(209 days)
The IDS-iSYS Free Testosterone assay is an in vitro diagnostic device intended for the quantitative determination of free testosterone in human serum or the IDS system. Measurement of free testosterone is used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, impotence in male and in females; hirsutism (excessive hair) and virilization) due to tumors, polycystic ovaries and androgenital syndromes.
The IDS-iSYS Free Testosterone assay consists of a reagent cartridge. The reagent cartridge contains multiple reagents:
- MP3: Magnetic particles coated with Streptavidin in a phosphate Pluronic buffer with sodium azide (NaN3) as preservative (
The provided document describes the analytical performance of the IDS-iSYS Free Testosterone assay but does not detail a device performance study with acceptance criteria in the typical format of a clinical trial for an AI/ML medical device. Instead, it focuses on the analytical characteristics of the in vitro diagnostic device, comparing it to a predicate device and demonstrating its performance through various laboratory tests.
Here's an attempt to structure the information based on your request, with the understanding that not all requested points are directly applicable to this type of IVD submission:
1. Table of Acceptance Criteria and Reported Device Performance
For an in vitro diagnostic device like the IDS-iSYS Free Testosterone, "acceptance criteria" and "reported device performance" are typically defined by analytical performance characteristics, such as sensitivity, precision, linearity, and interference. The document presents these values but does not explicitly state pre-defined acceptance criteria for each measurement that would be found in a clinical study protocol. However, we can infer performance targets based on the data presented and common medical device standards (e.g., CLSI guidelines).
| Acceptance Criteria (Inferred/Generic for IVD) | Reported Device Performance (IDS-iSYS Free Testosterone) |
|---|---|
| Analytical Sensitivity | |
| Limit of Blank (LoB) | 0.08 pg/mL |
| Limit of Detection (LoD) | 0.17 pg/mL |
| Limit of Quantitation (LoQ) | 0.40 pg/mL (with CV =60 yrs) |
* Males: 129 (21-39 yrs), 138 (40-59 yrs), 42 (>=60 yrs)
The provenance of these subjects is not stated, but they are described as "apparently healthy adults and children."
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable to this document. The "ground truth" for an IVD device like this is typically established by reference methods or gravimetric preparation of calibrators/controls, not by human expert opinion as would be the case for image-based AI/ML diagnostics. The values are quantitative measurements of a biochemical marker.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods (e.g., 2+1, 3+1) are common in studies where human readers interpret data (like medical images) and their agreement, or lack thereof, needs to be resolved. For an IVD, the "ground truth" is a measured concentration, and the accuracy is assessed against reference standards or established methods.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not applicable. An MRMC study assesses how human readers' performance changes with and without AI assistance. This device is an in vitro diagnostic assay, directly measuring a biomarker without human interpretation in the workflow described.
6. Standalone (Algorithm Only) Performance
The performance data presented throughout the document (LoB, LoD, LoQ, precision, linearity, cross-reactivity, interference, method comparison, matrix comparison) is the standalone performance of the IDS-iSYS Free Testosterone assay. This device is a fully automated assay system, and its performance is evaluated independent of human interpretive steps.
7. Type of Ground Truth Used
The ground truth for the analytical studies is generally based on:
- Known concentrations: For LoB, LoD, LoQ, linearity, cross-reactivity, and interference, samples are prepared with known or target concentrations of free testosterone and potential interfering substances.
- Comparative methods: For method comparison, a "commercially available quantitative free testosterone ELISA" serves as the comparative method against which the IDS-iSYS Free Testosterone is measured.
- Reference Intervals: For expected values, "95% reference interval for apparently healthy adults and children" was calculated using a non-parametric method, likely referring to the distribution of measurements in that population.
8. Sample Size for the Training Set
This information is not provided and is typically not applicable in the same way it would be for an AI/ML device. For an IVD assay, "training" involves the development and optimization of the assay reagents, protocols, and calibration, rather than training a machine learning model on a distinct dataset. The "training set" for an IVD refers to the samples used to develop and refine the assay's performance characteristics and establish its calibration curve, which is distinct from the analytical validation samples.
9. How the Ground Truth for the Training Set Was Established
This information is not explicitly provided in the document. For an IVD, the "ground truth" for developing a training set (i.e., for calibration) typically involves:
- Gravimetric preparation: Precisely weighing and dissolving a known amount of the analyte (free testosterone) in a suitable matrix to create primary calibrators with accurate, traceable concentrations.
- Reference methods: Using highly accurate and validated reference methods (e.g., LC-MS/MS, though not specified here) to assign values to calibrators or control materials.
- Standardization: Following established industry and regulatory standards (e.g., CLSI guidelines) for calibrator preparation and value assignment to ensure accuracy and traceability.
§ 862.1680 Testosterone test system.
(a)
Identification. A testosterone test system is a device intended to measure testosterone (a male sex hormone) in serum, plasma, and urine. Measurement of testosterone are 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 (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries, and adrenogenital syndromes.(b)
Classification. Class I.