(14 days)
The OSOM® Card II 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 II hCG-Urine Test uses color immunochromatographic technology with antibodies coated on the membrane. If hCG is present in urine, a blue test line in Result Window will appear to indicate a positive result.
Here's an analysis of the acceptance criteria and study details for the OSOM® Card II hCG-Urine Test, based on the provided text:
1. Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state quantitative acceptance criteria in a dedicated section. However, based on the "Substantial Equivalence" claim and the "Precision" study, the implied acceptance criteria are achieving high sensitivity and specificity comparable to the predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| High Sensitivity | 99.1% |
| High Specificity | 100% |
| 100% agreement with expected results for a panel of negative, low positive, and moderate positive samples | 100% agreement |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set:
- For the comparison study with OSOM® Classic hCG Urine Test: 217 urine specimens.
- For the physician's office evaluation: The exact number of samples in the "randomly coded panel consisting of negative, low positive and moderate positive samples" is not specified, but it was tested over three days at three different offices.
- Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be prospective, as the specimens were tested with the new device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The comparison study uses the "OSOM® Classic hCG Urine Test" as a comparator, which would imply the ground truth was established by that test or by an independent method against which both tests were compared. For the physician's office evaluation, "expected results" implies a pre-determined ground truth, likely established by laboratory reference methods or expert consensus, though the specific method and experts are not detailed.
4. Adjudication Method for the Test Set
- No explicit adjudication method (e.g., 2+1, 3+1) is described for either study. For the comparison study, it's assumed the results of the OSOM® Classic hCG Urine Test served as the reference. For the physician's office evaluation, the "expected results" served as the reference.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
- No MRMC study was done. This device is an in-vitro diagnostic (IVD) test, not an AI-assisted diagnostic tool. Therefore, questions regarding human reader improvement with AI assistance are not applicable.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
- A standalone performance evaluation was done. The "Precision" study, which reports sensitivity and specificity and the physician's office evaluation, assess the performance of the device itself (the OSOM® Card II hCG-Urine Test) in detecting hCG, without describing a human interpretation step that is separated from the device's inherent result output. The device itself produces a visual result (a blue test line).
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- For the comparison study: The ground truth was established by comparison to a legally marketed predicate device, the "OSOM® Classic hCG Urine Test." This implies the predicate device's results were considered the reference truth.
- For the physician's office evaluation: The ground truth was based on "expected results" for a "randomly coded panel consisting of negative, low positive and moderate positive samples." This suggests that the panel samples had their hCG status confirmed by a highly reliable reference method (e.g., quantitative hCG assay, expert-verified reference standard), ensuring known negative and positive concentrations.
8. The Sample Size for the Training Set
- The document describes performance studies (test sets) but does not mention a separate training set. This is typical for IVD devices where the "training" (if any, in the context of analytical performance) is done during development and validation, not explicitly detailed as a separate data set for an algorithm.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as no separate training set is described in the provided text.
§ 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.