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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

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).

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The Instant-View™ LH Ovulation Predicting Test is a qualitative immunoassay for the detection of human Luteinizing Hormone (hLH) in human urine to predict the occurrence of ovulation. This device is intended for professional and laboratory use only.
The Instant-View™ LH Ovulation Predicting Test is a qualitative immunoassay for the detection of human Luteinizing Hormone (hLH) in human urine to predict the occurrence of ovulation. It is for health care professional use, including at the point of care (physician's office labs, doctor's offices).

This test is a one-step lateral flow chromatographic immunoassay.
Instant-View™ LH Ovulation Predicting Test has two formats, cassette test and dip-strip test. The cassette test contains the dip-strip in a plastic housing.

The Instant-View™ LH Ovulation Predicting Test is a qualitative immunoassay designed to detect human Luteinizing Hormone (hLH) in human urine to predict ovulation. It is intended for professional and laboratory use only.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly mentions the following sample sizes for performance evaluation studies:

• Correlation Study:
  • 38 negative results (compared to predicate)
  • 62 positive results (compared to predicate)

The total number of samples isn't explicitly stated but can be inferred as at least 100 (38 negative + 62 positive) for the correlation study.

• Reproducibility Study: The number of samples for the reproducibility study is not explicitly stated, only that "all other results obtained were as expected" besides one discrepancy.

Data Provenance: The document does not specify the country of origin of the data. The studies appear to be prospective as they involved evaluations by personnel in various laboratory settings.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Number of Experts: Not specified.
• Qualifications of Experts: The reproducibility study states that "Evaluations were performed by personnel with diverse educational backgrounds and working experiences." This is a general statement and does not provide specific qualifications for establishing ground truth or interpreting results, beyond indicating they were laboratory personnel. For the correlation study, the ground truth seems to be established by comparison to the predicate device.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method for establishing ground truth or resolving discrepancies. In the reproducibility study, one discrepancy was observed, but the resolution method is not detailed beyond stating it was "within the range of 25% below the cutoff."

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This device is a diagnostic test kit, not a device requiring human-in-the-loop interpretation with an AI component. Therefore, the concept of "how much human readers improve with AI vs. without AI assistance" is not applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, a standalone performance evaluation was inherently done. The device itself is a one-step lateral flow chromatographic immunoassay that provides a visual result (presence of C line for control, T line for positive). The performance characteristics (sensitivity, correlation, reproducibility) are measured directly from the device's output, independent of an AI algorithm or complex human interpretation beyond reading the visible lines.

7. The Type of Ground Truth Used

• Correlation Study: The "ground truth" for the correlation study was established by comparison to a legally marketed predicate device (CLEARPLAN Easy™ One-Step Ovulation Predictor). The predicate device's results were assumed to be the correct reference.
• Sensitivity: The sensitivity of 20 mIU hLH/ml refers to a known concentration of hLH (WHO standards, LH 1st IRP 68/40). This indicates a laboratory-derived, quantitative standard.

8. The Sample Size for the Training Set

This information is not provided. As this is a traditional immunoassay device and not an AI/ML product, the concept of a "training set" in the context of machine learning is not applicable. The device's performance is based on its chemical and biological properties, not on a trained algorithm.

9. How the Ground Truth for the Training Set Was Established

As noted above, the concept of a "training set" is not relevant for this type of device. Therefore, no ground truth for a training set was established.

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The Phamatech At Home Ovulation Test is a rapid qualitative test for the detection of luteinizing hormone (LH) in urine. The cut-off concentration for this test is as follows: LH at 30mlU/mL. This assay is intended for use in the home to assist in determining the ovulation cycle. The Phamatech At Home Ovulation Test is intended for over the counter use.

Immunoassay for the qualitative detection of LH in urine. The At HOME OVULATION TEST, like many commercially available ovulation test kits, qualitatively measures the presence of luteinizing hormone by visual color sandwich one step immunoassay technology. All of the above devices rely on the basic immunochemical sandwich assay principle of recognition and formation of specific antibody / LH / colored (labeled) antibody complexes.

