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This product is intended for in vitro diagnostic use as a control product to assess the analytical performance of immunochemistry systems and clinical chemistry systems using methods for the quantitative measurement of the listed analytes. It is intended to provide the necessary control material required by inspection agencies for the evaluation of system performance. In addition, it will provide assistance when troubleshooting chemistry systems, reagent problems and calibration anomalies.

Device Description

DOCUMENT® CARDIAC Assayed Controls consist of three levels of a human serum matrix containing creatine kinase isoenzymes, lactate dehydrogenase isoenzymes 1 and 2, and myoglobin. The formulation design provides a liquid matrix intended for use on automated and semi-automated immunochemistry systems and clinical chemistry systems for the determination of total creatine kinase activity (CK), creatine kinase MB mass (CKMB), creatine kinase immunoinhibition (CKII), creatine kinase electrophoresis (CKELEC), total lactate dehydrogenase activity (LD), lactate de dehydrogenase electrophoresis for isoenzyme 1 and 2 (LD1; LD2), and myoqlobin (MYO).

AI/ML Overview

The provided 510(k) summary for the DOCUMENT® CARDIAC Assayed Control describes a control product intended to assess the analytical performance of immunochemistry and clinical chemistry systems. The acceptance criteria and the study proving the device meets these criteria are not presented in the typical format of an AI/ML device submission, as this is a traditional medical device (control material) submission from 1996.

Therefore, many of the requested fields are not applicable or cannot be extracted directly from the provided text. The submission focuses on demonstrating substantial equivalence to existing predicate devices based on its intended use, technical characteristics, and performance (specifically, inter-assay precision).

Here's an attempt to address your request based on the provided information, noting where information is not applicable (N/A) due to the nature of the device and the submission type:

Acceptance Criteria and Study for DOCUMENT® CARDIAC Assayed Control

The acceptance criteria for the DOCUMENT® CARDIAC Assayed Control are implicitly tied to demonstrating performance similar to existing predicate devices, particularly in terms of inter-assay precision for the listed analytes.

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Metric	Acceptance Criteria (Implicit)	Reported Device Performance (DOCUMENT® CARDIAC Assayed Control)
Intended Use	Comparable to predicate devices: monitoring accuracy and precision of relevant analytes.	Intended for in vitro diagnostic use as a control product to assess the analytical performance of immunochemistry and clinical chemistry systems using methods for the quantitative measurement of total CK, CKMB, CK Immunoinhibition, CK electrophoresis, total LD, LD1, LD2, and myoglobin.
Number of Levels	Providing appropriate control levels (at least 3, similar to some predicates).	Three (3) levels: Level I, Level II, Level III.
Type	Assayed control, similar to predicate devices it aims to replace for specific analytes.	Assayed.
Analytes	Should cover relevant cardiac analytes, potentially offering a broader panel than some individual predicates.	Covers total CK, CKMB, CK Immunoinhibition, CK isoenzyme electrophoresis, LD1 and LD2 isoenzyme electrophoresis, myoglobin (3 analytes group listed in comparison tables, referring to the number of types of analytes addressed, vs specific individual analytes tested).
Matrix	Human serum, liquid, matching key predicate characteristics.	Human serum, Liquid.
Dilution	None required, for ease of use.	None required.
Unopened Stability	"Until Expiration Date", comparable to predicates.	"Until Expiration Date".
Open Stability	Reasonable open stability (e.g., 45 days), comparable to or better than relevant predicates.	45 Days (better than Dade CK-MB/Myoglobin Immunoassay Control (14-20 Days) and Bio-Rad (15 Days), for the analytes compared).
Container	Plastic, Dropper Tip, for user convenience.	Plastic, Dropper Tip (similar to Abbott and Beckman products, different from Dade and Bio-Rad glass).
Inter-assay Precision	"Behaves in a similar manner compared to the predicate devices and is suitable for use as a control." (This is the primary demonstrated performance criterion).	"The results show that the DOCUMENT®CARDIAC Assayed Control behaves in a similar manner compared to the predicate devices and is suitable for use as a control for the listed analytes." (No specific numerical values or statistical comparisons are provided in this summary, but the statement confirms the study found similarity).

Study Proving Device Meets Acceptance Criteria:

The study conducted was a comparative performance study against predicate devices.

7. Test Results / Summary of the Study:

The study's objective was to demonstrate the equivalence of the DOCUMENT® CARDIAC Assayed Control to several predicate devices.

Methodology: The equivalence was assessed by comparing the inter-assay precision of the listed analytes using the DOCUMENT® CARDIAC Assayed Control against that of the specified predicate devices: Dade CK-MB/Myoglobin Immunoassay Controls, Abbott CK-MB Stat Controls, Bio-Rad Unassayed Chemistry Control, Beckman I.D-Zone Liquid CK Isoenzyme Control, and Beckman I.D-Zone Normal LD Isoenzyme Liquid Control.
Outcome: The submission states: "The results show that the DOCUMENT®CARDIAC Assayed Control behaves in a similar manner compared to the predicate devices and is suitable for use as a control for the listed analytes." While specific data points (e.g., coefficient of variation values) are not provided in this summary, the conclusion is that the device demonstrated comparable performance to the predicate devices in terms of inter-assay precision.

Additional Information (N/A or Not Provided for this Device/Submission Type):

Sample size used for the test set and the data provenance: N/A. This is a control material, not an AI/ML diagnostic. The "test set" would be the runs performed with the control on various instruments. The summary does not specify the number of runs or instruments used. Data provenance would typically be internal laboratory testing, likely prospective.
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): N/A. Ground truth for a control material is its assigned value(s) and acceptable range, typically established through extensive in-house characterization and sometimes method comparison studies, not expert consensus on images.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: N/A. Adjudication is not relevant for a control material.
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: N/A. This is completely irrelevant for a control material device.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: N/A. This is not an AI/ML algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For a control material, the "ground truth" is the assigned value for each analyte within the control, which is determined through precise analytical methods and often confirmed through multiple assays and laboratories.
The sample size for the training set: N/A. There is no AI/ML training set for this device.
How the ground truth for the training set was established: N/A. There is no AI/ML training set for this device.

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