(14 days)
The OSOM® Card Pregnancy Test is intended for the qualitative determination of human chorionic gonadotropin, hCG, in urine for early detection of pregnancy for home use.
OSOM® Card Pregnancy Test uses color immunochromatographic technology with antibodies coated on the membrane. If hCG is present in urine, a blue test line will appear to indicate a positive result.
Here's an analysis of the provided text to extract information about the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" as a separate section with pass/fail thresholds. However, it presents precision data which implies the expected performance. The key performance metrics are sensitivity and specificity.
| Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Sensitivity | High (e.g., >95%) | 99.1% |
| Specificity | High (e.g., >95%) | 100% |
| Overall Agreement (Consumer) | High (e.g., >95%) | 100% |
2. Sample Size for the Test Set and Data Provenance:
- Sample Size:
- For comparison to a professional hCG test: 217 urine specimens.
- For consumer testing: 74 participants.
- Data Provenance: The document does not specify the country of origin. It does not explicitly state if the data was retrospective or prospective, but "consumer testing" and comparison with a "professional hCG test" imply prospective collection for evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
The document broadly mentions "professional hCG test" and "clinical status" without detailing the number or specific qualifications of experts involved in establishing the ground truth for the 217 specimens or the 74 participants.
4. Adjudication Method for the Test Set:
The document does not describe any specific adjudication method (e.g., 2+1, 3+1). It states that the OSOM® Card Pregnancy Test was "compared to a professional hCG test, OSOM® Classic hCG Urine Test" and "consumer testing was conducted... evaluated against their clinical status." This implies a direct comparison rather than an adjudication process involving multiple human readers for discrepancies.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not explicitly done. The study compares the device's performance to a professional test and consumer clinical status, not human readers with or without AI assistance. The device itself is a diagnostic test, not an AI-assisted interpretation tool for human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Yes, a standalone performance evaluation was done. The precision data (sensitivity and specificity) of the OSOM® Card Pregnancy Test was determined by comparing its results directly to a "professional hCG test" and the "clinical status" of consumers. The OSOM® Card Pregnancy Test is a non-AI diagnostic kit, so its performance is inherently standalone.
7. The Type of Ground Truth Used:
- For sensitivity and specificity: Comparison to a "professional hCG test (OSOM® Classic hCG Urine Test)". This serves as a reference standard, implying it's a higher-tier or validated test used to establish the true presence or absence of hCG.
- For overall agreement (consumer testing): "Clinical status" of the 74 participants. This likely refers to a confirmed pregnancy status obtained through other clinical means (e.g., physician diagnosis, repeat lab tests).
8. The Sample Size for the Training Set:
The document does not mention any training set size. This device is described as an immunochromatographic test, not a machine learning model, so the concept of a "training set" in the context of AI is not applicable here.
9. How the Ground Truth for the Training Set Was Established:
As there is no mention of a training set for an AI/machine learning model, this question is not applicable. The device's design and manufacturing process would be based on established chemical and biological principles for immunochromatography rather than a data-driven training process.
§ 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.