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Elecsys PreciControl Universal is used for quality control of Elecsys immunoassays on Elecsys and cobas e immunoassay analyzers.

The Elecsys PreciControl Universal is a lyophilized product consisting of added antigens in a human serum matrix. During manufacture, the analytes are spiked into the matrix at the desired concentration levels.

The provided document is a 510(k) summary for the Elecsys PreciControl Universal. It describes a device modification to add Carcinoembryonic antigen (CEA) and total Prostate-Specific Antigen (PSA) controls. However, it does not contain explicit acceptance criteria or a detailed study section with performance data that directly addresses specific acceptance criteria for these newly added analytes or the overall device performance in a way that allows for a direct comparison table.

The document states: "The Elecsys PreciControl Universal was evaluated for value assignment and stability." This indicates that performance studies were conducted, but the results of these studies and any defined acceptance criteria are not explicitly presented within the provided text.

Therefore, many of the requested details cannot be extracted directly from this submission.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated in the provided document.
• Reported Device Performance: The document only mentions that the device "was evaluated for value assignment and stability." It does not provide specific performance data (e.g., accuracy, precision, stability limits) for the added CEA and tPSA analytes, nor for the existing analytes in relation to specific acceptance criteria.

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

• Sample Size: Not specified for any performance evaluation.
• Data Provenance: Not specified.
• Retrospective or Prospective: Not specified.

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)

• The device is a quality control material. Ground truth in this context would likely refer to the reference values assigned to the control material. The document does not describe the process of establishing these reference values or refer to "experts" in the clinical sense (like radiologists). It only states that analytes "are spiked into the matrix at the desired concentration levels" and that "value assignment" was evaluated.

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

• Not applicable as the nature of the "test set" and "adjudication" in the context of clinical interpretation is not relevant for this type of quality control device. The document mentions "value assignment," which implies a process for determining the target concentrations.

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

• Not applicable. This device is a quality control material for immunoassays, not a diagnostic imaging AI tool or a device that involves human interpretation of results requiring MRMC studies.

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

• This is a quality control material. Its "performance" is in its ability to consistently produce expected values when measured by an immunoassay analyzer. It does not involve an algorithm generating a diagnostic output to be evaluated as "standalone." The evaluation of "value assignment and stability" would be akin to a standalone performance evaluation for this type of device.

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

• For a quality control material, the "ground truth" is the assigned reference value for each analyte. The document indicates analytes are "spiked into the matrix at the desired concentration levels" and that "value assignment" was evaluated. The specific methodology for establishing these assigned values (e.g., using reference methods, internal standards, or consensus from multiple measurements) is not detailed.

8. The sample size for the training set

• This is a quality control material for immunoassay analyzers. It does not involve machine learning or a "training set" in the typical sense.

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

• Not applicable, as there is no "training set" for this type of device.

Summary of what is known:

The Elecsys PreciControl Universal is a lyophilized control product with added antigens in a human serum matrix. It is used for quality control of Elecsys immunoassays on Elecsys and cobas e immunoassay analyzers. The current submission is a modification to add Carcinoembryonic antigen (CEA) and total Prostate-Specific Antigen (PSA) controls. Evaluation was performed for "value assignment and stability." The predicate device is the Elecsys PreciControl Universal (K051687).

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Elecsys® PreciControl Universal is used for quality control of the Elecsys® immunoassays on the Elecsys® immunoassay systems.

The Elecsys® PreciControl Universal is a lyophilized product consisting of added antigens in human serum matrix. During manufacture, the analytes are spiked into the matrix at the desired concentration levels.

The provided document describes a 510(k) premarket notification for a medical device called "Elecsys® PreciControl Universal," a quality control material for immunoassays. The primary objective is to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in a quantitative manner for specific performance metrics like accuracy, precision, or sensitivity. Instead, the "study" evaluates value assignment and performance characteristics stability, and the overall acceptance is based on demonstrating substantial equivalence to the predicate device.

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

The document does not specify the sample size for the test set. It mentions "The Elecsys® PreciControl Universal was evaluated for value assignment and Performance Characteristics stability," but provides no details on how many runs, samples, or data points were used for these evaluations.

The data provenance (country of origin, retrospective/prospective) is also not mentioned within this 510(k) summary.

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 product is a quality control material, not a diagnostic device that interprets clinical images or data requiring expert consensus for ground truth. Therefore, the concept of "experts establishing ground truth" in the clinical sense (e.g., radiologists) is not applicable here. The "ground truth" for a quality control material would typically be its assigned target values and demonstrated performance characteristics (e.g., stability). These values are established through rigorous laboratory testing and statistical analysis following established standards for assay development and quality control manufacturing, rather than expert interpretation of individual cases.

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

Since this is a quality control material and not a device requiring human interpretation of results against a clinical ground truth, no adjudication method (like 2+1 on clinical cases) is mentioned or relevant. The "adjudication" would be in the form of laboratory quality control procedures and statistical analysis to ensure the product meets its specifications.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable to this device. MRMC studies are typically used for diagnostic imaging or similar devices where multiple human readers interpret cases, often with and without AI assistance, to measure the impact of the AI. This device is a quality control material for automated immunoassay systems; it does not involve human readers for interpretation, nor does it incorporate AI.

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

This refers to an "algorithm only" performance. While the Elecsys® PreciControl Universal is used with automated Elecsys® immunoassay systems, the device itself is a reagent (quality control material), not an algorithm. Its performance is evaluated through its physical and chemical properties and how it performs on those automated systems. The concept of "standalone algorithm performance" as typically applied to AI or diagnostic software does not directly apply here. The document describes the evaluation of the control's properties and its suitability for quality control on the specified analyzers.

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

The "ground truth" for a quality control material like Elecsys® PreciControl Universal would typically be:

• Assigned Target Values: These are the expected concentrations or activity levels of the analytes within the control material, established through a robust process of multiple measurements using a reference method or a well-characterized set of instruments, often with multiple lots and replicates.
• Established Performance Specifications: These include data on its stability (shelf life, open-vial stability, freeze-thaw stability, on-board stability), homogeneity, and commutability (though commutability is not explicitly discussed here for these specific analytes, it's a general concept for QC materials).

The document states, "The Elecsys® PreciControl Universal was evaluated for value assignment and Performance Characteristics stability." This implies that data was gathered to determine its assigned values and to confirm its stability profile.

8. The sample size for the training set

The concept of a "training set" is typically associated with machine learning or AI models. This device is a chemical reagent (quality control material). Therefore, there is no "training set" in the context of AI. The development process would involve extensive formulation, manufacturing, and testing to establish its characteristics, rather than training an algorithm.

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

As there is no "training set" in the AI sense for this device, this question is not applicable. The "ground truth" (assigned values and performance characteristics) for the quality control material itself is established through analytical testing and characterization during the manufacturing and validation process.

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