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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 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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