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For Over-the-Counter Setting:
The LensHooke® X3 PRO SE Semen Quality Analyzer used with LensHooke® Semen Test Cassette is an optical device for human semen analysis which provides direct and calculated quantitative measurements for:

1. Sperm concentration (M/mL)
2. Total motility (PR+NP, %)
   • Progressive motility (%)
   • Non-Progressive motility (%)
   • Immotility (%)
3. Sperm morphology (normal forms, %)
4. pH value

The LensHooke® X3 PRO SE Semen Quality Analyzer does not provide a comprehensive evaluation of a male's fertility status. It is a self-testing diagnostic system intended for human semen analysis of individuals at home to evaluate male fertility.

For Point-of-Care Professional Setting:
The LensHooke® X3 PRO Semen Quality Analyzer used with LensHooke® Semen Test Cassette is an optical device for human semen analysis which provides direct and calculated quantitative measurements for:

1. Sperm concentration (M/mL)
2. Total motility (PR+NP, %)
   • Progressive motility (%)
   • Non-Progressive motility (%)
   • Immotility (%)
3. Sperm morphology (normal forms, %)
4. pH value

The LensHooke® X3 PRO Semen Quality Analyzer does not provide a comprehensive evaluation of a male's fertility status. It is an in-vitro diagnostic system intended for human semen analysis of individuals in healthcare professional setting to evaluate male fertility.

Semen Quality Analyzer integrates optical design and image analysis and combined with artificial intelligence image processing method, to fully automated analysis of semen quality including sperm pH, semen concentration, motility, and morphology. The images are captured and recorded by cameras and with image processing methods, the locations of sperms are detected. The sperm concentration is analyzed by the sperm unit density; the sperm motility is calculated by tracing sperm trajectories and the sperm morphology is calculated by comparing head and tail percentage. Through camera, the chromatographic image of pH is captured and with image saturation and brightness analysis, the level of pH is determined.

The provided FDA 510(k) clearance letter and summary for the LensHooke X3 PRO Semen Quality Analyzer offer a high-level overview of the device and the studies conducted. However, it does not provide explicit details on the acceptance criteria for each performance metric (e.g., specific thresholds for accuracy, sensitivity, specificity, or precision for motility, concentration, and morphology), nor does it present the reported device performance against these criteria in a quantitative manner. The summary largely discusses the types of studies performed (repeatability, reproducibility, linearity, etc.) rather than the results of those studies.

Based on the provided text, here's an attempt to structure the information, highlighting where details are not explicitly stated in the document:

Acceptance Criteria and Device Performance Study for LensHooke X3 PRO Semen Quality Analyzer

The LensHooke X3 PRO Semen Quality Analyzer was evaluated through non-clinical and user performance studies to demonstrate substantial equivalence to its predicate device, the LensHooke X1 PRO Semen Quality Analyzer. While the document mentions various types of evaluations, explicit quantitative acceptance criteria and detailed performance results are not provided for each parameter.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The provided document states that "Verification and validation of test results were evaluated to establish the performance, functionality and reliability" and lists types of evaluations (repeatability, reproducibility, LoB/LoD/LoQ, linearity, interference, matrix comparison, sample volume, operating conditions, and stability). It also mentions a "User Performance Study." However, specific numerical acceptance criteria (e.g., minimum accuracy percentages, CVs for precision) and the achieved performance metrics are not detailed in this summary. The table below reflects the parameters measured but cannot fill in the acceptance criteria or reported performance based solely on this document.

Ask a specific question about this device

The LensHooke X12 PRO Semen Analysis System used with LensHooke Semen Test Slide is an optical device for human semen analysis which provides direct and calculated measurements for:
(1) Sperm concentration (M/mL)
(2) Total motility (PR+NP, %)
• Progressive Motility (PR, %)
(3) Sperm Morphology (normal forms, %)

The LensHooke X12 PRO Semen Analysis System used with LensHooke R10 Plus Sperm DNA Fragmentation Rapid Test Kit (SCD Assay) and LensHooke R11 Plus Sperm Double Strand DNA Fragmentation Rapid Test Kit (SDFR Assay) is an optical device for human semen analysis which provides direct measurement for:
(1) Sperm DNA Fragmentation Index (DFI, %)

The LensHooke X12 PRO Semen Analysis System does not provide a comprehensive evaluation of a male's fertility status. It is an in-vitro diagnostic system intended for human semen analysis of individuals in clinical laboratories to evaluate male fertility.

The i.MX 6ULL is a high performance, feature-rich and low-power processor.

The provided 510(k) summary for the LensHooke X12 PRO Semen Analysis System offers a high-level overview of the device and its claimed substantial equivalence to a predicate device. However, it lacks the detailed information typically required to fully describe the acceptance criteria and the study that proves the device meets those criteria.

