(23 days)
AimStep™ Pregnancy is intended for the qualitative identification of hCG (human Chorionic Gonadotropin) in urine to aid in the early determination of pregnancy. This test is for professional use.
The test utilizes a combination of monoclonal and polyclonal antibodies to selectively detect elevated levels of hCG. The assay is conducted by dipping the test strip into urine and observing for the formation of colored bands. The specimen migrates via capillary action along the membrane to react with the colored conjugate. Positive specimens react with the specific antibody-hCG-colored conjugate and form a colored band on the Specimen portion of the membrane. Absence of this colored band suggests a negative result. To serve as a procedural control, a colored band at the Control Zone will always appear regardless of the presence or absence of hCG.
Here's a breakdown of the acceptance criteria and the study details for the AimStep Pregnancy device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state quantitative acceptance criteria (e.g., "sensitivity must be >X%"). Instead, the primary acceptance criterion appears to be 100% concordance with a commercially available predicate device.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| 100% concordance with a commercially available test for positive and negative hCG detection in urine. | Concordance: 100% |
- AimStep™ positive results: 64
- Commercially available test positive results: 64
- AimStep™ negative results: 84
- Commercially available test negative results: 84 |
| Detects hCG concentrations of 20 mIU/ml and greater. | Detection Limit: 20 mIU/ml (This is stated as a capability, not directly verified against a specific acceptance threshold in the study summary, but it's part of the standard performance claim). |
| No cross-reactivity with hLH (300 mIU/ml), hFSH (1000 mIU/ml), and hTSH (1000 ulU/ml) in negative and positive urine. | No cross-reactivity observed. (This is stated as a direct finding, not a specific criterion in the table, but it's an important performance characteristic.) |
2. Sample Size and Data Provenance for the Test Set:
- Sample Size: 148 urine specimens
- Data Provenance: "A multi-center clinical evaluation was conducted." The document does not specify the country of origin or whether the data was retrospective or prospective.
3. Number of Experts and Qualifications for Ground Truth:
The document does not explicitly state the number of experts used or their qualifications to establish the ground truth. The "ground truth" for the comparative study was based on the results of "another commercially available test." This implies that the commercially available test itself served as the reference standard.
4. Adjudication Method for the Test Set:
There is no mention of an adjudication method. The comparison was a direct concordance between the AimStep™ device and the commercially available test.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study compares the performance of a device against another commercially available test, not human readers with and without AI assistance.
6. Standalone (Algorithm Only) Performance:
Yes, a standalone performance assessment was effectively done. The study directly evaluated the performance of the AimStep (device only) against another commercially available test. There is no human interpretation component described in the test procedure or the study, other than reading the colored bands. Therefore, the reported performance is the "algorithm only" or device-only performance.
7. Type of Ground Truth Used:
The ground truth used was concordance with an existing "commercially available test." This suggests that the predicate device's results were accepted as the known state (positive or negative for hCG).
8. Sample Size for the Training Set:
The document does not provide any information about a training set size. This type of diagnostic device (lateral flow immunoassay) typically does not involve a "training set" in the machine learning sense. Its development relies on biochemical engineering and validation, not algorithms trained on data.
9. How Ground Truth for the Training Set Was Established:
As there is no mention of a "training set" in the context of machine learning, this information is not applicable and therefore not provided in the document. The device's underlying mechanism is based on antigen-antibody reactions, where the "ground truth" for its development would be based on the known biochemical properties of hCG and the specificity/sensitivity of the antibodies used.
§ 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.