(8 days)
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
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Sensitivity | 100% |
| Specificity | 100% |
| Agreement | 100% |
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."
§ 862.1155 Human chorionic gonadotropin (HCG) test system.
(a)
Human chorionic gonadotropin (HCG) test system intended for the early detection of pregnancy —(1)Identification. A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class II.(b)
Human chorionic gonadotropin (HCG) test system intended for any uses other than early detection of pregnancy —(1)Identification. A human chorionic goadotropin (HCG) test system is a device intended for any uses other than early detection of pregnancy (such as an aid in the diagnosis, prognosis, and management of treatment of persons with certain tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class III.(3)
Date PMA or notice of completion of a PDP is required. As of the enactment date of the amendments, May 28, 1976, an approval under section 515 of the act is required before the device described in paragraph (b)(1) may be commercially distributed. See § 862.3.