Specifically, the document states: "Verification and validation of test results were evaluated to establish the performance, functionality and reliability of LensHooke X12 PRO Semen Analysis System. The evaluation included repeatability, reproducibility, LoB/LoD/LoQ, linearity, interference, sample volume, operating conditions, stability and matrix study." and "System Accuracy Study and User Performance study". These are general categories of tests, but the specific acceptance criteria and the results proving they were met are not explicitly provided.

Therefore, many parts of your request cannot be fully answered with the given text. I will fill in what can be inferred or is explicitly stated, and clearly mark what information is missing.

Device: LensHooke X12 PRO Semen Analysis System

The LensHooke X12 PRO Semen Analysis System is an optical device for human semen analysis that provides direct and calculated measurements for:

• Sperm concentration (M/mL)
• Total motility (PR+NP, %)
  • Progressive Motility (PR, %)
• Sperm Morphology (normal forms, %)
• Sperm DNA Fragmentation Index (DFI, %) (when used with specific test kits)

1. Table of Acceptance Criteria and Reported Device Performance

MISSING INFORMATION: The 510(k) summary does not provide a specific table of acceptance criteria or the numerical results for each performance metric (e.g., specific accuracy thresholds, precision ranges). It states that "results of performance evaluation... demonstrate that the subject devices are substantial equivalence to the predicate device," implying that the performance met acceptable levels, but the actual targets and outcomes are not detailed.

To illustrate what would be in such a table if the information were available in the provided text:

Note: The metrics like repeatability, reproducibility, LoB/LoD/LoQ, linearity, interference, sample volume, operating conditions, stability, and matrix study are mentioned as having been evaluated, which would typically have associated acceptance criteria and reported performances, but these are not disclosed in the provided FDA letter.

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

MISSING INFORMATION: The document states that a "System Accuracy Study" and "User Performance study" were performed for the non-clinical tests. However, the specific sample sizes (e.g., number of semen samples, number of users) used in these studies are not provided.

• Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. It only states the submitter is from Taichung, Taiwan, which might imply the studies were conducted there.

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

MISSING INFORMATION: The 510(k) summary does not specify the number of experts used to establish ground truth for the test set. It also does not specify the qualifications of these experts.

For the user performance study, it mentions "professional/English reading users, across educational backgrounds" but this refers to the users of the device being tested, not necessarily the experts establishing ground truth for the "System Accuracy Study."

4. Adjudication Method for the Test Set

MISSING INFORMATION: The document does not describe any adjudication method (e.g., 2+1, 3+1 consensus) used for establishing ground truth for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MISSING INFORMATION: The 510(k) summary does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance. This device is described as an "automated" and "optical device for human semen analysis," which implies a primary focus on automated measurement rather than AI assistance for human image interpretation in the same way an AI for radiology might function.

The "User Performance study" was described as demonstrating that "professional/English reading users... can easily understand and follow the labeling/user instructions to obtain accurate results while using Subject Device." This is a usability and user accuracy study, not an MRMC study comparing AI-assisted vs. unassisted human performance.

6. Standalone (Algorithm Only) Performance

Partially Addressed/Inferred: The device is described as an "optical device for human semen analysis which provides direct and calculated measurements" using "image analysis and combined with artificial intelligence image processing method." This implies that the device operates as a standalone algorithm to perform the semen analysis.

The "System Accuracy Study" would have been conducted to evaluate this standalone performance against a ground truth method (the predicate device "X1 RPO performed by lab personnel was used as a reference method" for the user performance study, and presumably for the system accuracy study as well, though it's not explicitly stated for the latter).

7. Type of Ground Truth Used

Inferred/Partially Addressed:

• For the "System Accuracy Study" and "User Performance Study," the predicate device, "X1 RPO performed by lab personnel was used as a reference method." The X1 RPO is also an automated semen analysis system. This means the ground truth was based on the measurements obtained from the predicate device (another automated system), presumably validated for accuracy.
• It is common in such evaluations that the predicate device's results are considered the "reference" or "ground truth" for comparison. However, true "ground truth" for semen analysis often involves manual microscopy by trained and experienced laboratory personnel following World Health Organization (WHO) guidelines, which is considered the gold standard for manual methods. The document does not explicitly state if the predicate device's performance itself was validated against such a manual gold standard, or if "lab personnel" performing X1 RPO analysis implies any manual verification for the study.

8. Sample Size for the Training Set

MISSING INFORMATION: The 510(k) summary does not provide any information about the sample size used for the training set for the AI/image processing algorithms.

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

MISSING INFORMATION: The 510(k) summary does not provide any information on how the ground truth for the training set was established. Given the device uses "artificial intelligence image processing method," training data with established ground truth would be essential, but details are not disclosed in this summary.

