(61 days)
Pacific Hemostasis Control Plasma (Abnormal) Level Theta is intended for use in a laboratory program of quality assurance for activated partial thromboplastin time (APTT) and prothrombin time (PT) results with short clotting times. PT and APTT clotting times at the low end, or below the locally determined normal reference range are often related to the presence of elevated levels of fibrinogen and factor VIII. Both of these proteins are elevated in response to an inflammatory stimulus, malignant disease process or trauma. Control Level Theta Plasma provides a means for verifying the lower extent of the reportable range of the PT and APTT, particularly the imprecision of short clotting times often encountered with these screening tests.
Control Level 6 Plasma is a lyophilized preparation of fresh human citrated plasma with added stabilizers and buffers. The reconstitution volume is 1.0 mL (with deionized or distilled water). Control Level Theta contains markedly elevated levels of human fibrinogen and factor VIII, and produces an abnormally short Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT) with a variety of end-point detection methods.
Here's a summary of the acceptance criteria and study details for the Coagulation Control Plasma (Abnormal) Level $\theta$ device, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Required for Pacific Hemostasis Control Level Theta) | Reported Device Performance (Pacific Hemostasis Control Level Theta) | Comparative Performance (Dade® Ci-Trol® Level I) |
|---|---|---|---|
| Within-run Precision (CV) | PT: ≤ 5% | PT (Dade Reagents): 1.35% | |
| PT (PH Reagents): 1.23% | PT (Dade Reagents): 0.74% | ||
| PT (PH Reagents): 0.82% | |||
| APTT: ≤ 5% | APTT (Dade Reagents): 0.55% | ||
| APTT (PH Reagents): 0.74% | APTT (Dade Reagents): 0.48% | ||
| APTT (PH Reagents): 0.79% | |||
| Between-run Precision (CV) | Not explicitly stated as a separate acceptance criteria, but implied to be comparable to predicate. | PT: 1.46% | |
| APTT: 1.29% | PT: 1.87% | ||
| APTT: 1.41% | |||
| Reconstituted Stability (6 hours at room temp) | ≤ 5% change in clot time over 6 hours | PT: 1.39% change | |
| APTT: 2.43% change | PT: 1.37% change | ||
| APTT: -0.19% change | |||
| Shorter Clotting Times | Control Level Theta should yield abnormally short PT and APTT compared to normal plasma with various end-point detection methods. | All reagent-instrument testing combinations yielded shorter PT and APTT clot times for Control Level Theta when compared to Pooled Normal Plasma. | Intended to yield clotting times within the normal reference range. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a specific sample size for the test set in terms of the number of patient samples. Instead, the evaluations were performed using:
- Two different instruments: MLA®-1000C™ & MLA®-1600 for within-run precision, and MLA®-1000C™ for between-run precision and stability.
- Nine PT reagents and seven APTT reagents across four different coagulation analyzers (manual LAbor Fibrintimer®, semiautomated MLA®-700, fully automated ACL-3000™6 and MLA®-1000C™) for demonstrating shorter clotting times.
- Data Provenance: The data appears to be from prospective studies/testing conducted by Pacific Hemostasis for the purpose of this 510(k) submission. There is no mention of country of origin for the data; it's presumed to be from the United States given the submission to the FDA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is a coagulation control plasma, not a diagnostic device that requires expert interpretation for ground truth. The "ground truth" for its performance is analytical (clotting times, precision, stability) measured by laboratory instruments.
4. Adjudication Method for the Test Set
Not applicable. As this is not an interpretive diagnostic device, no adjudication by experts for ground truth was performed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-powered diagnostic device, and therefore no MRMC study with human readers was conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The entire study is effectively a "standalone" performance evaluation of the control plasma itself, as it's an in-vitro diagnostic control material, not a software algorithm. Its performance is measured directly through laboratory instrument readouts.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established based on:
- Analytical measurements: Clotting times (PT and APTT), coefficient of variation (CV) for precision, and percentage change over time for stability.
- Comparison to a legally marketed predicate device: Dade® Ci-Trol® Coagulation Control, Level I, which is a pre-amendment device.
- Internal manufacturing specifications: E.g., "The manufacturing specification for Control Level Theta is for less than a 5% change in clot time over a 6 hour storage period."
8. The Sample Size for the Training Set
Not applicable. This is an in-vitro diagnostic control material, not a machine learning algorithm. Therefore, there is no "training set" in the context of AI/ML.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set.
§ 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.