FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The provided documents are an FDA 510(k) clearance letter and an Indications for Use statement for the Medical Electronics Systems, LLC, Sperm Quality Analyzer (SQA). The documents confirm the device's substantial equivalence to a predicate device and its intended uses. However, they do not contain detailed information regarding acceptance criteria or the specific study that proves the device meets those criteria.

The FDA clearance letter primarily focuses on regulatory approval based on substantial equivalence and does not elaborate on the specific performance studies. The Indications for Use statement outlines the parameters the SQA measures but does not provide performance metrics or study details.

Therefore,Based on the provided documents:

A table of acceptance criteria and the reported device performance: This information is not provided in the given documents. The documents refer to the device's ability to provide calculated measurements for various sperm parameters, but not the specific performance metrics (e.g., accuracy, precision) or acceptance criteria established for those metrics.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): This information is not provided in the given documents.
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): This information is not provided in the given documents.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: This information is not provided in the given documents.
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: This information is not provided in the given documents. The SQA is described as an "electro-optical device for semen analysis" providing calculated measurements, implying it automates measurements rather than assisting human readers in interpreting images.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The SQA is presented as an automated device that provides "calculated measurements," which suggests a standalone performance. However, specific study details to confirm this or its performance metrics are not provided in these documents.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): This information is not provided in the given documents.
The sample size for the training set: This information is not provided in the given documents.
How the ground truth for the training set was established: This information is not provided in the given documents.

To obtain the detailed information requested, one would typically need to refer to the full 510(k) submission summary or a separate technical report/clinical study report submitted to the FDA, which are not included in the provided snippets.

Summary

Regulation Number and Section

§ 864.5220 Automated differential cell counter.

(a)
Identification. An automated differential cell counter is a device used to identify one or more of the formed elements of the blood. The device may also have the capability to flag, count, or classify immature or abnormal hematopoietic cells of the blood, bone marrow, or other body fluids. These devices may combine an electronic particle counting method, optical method, or a flow cytometric method utilizing monoclonal CD (cluster designation) markers. The device includes accessory CD markers.(b)
Classification. Class II (special controls). The special control for this device is the FDA document entitled “Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA.”