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The SQA-iOw Sperm Quality Analyzer is an automated analyzer intended for in-vitro diagnostic use to determine the following parameters in semen:

Measured parameters:

• Sperm Concentration/ Total Sperm Concentration, millions/mL
• Motile Sperm Concentration (MSC), millions/mL
• Progressively Motile Sperm Concentration (PMSC), millions/mL (combines Rapidly and Slowly Progressive Motile Sperm Concentration, millions/mL)
• Normal Forms (% Normal Morphology), %

Derived parameters:

• Total Motility / Total Motile (PR + NP), %
• Progressive Motility (PR), % (combines Rapidly and Slowly Progressive, %)
• Non-Progressive (NP), %
• Immotile (IM), %

The SQA-iOw is intended for CLIA Waived settings. The SQA-iOw does not provide a comprehensive evaluation of a male's fertility status and is intended for in vitro use only.

The SQA-iOw Sperm Quality Analyzer is a PC-based analytical medical device that tests human semen samples. The device works with a computer application that manages the device, and information related to the patient, the sample, the test results and the facility.

After collection and preparation, 0.6 mL of semen sample is aspirated into a disposable SQA capillary sample delivery system and inserted into the SQA-iOw measurement chamber. The testing process takes approximately 75 seconds. The system performs an automatic self-test and auto-calibration upon start up, and checks device stability before each sample is run.

The SQA-iOw Sperm Quality Analyzer utilizes proprietary software code to both perform analysis of semen parameters and present those results on the user interface. This software is installed on a PC as a cloud-based application ("app") and is designed to perform all functions and features of the SQA-iO device, controlled by the user through a proprietary graphical user interface (GUI).

The SQA-iOw Sperm Quality Analyzer software analyzes semen parameters using signal processing technology. Sample testing is performed by capturing electrical signals as sperm moves through a light source in the SQA-iO optical block. These light disturbances are converted into electrical signals which are then analyzed by the SQA-iOw software. The SQA-iOw software applies proprietary algorithms to interpret and express these electrical signals and report them as various semen parameters.

The SQA-iOw Sperm Quality Analyzer package provides the SQA-iOw device and USB cable. SQA disposable capillaries, cleaning kits and related testing supplies and test kits are supplied individually.

Here's a breakdown of the acceptance criteria and the study proving the SQA-iOw Sperm Quality Analyzer meets them, based on the provided FDA 510(k) clearance letter:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA clearance letter does not explicitly list predefined quantitative acceptance criteria in a dedicated table format. Instead, it describes two precision studies and a method comparison study, concluding that the results "met the acceptance criteria." For the method comparison, it refers to "Passing-Bablok regression" with "Slopes, y-intercepts, and correlation coefficients, along with the 95% confidence intervals, were reported." The implicit acceptance criteria are typically that these statistical measures fall within a pre-specified range demonstrating equivalence to the predicate device.

Given the information provided, we can infer the acceptance criteria for the parameters measured and the reported performance.

2. Sample Size and Data Provenance

• Sample Size for Test Set:
  • CLIA Waived User Precision Study (Control Material): 270 measurements in total (3 sites x 9 users (3 per site) over 3 days per site x 3 levels x 10 replicates of each level).
  • CLIA Waived User Precision Study (Native Samples): 216 measurements total (9 native semen samples x 2 replicates per sample x 3 users/site x 4 time points).
  • Method Comparison Study: 380 donor semen samples.
• Data Provenance (Country of Origin and Retrospective/Prospective):
  • The Method Comparison Study was conducted across "Three U.S. sites."
  • The Precision studies were also multi-site, with the control material study having "3 sites". The native sample precision study was "across two sites."
  • The data appears to be prospectively collected for the purpose of these studies, as detailed study designs are provided, including number of sites, users, days, replicates, and samples. The samples used in the method comparison were "donor semen samples."

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts:
  • For the Method Comparison Study, there were "One or more TRAINED OPERATORS per site" (3 sites) who generated reference SQA-V results.
• Qualifications of Experts:
  • The experts (TRAINED OPERATORS) were described as "fully trained and considered appropriate for generating reference SQA-V results." Their specific professional qualifications (e.g., medical technologists, clinical lab scientists) or years of experience are not explicitly stated.

4. Adjudication Method for the Test Set

• The document implies that the ground truth for the method comparison study was established by the "TRAINED OPERATORS" using the predicate device (SQA-V). There is no mention of an adjudication process (e.g., 2+1, 3+1 consensus) among multiple experts to establish a "true" ground truth beyond the output of the predicate device operated by trained users. The samples were assayed "in singleton and in a blinded fashion" using both methods, suggesting a direct comparison rather than multi-reader adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No explicit MRMC comparative effectiveness study was described in terms of human readers improving with AI vs. without AI assistance. The study compares the performance of a new device (SQA-iOw operated by waived users) against a predicate device (SQA-V operated by trained users). It's a method comparison for an automated device, not an AI-assisted human reader study.