The Phamatech At HOME OVULATION TEST (Model 9032) is a rapid, qualitative immunoassay for the detection of luteinizing hormone (LH) in urine at a cut-off concentration of 30mlU/mL. It is intended for home use to assist in determining the ovulation cycle.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The exact sample sizes for the clinical sample correlation study, the clinical studies with professional users, and the consumer study are not explicitly stated in the provided document. The data provenance is described as "clinical specimens" and "clinical studies, performed at two independent laboratories," suggesting that the data is prospective and likely collected in a clinical setting. The country of origin of the data is not specified, but the manufacturer is based in San Diego, California, USA, implying the studies were likely conducted in the USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not explicitly state the number of experts used to establish the ground truth or their specific qualifications (e.g., "radiologist with 10 years of experience"). It mentions "professional users" in clinical studies, but their role in establishing ground truth versus simply performing the test is unclear.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the test set.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

A Multi Reader Multi Case (MRMC) comparative effectiveness study was not explicitly mentioned or described. The performance data focuses on the device's accuracy and correlation, not on comparing human reader performance with and without AI assistance. This device is a rapid diagnostic test, not an AI-driven image analysis tool.

6. Standalone Performance

Yes, standalone performance (algorithm only performance, without human-in-the-loop) was assessed. The "At HOME OVULATION TEST" is a standalone device that provides a visual result directly to the user, the manufacturer or a professional user would determine the performance data as reported above, but also included in this filing is consumer user performance. The device's performance metrics (correlation, overall accuracy) reflect its inherent ability to detect LH. The "consumer study" further assesses its standalone performance when interpreted by lay users.

7. Type of Ground Truth Used

The ground truth for the clinical sample correlation study was established by comparing the At HOME OVULATION TEST results to the Syntron Be Sure Test, a predicate device. For the clinical studies and consumer study, the ground truth would typically be established through established laboratory methods or medical assessment of the individual's LH levels, though the exact method is not detailed in the provided document. Given it's an ovulation test, the ground truth for LH levels would likely be based on quantitative immunoassay results or other accepted methods for measuring LH in urine.

8. Sample Size for the Training Set

The document does not provide information regarding a "training set" or its sample size. This device relies on "basic immunochemical sandwich assay principle," not on machine learning or AI models that require specific training sets.

9. How the Ground Truth for the Training Set Was Established

As there is no mention of a training set for an AI/ML model, there is no information on how its ground truth was established.

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The CLEARPLAN EASY Ovulation Test, an over-the-counter (OTC) in vitro diagnostic device, is a urine test for the detection of luteinizing hormone. It is intended to be used by women as an aid to conception by accurately and reliably predicting ovulation.

Not Found

This is a 510(k) premarket notification for the CLEARPLAN EASY Ovulation Test, a luteinizing hormone test system. The device is intended for over-the-counter use by women as an aid to conception by predicting ovulation.

Because this is a 510(k) clearance letter, it only establishes substantial equivalence to a predicate device and does not contain acceptance criteria or study data. To obtain the detailed study information, you would typically need to refer to the full 510(k) submission available from the FDA or directly from the manufacturer.

Therefore, I cannot fulfill your request for the acceptance criteria and study details based solely on the provided document. The document confirms the FDA has reviewed the submission and determined that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.

Without the full 510(k) submission or supporting study documents, I cannot provide the specific details requested in your prompt regarding acceptance criteria, sample sizes, expert qualifications, and study methodologies.

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The Ovulation Tester is an over-the-counter device intended to detect the most fertile days of a woman's menstrual cycle by the direct visualization of the characteristic peri-ovulatory ferning pattern seen in dried saliva. This ferning occurs due to increased levels of estrogen.

The Ovulation Tester is a complete system for identifying the most fertile day(s) of a woman's menstrual cycle using a direct saliva sample. These fertile days are detected through the observation of distinctive crystallization or ferning patterns seen on a glass slide. The test is selfadministered and is completely portable. The system requires no reagents nor specific storage conditions, can be performed with relative ease, and results may be interpreted within approximately 10 minutes of saliva application. The test is intended for over-the-counter (OTC) use.

