(95 days)
The Poly stat hCG Dipstick Test is intended to detect the presence of human chorionic gonadotrpin (hCG) in the urine of women who are suspected to be pregnant. The device is for the early detection of pregnancy.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA for "The Poly stat hCG Dipstick Test." While it states the device's indications for use and classification, it does not include detailed information regarding acceptance criteria, study design, or performance data that would typically be required to answer the requested questions. This document is an approval letter, not the submission itself.
Therefore, most of the requested information cannot be extracted from the provided text.
Here is what can be inferred or stated as missing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in this document. | Not specified in this document. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in this document.
- Data Provenance: Not specified in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified in this document.
- Qualifications of Experts: Not specified in this document.
4. Adjudication method for the test set:
- Not specified in this 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:
- Not specified in this document. This is a HCG dipstick test, not an AI-assisted diagnostic device, so an MRMC study related to AI assistance is unlikely and not applicable based on the device description.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not specified in this document. As it's a dipstick test, it's inherently a standalone diagnostic and not an "algorithm only" device in the typical sense of AI/software. Performance would be assessed inherently as standalone.
7. The type of ground truth used:
- Not specified in this document. For an hCG test, ground truth would typically be established by laboratory reference methods (e.g., quantitative hCG assays) or clinical outcomes.
8. The sample size for the training set:
- Not specified in this document.
9. How the ground truth for the training set was established:
- Not specified in this document.
Conclusion:
The provided document is an FDA approval letter (510(k) clearance) for a human chorionic gonadotropin (hCG) dipstick test. It confirms the device's substantial equivalence to a predicate device and its intended use for early pregnancy detection. However, this letter does not contain the detailed study results, acceptance criteria, sample sizes, or ground truth establishment methods that would have been part of the original 510(k) submission. To answer the specific questions, one would need to access the full 510(k) submission (K021386) submitted by Alidex, Inc.
§ 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.