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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 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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QwikCheck™ Test Strips are for in vitro diagnostic use for the determination of pH and leukocytes (WBCs) in semen. Test results are determined by comparing the color of the test patches to the color chart provided on the bottle label. The test is for professional use only.

Not Found

This document is a 510(k) clearance letter for the QwikCheck™ Test Strips, which are reagent strips for semen analysis. However, it does not contain the detailed acceptance criteria and study data needed to fully answer your request.

Specifically, the letter confirms that the device is substantially equivalent to a legally marketed predicate device, but it does not provide:

• A table of acceptance criteria and reported device performance.
• Details about samples, experts, or ground truth establishment.
• Information regarding standalone performance, MRMC studies, or training set details.

The letter focuses on regulatory approval based on substantial equivalence, rather than a detailed performance study report. To get the information you're looking for, you would typically need to review the original 510(k) submission document itself, or any accompanying performance study reports that were submitted to the FDA for review.

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