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The YO Home Sperm Test (YO 3.0) is a smartphone-based test for semen analysis performed by lay users.

The parameters reported by the YO Home Sperm Test (YO 3.0) are:

1. Total Sperm Concentration / Sperm Concentration, M/mL

2. Total Motile / Motility (PR + Non Progressive [NP]), %

3. Progressive Motility (PR), % (combines Rapidly and Slowly Progressive, %)

4. Motile Sperm Concentration (MSC), M/mL

5. Progressively Motile Sperm Concentration (PMSC), M/mL (combines Rapidly and Slowly Motile Sperm Concentration, M/mL)

The YO Home Sperm Test (YO 3.0) does not provide a comprehensive evaluation of a male's fertility status and is intended for in vitro, over the counter only.

The YO Home Sperm Test (YO 3.0) is a smartphone-based test for semen analysis performed by lay users.

The parameters reported by the YO Home Sperm Test (YO 3.0) are:

• 1. Total Sperm Concentration / Sperm Concentration, M/mL
• 2. Total Motile / Motility (PR + NP), %
• 3. Progressive Motility (PR), % (combines Rapidly and Slowly Progressive, %)
• 4. Motile Sperm Concentration (MSC), M/mL
• 5. Proqressively Motile Sperm Concentration (PMSC), M/mL (combines Rapidly and Slowly Motile Sperm Concentration, M/mL)

The YO Home Sperm Test (YO 3.0) utilizes proprietary algorithms to both conduct semen analysis, and present and store the results and videos on the user's smartphone and in the YO application ("app") is downloaded onto the user's own smartphone (iPhone/Android) and is controlled by the user through a proprietary graphical interface (GUI). The GUI quides the user through the process step by step on the App's screen and operates with the YO device.

The YO kit provides the supplies necessary to test up to six semen collection cups, pipettes for sample aspiration, fixed coverslip slides, liquefaction powder and a YO device that connects via WiFi to a smartphone and houses the YO slide. The YO software app guides the user through the sample preparation and testing process step-by-step with mandatory confirmation by the user of each completed step. The app also operates the YO device's camera and processor to provide a semen video.

The plastic YO device contains a fixed coverslip slide insertion channel, magnification lens, lens holder, WiFi camera and an LED that lights up the optical path. The YO software captures a video in HD (high definition) mode and implements a unique software algorithm to identify sperm and analyze the light fluctuations resulting from sperm movement to report semen values. The algorithm recognizes when the YO autofocus function has the best image and then defines the optimal area of the video for analysis.

When YO reports any semen value below the cut-off for normal, YO recommends performing an additional test with a new sample and to seek medical advice. YO cut-offs are based on WHO 6th ed. reference values for semen parameters, statistical modeling, and expert publications. The user is not required to perform any interpretation of the test results and YO does not review, verify, or interpret the video provided to the operator. The user can only observe and archive his test results and sperm video. YO does not provide a comprehensive evaluation of a male's fertility status and is intended for over-thecounter ), for in vitro use only.

The YO software quides the user through the testing process step by step on the smartphone's screen and operates in conjunction with the: YO device, smartphone's built-in camera, flash, and man-machine interface to report and store the results of 5 sperm parameters and a video of the user's semen samples. After analyzing the operator's semen video, the YO software reports both the quantitative results and an explanation about the 5 Semen parameters which are visually presented in the YO app directly following testing. In addition, the operator's sperm video is also presented in the test results section directly following the testing phase of the app.

Here's a summary of the acceptance criteria and the study proving the device meets those criteria, based on the provided text:

Device: YO Home Sperm Test (YO 3.0)

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Clinical Study (Method Comparison):

  • Sample Size: 309 comparative data sets overall. A minimum of 100 semen samples per site (across 3 US sites).
  • Data Provenance: Prospective. Conducted at three US sites, with lay users recruited to analyze their own samples or female users testing donor samples.

• Analytical Studies (Precision, LoD/LoQ, Linearity, Interference):

  • Sample Size for Precision (user repeatability): Approximately 20 users per site (3 sites), testing samples in triplicate.
  • Sample Size for Precision (professional user reproducibility): 15-30 native semen samples per site (3 sites), representing 3 levels, 2 reps per sample, 4 time points, 3 YO devices (total 360 measurements, 24 results per sample).
  • Sample Size for LoD/LoQ: Two samples (blank and low concentration), 5 YO3 devices, 2 lots of slides, 2 operators. Each level assayed 12 times on each device (60 results per level).
  • Sample Size for Linearity: Semen samples prepared at ten concentration intervals (low to high). Tested in three YO devices per concentration level.
  • Sample Size for Interference: Two concentration levels of semen samples and 11 potentially interfering substances.
  • Data Provenance: In-house analytical studies. Semen samples collected following WHO 6th ed. manual guidance from consented donors. Analyzed in a blinded fashion on SQA-iO and SQA-V.