6. Standalone (Algorithm Only) Performance

• The SQA-iOw is described as an "automated analyzer" that "utilizes proprietary software code to both perform analysis of semen parameters" and "applies proprietary algorithms to interpret and express these electrical signals and report them as various semen parameters." The performance measurements detailed (precision studies and method comparison) represent the standalone performance of the device/algorithm in processing samples and generating results for the specified semen parameters. There is no human-in-the-loop component in the measurement process itself.

7. Type of Ground Truth Used

• The ground truth for the Method Comparison Study was established using the results from the predicate device (SQA-V) operated by trained users. This serves as a "reference standard" or "comparative method" rather than an absolute ground truth such as pathology or outcomes data.
• For the Precision Studies, the ground truth is statistical variability around the mean measurements of control materials and native samples.

8. Sample Size for the Training Set

• The document does not provide information on the sample size used for the training set for the SQA-iOw's algorithms. The studies described are validation (test set) studies, not algorithm development or training data descriptions.

9. How Ground Truth for Training Set was Established

• The document does not provide information on how the ground truth for the training set was established, as it focuses on the validation studies. It only mentions that the device "applies proprietary algorithms" but not how these algorithms were developed or trained.

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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 SQA-iO Sperm Quality Analyzer is an automated point-of-care in vitro use only medical device for semen analysis performed by healthcare professionals (trained lab technicians). The SQA-iO does not provide a comprehensive evaluation of a male's fertility status.

The SQA-iO provides direct and calculated quantitative measurements for the following parameters:

Directly measured parameters:

• Sperm Concentration, M/mL ●
• . Motile Sperm Concentration (MSC), M/mL
• . Progressively Motile Sperm Concentration (PMSC), M/mL (combines Rapid and Slow PMSC, millions/mL)
• . Normal Forms (Normal Morphology), %

Calculated parameters:

• Total Motility (PR + NP), %
• . Progressive Motility (PR), % (combines Rapidly and Slowly Progressive Motility, %)
• Non-Progressive Motility (NP), % .
• Immotile (IM), %
• Functional Sperm Concentration (FSC), millions/mL ●

The SQA-iO is a PC-based analytical medical device that tests human semen samples. The device works with a computer application that manages the device, and information related to the patient, the sample, test results and the facility.

After collection and preparation, 0.6 mL of semen sample is aspirated into a disposable SQA capillary sample delivery system and inserted into the SQA-iO measurement chamber. The testing process takes approximately 75 seconds. The system performs an automatic self-test and auto-calibration upon start up, and checks device stability before each sample is run.

The SQA-iO utilizes proprietary software code to both perform analysis of semen parameters and to present those results on the user interface. This software is installed on the user's PC as a cloud-based application ("app") and is designed to perform all functions and features of the SQA-iO device, controlled by the user through a proprietary graphical interface (GUI).

The SQA-iO software analyzes semen parameters using signal processing technology. Sample testing is performed by capturing electrical signals as sperm moves through a light source in the SQA-iO optical block. These light disturbances are converted into electrical signals which are then analyzed by the SQA-iO software. The SQA-iO software applies proprietary algorithms to interpret and express these electrical signals and report them as various semen parameters.

The SQA-iO package provides all the supplies necessary to perform semen analysis: SQA-iO device, USB cable, SQA disposable capillaries, and a cleaning kit.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" for the clinical study endpoints for the SQA-iO. However, it presents the results of a method comparison study against a predicate device (SQA-V) and indicates the desired range for the statistical measures (slopes, y-intercepts, and correlation coefficients) to demonstrate substantial equivalence.

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

• Test Set Sample Size: 165 matched native semen samples (for most parameters; 155 for Morphology and FSC).
• Data Provenance: The study used "native human semen samples" from "consented donors" which suggests prospective collection. The study was conducted at "three sites," but the specific country of origin is not explicitly stated. The submitting company, Medical Electronic Systems LTD, is based in Israel, which could imply data from Israel or multinational sites.

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

• Number of experts: 12 SQA-iO operators across all sites who are "laboratory technicians or professionals who are familiar with semen analysis."
• Adjudication Method for Ground Truth (Predicate Device Results): An "expert operator assayed the same sample in duplicate on the SQA-V predicate, and the means of the SQA-V results were used as the comparator results." This implies a form of internal consistency/averaging from a single expert reading (on the predicate device), rather than a multi-expert consensus for the ground truth itself.

4. Adjudication method for the test set:

The term "adjudication method" typically refers to resolving discrepancies between multiple readers or between an AI and a reader. In this context, the study compares the SQA-iO device's measurements against the a predicate device (SQA-V). The predicate device's results were established by an "expert operator" in duplicate, and the mean of these results was used as the comparator. This is not an adjudication method in the traditional sense of resolving expert disagreement for a ground truth label, but rather establishing a reference measurement from the predicate.

