FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

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.

AI/ML Overview

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).

Summary

Regulation Number and Section

§ 862.1660 Quality control material (assayed and unassayed).

(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.