(443 days)
The Maybe MOM® Mini Ovulation Microscope is intended to be used only to indicate when a woman is ovulating by visualizing a woman's dried saliva on a lens. When a woman is ovulating, the increased secretion of estrogen is associated with a fern-like dried salivary pattern.
The MAYBE? MOM® Mini Ovulation Microscope identifies the most fertile day(s) of a woman's menstrual cycle using a direct saliva sample. The fertile day(s) are detected through the observation of distinctive crystallization or ferning patterns seen on a glass slide. The test is self-administered and is completely portable. It requires no reagents nor specific storage conditions and the testing can be performed with relative ease. The results may be interpreted as soon as saliva applied to the slide dries, usually within 2-6 minutes. The MAYBE? MOM® Mini Ovulation Microscope is to be marketed for over-the-counter (OTC) use.
The MAYBE? MOM® Mini Ovulation Microscope consists of:
- a black microscope eyepiece with a microscope slide .
- a rubber eye cup .
- a plastic cylindrical body .
- a battery .
- a light source. .
All of these parts are in place in the unit. The consumer does not do anything to the Mini Ovulation Microscope except to place a drop of saliva on the microscope eyepiece/slide, press the light source to illuminate the salivary feming pattern and focus the microscope to obtain the best view.
The Mini Ovulation Microscope is a hand-held, circular shaped mini microscope containing a miniaturized focusing lens and a miniaturized slide. The slide serves as the platform upon which the saliva is placed and for viewing the dried saliva pattern. The device also includes a miniaturized light source (light emitting diode - LED) that serves as the light source and electronic circuitry. The battery is operated with a replaceable 1.5-volt battery. The Mini Ovulation Microscope is completely reusable, and requires only the cleaning of the mini microscope slide to be reused.
The Mini Ovulation Microscope is designed to be used throughout the menstrual cycle. To perform the test, a small drop of saliva is placed on the slide. After the saliva air-dries (usually in 2-6 minutes), the eve piece is brought to close proximity to the eye for viewing. The black button on the bottom of the Mini Ovulation Microscope is pressed to activate the vellow light that allows viewing of the dried saliva pattern. The non-ovulatory (non-fertile) days are identified by "debris-like" substances, such as dots, circles, or random cells. Ovulatory days are characterized by distinct ferning patterns. Days when some ferning and some random "debris-like" patterns are seen are peri-ovulatory days during which some chance of pregnancy exists.
Here's a breakdown of the acceptance criteria and study information for the MAYBE? MOM® Mini Ovulation Microscope, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Accuracy in identifying impending ovulation (vs. urinary LH kit) | High accuracy (implicitly, to be substantially equivalent to predicate) | 97% accurate |
| Ferning identified within 48 hours pre/post 1st day of LH surge | High concordance (implicitly, to be substantially equivalent to predicate) | 92 out of 95 cycles |
| Readability by untrained users (ferning identified at least once by consumer when trained reader identified ferning) | High concordance (implicitly, to ensure OTC usability) | 25 out of 28 cycles |
Note: The document doesn't explicitly state numerical acceptance criteria in the typical sense (e.g., "must be >95% accurate"). Instead, the performance is presented as a demonstration of "substantial equivalence" to the predicate device, implying that the reported performance met the FDA's unstated bar for such equivalence.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size:
- Accuracy Study: 93 pre-menopausal women (number of cycles reported as 95 for ferning comparison)
- Readability Study: 28 untrained women
- Data Provenance: The document does not explicitly state the country of origin or if the data was retrospective or prospective. It implies a single "consumer use study," suggesting it was prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not explicitly state the number of experts used or their qualifications for establishing ground truth regarding the urinary LH kit results. It mentions "a trained reader" in the context of the readability study but doesn't specify if this individual was an "expert" in establishing ground truth for ferning patterns.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1). For the accuracy study, the device's performance was compared to "a urinary LH kit," which served as the ground truth reference. For the readability study, a "trained reader" was used as a reference.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus without AI assistance was not performed. The device itself is a direct visualization tool for the user, not an AI that assists with interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a sense, a standalone performance was evaluated. The device itself is designed for self-administration and self-interpretation. The stated 97% accuracy and ferning identification in 92/95 cycles reflect the device's ability to provide a result that aligns with the LH kit, which the user would then interpret. The "readability study" further confirms that untrained women can interpret the results provided by the device.
7. The Type of Ground Truth Used
- Accuracy Study: The ground truth was established by comparison to a urinary LH kit, which identifies the LH surge.
- Readability Study: The ground truth for ferning patterns was established by a "trained reader."
8. The Sample Size for the Training Set
The document does not provide any information about a training set for the device's development. This is expected as the device is a direct visualization tool, not an AI/ML algorithm that typically requires a large training dataset.
9. How the Ground Truth for the Training Set Was Established
Since there is no mention of a training set or an AI/ML algorithm that requires training, this question is not applicable to the MAYBE? MOM® Mini Ovulation Microscope as described. The device relies on direct observation of a physical phenomenon (salivary ferning).
§ 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.