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The MySet™ Pregnancy Test is a test for the qualitative determination of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy. For Over-The-Counter Use.

The MySet™ Pregnancy Test is to be used for detecting human Chorionic Gonadotropin (hCG) in urine. The presence of hCG usually appears about the seventh day after fertilization. The MySet™ Pregnancy Test will detect hCG in urine at a concentration level of 25 mIU/ml. The One-Step Pregnancy Test employs a unique combination of monoclonal-dye conjugate and mouse monoclonal-solid phase antibodies to selectively identify human Chorionic Gonadotropin (hCG) in urine. As the urine sample flows through the absorbent portion of the device, the antibody-dye conjugate binds to the hCG forming an antibody-antigen complex. This complex binds to the anti-hCG antibody in the positive reaction zone and produces a red color band if hCG concentration is equal to or greater than 25 mIU/ml. In the absence of hCG, there is no line in the reaction zone. Unbound conjugate binds to the reagents in the control zone, producing a red color band, demonstrating that the test is functioning correctly.

The MySet™ Pregnancy Test is a device designed for the qualitative determination of human chorionic gonadotropin (hCG) in urine, intended for the early detection of pregnancy for Over-The-Counter Use.

1. Acceptance Criteria and Reported Device Performance:

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

• Test Set Sample Size: Not explicitly stated. The document mentions "A method comparison was done," but does not provide the number of samples or subjects included in this comparison.
• Data Provenance: Not explicitly stated regarding country of origin. The study was a "method comparison" against an FDA-cleared device. It is a retrospective comparison as it compares to an already cleared device.

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

• Not applicable. The ground truth for the method comparison study was established by the performance of an existing, FDA-cleared predicate device (Stanbio True® 20 One-Step Pregnancy Test). No human experts were involved in establishing the ground truth beyond the initial validation of the predicate device.

4. Adjudication Method for the Test Set:

• Not applicable. The comparison was directly against the results of the predicate device. There was no mention of an adjudication process for discrepancies, likely due to the reported 100% agreement.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly conducted as described in the provided text. The study focused on a direct comparison of the device's performance against a predicate device, not on the impact of AI assistance on human readers.

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

• Yes, the performance data presented is for the standalone device, the MySet™ Pregnancy Test. The comparison was between the MySet™ device and the Stanbio True® 20 device operating independently. There is no indication of a human-in-the-loop component in the performance evaluation beyond the general user-friendliness testing by untrained women.

7. The Type of Ground Truth Used:

• The ground truth for the performance study was established by the results obtained from a legally marketed and FDA-cleared predicate device, the Stanbio True® 20 One-Step Pregnancy Test. This is a form of comparative ground truth where the performance of the new device is measured against a well-established and accepted standard. The predicate device itself would have been validated against a clinical ground truth (e.g., confirmed pregnancy via clinical assessment or other laboratory methods).

8. The Sample Size for the Training Set:

• Not applicable. This device is a manual, immunoassay-based pregnancy test, not an AI/algorithm-driven device that requires a training set in the computational sense. The "training" in this context refers to the manufacturing and formulation of reagents and device components.

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

• Not applicable, as this is not an AI/algorithm-driven device. The "ground truth" during product development would involve verifying the accuracy and sensitivity of the reagents and components to detect 25 mIU/ml hCG, likely through spiked urine samples or clinically confirmed pregnancy samples. The document states the device "employs a unique combination of monoclonal-dye conjugate and mouse monoclonal-solid phase antibodies," implying a biochemical design and manufacturing process, not an algorithmic training process.

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