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, an MRMC comparative effectiveness study was not done. The study performed was a method comparison study between the new device (SQA-iO) and a predicate device (SQA-V), not a study evaluating human reader performance with and without AI assistance.

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

Yes, the study describes the standalone performance of the SQA-iO device. The SQA-iO is an automated device that provides "direct and calculated quantitative measurements" for various sperm parameters. The comparison was primarily between the SQA-iO's automated output and the SQA-V's output (also an automated device, with human operators for loading/starting). While human operators (lab technicians) interact with the SQA-iO, the device itself generates the quantitative results without human interpretation of the images or signals for the reported parameters.

7. The type of ground truth used:

The ground truth for the comparison study was the measurements obtained from the predicate device, the SQA-V sperm analyzer, which was operated by an "expert operator" in duplicate. This is a reference device comparison rather than a direct comparison to an absolute "ground truth" established by a gold standard like pathology or long-term outcomes. The SQA-V's results were treated as the established benchmark.

8. The sample size for the training set:

The document does not explicitly state the sample size for the training set used for the SQA-iO's proprietary algorithms. The clinical data section focuses on the performance of the device after its development. The non-clinical data mentions using "native human semen samples" for various bench studies, but these are for analytical performance validation (precision, linearity, etc.), not explicitly described as a training set for algorithm development.

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

Not explicitly mentioned in the document. The document describes analytical and clinical validation studies. Information about the specific methods for establishing ground truth during the original training and development of the SQA-iO's proprietary algorithms is not provided.

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The LensHooke X1 PRO Semen Quality Analyzer used with LensHooke Semen Test Cassette is an optical device for human semen analysis which provides direct and calculated quantitative measurements for:

(1) Sperm concentration (10^6 per ml)

(2) Total motility (PR+NP, %)

• Progressive motility (%)

• Non-Progressive motility (%)

(3) Sperm morphology (normal forms, %)

(4) pH value

The LensHooke X1 PRO Semen Quality Analyzer does not provide a comprehensive evaluation of a male's fertility status. It is an in-vitro diagnostic system intended for human semen analysis of individuals in healthcare professional setting to evaluate male fertility.

The LensHooke X1 PRO SE Semen Quality Analyzer used with LensHooke Semen Test Cassette is an optical device for human semen analysis which provides direct and calculated quantitative measurements for:

-Sperm concentration (10^6 per ml) -Total motility (PR+NP, %) -Sperm morphology (normal forms, %) -pH value

The LensHooke X1 PRO SE Semen Quality Analyzer does not provide a comprehensive evaluation of a male's fertility status. It is a seff-testing, in-vitro diagnostic system intended for human semen analysis of individuals at home to evaluate male fertility. The systems are intended for single person use only and should not be shared.

Semen Quality Analyzer integrates optical design and image analysis and combined with artificial intelligence image processing method, to fully automated analysis of semen quality including semen pH, sperm concentration and motility. The images are captured and recorded by cameras and with image processing methods, the locations of sperms are detected. The sperm concentration is analyzed by the sperm unit density; the sperm motility is calculated by tracing sperm trajectories and the sperm morphology is calculated by comparing head and tail percentage. Through camera, the chromatographic image of pH is captured and with image saturation and brightness analysis, the level of pH is determined.

The provided text describes the 510(k) summary for the LensHooke X1 PRO Semen Quality Analyzer and LensHooke X1 PRO SE Semen Quality Analyzer. Here's a breakdown of the requested information based on the text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria alongside reported device performance values. It states that "Verification and validation of test results were evaluated to establish the performance, functionality and reliability of LensHooke X1 PRO SE Semen Quality Analyzer and LensHooke X1 PRO Semen Quality Analyzer. The evaluation included Repeatability, Reproducibility, LoB/LoD/LoQ and linearity, sample volume, operating conditions and stability." However, specific numerical targets for acceptance criteria and the corresponding device performance results are not detailed in this summary.

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

• Test Set Sample Size: The document does not specify the exact sample size used for the system accuracy study. It mentions a "user performance study" which involved English-speaking and reading lay users across educational backgrounds, and also Point-of-Care professionals or licensed registered nurses. However, the number of participants for these studies is not provided.
• Data Provenance: The document does not explicitly state the country of origin of the data. It also does not explicitly state whether the studies were retrospective or prospective, though "user performance study" typically implies a prospective design.

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

The document indicates that for the "System Accuracy Study and Layuser Performance study," the "SQA-V Analyzer performed by POC personnel was used as a reference method." This implies that the ground truth was established by the SQA-V Analyzer, and its performance was managed by Point-of-Care (POC) personnel. The text does not specify the number of individual experts or their detailed qualifications (e.g., "radiologist with 10 years of experience") beyond "Point-of-Care professionals or licensed registered nurses."

