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The QuantRx Female Fertility Test is intended to measure follicle-stimulating hormone (FSH) in urine as an ancillary screen of fertility for home use by women who are attempting to conceive.

The QuantRx Female Fertility Test is a rapid, immunochromatographic assay for the measurement of follicle-stimulating hormone (FSH) in human urine. The test is performed on day 3 of the menstrual cycle by urinating directly on the absorbent tip or by dipping it in a cup of urine, and observing for the formation of colored lines after 10 minutes. A test line of color intensity greater than or equal to the reference line indicates an FSH level of at least 10 mIU/mL is indicative of diminished ovarian reserve, which corresponds to reduced fertility. A test line intensity of less than the reference line is indicative of normal ovarian reserve.

Here's a breakdown of the acceptance criteria and study details for the QuantRx Female Fertility Test, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

Study Details

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

   • Primary Study: 209 females (for consumer study, and the same combination of fresh/blinded control specimens for professional study). The origin of this data (e.g., country) is not specified. It is likely prospective for the consumer and professional studies, as it describes a comparison to a validated lab method using freshly collected and blinded control specimens.
   • Supplemental Consumer Study: 48 females. 40 of these provided paired serum specimens. Data provenance (e.g., country) is not specified. This also appears to be prospective as it involves women performing the test and providing specimens.

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

   • The document refers to a "published, validated, quantitative, chemiluminescent method for urine follicle-stimulating hormone (FSH)" and an "FDA cleared serum FSH assay (DPC IRMA FSH; K893976)" as the ground truth.
   • The number of experts involved in the initial validation of these laboratory methods is not specified, nor are their individual qualifications (e.g., specific years of experience or board certifications). The ground truth is established by the results of these validated and cleared laboratory methods, rather than by human expert consensus on interpretations of the device's results.

3. Adjudication method for the test set:

   • No adjudication method (e.g., 2+1, 3+1) is described for the test set. The comparison is made directly between the QuantRx device's results and the results from the established laboratory methods.

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 MRMC comparative effectiveness study involving AI or human reader improvement with AI assistance was conducted or mentioned. This device is a rapid diagnostic test, not an AI-powered image analysis tool. The study did compare "trained user" vs. "layperson" performance, which is a form of multi-reader evaluation, but not focused on AI assistance. The concordance between trained user and layperson for the primary and supplemental studies was 98%, suggesting very high agreement between these two user groups.

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

   • This is not applicable to the QuantRx Female Fertility Test, as it is a visual, rapid immunochromatographic assay that requires human interpretation of color lines. It is not an algorithm-only device. The performance data explicitly includes "trained user" and "layperson" results, indicating human-in-the-loop performance.

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

   • The ground truth was established using results from a published, validated, quantitative, chemiluminescent method for urine follicle-stimulating hormone (FSH) and an FDA cleared serum FSH assay (DPC IRMA FSH; K893976). This is a laboratory-based, quantitative measurement of the analyte of interest.

7. The sample size for the training set:

   • The document describes performance studies (primary and supplemental) which serve as validation. It does not explicitly mention a separate "training set" in the context of machine learning, as this is not an AI/ML device. The studies described are evaluation studies comparing the device to reference methods.

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

   • See point 7. No specific "training set" or method for establishing its ground truth is described, as the device is a chemical immunoassay, not an AI/ML system that requires a distinct training phase.

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The Fertell Female Fertility Test is intended to measure Follicle Stimulating Hormone ("FSH") in urine as an adjunctive screen of fertility for home use by women who are attempting to conceive but have been unsuccessful.

The Fertell Female Fertility Test is a dipstick, lateral flow rapid test that measures FSH in an instream urine sample. The test is performed two days after the onset of menses (day 3 of the menstrual cycle) and is similar in design and use to a pregnancy test or an ovulation prediction test. It uses a monoclonal antibody to one antigenic determinant that is conjugated with colloidal gold and a second monoclonal antibody to a different antigenic determinant, the latter antibody being immobilized as a line on a nitrocellulose strip. FSH present in the urine reacts with the conjugated antibody and immobilized antibody, forming a "sandwich" immunocomplex at the site of the immobilized antibody. Unreacted conjugate is washed from the strip by the flow of excess sample. The appearance of a clear red line (test result) indicates FSH in the urine sample, with the intensity of the line proportional to the FSH concentration.

The nitrocellulose strip also has a comparator line of fixed intensity that corresponds to an FSH concentration of 10 IU/L. A test line of color intensity greater than or equal to the comparator line indicates a concentration of FSH of 10 IU/L or greater. This level is indicative of diminished ovarian reserve.

Here's a summary of the acceptance criteria and the study details for the Fertell Female Fertility Test, based on the provided 510(k) summary:

1. Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for the Test Set

The document does not explicitly state the sample size used for the test set in the consumer study. It also does not specify the country of origin of the data or whether the study was retrospective or prospective.

3. Number of Experts and Qualifications for Ground Truth

The document does not provide information on the number of experts used to establish ground truth for the test set or their qualifications. The professional comparisons are mentioned, but no details on their role in defining ground truth.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method used for the test set.

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

No MRMC comparative effectiveness study is mentioned in the provided text. The study focuses on lay user performance and comparison to professional or quantitative methods rather than evaluating human reader improvement with AI assistance.

6. Standalone (Algorithm Only) Performance

A standalone performance evaluation was conducted for the device. The "lay user also demonstrated >90% accuracy when compared to a professional. and when compared to a quantitative serum FSH tests, the Fertell Female Fertility test demonstrated >95% accuracy." This indicates the device's performance independent of real-time human interpretation, comparing its output directly to reference standards.

7. Type of Ground Truth Used

The ground truth used for the performance evaluation includes:

• Professional observation/interpretation: For assessing lay user accuracy.
• Quantitative serum FSH tests: For assessing the accuracy of the device's FSH measurement.

8. Sample Size for the Training Set

The document does not provide information about a specific training set or its sample size. This is a rapid diagnostic test, and typically, such devices are developed and validated rather than "trained" in the machine learning sense. The testing described likely covers validation rather than a separate training phase.

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

As no specific training set is mentioned in the provided text, information on how its ground truth was established is not available.

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