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510(k) Data Aggregation
(105 days)
Luminescence immunoassay for the in vitro diagnostic quantitative measurement of active free progesterone (a female hormone) in saliva. Measurements obtained by this device may be used in the diagnosis and treatment of disorders of the ovaries and can be used as an aid for confirmation of ovulation.
Luminescence immunoassay (LIA) based on the competition principle. An unknown amount of antigen present in the sample and a fixed amount of enzyme labeled antigen compete for the binding sites of the antibodies coated onto the wells. After incubation the wells are washed to stop the competition reaction. After addition of the luminescence substrate solution the intensity of the luminescence measured is inversely proportional to the amount of the antigen in the sample. Results of samples can be determined directly using the standard curve.
IBL Progesterone LIA - Acceptance Criteria and Study Details
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes the performance characteristics of the IBL Progesterone LIA. The acceptance criteria for these characteristics are not explicitly stated as distinct thresholds in the document, but rather the reported performance values themselves serve as the demonstration of the device's capability. For this analysis, we will interpret the reported performance as meeting the implicit acceptance criteria for a device of this type.
| Performance Metric | Reported Device Performance |
|---|---|
| Analytical Specificity (Cross-Reactivity) | |
| 17α-Hydroxyprogesteron | 1.84% |
| 6α-Methyl-17α-Hydroxyprogesteron | 1.41% |
| Pregnenolone | 0.41% |
| Deoxycorticosterone | 0.28% |
| Androsterone Sulfat | 0.25% |
| Androstenedion | 0.20% |
| Androsterone | 0.20% |
| DHEA-S | 0.11% |
| Corticosterone | 0.06% |
| Other substances tested | ≤ 0.1 % |
| Analytical Sensitivity (Limit of Detection) | 2.6 pg/mL (Mean signal (Zero-Standard) - 2SD) |
| Precision | |
| Intra-Assay (10 measurements) | Range (pg/mL): 11.5 - 822; CV (%): 6.0 - 0.7 |
| Inter-Assay (10 measurements) | Range (pg/mL): 10.6 - 817.1; CV (%): 18.8 - 3.4 |
| Linearity | Range (pg/mL): 7.5 - 779; Range (%): 78 - 120; Mean (%): 97 (Serial dilution up to 1:32) |
| Recovery | Range (pg/mL): 27 - 1497; Range (%): 82 - 121; Mean (%): 103 |
| Comparison Study | Correlation with a published RIA method: r² = 0.94, Regression formula: Y = 0.89 * RIA + 25.5 pg/mL |
| Normal Ranges (Reference Values) | Premenopausal Females (n=27 month profiles): Follicular phase: 28 - 82 pg/mL, Luteal phase (peak max): 127 - 446 pg/mL Postmenopausal Females (n=6): 18 - 51 pg/mL Males (n=49): < 59 pg/mL |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set:
- Clinical cycle profiling: 27 pre-menopausal women, 6 post-menopausal women, and 49 males.
- Comparison study: 97 adult healthy populations.
- Data Provenance: The document does not explicitly state the country of origin for the data. It mentions the manufacturer as IBL Immuno Biological Laboratories in Hamburg, Germany, which suggests the studies were likely conducted or overseen in Germany or Europe. The study is prospective for the clinical cycle profiling (samples collected throughout menstrual cycles), and likely also prospective or from a specific collection for the healthy populations in the comparison study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not mention the use of "experts" in the traditional sense (e.g., radiologists, pathologists) to establish ground truth.
For the comparison study, the "ground truth" was established by a "published procedure that used a modification in the handling of saliva for a typical RIA test." This implies a reference analytical method was used as the ground truth, rather than expert clinical judgment.
4. Adjudication Method for the Test Set
Not applicable. The ground truth was established by a reference analytical method, not by human expert consensus or adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The study focused on the analytical performance of the device and its correlation with a reference method, not on the impact of the device on human reader performance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, the studies reported in the document describe the standalone performance of the IBL Progesterone LIA device. The device autonomously measures progesterone levels in saliva. The comparison study assesses its agreement with a reference analytical method, which is a form of standalone performance evaluation.
7. The Type of Ground Truth Used
- For Analytical Performance (Specificity, Sensitivity, Precision, Linearity, Recovery): The ground truth is inherent in the analytical standards and reference materials used to challenge the assay and measure its performance characteristics. These are established laboratory methods.
- For Comparison Study: The ground truth was a published procedure using a modified RIA test for saliva progesterone. This serves as a reference method.
- For Normal Ranges: The "ground truth" here is the measured progesterone levels in a defined healthy population (pre-menopausal women, post-menopausal women, males) over specific physiological periods (menstrual cycle phases).
8. The Sample Size for the Training Set
The document does not explicitly describe a "training set" in the context of an algorithm or AI. The IBL Progesterone LIA is a luminescence immunoassay, not an AI/machine learning algorithm that requires a separate training phase. All listed sample sizes (27 pre-menopausal women, 6 post-menopausal women, 49 males, and 97 adult healthy populations) are related to the evaluation/test of the device's performance characteristics and establishment of reference ranges, not for training a model.
9. How the Ground Truth for the Training Set was Established
As noted above, there is no explicit "training set" for an AI/machine learning model. The device is a biochemical assay. The "ground truth" for evaluating its performance (as detailed in point 7) was established through scientifically accepted analytical methods and reference procedures.
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