4. Adjudication Method

The document does not mention an adjudication method (e.g., 2+1, 3+1) for establishing the ground truth. It states that the SQA-V Analyzer was used as the reference method, implying a direct comparison rather than a consensus-based adjudication process among multiple human experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance. The study focuses on the device's accuracy against a reference method and lay user performance.

6. Standalone Performance Study

Yes, a standalone performance study was done. The "System Accuracy Study" implicitly describes the algorithm's performance (as part of the LensHooke X1 PRO/PRO SE Analyzer) against a reference method (SQA-V Analyzer). The device is an "optical device... which provides direct and calculated quantitative measurements," meaning it operates autonomously to produce these measurements. The "Layuser Performance study" also evaluates the standalone device's accuracy when used by laypersons.

7. Type of Ground Truth Used

The ground truth for the system accuracy study was established using a "SQA-V Analyzer performed by POC personnel" as a reference method. This suggests a comparative reference method or known standard approach, rather than solely expert consensus, pathology, or outcomes data.

8. Sample Size for the Training Set

The document does not provide any information regarding the sample size used for the training set of the AI image processing algorithm.

9. How Ground Truth for the Training Set Was Established

The document does not provide any information on how the ground truth for the training set was established. It only mentions that the device uses "artificial intelligence image processing method" for analysis.

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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.,

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LensHooke X1 Semen Quality Analyzer for OTC use

The LensHooke X1 Semen Quality Analyzer used with LensHooke Semen is an optical device for human semen analysis which provides direct and calculated quantitative measurements for:

-Sperm concentration (10^6 per ml) -Total motility (PR+NP, %)

-Sperm morphology (normal forms, %)

-pH value

The LensHooke X1 Semen Quality Analyzer does not provide a comprehensive evaluation of a male's fertility status. It is a self-testing, in-vitro diagnostic system intended for human semen analysis of individuals at home to evaluate male fertility. The systems are intended for single person use only and should not be shared.

LensHooke X1 PRO Semen Quality Analyzer for prescription use

The LensHooke X1 PRO Semen Quality Analyzer used with LensHooke Semen Test Cassette is an optical device for human semen analysis which provides direct and calculated quantitative measurements for:

(1) Sperm concentration (10^6 per ml)

(2) Total motility (PR+NP, %)

• Progressive motility (%)

• Non-Progressive motility (%)

• (3) Sperm morphology (normal forms, %)

(4) pH value

The LensHooke X1 PRO Semen Quality Analyzer does not provide a comprehensive evaluation of a male's fertility status. It is an in-vitro diagnostic system intended for human semen analysis of individuals in healthcare professional setting to evaluate male fertility.

Semen Quality Analyzer integrates optical design and image analysis and combined with artificial intelligence image processing method, to fully automated analysis of semen quality including semen pH, sperm concentration and motility. The images are captured and recorded by cameras and with image processing methods, the locations of sperms are detected. The sperm concentration is analyzed by the sperm unit density; the sperm motility is calculated by tracing sperm trajectories and the sperm morphology is calculated by comparing head and tail percentage. Through camera, the chromatographic image of pH is captured and with image saturation and brightness analysis, the level of pH is determined.

Here's a breakdown of the acceptance criteria and the study details for the LensHooke X1 Pro Semen Quality Analyzer and LensHooke X1 Semen Quality Analyzer, based on the provided document:

Acceptance Criteria and Reported Device Performance

The document describes various non-clinical tests to establish performance, functionality, and reliability. The "performance" in the table refers to how well the device performed against the established acceptance criteria in the studies mentioned.

Study Information:

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

• Repeatability: 60 data points per sperm concentration/sperm motility/sperm morphology level (from 3 operator/analyzer/cassette combinations x 2 replicates x 2 runs x 5 times/day). The exact number of unique samples is not specified, but they were tested multiple times.
• Reproducibility:
  • Control solutions (pH, Concentration): 3 prepared latex beads concentration and pH levels, each tested in 5 replicates by 1 operator per day, across 3 lots of test system, with 1 lot per site. The total number of data points per level would be 3 (levels) * 5 (replicates) * X (days/operators) * 3 (lots/sites). The document specifies "3 lots of test system were used and 1 lot per site," suggesting 3 sites.
  • Motility and Morphology: 3 semen motile levels and 3 semen morphology levels, evaluated through 3 operator/analyzer/cassette lot combinations x 5 replicates x 5 times/day.
• LoB/LoD/LoQ: Two concentration levels, assayed in 5 replicates, with each of two lots.
• Linearity (Semen): Semen samples at 9 intervals (2 to 400 x 10^6/mL), tested in 3 replicates per lot per concentration level, using 1 analyzer and 3 lots of Cassettes.
• Linearity (pH): Semen samples at 13 pH intervals (5.8 to 8.2), tested in 3 replicates per lot per pH level, using two analyzers and 3 lots of Cassettes.
• Interference: 2 concentration levels of semen samples (50-100 and 100-200 x 10^6/mL) with 11 interference substances. 1 analyzer and 3 lots of test cassettes were used to perform 5 replicates per lot.
• Sample Volume (Semen): 3 lots of test cassette, semen samples at low and high concentrations, evaluated at 3 sample volumes (35, 40, 45 uL). Tested in 5 replicates.
• Sample Volume (pH): 3 lots of pH test, semen sample at pH 7.8, evaluated at 6 sample volumes (30, 40, 50, 60, 70, 80uL). Tested in 3 replicates per analyzer, 6 replicates in total.
• Operated Temperature and Humidity (Semen): 6 concentration levels of Semen samples, tested in 5 replicates.
• Operated Temperature and Humidity (pH): 3 pH levels of Semen samples, tested in 5 replicates.
• Test Strip Stability (Closed Vial): 3 lots of Test Cassette, and 3 Semen samples, test measurements in 3 replicates.
• System Accuracy Study and Layuser Performance Study: 106 subjects (with 100 tabulated findings).