The Ovulation Tester Kit consists of:

1. the Ovulation Tester device (see below for further details) with tracking disk
2. an extra tracking disk
3. the saliva brush applicator
4. the Instruction Booklet
5. a marking pencil
6. the storage bag

The Ovulation Tester device consists of

1. the black microscope eyepiece
2. the rubber eve cup (shown installed over the black eyepiece)
3. the tracking disk (stored in the unit)
4. the battery (already in place)
5. the light source (already in place)

The Ovulation Tester is a hand-held, circular shaped "minimicroscope" containing four sets of five miniaturized microscope slides in a plastic case. The slides are made from optical glass, and are placed on a round tracking disk; the disk serves as the platform for viewing the dried saliva patterns. One tracking disk may be used for several months. The device also includes a small built-in light (light emitting diode [LED]) as its light source for viewing the slides, a replaceable battery (1.5 volt) and electronic circuitry.

The system is designed to perform sequential testing over five consecutive days; the testing days are based on the woman's expected cycle length. To perform the test, a woman places a thin coat of saliva on a slide by means of the saliva brush applicator. After the saliva has been allowed to air-dry, the tracking disk is rotated so that the day-specific slide lines up at the proper opening. The device is brought in close proximity to the viewing eye, and a black button on the back of the device is pushed: this activates the green light to allow viewing of the dried saliva patterns. The preovulatory days are characterized by ferning patterns, while, on other days, the slides will appear with "debris-like" substances such as dots, circles, or cells.

Acceptance Criteria and Device Performance Study for TCI Ovulation Tester™

The provided document describes the TCI Ovulation Tester™, an over-the-counter device intended to detect the most fertile days of a woman's menstrual cycle by visualizing ferning patterns in dried saliva. The summary presents clinical and consumer study data to demonstrate its performance.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria with specific numerical thresholds for accuracy or readability. Instead, it presents performance metrics from studies as evidence of the device's capability. Based on the provided text, the implied acceptance is based on demonstrating equivalence to an existing urinary LH kit and acceptable readability by untrained users.

2. Sample Size and Data Provenance

• Test Set Sample Sizes:
  • Clinical Studies (Accuracy): 166 premenopausal women
  • Consumer Studies (Readability): 163 untrained women
  • Consumer Studies (Identification): The text mentions "another evaluation" with consumers, but the specific sample size for this 92% identification rate is not explicitly stated as distinct from the 163 for readability, though it implies a separate assessment.
• Data Provenance: The document does not specify the country of origin for the study data. It also does not explicitly state whether the studies were retrospective or prospective, but clinical and consumer studies for device validation are typically prospective.

3. Number of Experts and Qualifications for Ground Truth

• Clinical Studies (Accuracy): The ground truth for identifying impending ovulation was established by comparison to a "urinary LH kit." While the LH kit itself serves as a reference, the document does not specify the number of experts or their qualifications involved in interpreting the LH kit results or confirming the LH surge for the 166 premenopausal women.
• Consumer Studies (Readability/Identification): For the readability study, the performance of the untrained consumers was compared against a "trained reader." The number of trained readers is not specified, nor are their specific qualifications (e.g., years of experience, medical background).

4. Adjudication Method

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) used for establishing the ground truth or resolving discrepancies in either the clinical or consumer studies. The comparison for accuracy was against an LH kit, and for readability, it was against a "trained reader," implying a single point of reference without a multi-reader adjudication process mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is explicitly mentioned. The studies described focus on the standalone performance of the device and its readability by individual consumers compared to a reference (LH kit or trained reader), rather than comparing human readers with and without AI assistance to quantify an effect size.

6. Standalone Performance Study

Yes, a standalone performance study was done.