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

• Clinical Study Ground Truth: The comparator device was the SQA-V sperm quality analyzer operated by TRAINED OPERATORS. The text does not specify the number or detailed qualifications of these "trained operators" beyond that.
• Analytical Studies Ground Truth: The text mentions "comparative device, SQA-V" and for LoD/LoQ, confirmation of concentration by "manual microscope." For training ground truth, it implies the use of the SQA-iO and SQA-V, as well as WHO 6th ed. guidelines.

4. Adjudication method for the test set:

• The text describes a "method comparison study" where "Each semen sample was tested in singleton in a blinded fashion by each method using split aliquots." This indicates a direct comparison to a reference standard (SQA-V) rather than an expert consensus adjudication of specific cases.

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 MRMC comparative effectiveness study was done.
• This device is designed for lay users (Over-The-Counter) and the study compares the device's performance to a professional laboratory device (SQA-V), not human readers with and without AI assistance. The "lay users" are the primary operators of the YO device, and their performance with the device is what's being evaluated against the SQA-V.

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

• The analytical (bench) studies (Precision, LoD/LoQ, Linearity, Interference) assess the device's technical performance characteristics, which is essentially the "algorithm without human-in-the-loop" once the sample is loaded. However, the overall device function requires human interaction for sample preparation and device operation as instructed by the app.
• The clinical validation specifically compares the algorithm's performance when operated by intended lay users against results from the comparator device (SQA-V) operated by trained operators. So, while the underlying algorithm's accuracy is foundational, the clinical study explicitly includes human-in-the-loop for the test device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Clinical Study: The ground truth was established by comparison to a legally marketed predicate device, the SQA-V sperm quality analyzer, operated by trained professionals.
• Analytical Studies:
  • Precision, Linearity, Interference: Comparison against the SQA-V comparator device.
  • LoD/LoQ: Manual microscope verification for blank and low concentration samples.

8. The sample size for the training set:

• The document does not explicitly state the sample size used for the training set for the YO Home Sperm Test (YO 3.0) algorithms. It describes the data used for analytical validation and clinical validation, but not the development/training phase.

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

• The document does not detail how the ground truth for the training set was established. It states that the device "utilizes proprietary algorithms" and implements a "unique software algorithm to identify sperm and analyze the light fluctuations resulting from sperm movement." It also mentions "YO cut-offs are based on WHO 6th ed. reference values for semen parameters, statistical modeling, and expert publications." This implies the algorithms were developed and refined using data aligned with WHO standards and likely validated against reference methods like the SQA-V, but the specifics of the training data development are not provided.

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The YO™ Home Sperm Test is a smartphone based home test which provides a qualitative assessment of motile sperm concentration (MSC) in human semen. MSC is one aspect of a male semen examination. The YO™ Home Sperm Test does not provide a comprehensive evaluation of a male's fertility status and is intended for over-the-counter, in vitro use only.

YO™ is an over-the-counter device that provides a qualitative assessment of motile sperm concentration (MSC) in human semen. Results are reported as "LOW MSC RANGE" or "MODERATE/NORMAL MSC RANGE," requiring no user interpretation. The YO™ software application is downloaded onto the users' own smartphone and on-screen menus and instructions are shown on the phone's display so that the user is taken through the process step by step. The YO™ kit (purchased on the website) provides all the supplies necessary to evaluate two semen samples: two semen collection cups, two vials of liquefying powder (chymotrypsin), two pipettes for sample aspiration, two fixed coverslip slides for sample testing, one QC slide, and one YOT™ Clip that attaches to the smartphone and houses the fixed coverslip slide.

Here's a breakdown of the acceptance criteria and study details for the YO™ Home Sperm Test, based on the provided document:

Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria for the non-clinical and clinical studies are implicitly derived from the reported performance, as the document states that the results "exceeded 90%" and indicate the system is "safe and effective for its intended use."