Data Provenance: The document does not explicitly state the country of origin for the data or if it was retrospective or prospective. However, given Bonraybio Co., Ltd. is based in Taiwan and the studies involve human subjects ("subjects", "lay users"), it is likely the studies were prospective to gather new data for regulatory submission. The predicate device (SQA V) is from "Medical Electronic System, LLC," which is likely a US-based company.

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

• For the non-clinical performance studies (repeatability, reproducibility, linearity, etc.), the reference method was the SQA-V Analyzer (for semen parameters) and a pH meter (for pH). These are established laboratory methods/devices.
• For the Layuser Performance Study, the reference method was "SQA-V Analyzer performed by POC personnel." The "POC personnel" likely refers to healthcare professionals but their specific qualifications (e.g., years of experience, type of professional) are not detailed. It mentions "Point-of-Care professionals or licensed registered nurses" in the context of the study's objective, implying these are the types of individuals who established ground truth when the SQA-V was used for reference.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

The document does not describe an adjudication method for reconciling differences in ground truth establishment. The ground truth was based on comparison to an existing predicate device (SQA-V Analyzer) and a standard laboratory instrument (pH meter).

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, an MRMC comparative effectiveness study was not explicitly described in the provided text in the context of human readers improving with AI vs. without AI assistance.
• The study involved comparing the new device's performance to a predicate device (SQA-V Analyzer) and a pH meter.
• The "Layuser Performance Study" did involve human users (lay users and POC professionals) reading and using the device, but it focused on the device's accuracy and ease of use, not on measuring human performance improvement with or without AI assistance from the device. The device itself utilizes "artificial intelligence image processing" (page 5), but the studies described are device performance and user studies, not AI assistance (human-in-the-loop) comparative studies.

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

• Yes, a standalone performance of the algorithm (as embedded in the device) was done. All the non-clinical tests (Repeatability, Reproducibility, LoB/LoD/LoQ, Linearity, Interference, Sample Volume, Operated Temperature and Humidity, Test Strip Stability) evaluate the device's (which includes its embedded AI/image processing algorithms) performance directly against reference methods without a human interpretation step between the device's output and the final result. The device "fully automated analysis of semen quality including semen pH, sperm concentration and motility" (page 5).

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

• Primarily comparison to an established laboratory reference method/device: The SQA-V Analyzer (for sperm concentration, motility, and morphology) and a standard pH meter (for pH). These are considered highly reliable and validated methods/devices.

8. The sample size for the training set:

The document does not specify the sample size for the training set used for the device's "artificial intelligence image processing method." It primarily focuses on the validation/test sets for demonstrating performance against a predicate.

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

The document does not provide information on how the ground truth for the training set was established. While it states the device uses "artificial intelligence image processing method," it does not delve into the development or training process of this AI, nor the ground truth used therein.

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The Trak® Male Fertility Testing System is intended for semi-quantitative assessment of sperm concentration at 15 million sperm per milliliter (M/mL) or below, between 15 and 55 M/mL, and above 55 M/mL. It also provides a qualitative assessment of semen volume.

Sperm concentration and semen volume are only two factors that could impact a man's fertility status and time to pregnancy. For complete assessment of male reproductive health, the user should consult a physician. For in vitro, over the counter home use.

The revised Trak® Male Fertility Testing System (Trak) includes a small instrument (the Engine), disposable units in which liquefied semen sample is introduced and the result is interpreted (the Props), and consumables, including Volume Cups and sample droppers.

The Volume Cups are used collect, liquefy, and assess the volume of the semen sample. Markings on the Volume Cup allow the interpretation of volume at/below or above the 1.5 mL threshold. The Trak Engine and Props allow for the semi-quantitative assessments of total sperm concentration: below 15 million/mL, between 15 and 55 million/mL, and above 55 million/mL.

