Search Results

Lyphochek® Hemostasis Control is prepared from human plasma with added purified biochemicals and preservatives. The control is provided in lyophilized form for increased stability.

AI/ML Overview

The provided document describes the Lyphochek® Hemostasis Control, a quality control plasma. It does not describe an AI medical device or a study comparing AI performance against human performance. Therefore, I cannot provide information on acceptance criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance as these are not relevant to the given document.

The document focuses on demonstrating substantial equivalence to a predicate device (K020878) based on similarities in intended use, form, matrix, storage, and reconstituted stability claims, and verifying the stability of the new device for the specified analytes.

Here is the information that can be extracted from the provided text regarding the Lyphochek® Hemostasis Control:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense of a performance study for an AI device. Instead, it details product claims related to stability, which are effectively the performance characteristics that the device is intended to meet.

Performance Characteristic	Acceptance Criteria (Product Claim)	Reported Device Performance
Reconstituted Stability	All analytes stable for 8 hours at 2-25°C. Exception: Protein S stable for 8 hours at 2-8°C.	Product claims states these conditions are met.
Shelf Life	Three years when stored at 2-8°C.	Product claims states this condition is met.
Ongoing Studies	Real-time studies will be ongoing to support the shelf life of this product.	Confirmed that studies are ongoing to support the shelf life.
Analytes Included	Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT), Fibrinogen, Antithrombin III (AT III) Thrombin Time (TT), Factor II, V, VII, VIII, IX, X, XI, XII, Protein S (Functional) Protein C (Functional), Plasminogen, and D-dimer.	The device contains all listed analytes.

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

The document does not mention a "test set" or provide specific sample sizes for stability studies. It states that "All supporting data is retained on file at Bio-Rad Laboratories," indicating that data exists but is not elaborated upon in the summary. Data provenance (country of origin, retrospective/prospective) is not mentioned.

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

Not applicable. This device is a quality control material, not an AI diagnostic device requiring expert interpretation for ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable. This device is a quality control material.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This is not an AI diagnostic device designed to be used by human readers, so an MRMC study comparing human readers with and without AI assistance is not relevant.

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

No. This is not an AI algorithm.

7. The Type of Ground Truth Used

For a quality control product, the "ground truth" would be the assayed target values of the analytes within the control material, established through precise analytical methods and often an internal reference measurement system. The document does not specify how these target values were established.

8. The Sample Size for the Training Set

Not applicable. This is not an AI algorithm requiring a training set.

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

Not applicable. This is not an AI algorithm.

Ask a Question

Ask a specific question about this device

Page 1 of 1