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The Fact plus® One Step Pregnancy Test is a qualitative, consumer home-use, in vitro diagnostic immunoassay for the detection of human chorionic gonadotropin (hCG) in human urine for the early detection of pregnancy.

The intended use of both pregnancy tests is as a qualitative, consumer home-use, in vitro diagnostic immunoassay for the detection of human chorionic gonadotropin (hCG) in human urine. The modified device has demonstrated comparable performance characteristics to the predicate device.

This document is a 510(k) summary, which typically does NOT include detailed study results and acceptance criteria. Instead, it states that the modified device's performance is comparable to the predicate device and that this information is documented in the Design History File. Therefore, most of the requested information cannot be extracted from the provided text.

Here is what can be inferred:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated in this document. The document states "the modifications made to the predicate device...have not changed the original intended use or performance characteristics of the Fact plus One Step Pregnancy Test." This implies the acceptance criteria for the modified device would be to meet the established performance characteristics of the predicate device.
• Reported Device Performance: Not explicitly stated in this document. It only mentions that the "modified device has demonstrated comparable performance characteristics to the predicate device."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not available in the provided text. The document refers to a "Design History File" where this information would be maintained.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable/available. This is an in vitro diagnostic test for hCG, not an image interpretation task requiring expert readers. The ground truth for such tests would typically be established by a reference method (e.g., more sensitive laboratory-based hCG detection or clinical outcomes).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable/available. See point 3.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This is an in vitro diagnostic device, not an AI-assisted diagnostic tool that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• This is a standalone in vitro diagnostic kit (consumer home-use). Its performance is inherently "standalone" in the sense that the result is read by the user directly from the device. The document implies a performance study (comparing to the predicate) was conducted, but details are not provided.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• Not explicitly stated, but for an hCG test, the ground truth would typically be established by:
  • Reference laboratory hCG assays (e.g., quantitative serum hCG).
  • Confirmation of pregnancy through clinical follow-up or other methods.

8. The sample size for the training set

• Not available in the provided text. This is an in vitro diagnostic, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. Performance studies are conducted.

9. How the ground truth for the training set was established

• Not applicable. See point 8.

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