(64 days)
Immunoassay for in vitro diagnostic use in hospital, clinical laboratories and physicians' offices for the qualitative detection of human chorionic Gonadotropin (hCG) for the early detection of pregnancy.
Not Found
This FDA Premarket Notification (510k) letter, K981443, for the "BioSign™ hCG I - One Step Pregnancy Test" does not contain the detailed information necessary to fully answer the request regarding acceptance criteria and the study that proves the device meets those criteria.
The letter serves as an approval for the device based on its substantial equivalence to a legally marketed predicate device. It indicates that the FDA has reviewed the 510(k) submission, impliedly including performance data, but the letter itself does not describe that data.
Therefore, many of the requested elements cannot be extracted directly from the provided text. To answer these questions, one would need to refer to the actual 510(k) submission document (K981443) which would contain the study protocols, results, and acceptance criteria.
However, based on the limited information, here's what can be inferred or stated as not available:
1. A table of acceptance criteria and the reported device performance:
- Not available in the provided text. The letter states that the device is "substantially equivalent" to predicate devices for the stated indications for use (qualitative detection of pregnancy). This implies the performance data met some internal acceptance criteria within the 510(k) submission, but those criteria and the specific performance metrics are not detailed here.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not available in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not available in the provided text. For a qualitative immunoassay like a pregnancy test, ground truth would typically be established through a combination of clinical diagnosis, other laboratory methods, or possibly follow-up. The role of "experts" in the context of interpretation would be less relevant than for imaging devices, but specifics are missing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not available in the provided text.
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:
- Not applicable / Not available. This is a qualitative immunoassay for hCG, not an AI-assisted diagnostic imaging device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this type of product.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, implicitly. A one-step pregnancy test is inherently a standalone device. The "algorithm" here is the biochemical reaction and visual readout, which provides a direct result without human interpretation of complex images or data. The device's performance would be evaluated on its ability to correctly identify the presence or absence of hCG.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not explicitly stated in the provided text. For an hCG test, ground truth would typically be established by:
- Clinical diagnosis of pregnancy: Based on other clinical signs and symptoms, and possibly follow-up.
- Quantitative serum hCG levels: A reference method for precise hCG measurement.
- Confirmatory testing: Using another validated pregnancy test.
8. The sample size for the training set:
- Not applicable / Not available. For a traditional immunoassay device like this, there isn't a "training set" in the machine learning sense. Device development involves calibration and optimization, which uses samples, but the terminology of "training set" is generally for AI/ML models.
9. How the ground truth for the training set was established:
- Not applicable / Not available (as explained in point 8).
In summary, while the letter confirms FDA clearance for the BioSign™ hCG I - One Step Pregnancy Test based on substantial equivalence, the specific data regarding performance, acceptance criteria, study sizes, and methodologies are not included in this regulatory communication. That information would be found in the original 510(k) submission.
§ 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.