Trak uses the principle of density gradient separation to isolate sperm cells from human semen to provide an estimation of sperm concentration. The Trak Engine spins a test Prop to compact sperm cells within an introduced semen sample into a visible column (or "pellet"). The Prop gives a defined shape to the column, the height of which corresponds to the concentration of sperm cells in the sample. Since semen may also contain cell debris, immature sperm cells, and other contaminant particulates that could contribute to the apparent size of a pellet, it is necessary to filter out the contaminants. Trak achieves this filtering by removing contaminants from view based on density across a predefined liquid density medium.

During operation, approximately 0.17 mL of semen is metered by centrifugal action from the sample inlet into the metering chamber of the Prop. During rotation, the semen floats on "top" of the pre-loaded density medium. Sperm cells pass through the medium due to their high density while contaminants remain floating on the medium. When the spin sequence is complete, the sperm cells form a visible column that is displayed to the user for interpretation. Contaminants that are less dense than the liquid density medium are suspended "above" the medium, substantially separated from the sperm cells and are generally too diffuse to visualize.

This document describes the Trak® Male Fertility Testing System and the studies conducted to establish its performance, particularly focusing on the volume measurement component.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Semen Volume Assessment (Stage 1 Study: Interpretation of Photographs):
  • Sample Size: 232 semen sample photographs.
  • Data Provenance: Retrospective (photographs of samples with pre-established reference volumes). The country of origin is not explicitly stated.
• Semen Volume Assessment (Stage 2 Study: Interpretation of Simulated Sample in the Volume Cup):
  • Sample Size: 127 artificial semen samples (Cups filled with 1 mL, 1.2 mL, or 2 mL).
  • Data Provenance: Prospective (simulated samples prepared for the study). The country of origin is not explicitly stated.
• Precision of Volume Cup: 75 total replicates for each of 5 artificial semen samples (3 lots, 3 operators, 5 days, 5 replicates each).
• Functional Equivalence (Semen Liquefaction): 20 semen sample aliquots from three semen samples.
• Functional Equivalence (Trak Sperm Concentration Category Result Equivalence Study): 2 semen pools (10 M/mL and 20 M/mL), tested in 20 replicates for each cup type.
• Functional Equivalence (Semen Homogenization Study): Two semen samples formulated to two sperm concentrations differing by more than 50%. 20 aliquots taken from the top and bottom of each cup for each pool.

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

• Semen Volume Assessment (Stage 1 & 2): The ground truth was established by a "reference method" (calibrated scale for volume measurement). No specific number or qualifications of human experts for ground truth establishment are provided for these studies. For Stage 1, "trained technicians" also interpreted the photographs, effectively serving as an expert comparison to the lay subjects. Their qualifications are not explicitly detailed beyond being "trained."
• Sperm Concentration Category Result Equivalence Study: The ground truth for sperm concentration was established using Computer Assisted Semen Analysis (CASA). The qualifications of CASA operators or the number of such experts are not specified.

4. Adjudication Method for the Test Set

• The document primarily describes studies comparing device performance (Lay Subject or Trained Technician interpretation) against a "reference method" (calibrated scale for volume, CASA for concentration). This implies an objective ground truth, rather than an adjudication process between human readers.
• For the "Trained Technician vs Lay Subject" comparison in Stage 1, there's a direct comparison, but not an adjudication to establish a single truth; rather, it assesses agreement between these groups.

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 involving AI assistance for human readers is described. This device is an over-the-counter home-use system designed for direct user interpretation, not an AI-assisted diagnostic tool for expert human readers.

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

• The Trak® Male Fertility Testing System is a device with a visual readout interpreted by the user (human-in-the-loop). There is no description of a standalone algorithm performance without human interpretation. The "Engine" spins the sample, and the "Prop" creates a visible column, but the user "interprets" the column height for concentration and fluid height for volume.

7. The Type of Ground Truth Used

• Semen Volume Assessment: The ground truth was established by a "calibrated scale" for direct volume measurement. This is an objective measurement.
• Sperm Concentration Category Result Equivalence Study: The ground truth was established using Computer Assisted Semen Analysis (CASA). This is an objective, automated method.
• Functional Equivalence Studies (Liquefaction, Homogenization): Ground truth was established by quantitative volume measurements and sperm concentration assessments (presumably by CASA or similar lab methods).

8. The Sample Size for the Training Set

• The document does not explicitly mention a "training set" in the context of an algorithm or AI. The studies described are validation studies for the device's performance when used by humans. The device itself (Trak Engine and Props) is pre-calibrated and designed, so there isn't a traditional "training set" as understood in machine learning. However, the development and internal testing of the device would have involved samples, but these are not articulated as a distinct "training set" in this context.

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

• Since a formal "training set" for an algorithm is not described, the method for establishing its ground truth is not applicable in this document. The ground truth for the validation studies, as detailed in point 7, was established by objective reference methods like calibrated scales and CASA.

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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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