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ACCUNATE™-ONE STEP and ACCUNATE™-ONE STEP CASSETTE are rapid lateral flow colloldal gold immunological tests for the qualitative determination of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy.

ACCUNATE™-ONE STEP and ACCUANTE™-ONE STEP CASSETTE are rapid lateral flow colloidal gold immunological tests for the qualitative determination of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy.

The acceptance criteria and study proving the device meets them are as follows:

1. Acceptance Criteria and Reported Device Performance:

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

• Comparison Study:
  • Sample Size: 131 urine specimens.
  • Data Provenance: Not explicitly stated, but implies prospective collection as specimens were "from patients seeking confirmation of pregnancy" and tested "simultaneously" at three clinic sites. The country of origin is not specified, but the applicant and testing sites are located in the US.
• Sensitivity Study:
  • Sample Size: 20 urine specimens from normal males and non-pregnant females for each hCG concentration (0 IU/ml, 5 mIU/ml, 25 mIU/ml, 50 mIU/ml, and 100 mIU/ml), totaling 100 tests.
  • Data Provenance: Retrospective, as urine specimens were "spiked with hCG". The country of origin is not specified.

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

• Comparison Study: The ground truth for the comparison study appears to be established by the results of the predicate device, the Abbott Test Pack Plus™. No information is provided on the number or qualifications of experts involved in determining the "true" positive or negative status of the samples beyond the predicate device's results.
• Sensitivity Study: For the sensitivity study, the ground truth was established by the known concentration of spiked hCG. No human experts were involved in establishing this ground truth.

4. Adjudication Method for the Test Set:

• Comparison Study: Not explicitly stated. The document implies a direct comparison of results between the investigational devices and the predicate device. With 100% agreement, there was no need for adjudication of discordant results.
• Sensitivity Study: Not applicable, as the ground truth was based on known hCG concentrations.

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

• No, an MRMC comparative effectiveness study was not done. This device is a qualitative in vitro diagnostic test, not an imaging or diagnostic AI tool requiring human-in-the-loop performance evaluation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• Yes, the studies presented are standalone evaluations of the device's performance. Both the comparison study and the sensitivity study assessed the ACCUNATE™-ONE STEP devices' ability to detect hCG in urine without human interpretation influencing the final result beyond observing the test line.

7. Type of Ground Truth Used:

• Comparison Study: The ground truth was based on the results of a legally marketed predicate device, the Abbott Test Pack Plus™.
• Sensitivity Study: The ground truth was based on artificially created samples with known concentrations of hCG (spiked urine specimens).

8. Sample Size for the Training Set:

• This information is not provided. The 510(k) summary describes performance studies, not the development or training of an algorithm. Given the simplicity of the test type (lateral flow immunoassay), it is unlikely there was a "training set" in the sense of a machine learning algorithm. The "training" would be more akin to internal R&D and optimization of reagents and manufacturing processes.

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

• Not applicable, as a training set in the context of an algorithm or machine learning is not mentioned or relevant for this type of device submission.

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