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The Instant-View Pregnancy Urine 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 laboratory and professional use only.

A single step, visually read, qualitative chromatographic immunoassay, single use cassette test. The Instant-View TM Pregnancy Urine Test is designed for qualitative detection of the human chorionic gonadotropin (hCG) in urine. The test is for use as an aid in the diagnosis of early pregnancy. Both devices are one step, qualitative, visual lateral flow immuno-Chromatographic test in a sandwich complex format of anti-hCG antibody /hCG/ anti-hCG antibody.

Here's a breakdown of the acceptance criteria and the study details for the Instant-View™ Pregnancy Urine Test, based on the provided document:

1. Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" as a separate section with numerical thresholds for performance metrics. However, it implies acceptance through the comparison with a predicate device and the reported accuracy. The key implied acceptance criterion is 100% agreement/accuracy when compared to a legally marketed predicate device.

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

The document does not explicitly state the total sample size used for the correlation study or the clinical evaluation.

• Test Set Sample Size: Not explicitly stated.
• Data Provenance: The study was conducted at "a clinical lab and three physician's offices", suggesting results from real-world clinical settings, likely prospective as part of a testing and evaluation process. The country of origin is not specified, but given the submission to the FDA, it is implied to be within the United States.

3. Number of Experts and Qualifications for Ground Truth:

The document does not specify the number of individual experts or their detailed qualifications (e.g., "radiologist with 10 years of experience").

• Number of Experts: Not specified as individual numbers.
• Qualifications of Experts: Describes "persons with diverse educational backgrounds and working experience" from a clinical lab and physician's offices. This implies a range of healthcare professionals (e.g., lab technicians, nurses, physicians) who would routinely interpret such tests.

4. Adjudication Method for the Test Set:

The document does not describe a formal adjudication method (like 2+1 or 3+1). It states that the "evaluation results...agreed 100% with the results expected," which suggests a direct comparison against a known or expected outcome, rather than a reconciliation of differing interpretations among multiple experts.

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

No, a MRMC comparative effectiveness study was not explicitly done or reported in this summary. The study focuses on the device's performance against a predicate and agreement with expected results, not on how human readers' performance improves with or without the device.

6. Standalone (Algorithm Only) Performance:

Yes, the primary performance evaluation seems to be of the device in a standalone manner, as a "single step, visually read, qualitative chromatographic immunoassay." The results are based on the device's ability to correlate directly with the predicate device and expected outcomes, implying performance of the device itself rather than human-in-the-loop assistance.

7. Type of Ground Truth Used:

The ground truth was established through a combination of:

• Comparison to a legally marketed predicate device: The OSOM Pregnancy Urine Test. This implies the predicate device's results were considered the "truth" for the correlation study.
• Expected results in clinical settings: For the evaluation in the clinical lab and physician's offices, this likely refers to results confirmed by other methods or clinical consensus if there were any discrepancies with the predicate.

8. Sample Size for the Training Set:

The document does not mention a separate "training set" or its sample size. As this is a chromatographic immunoassay, not an AI/machine learning device, the concept of a training set in that context is not applicable. The development of such devices typically involves R&D and optimization, not a distinct "training set" as understood in machine learning.

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

This question is not applicable to this type of device, as it's not an AI/ML algorithm that requires a "training set" with established ground truth for learning. The device's underlying chemical and biological principles are established through scientific research and development, not data-driven training in the modern AI sense.

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