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The FORA PNC100 Digital Pregnancy Test is an in vitro diagnostic test device for the qualitative determination of human chorionic gonadotropin (hCG) in urine. It is intended for use as an aid in the early detection of pregnancy by lay users. Additional clinical examination should be performed to confirm the pregnancy. This device uses visually read lateral flow technology for the detection of hCG and provides a digitally read result. The device is intended for home use.

The TD-5301 Pregnancy Test (Strip) is an in vitro diagnostic test device for the qualitative determination of human chorionic gonadotropin (hCG) in urine. It is intended for use as an aid in the early detection of pregnancy by lay users. Additional clinical examination should be performed to confirm the pregnancy. This device uses visually read lateral flow technology for the detection of hCG. The device is intended for home use.

The FORA PNC100 Digital Pregnancy Test and TD-5301 Pregnancy Test are in vitro diagnostic medical devices, which use the qualitative assay in determining human chorionic gonadotropin (hCG) concentration in urine. The assay is based on an two-site sandwich immunoassay technology. TD-5301 Pregnancy Test consists of a test strip coated with reagents and enclosed in a plastic cassette. FORA PNC100 Digital Pregnancy Test consists of a meter and a plastic test stick containing a test strip. The meter has a slot where can be plugged with a test stick and activate the procedure. This device uses the same test strip, as TD-5301 Pregnancy Test.

The provided 510(k) summary for the FORA PNC100 Digital Pregnancy Test and TD-5301 Pregnancy Test focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed independent performance study with specific acceptance criteria and a comprehensive study design.

However, based on the information provided, here's a breakdown of what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size used for the test set in terms of the number of patient samples or the provenance of the data (e.g., country of origin, retrospective or prospective). The "Performance Studies" section mentions that "sensitivity, specificity and interference, in-use and storage stability studies were tested and verified with both the proposed devices," but details about these studies are not provided.

It also mentions a "user study," but the sample size for this study is not given.

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

This information is not provided in the document. The study described focuses on comparison to a predicate device and user-centric evaluation, not on establishing a ground truth by a panel of experts for diagnostic performance metrics.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of the submission (substantial equivalence to a predicate pregnancy test), a formal adjudication method for a diagnostic test set is not detailed. The "method comparison" implies a direct comparison of results between the new devices and the predicate.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a MRMC comparative effectiveness study is not mentioned. The document describes a "method comparison" between the proposed devices and the predicate, and a "user study" for ease of use. It does not mention a study evaluating human readers' improvement with or without AI assistance.

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

The FORA PNC100 Digital Pregnancy Test uses an "electronic read-out result" which implies an algorithm interpreting the lateral flow output. The document states "Software validation and meter reliability was performed specifically to ensure the performance of FORA PNC100 electronic read-out result." However, this does not explicitly describe a standalone diagnostic performance study using a clinical test set relative to a defined ground truth, but rather validation of the digital reading mechanism itself. The main performance claim is "over 99% agreement compared with the predicate."

7. The Type of Ground Truth Used

The primary "ground truth" for the performance claims appears to be comparison to the legally marketed predicate device (One Step HCG Urine Pregnancy Test Kit, K071930). The statement "Results show that there is over 99% agreement compared with the predicate" indicates that the predicate's results were used as the reference point for the comparison study. For the user study, the ground truth was presumably user feedback on clarity and ease of operation.

8. The Sample Size for the Training Set

The document does not mention a training set or any details about its size. This type of submission, for a lateral flow assay with a digital reader, typically focuses on analytical performance and comparison to a predicate rather than machine learning model training as one might find in AI/ML device submissions.

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

As no training set is discussed, this information is not applicable/provided.

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