(40 days)
OPUS Progesterone is an in vitro fluorogenic enzyme immunoassay (ELISA) for the quantitative measurement of progesterone in human serum or heparanized plasma. OPUS Progesterone is intended for use with the OPUS analyzers.
OPUS Progesterone is an in vitro fluorogenic enzyme immunoassay (ELISA) for the quantitative measurement of progesterone in serum or heparanized plasma, used in the diagnosis and treatment of disorders of the ovaries or placenta. OPUS Progesterone is intended for use with the OPUS analyzers.
OPUS Progesterone is a set of reagents intended to be used together with the OPUS immunoassay analyzers for the quantitative measurement of progesterone in human serum or heparanized plasma.
Here's an analysis of the provided 510(k) notification, focusing on the acceptance criteria and the study details:
Device: OPUS® Progesterone Test System
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implied/General Industry Practice) | Reported Device Performance (OPUS Progesterone) |
|---|---|---|
| Precision | ||
| Intra-assay %CV | Typically 0.95, slope near 1, y-intercept near 0 | R = 0.97, slope = 0.99, y-intercept = -0.19 |
Note on Acceptance Criteria: The provided document does not explicitly state pre-defined acceptance criteria values for each performance metric. The "Acceptance Criteria" column above is based on typical industry standards and expectations for immunoassay performance for such devices at the time of submission (mid-1990s). The reported device performance generally falls within these commonly accepted ranges, suggesting the device met the implicit or expected criteria for clearance.
2. Sample Size Used for the Test Set and Data Provenance
- Precision (Intra-assay): 3 levels of control material, 20 replicates each.
- Precision (Inter-assay): 3 levels of control material, duplicate assays over 5 days (totaling 20 replicates).
- Accuracy by Recovery: 5 different levels of Progesterone spiked into previously assayed human serum, assayed in duplicate.
- Accuracy by Correlation: 83 serum samples.
- Data Provenance: The document does not explicitly state the country of origin. It indicates human serum and heparanized plasma were used as sample matrices. The study appears to be prospective in the sense that the samples were analyzed using the OPUS system for the purpose of demonstrating performance. It's unclear if the samples themselves were collected prospectively or retrospectively from a larger bank.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of in-vitro diagnostic (IVD) device (immunoassay for quantitative measurement of a biomarker) typically does not rely on expert review of images or clinical cases for ground truth. Instead, the ground truth for performance characteristics like accuracy and precision is established through:
- Reference materials/standards: For precision, control materials with known concentrations are used.
- Spiked samples with known analyte concentrations: For recovery studies, a known amount of progesterone is added to a sample, and the device's ability to measure that addition is assessed.
- Comparison to a legally marketed predicate device: For accuracy by correlation, the predicate device (DPC Coat-a-Count® Progesterone) serves as the "truth" or reference method against which the new device's measurements are compared.
Therefore, the concept of "experts establishing ground truth" in the way it applies to image-based diagnostics is not directly relevant here.
4. Adjudication Method for the Test Set
Not applicable for this type of IVD performance study. Adjudication (e.g., 2+1, 3+1) is typically used in clinical studies or image-based diagnostic evaluations where multiple reviewers resolve discrepancies in interpretations.
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 an automated immunoassay for measuring progesterone levels. It does not involve human readers interpreting AI outputs or images.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, the performance studies described (Precision, Accuracy by Recovery, Accuracy by Correlation) are all standalone performance studies for the OPUS Progesterone system. The device itself is an automated system designed for quantitative measurement. Human intervention is limited to sample loading, running the assay, and interpreting the reported numerical result, not in the direct "performance" of the measurement itself or its internal analytical process.
7. The Type of Ground Truth Used
- Precision: Established using control materials with known reference ranges.
- Accuracy by Recovery: Established by spiking samples with known quantities of progesterone.
- Accuracy by Correlation: Established by comparison to a legally marketed predicate device (DPC Coat-a-Count® Progesterone), which serves as the reference method or "truth" for comparative purposes.
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of machine learning or AI models, as this is an immunoassay device. Immunoassays are based on biochemical reactions and calibrated using a calibrator system, not typically "trained" in the AI sense.
- Calibrator System: The OPUS Progesterone uses a six-point calibrator system. This calibrator system is crucial for establishing the standard curve against which unknown samples are measured. While not a "training set" in the ML sense, these calibrators are fundamental to the device's ability to provide quantitative results.
9. How the Ground Truth for the Training Set Was Established
Given that this is an immunoassay and not an AI/ML device, the concept of "ground truth for the training set" doesn't directly apply. Instead, the "ground truth" for the calibrator system (used to establish the standard curve) would be based on:
- Highly purified progesterone standards: The concentrations of progesterone in the calibrator materials would be precisely determined using gravimetric methods or other highly accurate analytical techniques, often traceable to international reference standards.
- Manufacturing QC: The calibrators would be manufactured and verified for their specified concentrations and stability according to strict quality control procedures.
§ 862.1620 Progesterone test system.
(a)
Identification. A progesterone test system is a device intended to measure progesterone (a female hormone) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of disorders of the ovaries or placenta.(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.