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The SwimCount® Harvester is intended for preparing motile sperm cells from semen for use in the treatment of infertile couples by Intracytoplasmic Sperm Injection (ICSI), In Vitro Fertilization (IVF) and Intrauterine Insemination (IUI) procedures.

The SwimCount® Harvester (1 mL and 3 mL) is a sperm separation device used to prepare sperm samples for Assisted Reproductive Technology (ART) procedures. The SwimCount® Harvester separates the sperm sample by allowing motile sperm cells to pass the SwimCount® Harvester's membrane system. The SwimCount® Harvester has a design/technology that utilizes the motility of the sperm cells (i.e. swim-up nature) to separate the motile sperm cells from the rest of the sperm population.

The SwimCount® Harvester has two processing volumes, 1 mL and 3 mL. The device consists of 3 compartments: 1) Sample compartment (1 mL or 3 mL), 2) Medium/Harvest compartment (0.8 mL for both device versions), and 3) Microporous polycarbonate (PC) filter membrane (10 um pore size).

Each device version has a Semen Inlet port that communicates with the lower sample compartment. The sample compartment is separated from the upper collection compartment by the microporous filter membrane. Semen is added to the lower compartment through the sample inlet port and cleared sperm separation medium (not provided) is added to the upper collection compartment through the Medium Inlet port. After incubation, the separated motile sperm cells are collected from the upper collection compartment through the Harvest Outlet port and used for subsequent assisted reproduction fertilization procedures.

The SwimCount® Harvester is supplied to the user as sterile (radiation), with a sterility assurance level of (SAL) of 10 6. The devices are individually packed and for single use only.

The provided text describes the 510(k) summary for the SwimCount® Harvester, a device for preparing motile sperm cells. Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided information:

1. Table of acceptance criteria and the reported device performance

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

• Performance testing: n=10 for each device variant (1 mL and 3 mL). This means 10 raw semen samples were processed through the 1mL device, and another 10 raw semen samples through the 3mL device.
• Data Provenance: The document does not specify the country of origin for the data or whether it was retrospective or prospective.

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

• The document does not provide information on the number of experts, their qualifications, or their involvement in establishing ground truth for the performance testing. Quality control or lab personnel would typically perform such assessments.

4. Adjudication method for the test set

• The document does not mention any adjudication method for the test set results.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a sperm separation device, not an AI-assisted diagnostic tool, so such a study would not be applicable.

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

• This device is a physical sperm separation device. Performance testing was done on the device itself, which is inherently a "standalone" or "algorithm-only" in the sense that it performs its function without a human actively making real-time processing decisions or interpretations during its operation. The human element is in its proper use according to the Instructions for Use.

7. The type of ground truth used

• For the performance testing, the "ground truth" implicitly refers to the initial assessment of % motile sperm and % progressive motile sperm cells (PMSC) in the raw semen samples before separation, compared to the same metrics in the harvested (processed) output samples. This is a direct measure of the device's functional performance in enriching motile sperm. The specific methodology for these measurements (e.g., manual count, CASA system) is not detailed.
• For the other tests (Endotoxin, HSSA, Sterilization, Package Integrity), the ground truths are defined by recognized standards and laboratory testing protocols.

8. The sample size for the training set

• This information is not applicable as the SwimCount® Harvester is a physical medical device, not a software algorithm that requires a training set.

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

• This information is not applicable as the SwimCount® Harvester is a physical medical device.

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