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StatusFirst™ hCG Serum/Urine test is in vitro diagnostic use for a qualitative detection of Human Chorionic Gonadotropin(hCG) in serum or urine for the detection of pregnancy.
Reflectance photometer for the measurement of concentration of analyte in various assays manufactured by PBM. The concentration is measured by density of light reflectance.
Reflectance photometer for a reading of test signal instead of visual reading in various qualitative assays manufactured by PBM.

StatusFirst™ hCG Serum/Urine is a qualitative test for the rapid detection of human chorionic gonadotropin (hCG) in serum or urine. The device is used with DXpress™ Reader.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text focuses on demonstrating substantial equivalence rather than explicit quantitative acceptance criteria. Therefore, the "acceptance criteria" here refer to the performance of the predicate device, which the new device aims to match or exceed.

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

• Sample Size: 116 specimens (for both urine and serum combined, or 116 for urine and 116 for serum separately - the wording "when 116 specimens were compared for urine test or for serum test" is slightly ambiguous but implies a significant sample size for comparison).
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the context of an FDA submission for a "StatusFirst™ hCG Serum/Urine" device suggests human clinical samples were used.

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

This information is not provided in the document. The comparison is made against a legally marketed predicate device (Icon 25 hCG), implying the predicate's results served as a comparative "ground truth" or reference, rather than independent expert adjudication.

4. Adjudication Method for the Test Set

This information is not provided. The study compares the results of the StatusFirst™ hCG Serum/Urine device with the Icon 25 hCG test. The predicate device's readings served as the reference point. The document notes that "disagreements were shown in the borderline samples," where "StatusFirst™ hCG Serum/Urine read the borderline samples as borderline level, whereas predicate device read most of borderline samples as positive," indicating a direct comparison rather than an adjudication process involving multiple third-party experts.

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

No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not performed or described. The device, DXpress™ Reader, is a reader for the hCG test strips, providing an objective reading instead of a visual reading by a human. The comparison is between an automated reading (DXpress Reader) and a visual reading (Icon 25 hCG), not an AI assisting human readers.

6. Standalone Performance

Yes, a standalone performance study was done. The 93% agreement reported is the direct performance of the StatusFirst™ hCG Serum/Urine device (read by the DXpress Reader) when compared against the predicate device. This is the device's performance without human-in-the-loop decision making, as the DXpress Reader automates the result interpretation.

7. Type of Ground Truth Used

The "ground truth" used for comparison was the results obtained from a legally marketed predicate device, the Icon 25 hCG test. This is an existing device comparison rather than an independent gold standard like pathology or clinical outcomes.

8. Sample Size for the Training Set

This information is not provided in the document. The document describes a performance evaluation of the final product, not the development or training of the device.

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

This information is not provided. Given that the document describes the performance of a medical device rather than a machine learning algorithm, the concept of a "training set" and "ground truth for the training set" in the context of AI is not explicitly relevant or discussed here. The device is an immunochromatographic assay read by a reflectance photometer, which implies established chemical/biological principles rather than a machine learning model trained on data.

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