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OPUS hLH Controls are quality control materials intended for use in the clinical laboratory to assess or verify the performance of the OPUS hLH assay, run on the OPUS analyzers.

OPUS hLH Controls are intended for use as quality control material to monitor the accuracy and precision of the OPUS hLH assay run on the OPUS analyzers.

The provided document is a 510(k) Notification for the OPUS hLH Controls, a quality control material, not an AI/ML powered device. As such, many of the requested categories in the prompt (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set sample size, how ground truth was established for training set) are not applicable to this type of medical device submission.

However, I can extract information related to the device performance characteristics, which serve as the acceptance criteria for this quality control material.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size:
  • Intra-assay precision: 20 replicates for each of the three levels of control material (total of 60 measurements).
  • Inter-assay precision: Duplicate measurements over a five-day period, totaling 20 replicates for each of the three levels of control material (total of 60 measurements).
• Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It is a submission for a quality control material, and such studies are typically performed in a controlled laboratory setting by the manufacturer (Dade-Behring Inc., located in Westwood, MA, USA).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device is a quality control material. Its "ground truth" (i.e., expected LH levels) is established during its manufacturing and assay process, not by expert review of patient data. The study focuses on the precision of the control material when run on an analyzer.

4. Adjudication method for the test set

Not applicable. There is no expert adjudication for the performance of a quality control material. The performance is assessed purely based on statistical precision metrics.

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, not an AI/ML-powered diagnostic tool requiring human reader studies.

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

Not applicable. This device is a quality control material for an immunoassay, not an algorithm.

7. The type of ground truth used

For quality control materials, the "ground truth" refers to the target or assigned values for the analytes within the control. These are established through:

• Manufacturer's internal assays: Batch testing during production to determine the concentration of hLH at each control level.
• Assigned values: The control material is "assayed," meaning it comes with lot-specific values, likely determined by the manufacturer against a reference method or standard.

The study then assesses how precisely the OPUS hLH assay measures these known levels within the control material.

8. The sample size for the training set

Not applicable. Quality control materials do not typically have a "training set" in the context of AI/ML or classification algorithms.

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

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

Ask a specific question about this device

OPUS hLH is a fluorogenic enzyme assay for use with the OPUS analyzers used in the quantitative measurement of lutenizing hormone (LH) in serum or plasma.

OPUS hLH is based on the principle of sandwich binding immunoassay. Each test module contains a solid phase anti-LH polyclonal antibody immobilized onto glass fiber. An anti-LH monoclonal antibody/alkaline phosphatase conjugate solution and a wash/substrate soluiton (4-methylumbellifery|phosphate) are sealed in separate wells within the test module.

The provided text describes a 510(k) premarket notification for the OPUS hLH assay. This document focuses on demonstrating substantial equivalence to a legally marketed device rather than establishing new safety and effectiveness through a rigorous clinical trial with explicit acceptance criteria for diagnostic accuracy metrics. Therefore, some of the requested information (e.g., number of experts, adjudication method, MRMC study, sample size for training set, specific ground truth for training set) is not typically found in this type of submission for in-vitro diagnostic devices.

However, based on the provided text, I can infer and extract information to address your request as best as possible.

Here's a breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

For in-vitro diagnostic assays like OPUS hLH, acceptance criteria are often defined by performance characteristics such as precision, accuracy (correlation and recovery), and interference. The submission usually aims to show that the new device performs comparably to or within acceptable ranges relative to the predicate device or established analytical standards.

Ask a specific question about this device