• Accuracy Study: The "clinical studies with 166 premenopausal women" assessed the device's ability to identify impending ovulation (93% accuracy) compared to a urinary LH kit. This is a measure of the algorithm/device's performance in detecting the intended biological event.
• Readability Study: The "consumer studies with 163 untrained women" assessed how well untrained users could interpret the device's results (93% readability). This also represents a form of standalone performance, albeit from the user's perspective.

7. Type of Ground Truth Used

• Clinical Studies (Accuracy): The ground truth for "impending ovulation" was established by comparison to a urinary LH kit, which detects the midcycle LH surge. This is a biochemical marker/reference standard.
• Consumer Studies (Readability/Identification): The ground truth for "ferning" was established by a trained reader (expert interpretation) or by inference from the LH kit results for the timing of ovulation.

8. Sample Size for Training Set

The document does not provide any information about the sample size used for a training set. This suggests that the device's core mechanism for detecting ferning patterns likely relies on optical observation and user interpretation based on instructions, rather than a machine learning model that would require a distinct training set for algorithm development.

9. How Ground Truth for Training Set Was Established

Since no training set is mentioned for an algorithm, there is no information on how ground truth for a training set was established. The device operates on the principle of direct visualization of ferning patterns by the user, guided by the instruction booklet.

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The QUIK-CHECK™ Ovulation Predictor Test is a qualitative, one-step, midstream assay for the detection of human Luteinizing Hormone (LH) in urine as an aid in conception by reliably predicting ovulation. The QUIK-CHECK™ Ovulation Predictor Test is intended for use by the lay consumer.

The QUIK-CHECK™ Ovulation Predictor Test is a midstream test used for the qualitative measurement of Luteinizing Hormone (LH) and the detection of the LH surge in a woman's urine as an aid in reliably predicting ovulation. The ovulation predictor test is intended for use outside the body (in vitro diagnostic use) by women at home. The QUIK-CHECK™ ass outside the counter (OTC) device that will be sold under that will be sold under the QUIK-CHECK™ brand and various private labels. The QUIK-CHECK™ Ovulation Predictor Test employs a unique combination of monoclonal antibody-dye particle conjugates and polyclonal-solid phase antibodies to selectively identify human Luteinizing Hormone (LH) in urine. As the urine flows through the absorbent portion of the device, the antibody-dye particle conjugate binds to the LH, forming an antibodyantigen complex. This complex binds to the anti-LH antibody in the test zone and produces a pink-rose color band. The color intensity of this band is equal to or greater than that of the control band when the LH concentration is greater than 40 mIU/mL. In urine with LH concentrations of less than 40 mIU/mL, the band in the test zone will appear lighter than the control band. In the absence of LH in urine, no test band will show up in the test zone. The test has also incorporated a control system where a pink-colored band will always appear in the control zone, demonstrating that the test is functioning correctly.

Here's a breakdown of the acceptance criteria and study details for the QUIK-CHECK™ Ovulation Predictor Test, based on the provided text:

Acceptance Criteria and Device Performance

* Note: The document explicitly states "95% confidence Intervals" for the accuracy percentages.

Study Information

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: 100 females
• Data Provenance: The study was a "clinical trial" with volunteers conducting testing at "home" and providing "urine samples." The "study coordinator tested each sample." There's no explicit mention of the country of origin, but the manufacturer and correspondent are in the US, while the manufacturing plant is in China. Given the context of a 510(k) summary for the US market, it's highly probable the clinical trial was conducted in the US. The data is prospective as it involved volunteers performing tests over a menstrual cycle.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:

• Number of Experts: Not explicitly stated as "experts" establishing ground truth. The "study coordinator" tested each sample using both the QUIK-CHECK™ and the ClearPlan Easy® Tests. Given the context of comparing the new device to a predicate, the ClearPlan Easy® Test itself served as the reference for ground truth in this comparative study. Separately, one part of the analysis involved a "Trained Lab Technician" for both devices.
• Qualifications: "Trained Lab Technician." No specific details on their years of experience or precise qualifications (e.g., specific certifications) are provided.

