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This test is a qualitative immunoassay for the detection of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy. This test is for Over-The-Counter use only.

A qualitative visual immuno-chromatographic assay, single step, single use stick test

The provided text details the 510(K) summary for the Instant-View™ Pregnancy Urine Mid-Stream Test, manufactured by Alfa Scientific Designs, Inc. This diagnostic device is a qualitative visual immuno-chromatographic assay for the detection of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy, intended for Over-The-Counter (OTC) use.

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 and Data Provenance for the Test Set

• Consumers for User Study: The exact sample size for the consumer study is not explicitly stated, but the text mentions "consumers" in the plural, suggesting more than one.
• Professionals for User Study: The exact sample size for professionals is not explicitly stated.
• POL Sites for Repeatability Study: Three POL sites were used in the evaluation.
• Data Provenance: The document does not explicitly state the country of origin of the data. Given the submission is to the US FDA, it is highly likely the studies were conducted in the US. The studies appear to be prospective, specifically designed to gather data for the 510(k) submission.

3. Number of Experts and Qualifications for Ground Truth - Test Set

• Consumer Study: The "actual patient status" and those provided by "professionals" served as the ground truth. The qualifications of these "professionals" are not specified, but they are likely clinical laboratory professionals or physicians involved in pregnancy diagnosis.
• Correlation Study: The results from the predicate device (OSOM Pregnancy Urine Test) served as the ground truth.
• POL Evaluations: The "expected results" were used as ground truth. The expertise involved in defining these "expected results" is not explicitly detailed but would typically involve laboratory standards and potentially qualified lab personnel.

4. Adjudication Method for the Test Set

• Consumer Study: The text mentions "100% agreed with that obtained from the professionals and the actual patient status. No discrepancy was found." This suggests a direct comparison method, where the consumer's self-interpretation was checked against professional interpretation and/or the actual clinical status.
• Correlation Study: "Accuracy by correlation of the results from the Instant-View™ Pregnancy Urine Mid-Stream Test and the predicate device was 100%." This implies a direct comparison for agreement, where the predicate device's result was the reference.
• POL Evaluations: "Evaluation results from three POL sides agreed 100% with the results expected." This indicates consensus among the POL sites or agreement with a predefined standard.
  No explicit adjudication method like "2+1" or "3+1" is mentioned, rather direct comparison and high agreement were the reported outcomes.

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

• No MRMC study is explicitly described within the provided text. The studies focus on standalone device performance, correlation with a predicate, and consumer usability without comparing human readers' performance with and without AI assistance. The device itself is a qualitative visual test, not an AI-assisted diagnostic tool for human interpretation.

6. Standalone (Algorithm Only) Performance

• Yes, standalone performance was done. The "Discussion and Conclusion" sections heavily emphasize the device's independent performance by correlating its results with the predicate device and establishing its own accuracy and repeatability. The "consumer studies" also implicitly evaluate the standalone performance as interpreted by consumers. The device is a "single step, single use stick test," meaning its performance is inherently standalone.

7. Type of Ground Truth Used

• Expert Consensus/Clinical Standard: For the consumer study, the ground truth was based on "professionals and the actual patient status," which implies a clinical diagnosis or gold standard from trained personnel.
• Predicate Device Results: For the correlation study, the results of the legally marketed predicate device (OSOM Pregnancy Urine Test) served as the ground truth.
• Expected Results/Laboratory Standards: For the POL evaluations, the ground truth was "results expected," which would be based on established laboratory testing standards for hCG.

8. Sample Size for the Training Set

• The document does not explicitly mention a training set in the context of machine learning or algorithm development. The device is a lateral flow immunoassay, not a software-based AI algorithm that typically requires a training set. The studies described are validation studies for the finished product.

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

• As there is no explicit mention of a training set or AI algorithm development, this point is not applicable based on the provided text. The ground truth establishment described pertains to the validation (test) phase.

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