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The DSL-10-4000 ACTIVE™ Testosterone Enzymeimmunoassay (EIA) Kit provides materials for the quantitative measurement of testosterone in serum. This assay is intended for in vitro diagnostic use. Measurement of testosterone is used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delayed or precocious puberty, impotence in males and in females hirsutism and virilization due to tumors, polycystic ovaries and adrenogenital syndrome.

The EIA format is a competitive binding protein assay. Enzyme-labeled Testosterone competes with un-labeled Testosterone in the serum sample for binding sites with the Anti-Testosterone antibody in microtitration wells. Separation of free from bound Testosterone is achieved by washing and decanting the microtiter plates after incubation. The resultant is analyzed in a spectrophotometer for absorbance. The amount of enzyme-labeled Testosterone bound to the antibody is inversely proportional to the concentration of the Testosterone present in the sample.

The provided document describes the DSL ACTIVE™ Testosterone EIA kit and its substantial equivalence to the DSL Testosterone RIA. There is no information regarding a specific device that uses AI or machine learning, nor any "acceptance criteria" in the sense of performance thresholds that the device must meet to be considered effective, other than demonstrating substantial equivalence to a predicate device.

However, based on the information provided, we can infer how the substantial equivalence was demonstrated, which serves as the "acceptance criteria" for marketing the device.

Here's an analysis based on the provided text, structured to answer your questions where applicable, and noting where information is not available:

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

The primary "acceptance criteria" for the DSL ACTIVE™ Testosterone EIA kit was to demonstrate substantial equivalence to a legally marketed predicate device, the DSL Testosterone RIA. This was evaluated through a comparison study of human serum samples.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: 150 human serum samples (n = 150).
• Data Provenance:
  • Country of Origin: Not explicitly stated. However, given the submitting company's address is in Webster, Texas, USA, and the FDA's jurisdiction, it's highly probable the samples were collected in the United States.
  • Retrospective or Prospective: Not explicitly stated. However, the samples were "collected and assayed" for the purpose of the comparison, which could imply a prospective collection, or a retrospective selection from a bank of samples. The crucial point is that they were chosen to represent a range of Testosterone levels ("low, intermediate and high").

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

This is not applicable in this context. The "ground truth" for this type of in vitro diagnostic device is the measurement itself, and the comparison is against another established, legally marketed assay (the predicate device). There is no mention of experts establishing ground truth in the sense of clinical interpretation or diagnosis. The predicate device's results serve as the reference.

4. Adjudication Method for the Test Set

Not applicable. This was a direct comparison of quantitative measurements from two assays, not an adjudicated review of interpretations.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This is an in vitro diagnostic device for quantitative measurement, not an imaging or interpretive device that would involve human readers in the way an MRMC study evaluates. There's no AI component mentioned that would assist human readers.

6. Standalone (Algorithm Only) Performance Study

Yes, in a sense. The "device performance" described (Y = 0.094(X) + 0.1 with r = 0.93) is the standalone performance of the DSL ACTIVE™ Testosterone EIA kit when compared to the DSL Testosterone RIA. The kit operates independently to produce a quantitative result. There is no human-in-the-loop component for the assay's function itself.

7. Type of Ground Truth Used

The "ground truth" was established by the predicate device's measurement results (DSL Testosterone RIA). The new device's measurements were compared against these established measurements. There was no pathology, expert consensus (in the diagnostic sense), or outcomes data used to establish "ground truth" for the individual sample values.

8. Sample Size for the Training Set

No training set is mentioned. This is a traditional immunoassay, not a machine learning model.

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 Device and Approval:

The DSL 10-4000 ACTIVE™ Testosterone EIA Kit is a competitive binding protein assay designed for the quantitative measurement of Testosterone in human serum. It works by having enzyme-labeled Testosterone compete with un-labeled Testosterone from the sample for binding sites on an Anti-Testosterone antibody. The amount of enzyme-labeled Testosterone bound is inversely proportional to the Testosterone concentration in the sample.

The device was cleared for marketing by the FDA as substantially equivalent to the DSL Testosterone RIA. The demonstration of substantial equivalence was based on a comparison study of 150 human serum samples. Linear regression analysis of the results between the new device (Y) and the predicate device (X) yielded the equation Y = 0.094(X) + 0.1 with a correlation coefficient (r) of 0.93. This high correlation coefficient suggests a strong agreement between the two assays across a range of Testosterone levels (low, intermediate, and high), thereby meeting the implicit acceptance criteria for substantial equivalence.

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