(58 days)
Signal™ is a visual and rapid test for the qualitative determination of human chorionic gonadotropin (hCG) in urine to aid in early detection of pregnancy. This test is intended for over-the-counter use.
Signal™ detects the presence of hCG in urine by using a combination of polyclonal and monoclonal antibodies on the reagent pad and the test strip. The assay begins functioning with the addition of urine onto the absorbent wick. Through capillary action the urine is pulled along the membrane to the reagent pad where the hCG reacts with the conjugate. Positive results are determined by two colored lines in the window. The absence of hCG produces only one colored line in the window.
Here's an analysis of the provided information, structured to address your specific points:
The provided text contains limited details regarding the acceptance criteria and the full study methodology. Based on the available summary, here's what can be extracted:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Specificity | >99% acceptance |
| Sensitivity | >99% acceptance |
| Accuracy | >99% acceptance |
| Interfering Substances | >99% acceptance |
| Stability Studies | >99% acceptance |
| Laboratory Comparison Study | >99% accuracy (with SAS™ Pregnancy Strip Test Kits) |
Note: The exact numerical values for specificity, sensitivity, and accuracy are not provided, only that they exceeded "99% acceptance." It's unclear if "acceptance" refers to meeting a pre-defined threshold or simply indicating a high performance.
Study Information
The document describes a "Laboratory Comparison Study" and mentions other performance studies.
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Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: For the "Laboratory Comparison Study," a sample size of 100 test devices was used.
- Data Provenance: Not explicitly stated. Given it's a laboratory comparison study of a diagnostic device, it likely involved collected human urine samples, but no specifics on country of origin or whether it was retrospective or prospective are provided.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. For a pregnancy test, the "ground truth" would typically be established through a reference method (e.g., a laboratory-grade hCG assay with known performance characteristics) or clinical confirmation of pregnancy. The document only mentions comparison against another device (SAS™ Pregnancy Strip Test Kits).
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Adjudication method for the test set:
- This information is not provided in the document. It's unlikely that "adjudication" in the sense of expert review of ambiguous cases would be required for a one-step qualitative pregnancy test unless there were discrepancies between the device and the reference standard that needed resolution.
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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, an MRMC comparative effectiveness study was not done. This device is a rapid, one-step visual test intended for over-the-counter home use, meaning the "reader" is typically the end-user. As such, there is no AI component or human assistance model relevant to an MRMC study for this device.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Partially applicable. This device is a standalone diagnostic test. Its performance metrics (specificity, sensitivity, accuracy) were assessed for the device itself without explicit human "in-the-loop" assistance. However, it's a visual test, meaning a human always interprets the result (the presence or absence of colored lines). Therefore, the "standalone" performance here refers to the chemical and physical reaction of the device, assuming correct interpretation by the user.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The primary ground truth for the "Laboratory Comparison Study" was another device: SAS™ Pregnancy Strip Test Kits.
- For the "Specificity, Sensitivity & Accuracy" studies, the ground truth would have been established by confirming the presence or absence of hCG in urine samples, likely using a laboratory reference method (e.g., quantitative hCG assay). The document does not specify the exact method for this initial ground truth.
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The sample size for the training set:
- This information is not provided in the document. For non-AI/ML devices like this pregnancy test, there isn't a "training set" in the computational sense. The device's design is based on established biological and chemical principles, and its performance is validated through testing on various samples, not through iterative training.
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How the ground truth for the training set was established:
- As there is no "training set" in the AI/ML context for this device, this question is not applicable. The ground truth for validating the device's performance would be established as described in point 6.
§ 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.