(39 days)
The WH Accu Test™ Pregnancy Test is a test for the qualitative determination of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy. For Laboratory Professional Use Only. This device is not for use in the Over the Counter market.
The WH Accu Test™ 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 WH Accu Test ™ Pregnancy Test will detect hCG in urine at a concentration level of 25 mIU/ml. The WH Accu Test™ Pregnancy Test will be sold for professional use only.
The WH Accu Test™ Pregnancy Test is a qualitative assay designed to detect human Chorionic Gonadotropin (hCG) in urine for early pregnancy detection, intended for professional laboratory use.
Here's an analysis of its performance and the study details:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state pre-defined acceptance criteria (e.g., "Sensitivity must be >= 95%"). Instead, it compares the device's performance directly against a legally marketed predicate device (Fisher SURE VUE) and demonstrates equivalency. The reported performance is based on achieving 100% agreement with this predicate.
| Metric | Reported Device Performance (WH Accu Test™) |
|---|---|
| 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 test set. It mentions a "clinical trial" but does not provide details on the number of urine samples or patients involved. The data provenance (country of origin, retrospective or prospective) is also not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
The document states that a "trained Laboratory Technician performed testing in a CLIA registered laboratory." It does not specify the number of technicians or their detailed qualifications (e.g., years of experience). The ground truth was established by comparing the WH Accu Test™ to the predicate device, Fisher SURE VUE.
4. Adjudication Method for the Test Set:
The document does not describe an adjudication method such as 2+1 or 3+1. The performance data is presented as a direct comparison and agreement with the predicate device (Fisher SURE VUE).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
A multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The study focused on the performance of the device itself compared to a predicate device, rather than the improvement of human readers with or without AI assistance.
6. Standalone Performance Study:
Yes, a standalone performance study was done. The "Performance Data" section details the sensitivity, specificity, and agreement of the WH Accu Test™ as a standalone device, compared to the Fisher SURE VUE. This demonstrates the algorithm's (or in this case, the test's) performance without human interpretation as the variable. The test is designed to provide a visual positive or negative result.
7. Type of Ground Truth Used:
The ground truth for the test set was established using a predicate device (Fisher SURE VUE), a commonly used pregnancy test. This is an example of using a "comparator" or "reference method" as the ground truth.
8. Sample Size for the Training Set:
The document does not provide any information about a "training set" or its sample size. This type of in-vitro diagnostic device (lateral flow immunoassay) typically does not involve a machine learning model that requires a distinct training set in the conventional sense. The test's performance is inherent in its chemical and biological components.
9. How the Ground Truth for the Training Set Was Established:
As there is no mention of a training set, the method for establishing its ground truth is not applicable.
§ 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.