(97 days)
The MiniClinic Ovulation Predictor is a monoclonal antibody-based immunoassay intended for the visual qualitative detection of human Luteinizing Hormone (hLH) in urine. This test is used to detect the mid-cycle LH surge which occurs approximately 24 hours prior to ovulation. By predicting ovulation, conception can be planned most effectively. Its intended use is identical to that of several over-the-counter (OTC) products currently available for home use.
The MiniClinic Ovulation Predictor is a qualitative visual test system for the detection of human Luteinizing Hormone (hLH) in urine as an indicator of ovulation and would be classified as a Human Luteinizing Hormone Test System.
Here's an analysis of the provided text regarding the MiniClinic Ovulation Predictor, focusing on the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state formal acceptance criteria (e.g., a specific sensitivity or specificity threshold to be met). However, it does describe the device's intended function and principles of operation, which, when successful, would indicate acceptable performance. The "reported device performance" in this context refers to the device's ability to produce a colored line when hLH is present above baseline and to provide a control line.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Detection of hLH surge: Ability to visually detect hLH levels above baseline. | "Levels of hLH above baseline values will produce colo[r]" on the test line, forming a visible reddish band along the immobilized goat anti-hLH. The amount of color is proportional to the amount of hLH. |
| Control mechanism: Presence of a reliable control to confirm test validity. | A control line consisting of immobilized goat anti-mouse IgG binds the conjugate and forms a colored line, "regardless of whether hLH is present in the urine or not." The concentration of control components is adjusted to provide a comparison for the test line. This indicates the test ran correctly. |
| Qualitative result: Provide a clear visual qualitative indication. | "A visible reddish band is formed along the exact location of the immobilized goat anti-hLH antibody." This signifies a positive result. |
| Intended Use Equivalence: Substantially equivalent to existing FDA-approved products. | Vanguard Biomedical Corporation considers the device "substantially equivalent to other comparable FDA-approved products in intended use, test procedure, and test principles." Specifically lists Conceive ® Ovulation Predictor and Clearplan Easy One Step Ovulation Predictor as comparable. |
It is important to note that this document is a 510(k) summary (from 1996), which focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study results with specific performance metrics (like sensitivity, specificity, or accuracy percentages). Therefore, explicit quantitative acceptance criteria and their direct fulfillment are not present.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The 510(k) summary describes the principles and procedures of the device and its intended use, but it does not detail any specific clinical or analytical studies with test sets, sample sizes, or data provenance (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This information is not provided in the document. There is no mention of a test set, experts, or ground truth establishment for a specific study.
4. Adjudication Method for the Test Set
This information is not provided in the document. As there's no mention of a test set or study design, no adjudication method is described.
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
This information is not provided in the document. This device is a pre-AI era, qualitative visual test for direct consumer use. There would be no MRMC study involving AI assistance for this type of product.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/provided. The MiniClinic Ovulation Predictor is a visual, qualitative immunoassay. It does not involve an algorithm or AI. The "performance" is the visual interpretation by the user.
7. The Type of Ground Truth Used
This information is not explicitly stated in the context of a formal study with a defined ground truth. For this type of device, the "ground truth" during its development and validation would likely involve:
- Laboratory-controlled hLH concentrations: Testing the device with known concentrations of hLH in urine samples (or synthetic urine) to confirm its ability to detect levels above a certain threshold and produce a proportional color.
- Correlation with other hLH measurement methods: Comparing the device's results with quantitative laboratory assays for hLH to confirm accuracy.
- Correlation with actual ovulation: Ultimately, the "ground truth" for its intended use (predicting ovulation) would be the actual occurrence of ovulation, confirmed through other methods like basal body temperature, ultrasound, or subsequent pregnancy.
However, the provided text does not describe any specific studies that established ground truth using these or other methods.
8. The Sample Size for the Training Set
This information is not provided in the document. As a chemical/immunological test, it wouldn't typically have a "training set" in the machine learning sense. Its development would involve chemical optimization and analytical validation.
9. How the Ground Truth for the Training Set Was Established
This information is not provided and is largely not applicable in the context of an immunoassay device. The "ground truth" relevant to its development would involve the chemical properties and concentrations of hLH, and the optimization of the antibody-conjugate system to react reliably with hLH.
§ 862.1485 Luteinizing hormone test system.
(a)
Identification. A luteinizing hormone test system is a device intended to measure luteinizing hormone in serum and urine. Luteinizing hormone measurements are used in the diagnosis and treatment of gonadal dysfunction.(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.