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The Applied DNA Technologies Bionexia™ hCG Pregnancy Serum/Urine Cassette and Dipstick Tests are rapid chromatographic immunoassays for the visual, qualitative detection of human chorionic gonadotropin (hCG) in serum or urine specimen to help in the early determination of pregnancy. The test kits are for health care professionals use including professionals at physician's office labs (POLs). For a final Diagnosis of pregnancy, a more specific alternative clinical method must be used to obtain a confirmed analytical result.

The Bionexia™ hCG Pregnancy Serum/Urine Test are distributed in both Cassette and Dipstick formats. Each test reagent strip contains mouse monoclonal anti-u-hCG antibody coated membrane and a dried chemical pad containing mouse monoclonal anti-ß-hCG anybody colloidal gold conjugate. The control antibodies are goat anti-mouse IgG.

Here's a breakdown of the acceptance criteria and the study details for the Bionexia™ hCG Pregnancy Serum/Urine Cassette and Dipstick Tests, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Accuracy/Comparison Study (Test Set):

  • Serum: 95 clinical serum specimens.
  • Urine: 94 clinical urine specimens.
  • Additional evaluation: 20 negative and 29 positive serum & urine specimens (total 49) were re-evaluated at a third site.
  • Data Provenance: Clinical specimens. The study was conducted at two Physician's Office Labs (POLs) sites, with additional re-evaluation at a third site. The country of origin is not explicitly stated, but the submission is to the FDA in the USA. The data appears to be prospective in the sense that the new device was tested on these clinical specimens.

• Sensitivity and Cross-reactivity Study (Test Set):

  • Sensitivity: Standardized to the WHO Fourth International Standard 75/589, implying a controlled, possibly spiked, sample set. Specific sample count not provided, but it states detection at 20mIU/ml or greater.
  • Cross-reactivity: Evaluated at 0 mIU/ml (negative) and 20 mIU/ml (positive) hCG specimens. Specific sample count for each cross-reactant not provided, but it implies tests performed with each substance at the specified level. Likely spiked control studies.

• Reproducibility Study (Test Set):

  • Serum Controls: 100 tests (25 tests across 4 lots) for each hCG concentration level (0, 10, 12.5, 15, 17.5, 20, 25, 30, 35, 40, 100 mIU/ml).
  • Urine Controls: 100 tests (25 tests across 4 lots) for each hCG concentration level (0, 10, 12.5, 15, 17.5, 20, 25, 30, 35, 40, 100 mIU/ml).
  • Data Provenance: This appears to be spiked control studies using prepared control samples rather than clinical specimens.

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

• The document implies that the predicate device (ACON One Step Pregnancy Urine/Serum Test) results were used as the reference point (ground truth) for the accuracy/comparison study. It doesn't explicitly mention external experts adjudicating the Bionexia™ results against a separate "true" ground truth. The comparison is against an already legally marketed and accepted device.
• For the POLs site study, it is implied that healthcare professionals (the intended users) performed the tests and interpreted the results. The specific number or qualifications of these professionals are not detailed, but they are referred to as "health care professionals use including professionals at physician's office labs (POLs)."

4. Adjudication Method for the Test Set

• The primary method for the accuracy/comparison study was a direct comparison to the predicate device. A "blind-labeled" approach was used (meaning the testers likely didn't know which sample was which device), but there's no mention of a formal adjudication method (like 2+1 or 3+1 consensus) for discrepancies if they arose between the new device and the predicate. Given the 100% agreement, no adjudication would have been necessary in those specific cases.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve With AI vs Without AI Assistance

• No, an MRMC comparative effectiveness study was not done. This document describes the performance of a rapid in-vitro diagnostic (IVD) test, not an AI-assisted diagnostic tool. Therefore, the concept of human readers improving with AI assistance is not applicable here. The device itself performs the detection, with visual interpretation by the healthcare professional.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Yes, a standalone performance was done for the device. The accuracy, sensitivity, cross-reactivity, and reproducibility studies demonstrate the performance of the Bionexia™ hCG Pregnancy Tests themselves, irrespective of the human factor beyond the visual interpretation of the test line. The device is designed for visual qualitative detection, meaning the "algorithm" is inherent in the chemical reactions and visual indicators. The results presented are the device's performance in detecting hCG.

7. The Type of Ground Truth Used

• Accuracy/Comparison Study: The ground truth was established by the results of a legally marketed predicate device (ACON One Step Pregnancy Urine/Serum Test). This serves as a comparative ground truth.
• Sensitivity: The ground truth was based on the WHO Fourth International Standard 75/589 for hCG concentration, which is a standardized reference.
• Cross-reactivity and Reproducibility: Ground truth was established by using controlled, spiked samples with known concentrations of hCG and other related hormones/substances.

8. The Sample Size for the Training Set

• The document does not explicitly describe a "training set" in the context of machine learning or AI. For IVD devices like this, the development process typically involves internal testing and optimization (which could be considered analogous to training data for the device's design), but this is not typically reported as a formal "training set" with specific numbers in regulatory summaries. The data provided focuses on validation (test set) performance.

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

• As a traditional IVD device, there isn't a "training set ground truth" in the AI sense. The development of the device (choosing antibodies, membrane materials, concentrations, etc.) would be guided by established biochemical principles and internal testing using known hCG standards and samples with confirmed values, which serves a similar function to establishing "ground truth" during product development. However, these specific details of the development process and internal testing are not provided in this 510(k) summary, which focuses on validation data for regulatory submission.

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