Study Details

1. Sample sizes used for the test set and the data provenance:

• Reproducibility/Repeatability (Non-clinical): At least 60 subjects per site (two sites, one internal and one external). Samples were grouped into three MSC categories (Positive 8 M/mL), with approximately 20 samples per group. 480 measurements per site were performed. Data provenance is implied to be laboratory-generated samples at the internal (MES) and external (Ruppin College) sites. It is retrospective in the sense that laboratory-prepared samples were used to control specific variables.
• Detection Limit (Non-clinical): Four semen samples prepared to represent four MSC levels (0 M/mL, 2-3 M/mL, 5-6 M/mL, 8-9 M/mL), assayed in duplicate. Data provenance similar to reproducibility study.
• Analytical Specificity (Non-clinical): Three "LOW MSC RANGE" and three "MODERATE/NORMAL MSC RANGE" semen samples, each split into aliquots for various contaminants and controls. A separate study used three "LOW" and three "MODERATE/NORMAL" MSC samples for urine and saliva interference. Data provenance similar to reproducibility study.
• MSC Cut-off Trial (Non-clinical): 100 fresh human semen samples (approximately 50/50 split above and below 6 M/mL MSC cutoff). 10% were prepared samples to better represent samples close to the cutoff. Data provenance similar to reproducibility study.
• Clinical Study (Test Set): 316 samples across three clinical sites (one in Israel, two in the US). These were prospective samples from male subjects.

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

• Non-clinical studies: The ground truth for MSC values in non-clinical studies (Reproducibility, Detection Limit, Analytical Specificity, MSC Cut-off) was established using the SQA-V sperm analyzer, which is a legally marketed predicate device cleared under K021746. No specific number of experts is mentioned as directly establishing these ground truths, but the SQA-V is an established laboratory-based instrument.
• Clinical Study: The ground truth for the clinical study was established by two SQA-V systems (predicate device), with their results averaged. While not explicitly stated as "experts," the SQA-V is an established clinical laboratory method used by trained professionals to determine semen parameters. Additionally, "trained health care professionals (HCPs, trained users)" who performed a separate YO™ test served as a comparison point for the lay user results.

3. Adjudication method for the test set:

• For non-clinical studies (MSC Cut-off Trial): The SQA-V generated numerical MSC data, which was then converted to qualitative results ("LOW MSC RANGE" or "MODERATE/NORMAL MSC RANGE") based on the 6 M/mL cutoff. This essentially serves as the adjudicator.
• For clinical studies: The SQA-V results (averaged from two systems and then converted to qualitative categories) served as the comparator/ground truth against which both lay user YO™ results and trained user YO™ results were compared. There was no explicit "adjudication" in the sense of multiple human experts reviewing discrepancies; instead, the SQA-V was the reference standard.

4. 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 was not an MRMC comparative effectiveness study in the traditional sense of evaluating human reader improvement with AI assistance. The YO™ Home Sperm Test is designed for standalone over-the-counter use by lay users, with the device itself providing the qualitative assessment.
• The study did compare lay users' performance with the device against a laboratory reference (SQA-V) and against trained users with the device. This assesses the device's accuracy when used by its target demographic. No "human reader improvement with AI vs without AI" effect size can be determined from this study design as there is no "without AI" human reading component.

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

• Yes, a standalone performance was done for internal validation and non-clinical studies. The non-clinical studies (Reproducibility, Detection Limit, Analytical Specificity, MSC Cut-off Trial) assessed the YO™ system (device and algorithm) against the SQA-V without explicit human interpretation being part of the YO™ device's output. The YO™ device outputs "LOW MSC RANGE" or "MODERATE/NORMAL MSC RANGE" directly.
• The clinical study primarily focused on the device's performance with a human user interaction (lay users following instructions). However, the underlying technology performing the sperm analysis and classification into MSC ranges is the standalone algorithm of the YO™ device.

6. The type of ground truth used:

• Predominantly expert consensus via a legally marketed predicate device (SQA-V). For all quantitative evaluations, the SQA-V sperm analyzer served as the gold standard. The SQA-V itself is an instrument used by trained professionals and provides objective measurements, which are then categorized based on WHO guidelines.

7. The sample size for the training set:

• The document does not explicitly state the sample size used for the training set for the YO™ device's algorithm. The non-clinical and clinical studies described are performance validation studies, not algorithm training studies.

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

• Since the training set size is not provided, the method for establishing its ground truth is also not explicitly stated in this document. However, given that the SQA-V is used as the comparative method for all validation, it is highly probable that similar laboratory-based, SQA-V derived measurements and classifications would have been used to establish the ground truth for any training data.

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