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• 1. As a component of the standard analysis of semen in the diagnosis of suspected male infertility,
• 2. As a component of analyses for determining the proper course of IVF treatment of infertility.

Not Found

This is an FDA 510(k) clearance letter, which means the device has been found substantially equivalent to a predicate device. It does not typically contain the detailed study results and acceptance criteria in the format requested. The letter primarily confirms regulatory approval based on the information submitted by the manufacturer.

However, based solely on the provided text, here's what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance:

This information is not provided in the FDA clearance letter. Acceptance criteria and specific performance metrics are typically detailed within the 510(k) submission itself, not in the clearance letter.

2. Sample size used for the test set and the data provenance:

This information is not provided in the FDA clearance letter.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the FDA clearance letter.

4. Adjudication method for the test set:

This information is not provided in the FDA clearance letter.

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

This information is not provided in the FDA clearance letter. The device, "HBA Sperm-Hyaluronan Binding Assay," sounds like a diagnostic assay rather than an AI-assisted imaging device, so an MRMC study with human readers assisting AI (or vice-versa) is unlikely to be relevant.

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

This information is not explicitly provided in the FDA clearance letter. The device name "HBA Sperm-Hyaluronan Binding Assay" suggests a lab-based assay, which typically operates in a standalone manner to produce a result, which is then interpreted by a human. However, the details of its performance study, including whether it's standalone, are not in this document.

7. The type of ground truth used:

This information is not provided in the FDA clearance letter. For a "Sperm-Hyaluronan Binding Assay," ground truth would likely be established through other recognized methods of evaluating sperm functionality or infertility, but these methods are not detailed here.

8. The sample size for the training set:

This information is not provided in the FDA clearance letter.

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

This information is not provided in the FDA clearance letter.

In summary: The provided document is an FDA 510(k) clearance letter, which confirms that the device, HBA Sperm-Hyaluronan Binding Assay, is substantially equivalent to a legally marketed predicate device. It does not contain the detailed study information, acceptance criteria, sample sizes, or ground truth methodologies that would typically be found in the manufacturer's 510(k) submission or a peer-reviewed study publication. The letter focuses on the regulatory decision rather than the technical specifics of the validation study.

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