(80 days)
The One-Step Double-Chek™ Pregnancy Test is a test for the qualitative determination of human chorionic gonadotropin (hCG) in urine and serum, for the early detection of pregnancy. For Laboratory Professional Use Only.
The One-Step Double-Chek™ Pregnancy Test is to be used for detecting human Chorionic Gonadotropin (hCG) in urine and serum. The presence of hCG usually appears about the seventh day after fertilization. The One-Step Double-Chek™ Pregnancy Test will detect hCG in urine and serum at a concentration level of 25 mIU/ml. The One-Step Double-Chek™ Pregnancy Test will be sold for professional use only.
Here's a breakdown of the acceptance criteria and the study details for the One-Step Double-Chek™ Pregnancy Test, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Sensitivity | 100% | 100% |
| Specificity | 100% | 100% |
| Agreement | 100% | 100% |
Note: The document states, "The One-Step Double-Chek™ Pregnancy Test when compared with another commonly used pregnancy test (Abbott TestPack Plus) demonstrated 100% performance." This implies that the acceptance criteria for sensitivity, specificity, and agreement were 100% when compared to the predicate device.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the total number of samples used in the clinical trial. It only states that a "clinical trial was done."
- Data Provenance: The document does not specify the country of origin. It does state that "A trained Laboratory Technician performed testing in a CLIA registered laboratory," which suggests a professional laboratory setting. The study appears to be prospective as it's a clinical trial comparing the new device to an existing one.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- The document implies that the ground truth was established by medical professionals as it states: "All pregnancy results were confirmed by physical examination and/or ultrasound."
- It does not specify the number of experts or their specific qualifications (e.g., "radiologist with 10 years of experience"). It only identifies them broadly as professionals capable of performing physical examinations and ultrasounds.
4. Adjudication Method for the Test Set
- The document does not describe a specific adjudication method like 2+1 or 3+1. The ground truth was established by "physical examination and/or ultrasound," which implies a direct medical assessment rather than a consensus among multiple reviewers of the test results themselves.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not explicitly mentioned or conducted in the context of human readers improving with AI vs. without AI assistance. The comparison was between the One-Step Double-Chek™ Pregnancy Test and the Abbott TestPack Plus, both used by a laboratory technician. The study does not involve AI or human reader assistance.
6. Standalone (Algorithm Only) Performance Study
- Yes, a standalone performance study was conducted. The "Performance Data" section directly reports the device's performance (sensitivity, specificity, agreement) when compared to a predicate device. This is a standalone assessment of the device's accuracy in detecting hCG. There is no human-in-the-loop component mentioned for the reported performance metrics.
7. Type of Ground Truth Used
- The type of ground truth used was outcomes data and expert assessment. Specifically, "All pregnancy results were confirmed by physical examination and/or ultrasound." This indicates that actual clinical outcomes (pregnancy status) confirmed by medical examination were used as the gold standard.
8. Sample Size for the Training Set
- The document does not provide any information regarding a "training set" or its sample size. This is a diagnostic test where performance is typically evaluated on a test set against a known ground truth, rather than having a distinct training and test set in the machine learning sense. The device's performance is demonstrated through its clinical trial on a single set of samples.
9. How the Ground Truth for the Training Set Was Established
- As no training set is mentioned, this information is not applicable or provided.
§ 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.