4. Adjudication Method for the Test Set:

• The text describes a direct comparison: "The study coordinator tested each sample using the QUIK-CHECK™ and the ClearPlan Easy® Tests. The data obtained was recorded as Negative (no surge) or Positive (surge)." There is no mention of an adjudication method involving multiple readers resolving discrepancies. The comparison is directly between the two tests' results as interpreted by the study coordinator or consumer.

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:

• No, an MRMC comparative effectiveness study involving AI assistance for human readers was not conducted. This device is an in-vitro diagnostic test, not an AI-powered system providing assistance to human readers for image interpretation or diagnosis. The comparisons are between two similar diagnostic tests, used either by trained personnel or consumers.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done:

• This question is not applicable in the typical sense of AI algorithms. The device itself is a standalone diagnostic test. Its performance was evaluated both when interpreted by "Trained Lab Technician" and by the "Consumer," indicating the device's standalone performance under different user conditions.

7. The Type of Ground Truth Used:

• The ground truth in this study was established by comparative testing against a legally marketed predicate device, the ClearPlan Easy® Ovulation Test. The aim was to demonstrate "substantial equivalence" to this established product. The "data obtained was recorded as Negative (no surge) or Positive (surge)" for both devices, implying the ClearPlan Easy® result served as the de-facto ground truth for evaluating the QUIK-CHECK™ device's accuracy in identifying LH surges.

8. The Sample Size for the Training Set:

• The document describes "A clinical trial... to compare the performance." This sounds like a validation or test set rather than a training set as would be discussed for machine learning algorithms. There is no mention of a separate "training set" or a developmental phase with a distinct sample size for this device. The 100 females served as the test set for the performance evaluation.

9. How the Ground Truth for the Training Set Was Established:

• As there is no distinct "training set" mentioned in the context of this 510(k) summary for a point-of-care diagnostic device, this question is not explicitly addressed. The development of such devices typically involves internal testing and calibration, but the provided text focuses on the clinical validation study for regulatory submission.

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The Ovulation Predictor test is used for the qualitative measurement of LH and the detection of LH surge in a woman's urine as an aid in conception by accurately and reliably predicting ovulation. The Ovulation Predictor test is intended for use outside the body (in vitro diagnostic use) by women at home. The Ovulation Predictor test is an over the counter (OTC) device that will be sold under the name Inverness Medical Early Ovulation Predictor, an under various private labels as One Step Ovulation Predictor or Ovulation Predictor.

The Ovulation Predictor test is used for the qualitative measurement of LH and the detection of LH surge in a woman's urine as an aid in conception by accurately and reliably predicting ovulation. The Ovulation Predictor test is intended for use outside the body (in vitro diagnostic use) by women at home. The Ovulation Predictor test is an over the counter (OTC) device that will be sold under the name Inverness Medical Early Ovulation Predictor, an under various private labels as One Step Ovulation Predictor or Ovulation Predictor. The technological characteristics are the same because both devices are One-step urine tests that measure LH immunochromatographically, and have the same safety and effectiveness.

The provided text describes the K991386 submission for the Early Ovulation Predictor (stick), One Step Ovulation Predictor (stick), and Ovulation Predictor (stick). Here's a breakdown of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

Explanation: The document explicitly states, "Both devices are 99% accurate," referring to the new device and the predicate device. This establishes the 99% accuracy as the critical performance metric for substantial equivalence.

Study Information:

1. Sample size used for the test set and the data provenance:

• Test Set Sample Size: Not specified. The document generally refers to "clinical studies tests" without providing specific numbers for the test set.
• Data Provenance: Not specified. It's unclear if the data was retrospective or prospective, or the country of origin.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not specified. The document does not describe the nature of clinical studies in enough detail to determine how ground truth was established, nor does it mention experts.

3. Adjudication method for the test set:

• Not specified. There is no information regarding any adjudication process for the test set.

