(55 days)
The OSOM™ Card hCG-Urine Test is intended for the qualitative determination of human chorionic gonadotropin (hCG) in urine for early detection of pregnancy. FOR LABORATORY AND PROFESSIONAL IN VITRO USE ONLY.
OSOM Card hCG-Urine Test uses color immunochromatographic technology with antibodies coated on the membrane. If hCG is present in urine, a red test line in Result Window will appear to indicate a positive result.
Here's a breakdown of the acceptance criteria and study information for the OSOM™ Card hCG-Urine Test, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance | Study Type | Comparison Device/Method |
|---|---|---|---|
| Sensitivity (Ability to correctly identify positive samples) | 100% | Comparative Study | Abbott TestPack Plus hCG Urine Test |
| Specificity (Ability to correctly identify negative samples) | 100% | Comparative Study | Abbott TestPack Plus hCG Urine Test |
| Agreement with Expected Results for negative, low positive, and moderate positive samples | 100% agreement | Evaluation at Physician Offices | Expected results (implied gold standard for panel) |
2. Sample Size Used for the Test Set and Data Provenance
- Comparative Study (Sensitivity & Specificity):
- Sample Size: 227 urine specimens
- Data Provenance: Not explicitly stated (e.g., country of origin). The study seems retrospective as it compared the OSOM Card hCG-Urine Test to the Abbott TestPack Plus hCG Urine Test using these specimens.
- Evaluation at Physician Offices:
- Sample Size: A "randomly coded panel consisting of negative, low positive and moderate positive samples." The exact number of samples in this panel is not specified, but it was tested over three days.
- Data Provenance: Not explicitly stated, but implies prospective testing in a clinical setting ("three physicians offices").
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The "expected results" for the physician office evaluation and the reference values for the 227 urine specimens are not attributed to specific experts or their qualifications.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC study was not explicitly mentioned or described. The studies focused on device performance against a predicate device and known panels, not on comparing human readers with and without AI assistance.
- Effect size of human readers improving with AI vs. without AI assistance: Not applicable, as this was not an AI-assisted device study.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Yes, a standalone performance study was implicitly done. The OSOM Card hCG-Urine Test is a qualitative immunoassay. The reported sensitivity and specificity of 100% and the 100% agreement with expected results in physician offices represent the performance of the device itself (the "algorithm" in a broad sense, though it's a chemical reaction and visual interpretation) without explicitly factoring in trained human readers as a separate variable in these performance metrics. The device's output (presence/absence of a red line) is a direct result.
7. The Type of Ground Truth Used
- Comparative Study: The "ground truth" for the 227 urine specimens appears to be established by the Abbott TestPack Plus hCG Urine Test. The OSOM test's results were compared against this predicate device. This is a form of agreement with a recognized standard.
- Evaluation at Physician Offices: The ground truth for the "randomly coded panel" was based on "expected results." This suggests a known panel with confirmed concentrations of hCG (or absence thereof), likely derived from quantitative assays or spiking experiments, implying a form of reference standard/laboratory-confirmed truth.
8. The Sample Size for the Training Set
This information is not applicable/not provided as this device is a qualitative immunochromatographic test, not an AI/machine learning algorithm that requires a "training set" in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided for the reasons stated above.
§ 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.