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Pacific Hemostasis Immunodepleted Factor V Deficient Plasma is intended for use in a clinical laboratory for the quantitative measurement of Factor V activity. Factor V activity in patient or control plasma is assayed by the amount of Prothrombin Time (PT) correction produced by the test plasma when mixed with Factor V deficient plasma. Results are compared to the degree of PT correction of a reference plasma with known Factor V activity. A pool of normal plasma is considered to vield 100% correction in the PT time, and has 100% of the normal Factor V concentration.

Pacific Hemostasis Immunodepleted Factor V Deficient Plasma is intended for use in the quantitative determination of Factor V activity in patient plasma… Factor..V. activity in plasma is assayed by the amount of Prothrombin Time correction produced " The correction of the unknown by the test plasma when mixed with factor deficient plasma. is compared to that produced by a reference plasma of known normal activity.

Pacific Hemostasis (PH) Immunodepleted Factor V Deficient Plasma is a lyophilized preparation of fresh human plasma with added buffers. PH Immunodepleted Factor V Deficient plasma is intended for use in a clinical laboratory for the quantitative measurement of Factor V activity. The product is prepared from pooled normal plasma depleted of factor V by immobilized, highly specific antibodies. The Factor V activity contained in the product is less than 1% of normal levels. All other coaqulation factors are within the normal range. The reconstitution volume is 1.0 mL (with deionized or distilled The product is available in packages containing 10 vials. The water). reconstituted plasma is stable for 8 hours when stored stoppered at 2-8°C. Each unit of source material used in the preparation of this product has been tested by an FDA approved method and found non-reactive for HB Ag (Hepatitis B Surface antigen) and negative for antibodies to HIV and HCV. However, since no known test method can offer complete assurance that product derived from human blood will not transmit Hepatitis. AIDS, or other infectious diseases, this product should be handled as potentially infectious biological material.

Here's an analysis of the provided text, focusing on the acceptance criteria and study data for the "Immunodepleted Factor V Deficient Plasma" device.

A significant limitation of this document is that it is a 510(k) summary from 1997, which means it pre-dates the modern standards for reporting clinical study details for medical devices, especially AI/ML-enabled devices. The focus here is on demonstrating substantial equivalence to a predicate device rather than strictly defining and proving acceptance criteria in the current sense. Therefore, certain requested information (like specific AI/ML study details, expert qualifications for ground truth, or MRMC studies) is not applicable or not provided in this type of document.

Device Name: Immunodepleted Factor V Deficient Plasma (Human, Dried)
Predicate Device: Dade® Immunoadsorbed Factor V Deficient Plasma (Human), K912679

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) (substantial equivalence), the "acceptance criteria" are implicitly met by demonstrating comparable performance to the predicate device within acceptable laboratory variability. The specific numerical targets for "acceptance" are derived from the performance of the predicate device and general good laboratory practice for coagulation assays.

Note: The acceptance criteria are "implicitly" derived from demonstrating "substantial equivalence" to the predicate device, K912679. This means the new device's performance is expected to be comparable to or better than the predicate's performance within typical laboratory variability. The narrative specifically highlights cases like the higher CV for PH's Level 3 control not being "clinically significant" due to the very low FV activity level and its use for internal reference, indicating the clinical context for acceptance.

2. Sample Size Used for the Test Set and Data Provenance

The "test set" here refers to the samples used to evaluate the performance of the new device relative to the predicate.

• Day-to-Day Precision Studies:
  • Standard Curves: n=10 runs (on 10 different days) for each product (Pacific Hemostasis and Dade).
  • Factor V Activity Recovery: n=10 runs for each of the five reference plasmas tested with both products (Pacific Hemostasis and Dade). This totals 50 data points for PH and 50 for Dade for FV recovery.
• Reconstituted Stability Study: "Several vials" of each brand were pooled for testing 8-hour stability. The comparison was between "freshly reconstituted" and "8-hour stored" plasmas, likely involving single or replicate runs for standard curves and reference plasma recovery at each time point.
• Instrument Compatibility Study: For each of the five instruments, standard curves were generated (likely n=1) and Factor V activity was determined for the five different reference plasmas using both PH and Dade products. This implies 5 reference plasmas * 5 instruments * 2 products = 50 data points for FV recovery across instruments.

Data Provenance: The study appears to be prospective in nature, as it describes experiments conducted specifically for this submission (e.g., "Day-to-day precision studies were performed..."). The data is almost certainly domestic (USA), as the submitting company is based in Huntersville, NC, and the instruments mentioned (MLA®-1000C™, Amelung KC 4 ATM, BBL® Fibrometer, MLA®-700, and ACL-3000PLUS) are commonly used in US clinical laboratories. The document states these instruments "represent approximately 80% of the clinical analyzers currently used in this country."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This document is for a laboratory reagent; therefore, the concept of "ground truth" established by human experts (like radiologists) for a diagnostic image is not directly applicable.

• Ground Truth: The "ground truth" for the Factor V levels in the reference plasmas (UCRP, ACRP, Abnormal Factor V Controls) was their "assigned Factor V values." These values would have been established by the manufacturer (Pacific Hemostasis) using validated methods and reference materials, likely against an international standard or a well-characterized normal plasma pool.
• Experts: No external "experts" are explicitly mentioned for establishing the ground truth of these reference plasmas in the context of this 510(k) submission. The manufacturer is responsible for establishing these assigned values.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving interpretation of subjective results or disagreements between readers. Since this is a laboratory reagent assay, there is no "adjudication method" in the traditional sense. The data is quantitative and objective (e.g., %CV, slope, R² values). Methodological consistency (e.g., running on an automated coagulator like MLA®-1000C™ to minimize human error) and established laboratory protocols are used to ensure data quality and reliability.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, this is not applicable. An MRMC study is designed for evaluating human performance on diagnostic tasks, often involving image interpretation, with and without AI assistance. This submission describes the performance of a laboratory reagent, not an AI-powered diagnostic tool, and involves instrument-based measurements rather than human interpretation of cases. Therefore, there is no "AI assistance" component or human reader improvement effect to measure.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. The device is a laboratory reagent. Its performance is inherently "standalone" in the sense that it functions chemically in an assay, but it is always used within a human-operated laboratory workflow on an instrument. It is not an algorithm, so "algorithm-only" performance is not a relevant concept here. The data represents the performance of the reagent system in controlled laboratory settings.

7. The Type of Ground Truth Used

The ground truth used was "assigned Factor V values" of various reference plasmas (e.g., Universal Coagulation Reference Plasma (UCRP), Abnormal Coagulation Reference Plasma (ACRP), and Abnormal Factor V Controls). These assigned values represent the known or expected Factor V activity in these control materials, serving as a benchmark for accuracy and recovery.

8. The Sample Size for the Training Set

This is not applicable/not provided. The device is a chemical reagent, not an AI/ML algorithm that requires a "training set" of data. The manufacturing process and quality control methods ensure the product's characteristics, but it's not "trained" on data in the computational sense.

9. How the Ground Truth for the Training Set Was Established

This is not applicable. As stated above, there is no "training set" for this type of device. The "ground truth" for the reference materials used in testing (as described in point 7) would have been established by the manufacturer through validated assays and traceability to recognized standards, but this is not a "training set ground truth."

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