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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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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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