Search Results

Atlas Home Pregnancy Test (Midstream Format) is a home use (OTC) rapid chromatographic immunoassay for the qualitative detection of human Chorionic Gonadotropin (hCG) in the urine to aid in the early detection of pregnancy.

Home Pregnancy Test (Midstream Format) is an OTC single use rapid Atlas chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy.

Here's a breakdown of the acceptance criteria and study information for the Atlas Home Pregnancy Test (Midstream format), based on the provided text:

Acceptance Criteria and Device Performance

Study Details

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

• The document states "clinical studies results included in this file" but does not provide specific sample sizes for the test set.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). The submitter is based in Jordan, but the location of the clinical study participants is not mentioned.

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

• Not specified. The document does not provide details on how ground truth was established, including the number or qualifications of any experts involved.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not specified. The document does not describe any adjudication method for establishing ground truth.

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:

• No, an MRMC comparative effectiveness study was not done. This device is a rapid diagnostic test (pregnancy test) meant for direct consumer use (OTC) and does not involve human "readers" in the context of image interpretation or similar roles where AI assistance would be relevant.

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

• Yes, this is essentially a standalone (algorithm only) test. As an Over-The-Counter (OTC) home pregnancy test, the performance measured is the device's ability to detect hCG without any "human-in-the-loop" interpretation beyond reading the result lines as positive or negative. The reported accuracy, detection limit, and specificity are inherent to the device's mechanism.

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

• Not explicitly stated on how ground truth was established for the clinical studies. For pregnancy tests, ground truth typically involves confirmation through a laboratory-based quantitative hCG test or clinical confirmation of pregnancy (e.g., ultrasound, follow-up). The document only mentions "clinical studies results" without detailing the ground truth method.

8. The sample size for the training set:

• Not applicable/Not provided. As a chromatographic immunoassay, this device does not typically involve "training sets" in the same way machine learning algorithms do. Its performance is based on its chemical and biological composition and reaction.

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

• Not applicable/Not provided. See the explanation for point 8.

Ask a specific question about this device