4. 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:

• No, an MRMC study was not done. This device is an in-vitro diagnostic (IVD) for home use, which typically does not involve human readers in the same way an imaging AI device would. The core claim is about the device's ability to detect LH levels, not about assisting human interpretation of complex medical data.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

• Yes, by nature. The device is a "One-step urine test that measure LH immunochromatographically," intended for home use by women. It provides a direct result (qualitative measurement of LH), meaning its performance is inherently standalone, without a "human-in-the-loop" to interpret an algorithm's output. The comparison is between the new device and a predicate device, both operating as standalone tests.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Implied ground truth related to LH detection. While not explicitly stated, the ground truth would likely be established through a validated laboratory method for measuring Luteinizing Hormone (LH) levels in urine. This would serve as the reference standard against which both the new device and the predicate device's results are compared to determine their "accuracy" in detecting LH surge.

7. The sample size for the training set:

• Not specified. The document only mentions "Laboratory and clinical studies tests" without detailing training sets.

8. How the ground truth for the training set was established:

• Not specified. As the training set size and characteristics are not provided, the method for establishing its ground truth is also unknown. It would presumably involve similar laboratory methods for LH detection as the ground truth for the test set.

In summary, the provided submission focuses on establishing substantial equivalence to a predicate device (ClearPlan® Easy ovulation test) based on identical technological characteristics and demonstrated equivalent performance (99% accuracy) through laboratory and clinical studies. However, detailed methodological information regarding sample sizes, ground truth establishment, and study design elements common in more complex AI/imaging device submissions is largely absent.

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The Ovulation Predictor test is used for the qualitative measurement of LH and the detection of LH surge in a woman's urine as an aid in conception by accurately and reliably predicting ovulation. The Ovulation Predictor test is intended for use outside the body (in vitro diagnostic use) by women at home. The Ovulation Predictor test is an over the counter (OTC) device that will be sold under the name Inverness Medical Early Ovulation Predictor, and under various private labels as Early Ovulation Predictor or Ovulation Predictor.

The Ovulation Predictor test is used for the qualitative measurement of LH and the detection of LH surge in a woman's urine as an aid in conception by accurately and reliably predicting ovulation. The Ovulation Predictor test is intended for use outside the body (in vitro diagnostic use) by women at home. The Ovulation Predictor test is an over the counter (OTC) device that will be sold under the name Inverness Medical Early Ovulation Predictor, and under various private labels as Early Ovulation Predictor or Ovulation Predictor.

The provided text describes an Ovulation Predictor (cassette) device. Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not explicitly stated. The text only mentions "Laboratory and clinical studies tests."
• Data Provenance: Not explicitly stated. The text does not specify the country of origin of the data or whether the studies were retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• Number of Experts: Not mentioned.
• Qualifications: Not mentioned.

4. Adjudication Method for the Test Set:

• The text does not mention any adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• Was it done?: No. This device is an in-vitro diagnostic test for qualitative measurement of LH, not an imaging device requiring human reader interpretation in the same way as an MRMC study. The comparison was against a predicate device's performance.
• Effect Size: Not applicable.

6. Standalone (Algorithm Only) Performance:

• Was it done?: Yes. The "Summary of Performance Data" states that "Laboratory and clinical studies tests demonstrate that Ovulation Predictor (cassette) provides equivalent performance to the ClearPlan® Easy ovulation test." The reported 99% accuracy is for the device itself.

7. Type of Ground Truth Used:

• The ground truth is implied to be based on the established accuracy and performance of the predicate device (ClearPlan® Easy ovulation test). For ovulation prediction tests, the ground truth for "accuracy" typically refers to the device's ability to correctly identify the LH surge when compared to a reference method or clinical ovulation event. The text does not specify the exact method used to establish ground truth (e.g., direct measurement of LH in a lab setting, correlation with actual ovulation confirmed by other means).

8. Sample Size for the Training Set:

• Not applicable. This device is described as an immunochromatographic assay, not an AI or machine learning model that requires a training set in the conventional sense. Its "training" would be more akin to assay development and optimization rather than machine learning training.

9. How Ground Truth for the Training Set Was Established:

• Not applicable, as there is no mention of a machine learning training set.

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