reagent has been tested by an FDA approved method and found non-reactive for HBsAG and negative for antibodies to HIV and HCV.
Here's an analysis of the provided text regarding the Coagulation Control Level 2 (Abnormal) device, structured according to your requested information:
Acceptance Criteria and Study for Coagulation Control Level 2 (Abnormal)
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the "Pacific Hemostasis Coagulation Control Level 2 (Abnormal)" device were implicitly established through comparison to a legally marketed predicate device, the "Dade Ci-Trol Coagulation Control Level II" (K771346). The primary metric for substantial equivalence was precision (both between-run and within-run), as measured by the Coefficient of Variation (CV%) and standard deviation (SD) of Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT) values.
| Metric (Acceptance Criteria) | Predicate Device Performance (Dade Ci-Trol Level II) | Proposed Device Performance (Pacific Hemostasis Level 2) | Substantial Equivalence Evaluation |
|---|---|---|---|
| Between-run Precision (PT) | CV% = 4.97, SD = 1.86, Mean = 37.3 | CV% = 4.29, SD = 1.76, Mean = 41.0 | Proposed device's CV% (4.29) is lower than predicate's (4.97), indicating comparable or better precision. |
| Between-run Precision (APTT) | CV% = 1.52, SD = 0.59, Mean = 39.0 | CV% = 2.42, SD = 1.10, Mean = 45.4 | Proposed device's CV% (2.42) is slightly higher than predicate's (1.52), but still within generally accepted clinical ranges for control materials (typically <5% or <10% for clotting assays, though no explicit threshold is given here beyond comparison). The summary states "substantially equivalent data." |
| Within-run Precision (PT) | Average CV% = 6.12 | Average CV% = 5.31 | Proposed device's CV% (5.31) is lower than predicate's (6.12), indicating comparable or better precision. |
| Within-run Precision (APTT) | Average CV% = 0.71 | Average CV% = 0.73 | Proposed device's CV% (0.73) is very close to predicate's (0.71), indicating comparable precision. |
| General Acceptance Principle | Data should be "substantially equivalent" to the predicate. Specifically, for both controls, a CV of less than 5% was obtained for PT and APTT between-run testing (stated for both devices collectively). For within-run, average CVs were less than 7% for PT and less than 1% for APTT. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size:
- Between-run Precision: 20 duplicate measurements over a 10-day period. This implies 20 data points per day for 10 days, for a total of 200 measurements per device, per test (PT or APTT).
- Within-run Precision: 3 runs of 20 duplicate measurements. This means 60 measurements per device, per test (PT or APTT) for the "average %CV shown."
- Data Provenance: Not explicitly stated, but typically such studies for regulatory submissions are conducted in a controlled laboratory environment by the manufacturer or a contracted lab. There is no information about the country of origin of the data, nor whether it was retrospective or prospective. Given the nature of a device submission, it would almost certainly be prospective data collection specifically for this study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of device (a coagulation control) does not typically involve human expert interpretation for "ground truth" in the way a diagnostic imaging AI might. The "ground truth" for its performance is derived from analytical measurements obtained from laboratory instruments (for PT and APTT). Therefore, the concept of "experts establishing ground truth" with their qualifications is not applicable here. The accuracy of the "ground truth" (the measured PT/APTT values) relies on the proper calibration and operation of the coagulation analyzers used in the study.
4. Adjudication Method for the Test Set
Not applicable. As explained in point 3, the ground truth is based on quantitative laboratory measurements, not expert consensus requiring 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. This is an in vitro diagnostic (IVD) control device, not an AI-powered diagnostic tool for human interpretation. Therefore, no MRMC study or assessment of human reader improvement with/without AI assistance was conducted or would be relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a sense. The "device" in this context is the coagulation control solution itself. The performance study measures the intrinsic analytical characteristics (precision) of this solution when run on standard laboratory equipment, without any human interpretive component being evaluated or an AI algorithm involved. The focus is on the performance of the control material, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for evaluating the performance of the Coagulation Control Level 2 (Abnormal) involved analytical measurements of Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT) values from a coagulation analyzer. These are objective, quantitative measurements that define the expected performance characteristics of the control material.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a "training set." The device is a lyophilized plasma preparation, and its performance is evaluated directly through laboratory testing.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As this is not an AI/ML device, there is no training set or associated ground truth establishment process in the context of machine learning. The "ground truth" for the device's characteristics is established through its formulation (adulteration to achieve abnormal PT/APTT values) and verified through direct analytical measurement.
Ask a specific question about this device
Page 1 of 1