(86 days)
Clearblue® Plus Pregnancy Test is an over-the-counter urine hCG test which is intended for the detection of pregnancy. The test is indicated for use from four days before the expected period (5 days before the missed period).
Not Found
This FDA 510(k) clearance letter for the Clearblue Plus Pregnancy Test does not contain the detailed scientific study information requested. The document focuses on regulatory approval based on substantial equivalence to a predicate device, rather than providing the specifics of performance studies, acceptance criteria, or ground truth establishment.
Therefore, most of the requested information cannot be extracted from the provided text.
However, I can extract the following:
1. Table of Acceptance Criteria and Reported Device Performance:
- This information is not present in the provided document. The 510(k) summary (which is a separate document typically submitted with the 510(k) application) would contain this.
2. Sample size used for the test set and the data provenance:
- This information is not present in the provided document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not present in the provided document.
4. Adjudication method for the test set:
- This information is not present in the provided document.
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:
- This is a pregnancy test, not an AI-assisted diagnostic device for image interpretation. Therefore, an MRMC study with AI assistance is not applicable and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This is a pregnancy test; the "algorithm" is the biochemical reaction and visual interpretation. Standalone "algorithm only" performance, in the AI sense, is not applicable and not described. The device's performance is inherently "standalone" in its function as a qualitative diagnostic test.
7. The type of ground truth used:
- This information is not present in the provided document. For a pregnancy test, ground truth would typically be established by laboratory methods for hCG concentration (e.g., quantitative serum hCG).
8. The sample size for the training set:
- This information is not present in the provided document. "Training set" as understood in machine learning contexts is not applicable here.
9. How the ground truth for the training set was established:
- This information is not present in the provided document. "Training set" and its ground truth establishment are not applicable in the context of this regulatory clearance document for a pregnancy test.
§ 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.