(126 days)
for the quantitative determination of progesterone in human serum and plasma (heparin or EDTA).
AxSYM Progesterone is a microparticle enzyme immunoassay for the quantitative determination of progesterone in human serum and plasma (heparin or EDTA). AxSYM Progesterone is calibrated with Abbott calibrators and Abbott controls are used for verification of the calibration and to monitor the performance of the Abbott AxSYM System.
This document is a 510(k) summary for a diagnostic test, not an AI device. Therefore, many of the requested categories (e.g., number of experts for ground truth, adjudication method, MRMC studies, standalone algorithm performance, training set details) are not applicable or cannot be extracted from this type of regulatory submission. The summary focuses on demonstrating substantial equivalence to a predicate device for an in-vitro diagnostic (IVD) assay.
Here's the information that can be extracted, with explanations for the inapplicable sections:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Strong correlation with predicate device | Correlation coefficient: 0.96 |
| Slope close to 1.0 (indicating similar proportionality) | Slope: 0.86 |
| Low standard error of Y-estimate (indicating good fit) | Standard error of Y-estimate: 2.29 |
| Y-axis intercept close to 0 (indicating no significant bias) | Y-axis intercept: 0.77 ng/mL |
| Dynamic range comparable to predicate device | Dynamic range: 0 - 40 ng/mL progesterone |
| Intended Use comparable to predicate device | Quantitative determination of progesterone in human serum/plasma |
Note on Acceptance Criteria: The document implies these as acceptance criteria through the reported correlation analysis. In 510(k) submissions for IVDs based on substantial equivalence, the "acceptance criteria" are generally that the new device performs comparably to the predicate device across relevant performance characteristics (e.g., accuracy, precision, dynamic range, analytical sensitivity, analytical specificity). The correlation analysis directly addresses accuracy relative to the predicate.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: 209 specimens
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). This is typical for older 510(k) summaries which often focused on the statistical results rather than detailed demographic or collection information for the samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is an in-vitro diagnostic test for a biomarker (progesterone). The "ground truth" for the test set is established by the measurements from the predicate device (Diagnostics Products Corporation Coat-A-Count® Progesterone assay), which itself is assumed to be an accurate measurement of progesterone. There are no human "experts" establishing ground truth in the sense of image interpretation or clinical diagnosis for this type of device.
4. Adjudication method for the test set
- Not Applicable. See point 3. The comparison is directly between the new device's readings and the predicate device's readings. There is no adjudication process involving human review of discrepancies.
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 is not an AI device or an imaging device requiring human reader interpretation. It is an automated immunoassay for a biomarker.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, by definition. This is an automated in-vitro diagnostic assay. Its performance is evaluated intrinsically through its ability to accurately measure progesterone. There isn't a "human-in-the-loop" component in the direct operation or result generation of the assay itself, beyond an operator running the instrument. The comparison is between two automated assay systems.
7. The type of ground truth used
- Predicate Device Measurement: The "ground truth" for the performance study (correlation analysis) was the quantitative determination of progesterone in the same specimens by the Diagnostics Products Corporation Coat-A-Count® Progesterone assay.
8. The sample size for the training set
- Not Applicable. This is not an AI/machine learning device that requires a training set in the conventional sense. It's a chemical immunoassay system. The system is "calibrated" using Abbott calibrators, but this is a different concept than training an AI model.
9. How the ground truth for the training set was established
- Not Applicable. See point 8. The "calibration" is performed using known concentration standards (Abbott calibrators), not a "training set" with established ground truth labels in the AI context.
§ 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.