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AimStep™ Pregnancy is intended for non-professional use for the qualitative identification of hCG (human Chorionic Gonadotropin) in urine to aid in the determination of pregnancy.

The test utilizes a combination of monochonal and polyclonal antibody reagents to selectively devect elevated levels of hCG. The assay is conducted by adding urine to the test device and observing for the formation of colored lines. The specimen migrates via capillary action along the membranc to react with the colored conjugate. Positive specimens react with the specific antibody-hCG-colored conjugate and form a colored line on the "Test Region" of the membrane. Absence of this colored line suggests a negative result. To serve as a procedural control, a colored line at the Control Region will always appear regardless of the presence or absence of hCG.

This document describes the acceptance criteria and study proving the performance of the AimStep™ Pregnancy (Home Test).

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: 137 female participants.
• Data Provenance: The document does not explicitly state the country of origin. It is a "clinical trial," which implies prospective data collection, but this is not explicitly confirmed. Given the context of a 510(k) submission to the FDA, it is highly likely the study was conducted in the USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not mention the use of experts to establish ground truth for the test set. The comparison was made against a predicate device (Clearview™ Easy HCG Pregnancy Test), which itself is a legally marketed device for pregnancy determination. The results of the predicate device served as the reference for comparison.

4. Adjudication Method for the Test Set

Not applicable. The study compared the device's results directly to a predicate device, not against an adjudicated ground truth from multiple experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study focused on the performance of the device against a predicate device, not on the improvement of human readers with or without AI assistance.

6. Standalone Performance Study

Yes, a standalone performance study was conducted in the sense that the AimStep™ Pregnancy device was evaluated on its own ability to detect hCG and its correlation with a predicate device. The accuracy of detecting hCG at 20 mIU/ml and greater, and the lack of cross-reactivity, represent standalone performance metrics.

7. Type of Ground Truth Used

The ground truth for the clinical trial was established by the results of the legally marketed predicate device, the Clearview™ Easy HCG Pregnancy Test. This implies a "device-to-device comparison" ground truth where the established accuracy of the predicate device is assumed to be the truth for the purpose of comparison. The primary function of the test is for "identification of hCG," and its ability to detect specific concentrations and show no cross-reactivity suggests a chemical/biological assay's intrinsic truth as well.

8. Sample Size for the Training Set

The document does not explicitly mention a training set or its sample size. The description of the device's performance (e.g., detection limit, cross-reactivity) suggests laboratory testing and standardization, which would involve samples, but these are not referred to as a "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as a "training set" in the context of machine learning is not described. The device's performance characteristics (detection limit, cross-reactivity) would have been established through laboratory experiments and standardization to the World Health Organization Third International Standard, which serves as a definitive reference for hCG measurement.

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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.

• 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.

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