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The Microcal Normal and Abnormal Controls are lyophilized human sera intended for use as assayed quality control sera to monitor the precision of cellulose acetate based protein electrophoresis testing methods.

lyophilized human sera intended for use as assayed quality control sera

This is a 510(k) premarket notification for a quality control material and as such, the document primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study description with acceptance criteria for a novel diagnostic device. Therefore, much of the requested information regarding acceptance criteria, study design elements (sample size, expert qualifications, etc.), MRMC studies, standalone performance, and training set details are not typically found in this type of submission.

However, I can extract what is implied regarding equivalence.

Here's the analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present a formal table of acceptance criteria with reported device performance in the way a diagnostic device submission might. Instead, the "acceptance criteria" for a quality control material like this is substantial equivalence to a predicate device.

• Acceptance Criteria (Implied): The Microcal Control Serum for Protein Electrophoresis performs equivalently to a legally marketed predicate device in monitoring the precision of cellulose acetate-based protein electrophoresis testing methods. This equivalence is demonstrated through comparative testing.
• Reported Device Performance: The FDA has determined that the device is "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices."

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

• Sample Size (Test Set): Not explicitly stated in this document. Substantial equivalence for a quality control material would typically involve comparing the performance of the new device against the predicate device across a range of analytes and concentrations. The specific number of replicates or runs is not detailed here.
• Data Provenance: Not explicitly stated. For such a device, the data would likely be generated in a laboratory setting. There is no information regarding country of origin or whether the study was retrospective or prospective.

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

• Not Applicable. For a quality control material, the concept of "ground truth" established by experts for a test set, in the way it applies to diagnostic devices, is not relevant. The analytical performance of the control material (e.g., its assigned values, stability) is compared to a predicate, not to an expert-interpreted diagnostic outcome.

4. Adjudication Method for the Test Set

• Not Applicable. As there's no expert interpretation of diagnostic cases, there's no adjudication method in the traditional sense. The equivalence would be determined through analytical comparison.

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

• No. This type of study is not relevant for a quality control material. MRMC studies are typically used for diagnostic imaging devices where human readers interpret medical images, and the AI's impact on their performance is assessed.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Yes (Implicit). A quality control material like this would be evaluated in a "standalone" analytical performance context, meaning its intrinsic properties and performance are assessed without direct human intervention in its function. However, it's not an "algorithm" in the typical sense of AI/software. The performance of the control material itself is what's being evaluated.

7. The Type of Ground Truth Used

• Predicate Device Performance/Reference Values. The "ground truth" in this context is the established and legally marketed performance of the predicate device, against which the Microcal Control Serum is compared for substantial equivalence in monitoring protein electrophoresis. The values assigned to the control material would also be part of this "ground truth" and are typically established through robust analytical methods.

8. The Sample Size for the Training Set

• Not Applicable. This is a quality control material, not an AI or machine learning algorithm that requires a "training set."

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

• Not Applicable. (See point 8).

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