(43 days)
AimStick™ PBD Pregnancy is intended for the qualitative identification of hCG (human Chorionic Gonadotropin) in urine to aid in the determination of pregnancy. This test is for professional use.
The test utilizes a combination of momelonal 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 of hCG.
Here's a breakdown of the acceptance criteria and the study details for the AimStick™ PBD Pregnancy test, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" in a numerical or percentage format beyond the concordance. However, based on the study's design and reported results, the implied acceptance criterion for substantial equivalence in this context is 100% concordance with a legally marketed predicate device.
| Acceptance Criteria | Reported Device Performance (AimStick™ PBD Pregnancy) |
|---|---|
| 100% concordance with a commercially available pregnancy test | 100% concordance with a commercially available test |
| Detection of hCG concentrations ≥ 20 mIU/ml | Detects hCG concentrations of 20 mIU/ml and greater |
| No cross-reactivity with hLH, hFSH, hTSH | No cross-reactivity reported |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 150 urine specimens.
- Data Provenance: Not specified (e.g., country of origin). The study is described as a "multi-center clinical evaluation," implying real-world samples. It is a retrospective study as it involves testing existing (collected) urine specimens.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide information on the number or qualifications of experts used to establish the ground truth for the test set. Instead of expert consensus, the "ground truth" for the comparative study was the result obtained from the "other commercially available test."
4. Adjudication Method for the Test Set
The document does not specify an adjudication method. Since the "ground truth" was based on a single comparative test, an adjudication process as typically understood (e.g., 2+1 adjudication by human readers) was not applicable in this context. The concordance was directly calculated by comparing the results of the two tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not conducted. This study compares the performance of a new device against a predicate device, rather than assessing improvements in human reader performance with AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, a standalone performance evaluation was conducted. The AimStick™ PBD Pregnancy test is an in vitro diagnostic device, and its performance (detecting hCG, sensitivity, specificity/cross-reactivity) is assessed as a standalone product. The clinical evaluation compares its standalone performance to another standalone diagnostic. There is no "human-in-the-loop" component in the operation of this test strip.
7. The Type of Ground Truth Used
The primary ground truth for the "multi-center clinical evaluation" was the results obtained from a "commercially available test." This serves as a comparative ground truth for establishing substantial equivalence.
Additionally, internal validation was performed for the device's sensitivity and specificity:
- Sensitivity ground truth: Known concentrations of hCG (20 mIU/ml and greater) and negative urine (0 mIU/ml hCG) were used.
- Specificity/Cross-reactivity ground truth: Known concentrations of hLH, hFSH, and hTSH added to negative and positive urine were used.
8. The Sample Size for the Training Set
The document does not specify a training set sample size. For in vitro diagnostic devices like pregnancy tests, "training sets" in the context of machine learning (AI) are not typically applicable. The device's components (monoclonal and polyclonal antibodies) are developed and optimized through laboratory research and development, not by "training" an algorithm on a dataset.
9. How the Ground Truth for the Training Set Was Established
As noted in point 8, the concept of a "training set" and associated ground truth is not applicable to this type of diagnostic device. The performance characteristics of the antibodies and test strip components are established through controlled laboratory experiments and analytical studies, not through AI training protocols.
§ 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.