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Liquichek Cardiac Markers Control LT is prepared from human serum with added constituents of human and animal origin, preservatives and stabilizers. The control is provided in liquid form.

AI/ML Overview

The provided text describes a medical device called "Liquichek™ Cardiac Markers Control LT" and its 510(k) submission to the FDA. This document is a premarket notification for a Class I quality control material. It primarily focuses on demonstrating substantial equivalence to a predicate device and does not involve clinical studies with human subjects or AI algorithms. As such, many of the requested categories for acceptance criteria and study details are not applicable.

Here's an analysis based on the provided text, addressing the applicable points:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (quality control material), the "acceptance criteria" relate to its stability and performance as a control. The document focuses on demonstrating that the new device meets these expectations, particularly in comparison to its predicate.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Intended Use	For use as an assayed quality control serum to monitor the precision of laboratory testing procedures	The new device meets this intended use, identical to the predicate device.
Form	Liquid	The new device is in liquid form, identical to the predicate device.
Matrix	Human serum based	The new device is human serum based, identical to the predicate device.
Storage (Unopened)	-20°C or colder; Until expiration date	The new device requires storage at -20°C or colder until its expiration date, identical to the predicate device.
Open Vial Stability	All analytes stable for 10 days, with NT-proBNP stable for 5 days.	"All analytes will be stable for 10 days with the following exceptions: NT-proBNP will be stable for 5 days." This is a specific claim made by the manufacturer based on their stability studies.
Shelf Life	2 years at -20°C or colder	"2 years at -20°C or colder." This is a specific claim made by the manufacturer based on their stability studies, with real-time studies reported as ongoing to support this claim.
Composition (Analytes)	Includes NT-proBNP, CK-MB Isoenzyme, Digitoxin, Homocysteine, Myoglobin, Troponin I, Troponin T	The new device contains these specified analytes. The predicate device did not contain NT-proBNP. The inclusion of NT-proBNP in the new device is a key difference. The device performance here is simply that it contains these analytes and is intended to function as a control for them.
Number of Levels	Levels 1, 2, 3 and Low Level	The new device offers these four levels. The predicate device only offered Levels 1, 2, and 3. The device performance here refers to its composition including these levels.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document refers to "Stability studies" and "real time studies" but does not detail the sample sizes (e.g., number of lots, vials tested), the specific experimental design, or the provenance of the data beyond being conducted by Bio-Rad Laboratories. Given this is a control material, the "test set" would likely refer to samples of the control material itself used for various stability and performance assessments, rather than patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable for this type of device. "Ground truth" in the context of diagnostic interpretation by experts is not relevant for a quality control material. The "truth" for a control material is its assayed value and its stability parameters, determined through chemical and analytical testing procedures.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable. Adjudication methods are typically used in clinical studies where subjective interpretation or discordance among experts requires resolution. For a quality control material, analytical methods are used to determine performance.

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

This is not applicable and was not done. The device is a quality control material, not an AI-powered diagnostic tool or a device that impacts human reader performance.

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

This is not applicable and was not done. This device is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For this device, the "ground truth" would be established through analytical testing and certified reference materials/methods. The stability claims (open vial, shelf life) and the assayed values for the cardiac markers are determined using validated laboratory procedures and instruments, often calibrated against primary and secondary reference materials. This is an objective chemical/analytical "truth" rather than a subjective expert interpretation.

8. The sample size for the training set

This is not applicable. This device is not an AI algorithm and therefore does not have a "training set" in the machine learning sense. The manufacturer would have internal R&D data from various batches and experiments to establish the product's characteristics, but this isn't a "training set."

9. How the ground truth for the training set was established

This is not applicable for the same reasons as point 8.

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