(79 days)
The ACON +/- Midstream Pregnancy Test is for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine to aid in the early detection of pregnancy. It is for over-the-counter use.
ACON +/- Midstream Pregnancy Test is a modified device from the previously FDA-cleared ACON ACON +/- Mustleann Fregnancy Test is a The immunochemical formulation, which employs an Midsleam Tregnancy Color particle sandwich binding, lateral flow immunoassay for the detection of hCG, remains the same for the modified device. With the incorporation of a proprietary moisture-sensitive dye pad within the test strip, an additional test line perpendicular to the regulation thoisture-sellsitive dyc pac willin the test bevice. The moisture-sensitive dye pack to treasur the test the will develop for the mounted test connect by urine sample. Regardless of the test result, this change from coloness to pinnered color with the user. While the un-modified device will have a colored test line developed in the result window for positive result and no colored line for negative colored test inte developed in the result willion to press. "+" pattern in the result window for positive result, and a colored "-" pattern for negative result.
ACON +/- Midstream Pregnancy Test
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Ability of laypersons to correctly read and interpret test results | >99% accuracy (259/260 with 95% confidence interval of 97.9-99.9%) |
2. Sample size used for the test set and the data provenance
- Sample size: 260 participants (referred to as "lay persons"). The origin of the participants (country) is not specified.
- Data provenance: Prospective, as it involved participants actively using and interpreting the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not explicitly state the number or qualifications of experts used to establish the ground truth for the layperson readability study. However, the study focuses on the layperson's ability to interpret predefined "positive" or "negative" signs (+ or -) on the test, rather than a clinical diagnosis. The ground truth for individual test results would likely have been established by performing the test and observing the expected chemical reaction (presence or absence of hCG) against a known standard.
4. Adjudication method for the test set
The document does not describe an explicit adjudication method for the layperson readability study. The study's focus was on the participants' interpretation of the displayed result, implying that each participant's interpretation was compared against the intended (correct) interpretation for that specific test result.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a rapid diagnostic test, not an AI-powered diagnostic tool requiring human-in-the-loop assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable, as the device is not an algorithm or AI. The "standalone" performance here refers to the device's ability to qualitatively detect hCG at a specific cutoff concentration, which is stated to be 25 mIU/mL. The document also states that urine samples with 0 mIU/mL hCG (negative) and 25 mIU/mL hCG (positive) did not interfere with correct reading.
7. The type of ground truth used
For the layperson readability study, the ground truth was the intended visual interpretation of the test result patterns ("+" for positive, "-" for negative).
For the device's analytical performance (hCG detection), the ground truth for establishing sensitivity was against World Health Organization Fourth International Standard for Chorionic Gonadotropin.
8. The sample size for the training set
The document does not mention a "training set" as this is not an AI/machine learning device. The clinical study described is a readability study, which serves as a validation of the device's ease of use for its intended over-the-counter user.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
§ 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.