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The One-Step Pregnancy Test is a test for the qualitative determination of human chorionic gonadotropin (hCG) in urine, for the early detection of pregnancy. For Over-The-Counter Use.

The One-Step Pregnancy Test is to be used for detecting human Chorionic Gonadotropin (hCG) in urine. The presence of hCG usually appears about the seventh day after fertilization. The One-Step Pregnancy Test will detect hCG in urine at a concentration level of 25 mIU/ml. The One-Step Pregnancy Test will be sold for under private label in the Over-the-Counter Market.

Here's a breakdown of the acceptance criteria and the study details for the One-Step Pregnancy Test:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size used for the clinical trial.

The data provenance is a "clinical trial" comparing the One-Step Pregnancy Test to an FDA-cleared product (Stanbio True 20 One-Step Pregnancy Test). The document does not specify the country of origin or whether the data was retrospective or prospective, though a "clinical trial" generally implies a prospective study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not specify the number of experts used. However, it states that "All pregnancy results were confirmed by physical examination and/or ultrasound." This implies that medical professionals (likely physicians or sonographers) were involved in establishing the ground truth, but their specific qualifications or number are not detailed.

4. Adjudication Method for the Test Set

The document does not explicitly state an adjudication method (e.g., 2+1, 3+1). It only mentions that "All pregnancy results were confirmed by physical examination and/or ultrasound," suggesting a direct verification method rather than a multi-reader, consensus-based one for the initial test results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The study compares the performance of the device against a predicate device, and the ground truth was established by physical examination and/or ultrasound, not by human readers interpreting the test results with and without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, this was a standalone performance study. The "One-Step Pregnancy Test" is a diagnostic device that provides a direct result (presence or absence of a color band), not an AI algorithm that assists a human reader. The performance metrics (sensitivity, specificity, agreement) reflect the device's ability to accurately detect hCG on its own.

7. The Type of Ground Truth Used

The ground truth used was outcomes data and clinical assessment, specifically "physical examination and/or ultrasound."

8. The Sample Size for the Training Set

The document does not mention details about a "training set" as it refers to a medical device for in-vitro diagnostic use, not an AI/machine learning model that typically requires separate training and test sets. The performance data presented is likely from a clinical validation study rather than algorithm training.

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

As there is no explicit mention of a "training set" for an AI algorithm, this question is not directly applicable. For the clinical trial, the ground truth was established by "physical examination and/or ultrasound."

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The One-Step Pregnancy Test is a test for the qualitative determination of human chorionic gonadotropin (hCG) in urine, for the early detection of pregnancy. For Over-The -Counter l Jse.

The One-Step Pregnancy Test is to be used for detecting human Chorionic Gonadotropin (hCG) in urine. The presence of hCG usually appears about the seventh day after fertilization. The One-Step Pregnancy Test will detect hCG in urine at a concentration level of 25 mIU/ml. The One-Step Pregnancy Test will be sold for under private label in the Over-the-Counter Market.

Here's a breakdown of the acceptance criteria and study details for the One-Step Pregnancy Test, based on the provided 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance:

The submission does not explicitly state pre-defined acceptance criteria with numerical targets. Instead, the study aimed to demonstrate "substantial equivalence" to a predicate device, for which "100% performance" appears to be the implied acceptance.

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

• Sample Size: Not explicitly stated in the document. The wording "A clinical trial was done" and "These data clearly demonstrate..." suggests a sufficient sample size was used to achieve 100% agreement, sensitivity, and specificity, but the exact number of participants or samples is not provided.
• Data Provenance: The document does not specify the country of origin. The study was a "clinical trial," which implies a prospective collection of data comparing the device to a predicate.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

• Number of Experts: Not explicitly stated.
• Qualifications: The ground truth was "confirmed by physical examination and/or ultrasound." This implies that licensed medical professionals (e.g., physicians, sonographers) were involved in establishing the ground truth, but their specific number, experience level, or specialty are not detailed.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not explicitly stated. The ground truth was based on "physical examination and/or ultrasound," which implies an independent clinical assessment rather than a consensus among multiple readers of the device's output.

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

• Was an MRMC study done? No, an MRMC comparative effectiveness study was not done. The study compared the device's performance to another FDA-cleared pregnancy test and confirmed its results with clinical outcomes, not by evaluating human readers' interpretation with and without AI assistance.

6. Standalone Performance Study:

• Was a standalone study done? Yes, the performance data provided (Sensitivity, Specificity, Agreement) reflects the standalone performance of the One-Step Pregnancy Test. The device itself produced the results, which were then compared to the predicate device and clinical ground truth. The statement "Testing by untrained women of childbearing years confirmed that the test can be effectively performed by untrained individuals" also points to testing the device's standalone usability.

7. Type of Ground Truth Used:

• Ground Truth Type: Clinical outcomes data. Specifically, "All pregnancy results were confirmed by physical examination and/or ultrasound."

8. Sample Size for the Training Set:

• Sample Size: Not applicable. This device is a biochemical assay (lateral flow immunoassay), not an AI/machine learning model, so there is no training set in the conventional sense. The device's performance is inherently based on its chemical/biological design and manufacturing, not a learned algorithm.

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

• Ground Truth Establishment: Not applicable, as there is no training set for this type of device. The "ground truth" for developing and validating the assay's ability to detect hCG would have come from established biochemical principles, spiked samples with known hCG concentrations, and clinical samples with confirmed pregnancy status.

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