(14 days)
The DSL. Androstenedione EIA assay is intended for the quantitative determination of androstenedione in human serum. The measurement of androstenedione is used in the diagnosis and treatment of females with excessive levels of androgen production.
The EIA format is a competitive binding protein assay. Enzyme-labeled androstenedione competes with un-labeled androstenedione in the serum sample for binding sites to the androstenedione antibody coated to the microtitration well provided with the kit. Separation of free from bound androstenedione is achieved by aspirating and washing the wells. The resultant is analyzed in a spectrophotometer for bound absorbance. The amount of enzymelabeled androstenedione bound to the antibody is inversely proportional to the concentration of the androstenedione present in the sample.
The provided document does not describe an AI/ML powered medical device. It describes an Androstenedione EIA Kit, which is a laboratory test kit used for the quantitative measurement of androstenedione in human serum. Therefore, the questions related to AI/ML device performance, such as acceptance criteria for AI performance, sample sizes for test and training sets for an algorithm, expert ground truth establishment, MRMC studies, and standalone algorithm performance, are not applicable.
The document discusses the substantial equivalence of the DSL 10-3800 Androstenedione EIA kit to its predicate device, the DSL 3800 Androstenedione RIA.
Here's the relevant information that can be extracted:
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Acceptance Criteria and Reported Device Performance: This section is not applicable in the typical AI/ML sense. Instead, the document demonstrates substantial equivalence through a correlation study between the new EIA kit and a predicate RIA kit.
- Acceptance Criteria (Implied for Substantial Equivalence): The goal was to show substantial equivalence, often demonstrated by a strong correlation. While no specific acceptance criteria (e.g., r > 0.90) are explicitly stated, the reported correlation coefficient of 0.85 and the linear regression equation are presented as evidence of equivalence.
- Reported Device Performance (Comparison of New vs. Predicate):
- Linear Regression Equation: Y = 1.07(X) + 0.02
- Correlation Coefficient (r): 0.85
(Where Y is the result from the DSL 10-3800 Androstenedione EIA kit and X is the result from the DSL 3800 Androstenedione RIA kit)
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Sample size used for the test set and the data provenance:
- Sample Size: 80 patient samples (n=80).
- Data Provenance: Not explicitly stated, but implies human serum samples. The origin country is not mentioned. It is a retrospective comparison using collected samples.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in this context is the measurement by the predicate device (DSL 3800 Androstenedione RIA). No human experts were involved in establishing "ground truth" for the individual sample values beyond performing the assays.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This is a comparison of two quantitative assay methods, not an imaging or diagnostic interpretation task requiring adjudication.
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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 is a laboratory test kit, not an AI-assisted diagnostic tool for human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a laboratory test kit, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for the comparison study was the measurement results obtained from the predicate device (DSL 3800 Androstenedione RIA). The predicate device itself would have been validated against a reference method or clinical outcomes previously.
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The sample size for the training set: Not applicable. This is not a machine learning model.
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How the ground truth for the training set was established: Not applicable. This is not a machine learning model.
§ 862.1075 Androstenedione test system.
(a)
Identification. An androstenedione test system is a device intended to measure androstenedione (a substance secreted by the testes, ovary, and adrenal glands) in serum. Adrostenedione measurements are used in the diagnosis and treatment of females with excessive levels of androgen (male sex hormone) production.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.