Search Results

The Preg-Q hCG Early Pregnancy Test is a rapid visual test for the qualitative detection of hCG in urine to aid in the determination of pregnancy. This test is for over- the-counter, central laboratory, and point of care hospital use.

The Preg-Q early pregnancy test is a rapid visual test for the qualitative detection of hCG in urine to aid in the determination of pregnancy.

The provided text describes the "Preg-Q Early Pregnancy Test," a rapid visual test for the qualitative detection of hCG in urine to aid in the determination of pregnancy. The submission is a 510(k) premarket notification, indicating it's a new device seeking to prove substantial equivalence to a legally marketed predicate device.

However, the provided text does not contain the acceptance criteria or a detailed study description with performance metrics for the Preg-Q Early Pregnancy Test. The "Device Comparison" table only lists the types of testing completed (Interference, Accuracy, Sensitivity, Specificity, Reading Time, OTC Comparison) and indicates they are "Same" as the predicate device (Testpack Plus HCG Urine K954029), but it does not provide the actual quantitative acceptance criteria or reported performance results from these tests.

Therefore, I cannot fully answer your request based on the provided input. I can only infer what types of studies were likely performed based on the "Testing Completed" section.

Here's what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The device is for qualitative detection of hCG in urine, which typically uses laboratory reference methods or expert interpretation of clinical signs/symptoms for ground truth, but the details are not provided.

4. Adjudication method for the test set:

• Adjudication Method: Not specified.

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:

• MRMC Study: Not applicable. This is a rapid visual pregnancy test, not an AI-assisted diagnostic tool involving human readers interpreting outputs.

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

• Standalone Performance: The "Preg-Q Early Pregnancy Test" is described as a "rapid visual test" for "over-the-counter, central laboratory, and point of care hospital use." This implies a standalone diagnostic performance by the test device itself, without an algorithm or human-in-the-loop AI assistance. However, the specific results of this standalone performance are not detailed.

7. The type of ground truth used:

• Type of Ground Truth: Not explicitly stated. For a pregnancy test, ground truth typically involves confirmation by other established laboratory tests (e.g., quantitative hCG assays), clinical examination, or follow-up. The document does not specify which was used.

8. The sample size for the training set:

• Sample Size (Training Set): Not applicable, as this device does not appear to involve machine learning or a training set in the conventional sense.

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

• Ground Truth (Training Set): Not applicable, as this device does not appear to involve machine learning or a training set.

In summary, the provided 510(k) summary is very high-level and focuses on the device's intended use and comparison to a predicate device. It lacks the detailed study results and acceptance criteria that would typically be found in a more comprehensive clinical study report.

Ask a specific question about this device