(13 days)
Pacific Hemostasis Coagulation Control Level 1 is intended for use as a control to monitor the performance of routine coagulation assays, i.e. Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT) and Fibrinogen assays. It will yield PT, APTT and Fibrinogen values in the normal range.
Pacific Hemostasis Coagulation Control Level 1 (Normal) is a lyophilized preparation of citrated plasma obtained from healthy donors. 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 acceptance criteria and study for the Coagulation Control Level 1 (Normal) device:
1. Table of Acceptance Criteria and Reported Device Performance
The device is a Coagulation Control (Level 1, Normal) and its performance is assessed based on precision (between-run and within-run) for Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT) assays, and the expected range for Fibrinogen. The acceptance criteria are implicitly derived from the "substantially equivalent" claim to the predicate device (Dade Ci-Trol Coagulation Control Level 1). The study demonstrates that the Pacific Hemostasis device falls within similar precision limits and expected Fibrinogen ranges as the predicate.
| Assay | Performance Metric | Acceptance Criteria (Implicit - based on predicate's performance and "substantially equivalent" claim) | Reported Device Performance (Pacific Hemostasis) | Predicate Device Performance (Dade) |
|---|---|---|---|---|
| Prothrombin Time (PT) | Between-run Precision (CV%) | Less than 2.0% | 1.22% | 1.39% |
| Within-run Precision (Avg CV%) | Less than 1.5% | 1.39% | 1.20% | |
| Activated Partial Thromboplastin Time (APTT) | Between-run Precision (CV%) | Less than 2.0% | 0.79% | 1.52% |
| Within-run Precision (Avg CV%) | Less than 1.0% | 0.70% | 0.70% | |
| Fibrinogen | Result Range | In the normal range | 287 mg/dL | 268 mg/dL |
Notes on Acceptance Criteria: The document directly states that "For both controls a CV of less than 2.0% was obtained for PT and APTT between-run testing" and "The average CV's obtained for within-run precision were less than 1.5% for PT testing, and less than 1.0% for APTT testing of both products." These statements are presented as observed performance but implicitly serve as the benchmark for substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size:
- Between-run Precision: 20 duplicate measurements over a 10-day period. This means 20 measurements for PT and 20 for APTT for both the Pacific Hemostasis product and the Dade product.
- Within-run Precision: 3 runs of 20 duplicate measurements. The average %CV is reported. This implies 60 original measurements for PT and 60 for APTT for both products to calculate the average.
- Fibrinogen: The sample size for Fibrinogen is not explicitly stated in terms of number of measurements, but a single representative value (287 mg/dL for Pacific Hemostasis and 268 mg/dL for Dade) is given.
- Data Provenance: The document does not explicitly state the country of origin of the data. However, the applicant (Pacific Hemostasis) is based in Huntersville, NC, USA. The study is a prospective performance study conducted specifically for this premarket notification.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This type of study for a coagulation control material does not typically involve human experts establishing a "ground truth" in the way a medical image diagnosis aid would. The "ground truth" here is the performance characteristics of a known, legally marketed predicate device (Dade Ci-Trol Coagulation Control Level 1) and the established normal ranges for PT, APTT, and Fibrinogen in a laboratory setting.
4. Adjudication Method for the Test Set
Not applicable. This is a laboratory performance study of a control material, not a clinical study requiring adjudication of diagnoses or interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No, an MRMC comparative effectiveness study was not done. This study is focused on the device's analytical performance (precision and expected range) compared to a predicate device, not on human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, this is essentially a standalone performance study of the coagulation control material. The device itself (the control plasma) is being evaluated for its inherent analytical characteristics (precision and consistency), not as an algorithm or with human interaction once the test is set up.
7. The Type of Ground Truth Used
The "ground truth" is established by:
- The known, validated performance characteristics of the legally marketed predicate device (Dade Ci-Trol Coagulation Control Level 1).
- Clinically accepted normal ranges for PT, APTT, and Fibrinogen assays, which the control is designed to fall within.
8. The Sample Size for the Training Set
Not applicable. This is a premarket notification for a control material, not a machine learning model that requires a training set. The "development" of the product would have involved internal testing and formulation, but not in the context of a "training set" for an algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set mentioned or implied for this device.
§ 864.5425 Multipurpose system for in vitro coagulation studies.
(a)
Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.(b)
Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.