(101 days)
The DSL FSH IRMA assay is intended for the quantitative determination of FSH in human serum. The measurement of FSH is used as a diagnostic aid in the diagnosis and treatment of pituitary gland and gonadal disorders.
The IRMA format is a non-competitive assay in which the analyte to be measured is "sandwiched" between two antibodies. The first antibody is immobilized to the inside wall of the test tube, the other antibody is radiolabelled for detection. The analyte present is bound by both the antibodies to form a "sandwiched" complex. Unbound materials are removed be decanting and washing the tubes. The resultant is analyzed in a gamma counter for bounds counts per minute. The amount of bound FSH is directly proportional to the concentration of the FSH present in the sample.
The provided text describes a medical device, the DSL 4700 FSH IRMA Kit, and a study conducted to demonstrate its substantial equivalence to a predicate device, the DPC FSH IMMULITE. However, the information needed to fully answer your request regarding acceptance criteria and a detailed study description is largely not present in the provided text.
Here's a breakdown of what can and cannot be answered based on the given information:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated. For a quantitative assay, acceptance criteria typically involve predefined thresholds for correlation coefficient (r), slope, intercept, bias, and precision. None of these are provided as acceptance criteria.
- Reported Device Performance:
- Correlation Coefficient (r): 0.98
- Linear Regression Equation: Y = 0.66(X) + 1.26 (where Y is the DSL FSH IRMA result and X is the DPC FSH IMMULITE result)
| Performance Metric | Reported Value | Acceptance Criteria (Not provided) |
|---|---|---|
| Correlation Coefficient (r) | 0.98 | Not stated |
| Linear Regression Slope | 0.66 | Not stated |
| Linear Regression Intercept | 1.26 | Not stated |
2. Sample sized used for the test set and the data provenance
- Sample Size for Test Set: 81 patient samples.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). It mentions "patient samples were collected," which could imply prospective collection, but without further detail, it's unclear. The company is registered in Webster, Texas, USA, which might suggest the samples were collected in the US, but this is an inference, not a direct statement.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This study is a method comparison study comparing a new device (DSL FSH IRMA Kit) against an existing predicate device (DPC FSH IMMULITE). It does not involve establishing a ground truth against human expert interpretation or pathology. The "ground truth" in this context is the measurement provided by the predicate device.
4. Adjudication method for the test set
- Not applicable. See point 3.
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
- No. This is not an MRMC study. It's a method comparison for a laboratory diagnostic kit, not an AI-assisted diagnostic imaging or interpretation system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, effectively. This device is a lab assay kit. Its performance is inherent to the kit itself, which is a "standalone" analytical device, not requiring human interpretation of complex patterns like images. The results are quantitative measurements.
7. The type of ground truth used
- The "ground truth" in this comparative study is the measurement obtained from the DPC FSH IMMULITE, which is the predicate device. The study aims to show that the DSL FSH IRMA Kit provides results consistent with this established method.
8. The sample size for the training set
- Not provided. The text describes a "development" phase for the kit, but does not provide details on a separate "training set" used in the context of machine learning or algorithm development. For an IRMA kit, development involves optimization of reagents, antibodies, and protocols, which is different from training a machine learning model.
9. How the ground truth for the training set was established
- Not applicable/Not provided. As noted in point 8, the concept of a "training set ground truth" in the machine learning sense doesn't directly apply here. The "ground truth" for optimizing an IRMA assay would be achieving desired analytical performance characteristics (e.g., sensitivity, specificity, linearity, precision) using traceable standards and reference materials, but the text does not detail this process for a "training set."
Summary of what is present and what is missing:
- Present: Device name, purpose, assay principle, predicate device, sample size for comparison study (test set), and key statistical results (r, regression equation) for the comparison.
- Missing from text: Explicit acceptance criteria, detailed data provenance, any information related to expert ground truth or adjudication (as it's not relevant for this type of test), specifics on how the kit was "trained" or developed in a context relevant to your questions.
§ 862.1300 Follicle-stimulating hormone test system.
(a)
Identification. A follicle-stimulating hormone test system is a device intended to measure follicle-stimulating hormone (FSH) in plasma, serum, and urine. FSH measurements are used in the diagnosis and treatment of pituitary gland and gonadal disorders.(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.