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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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