Search Results

WHOLEPOWER Pregnancy Rapid Test Cassette is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in early detection of pregnancy.

WHOLEPOWER Pregnancy Rapid Test Midstream is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in early detection of pregnancy.

WHOLEPOWER Pregnancy Rapid Test Strip is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in early detection of pregnancy.

WHOLEPOWER Pregnancy Rapid Test measures the presence of the hormone Human Chorionic Gonadotrophin (HCG) in human urine for the early detection of pregnancy. The test devices are in three different formats: Strip, Cassette and Midstream. Each test kit contains a test device sealed in a desiccated aluminum pouch and a package insert. The cassette format also contains a dropper.

The provided document describes the performance characteristics of the WHOLEPOWER Pregnancy Rapid Test (Cassette, Strip, Midstream). Here's a breakdown of the acceptance criteria and study details:

1. A table of acceptance criteria and the reported device performance

The document defines certain performance thresholds, particularly for sensitivity and agreement with a predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Analytical Performance (Precision/Reproducibility/Sensitivity):
  • Test Set Size: For each hCG concentration level (0, 12.5, 18.75, 22.5, 25, 50, 100, 200 mIU/mL), there were 3 lots * 30 replicates (3 operators * 2 runs/day * 15 days, which seems to imply 30 replicates per lot for each concentration if the 15 days * 2 runs * 3 operators is across all lots, or 30 replicates come from something else). The table shows 30 replicates per lot per concentration for each format (Strip, Cassette, Midstream). So, 8 hCG concentrations * 3 lots * 30 replicates = 720 tests per format across all sensitivity tests.
  • Data Provenance: Negative urine was spiked with hCG standard. The source of the negative urine or the location of the testing is not specified, but the product submitter is Wholepower Biotech Co., Ltd. from China. This study appears to be laboratory-controlled.
• Method Comparison Study with Predicate Device:
  • Test Set Size: 120 urine samples from women.
  • Data Provenance: Urine samples were collected from 120 women presenting to test for pregnancy at OB/GYN Physician's offices. It is a prospective study as samples were collected for the study. The country of origin is not explicitly stated but implied to be where the applicant would conduct clinical studies.
• Lay Person Study:
  • Test Set Size: 300 individual women.
  • Data Provenance: Women from "three sites were chosen for the study." The country of origin is not explicitly stated. It is a prospective study, involving self-testing by participants.

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

• Analytical Performance: The ground truth for hCG concentrations was established by spiking negative urine with hCG standards "Traceable to the 4th WHO." No human experts were involved in establishing the ground truth for these spiked samples, as it's a controlled laboratory preparation.
• Method Comparison Study: "All samples were tested by two different health professionals for each format at each of the 3 OB/GYN Physician's offices for a total of 18 operators with the proposed and the predicate devices." The ground truth was based on the predicate device and the new device results, observed by these health professionals. Their qualifications are listed as "health professionals," but no specific details (e.g., years of experience, specialty) are provided.
• Lay Person Study: "Each subject also provided a sample for professional testing with the candidate device as well." The ground truth for the lay person study was established by "professional testing," presumably referring to qualified laboratory personnel or healthcare professionals. Their specific number and qualifications are not detailed beyond "professional testing."

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

• Analytical Performance: Not applicable, as the ground truth was based on precisely prepared spiked samples.
• Method Comparison Study: The document states, "All samples were tested by two different health professionals for each format...". It doesn't explicitly detail an adjudication method beyond two professionals testing. It compares the new device's results with the predicate device's results. It's not clear if there was independent adjudication for discrepancies between the two health professionals' readings or between the new device and predicate. The agreement percentages suggest a direct comparison rather than a consensus-based adjudication from multiple readers.
• Lay Person Study: The comparison is between "Lay person" results and "Professional" results. There is no mention of an adjudication process among multiple professionals or for discrepancies between lay persons' results and professional results if they exist. The "Professional" result serves as the reference.

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

There is no mention of an AI-assisted device or an MRMC comparative effectiveness study where human readers improve with AI assistance. This device is a rapid diagnostic test, not an AI-powered image analysis system.

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

This question is not applicable. The WHOLEPOWER Pregnancy Rapid Test is a point-of-care, visually interpreted immunoassay. It does not involve an algorithm or an AI component operating in a standalone manner. The "standalone" performance here refers to the device's ability to provide a result, which is then interpreted by a human user (either a health professional or a lay person).

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

• Analytical Performance: Ground truth was established by spiking negative urine with known concentrations of hCG standards traceable to WHO International Standard.
• Method Comparison Study: The ground truth for the comparison was primarily based on the results obtained from a legally marketed predicate device on patient urine samples, observed by health professionals.
• Lay Person Study: The ground truth was established by professional testing using the candidate device on the same urine samples as the lay persons.

8. The sample size for the training set

The document does not describe any machine learning or AI components, and therefore no explicit "training set" in the context of AI development is mentioned. The studies described are for analytical and clinical performance validation of a rapid diagnostic test.

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

As there is no mention of a training set for an AI/ML model, this question is not applicable.

Ask a specific question about this device