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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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The SwimCount™ Sperm Quality Test is a qualitative test that detects sperm concentration above or below 5,000,000 Progressive Motile Sperm Cells per mL (PMSCs/mL). The test is intended for use as an aid in the determination of a man's fertility status. For in vitro, over-the-counter use.

The number of progressively motile sperm cells is only one factor that contributes to a male's fertility status. The SwimCount™ Sperm Quality Test does not provide a complete evaluation of a male's fertility status. For a comprehensive assessment of male fertility status then the patient should consult a physician.

The SwimCount™ Sperm Quality Test is intended for in vitro, over-the-counter, use and is a prescreening sperm quality test that measures the number of Progressive Motile Sperm Cells per mL (PMSCs/mL) .

The SwimCount™ Sperm Quality Test is a qualitative test that detects sperm concentration above or below 5,000,000 Progressive Motile Sperm Cells per mL (PMSCs/mL).

The SwimCount™ Sperm Quality Test cut-off value is derived from the WHO laboratory manual for the Examination and processing of human semen, 5th edition guidelines 2010.

The SwimCount™ Sperm Quality Test Kit includes the following components:

• SwimCount™ Sperm Quality Test Box ●
• SwimCount™ Sperm Quality Test Device ●
• Semen Collection Cup (used to collect the sperm sample is to remain in the sample cup for 30 minutes)
• . Semen Transfer Pipette (syringe) (used to stir the semen sample 10 times before adding the sample to the Device and further used to collect 0.5 mL semen sample from the sperm sample placed in the cup)
• SwimCount™ Sperm Quality Test Instructions for Use .

The acceptance criteria and study proving the device meets those criteria are detailed below, primarily extracted from the "Summary - SwimCount™ Sperm Quality Test" section of the provided document.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" as a separate section with specific numerical targets. However, the performance outcomes of key studies (Multi-Center Clinical Study and Lay-User Usability/Interpretation Studies) serve as the implicitly accepted performance metrics for substantial equivalence. The primary clinical performance metrics are Sensitivity, Specificity, and Accuracy against the manual sperm count reference. For usability, the emphasis is on the percentage of correct interpretations by lay-users.

Here's a table summarizing the reported device performance, effectively serving as the demonstrated acceptance criteria through the provided study results:

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

• Multi-Center Clinical Study (Test Set):

  • Sample Size: 308 net semen samples across four centers. A total of 323 samples were initially collected, but 15 were excluded for analysis due to various reasons (e.g., <2 days abstinence, globospermia, hematospermia, leucospermia, samples <0.5 mL, too viscous).
  • Data Provenance: Prospective collection. The study was conducted at 4 different sites:
    • 2 sites in Denmark (Fertility Clinic Ciconia, Nordic Cryo Bank/European Sperm Bank)
    • 1 site in Spain (Fertility Clinic IVI)
    • 1 site in Turkey (Acibadem Fulya Hospital)
  • Patient Category: Males attending fertility clinics and donors from a sperm bank.

• Lay-User Usability Study (Test Set):

  • Sample Size: 81 Lay-Users. Each Lay-User performed the test with their own semen sample.
  • Data Provenance: Implied prospective, as lay-users performed the test and provided feedback. Country of origin not explicitly stated, but given the company's location (Denmark) and the clinical study sites, it's likely European or a mix.

• Consumer Interpretation Study (Test Set):

  • Sample Size: 81 participants (Lay-Users), who evaluated 10 SwimCount™ Sperm Quality Test result pictures each, resulting in a total of 810 picture interpretations.
  • Data Provenance: Implied prospective, involves users interpreting pre-existing images. Country of origin not explicitly stated.

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

• Multi-Center Clinical Study:

  • Experts: The document states "compared the test results obtained by standard microscopy" and "Manual Sperm Count Reference." While the exact number of experts (e.g., lab technicians, embryologists, andrologists) involved in performing the "standard microscopy" is not specified, it implies that trained laboratory professionals at each of the four clinical sites established the ground truth.
  • Qualifications: Not explicitly stated beyond "standard microscopy" implying trained laboratory personnel at fertility clinics and sperm banks. The reference to "Manual Sperm Count Reference" used in the comparison implies established laboratory protocols and trained personnel.

• Lay-User Usability Studies (Performance & Interpretation):

  • Experts: For the "Lay-User Usability Study," it states that "Laboratory Professionals" judged the 81 Lay-User results from uploaded pictures, with 79 out of 81 agreeing (97.53%). For the "Consumer Interpretation Study," it also implies laboratory professionals or a defined standard for the "Manual Sperm Count Reference" to which the interpretations of the 810 pictures were compared to establish ground truth for correct vs. incorrect calls.
  • Qualifications: "Laboratory Professionals" are mentioned, suggesting individuals with relevant training in laboratory procedures and result interpretation, likely associated with sperm analysis. No specific years of experience or board certifications are provided.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method (e.g., 2+1, 3+1) for resolving discrepancies in the ground truth establishment for the primary clinical test set. The ground truth for the clinical study was established by "standard microscopy." It is common for such laboratory procedures to have internal quality control and potentially double-checking mechanisms, but these are not detailed.

For the Lay-User studies, ground truth for their interpretations was established by "Laboratory Professionals" analyzing the pictures. The adjudication in this context seems to be the comparison of the Lay-User's interpretation against the expert-determined ground truth for each picture/test.

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

No, an MRMC comparative effectiveness study was not explicitly mentioned or performed. The studies focused on the device's performance (sensitivity, specificity, accuracy) against a "manual sperm count reference" (ground truth) and lay-user's ability to use and interpret the device. There is no information provided about human readers improving with AI vs. without AI assistance, as this is a qualitative over-the-counter test and not an AI-assisted diagnostic tool.

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

The SwimCount™ Sperm Quality Test is a qualitative, over-the-counter, in vitro diagnostic device that relies on a user's visual interpretation of a color change. It is not an algorithm-driven device or an automated system that provides a numerical output for human interpretation. Therefore, a "standalone algorithm-only" performance study as typically understood for AI/ML devices is not applicable here. The device's performance is intrinsically linked to the user's ability to follow instructions and interpret the color change, which is why the "Lay-User Usability Study" is crucial.

7. The Type of Ground Truth Used

• Multi-Center Clinical Study: The ground truth was established by "standard microscopy" for Progressive Motile Sperm Cells per mL (PMSCs/mL). This method is considered a laboratory reference standard in semen analysis.
• Repeatability/Reproducibility Studies: The ground truth for PMSC concentration levels was determined by "conventional microscopy."
• Lay-User Usability & Consumer Interpretation Studies: The ground truth for the test results (Low vs. Normal Sperm Quality) was established by "Laboratory Professionals" or based on the "Manual Sperm Count Reference."

8. The Sample Size for the Training Set

The document does not detail a separate "training set" as it would for a machine learning or AI model development. This device appears to be a chemical/biological assay with a visual readout, not a system that requires a distinct data-driven training phase in the context of AI/ML. The development and optimization of the assay itself would have involved laboratory work and testing, but not in the sense of an "AI training set."

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

As noted above, a "training set" in the context of data-driven models is not described for this device. The accuracy and performance of the device's mechanism (staining mitochondria, color change correlation) would have been established through traditional laboratory R&D, likely using internal samples with ground truth determined by standard microscopy. The document focuses on the validation studies (clinical, usability, analytical) that demonstrate the device's performance against predefined standards.

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