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510(k) Data Aggregation
(253 days)
Bonraybio Co., LTD.
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:
- Sperm concentration (M/mL)
- Total motility (PR+NP, %)
- Progressive motility (%)
- Non-Progressive motility (%)
- Immotility (%)
- Sperm morphology (normal forms, %)
- 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:
- Sperm concentration (M/mL)
- Total motility (PR+NP, %)
- Progressive motility (%)
- Non-Progressive motility (%)
- Immotility (%)
- Sperm morphology (normal forms, %)
- 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.
| Parameter Measured | Acceptance Criteria (Not Explicitly Stated in Document) | Reported Device Performance (Not Explicitly Stated in Document) |
|---|---|---|
| Sperm Concentration (M/mL) | e.g., Accuracy within X% of reference; CV |
Ask a specific question about this device
(270 days)
Bonraybio Co., LTD.
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:
| Performance Metric | Acceptance Criteria (Example) | Reported Device Performance (Example based on typical expectations for such devices, not found in text) |
|---|---|---|
| Sperm Concentration | % bias within +/- X% of reference; R² > 0.Y vs. reference | (e.g., Bias 90%; Bias 85%; Bias 80% for normal forms) |
| DNA Fragmentation Index | % bias within +/- D% of reference | (e.g., Bias 0.YY across specified range |
| Interference | No significant interference from common substances | (e.g., Bilirubin, Triglycerides, Hemolysate at specified levels) |
| Stability | Device/reagents stable under specified conditions | (e.g., Stable for X months/hours) |
| Usability (User Perf. Study) | User accuracy/ease of use met pre-defined criteria | (e.g., High scores on participant questionnaire) |
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.
Ask a specific question about this device
(131 days)
Bonraybio Co., LTD.
The LensHooke CA0 Sperm Separation Device and the LensHooke CA1 Sperm Separation Device are intended for preparing motile sperm from semen for use in the treatment of infertile couples by intracytoplasmic sperm injection (ICSI), in vitro fertilization (IVF) and intrauterine insemination (IUI) procedures.
The LensHooke CA0 Sperm Separation Device and LensHooke CA1 Sperm Separation Device are used to prepare motile sperm from semen based on the mobility of motile sperm. The LensHooke Sperm Separation Device has a base and filter layers to separate and process the semen sample. The LensHooke Sperm Separation Device has two models, CA0 with one filter layer and CA1 with two filter layers. Liquefied semen (1 mL) is added to the base and sperm washing medium is added to the filter via a filter port. After incubation, the separated sperm are collected from the filter layer via the filter port. The subject devices are radiation-sterilized with a sterility assurance level (SAL) of 10 °. The LensHooke Sperm Separation Devices are individually packaged and for single-use only.
The device in question is the LensHooke CA0 Sperm Separation Device and the LensHooke CA1 Sperm Separation Device.
Here's a breakdown of the acceptance criteria and supporting study details:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Human Sperm Survival Assay (HSSA): ≥80% of the control motility at 24 hours after exposure for 30 minutes. | The HSSA was performed before and after accelerated aging to support a 2-year shelf life. The rate of motile sperm after incubation was compared to that of a control (no exposure to the subject device). The device met this criterion. |
| Endotoxin: ≤20 EU/device | The device demonstrated levels of endotoxin below or equal to 20 EU/device, as confirmed by USP and ANSI/AAMI ST72:2019 testing. |
| Sterility: 10⁻⁶ SAL (Sterility Assurance Level) | The device underwent Sterilization Validation Study per ISO 11137-1:2006, confirming a sterility assurance level of 10⁻⁶. |
| Package Integrity (Seal Strength): Met requirements of ASTM F88/F88M-15 | Package integrity testing following accelerated aging per ASTM F1980-21 included Seal strength testing Per ASTM F88/F88M-15. The device met this criterion. |
| Package Integrity (Dye Penetration): Met requirements of ASTM F1929-15 | Package integrity testing following accelerated aging per ASTM F1980-21 included Dye penetration testing per ASTM F1929-15. The device met this criterion. |
| Transportation Simulation: Met requirements of ISTA 3A (2018) | A Transportation Simulation Study per ISTA 3A (2018) was conducted to ensure the device's integrity during transport. The device met this criterion. |
| Sperm Separation Performance (Motility Improvement): Improvement in percentage of motile sperm and progressively motile sperm in output samples compared to input samples. | CA0 device: Average improvement in total motility of 24.4% and an average improvement in progressive motility of 26.6%. |
| CA1 device: Average improvement in total motility of 25.9% and an average improvement in progressive motility of 27.1%. | |
| Note: Specific quantitative acceptance criteria for motility improvement were not explicitly stated in the provided text, but the reported improvements demonstrate effective performance. | |
| Shelf-Life: 24 months | Supported by package integrity and HSSA testing after accelerated aging. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the numerical sample size for the "test set" in terms of number of donor semen samples used for the Human Sperm Survival Assay (HSSA) or the Sperm Separation Performance study. It mentions using "donor sperm" and "donor semen samples" without specifying the quantity.
- Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. The studies described are primarily benchtop or laboratory performance tests, not clinical studies involving expert interpretation of results to establish ground truth in the context of diagnostic accuracy.
4. Adjudication Method for the Test Set:
This information is not applicable as the studies are technical performance tests and not clinical studies requiring expert adjudication of case interpretations.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. The studies described are focused on the device's technical performance in isolating motile sperm and maintaining sperm viability, not on comparing reader effectiveness with and without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, the studies described are standalone performance evaluations of the device (LensHooke CA0/CA1 Sperm Separation Device) without human-in-the-loop performance considerations. The device is a physical product designed for sperm separation, not an AI algorithm.
7. The Type of Ground Truth Used:
The ground truth for the performance studies was established through:
- Laboratory measurements and assays: For HSSA, this involves measuring sperm motility percentage using established laboratory methods. For endotoxin, it's quantitative measurement against a standard. For sterility, it's confirmation of a specific SAL.
- Comparison to control samples: In the HSSA, the motility of sperm exposed to the device was compared to that of a control group (sperm not exposed to the device).
- Direct measurement of output characteristics: For sperm separation performance, the percentage of motile and progressively motile sperm in the output samples was directly measured and compared to the input samples.
- Industry standards and specifications: For physical tests like package integrity and transportation simulation, the ground truth is adherence to the specified ASTM and ISTA standards.
8. The Sample Size for the Training Set:
This information is not applicable. The LensHooke CA0/CA1 Sperm Separation Device is a physical medical device, not an AI/machine learning algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as the device is not an AI/machine learning algorithm requiring a training set.
Ask a specific question about this device
(92 days)
Bonraybio Co., Ltd.
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.
Ask a specific question about this device
(282 days)
Bonraybio Co., Ltd.
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.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance/Conclusion |
|---|---|---|
| Repeatability | Calculated CV (%) for pH, Concentration, Motility, and Morphology within 10% | Within 10%: "It was demonstrated that the calculate CV (%) pH, Concentration, Motility and morphology were within 10%." |
| Reproducibility | Calculated CV (%) for pH, Concentration, Motility, and Morphology within 10% | Within 10%: "It was demonstrated that the calculate CV (%) pH, Concentration, Motility and morphology were within 10%." |
| LoB/LoD/LoQ (Semen) | LoB, LoD, LoQ established at specific concentrations | Established: LoB: 0 x 10^6/mL, LoD: 1.8 x 10^6/mL, LoQ: 7.2 x 10^6/mL. (Note: The document uses "10%mL" which likely means 10^6/mL). |
| Linearity (Semen) | Mean slope above 0.95 and R^2 values above 0.99 | Linear from 2 to 350 x 10^6/mL: "Analysis of results indicated Semen linear regression between device and reference method shows mean slope above 0.95 and R2 values above 0.99. The results support the claim that the candidate assay is linear from 2 to 350 x10^6/mL concentrations." |
| Linearity (pH) | Linear from pH 5.8 to 8.2 | Linear from pH 5.8 to 8.2: "The results support the claim that the pH is linear from pH 5.8 to 8.2." |
| Interference | Meet CLSI: EP7-A2 acceptance criteria | No significant interference: "The study results indicate that all tested 11 interference substances meet CLSI: EP7-A2 acceptance criteria for therapeutic levels of concentration. Tested substances do not cause significant interference." |
| Sample Volume (Semen) | CV within 5% and bias within 20% for semen concentration | Within criteria for 35-45 µL: "The study results demonstrate the CV is within 5% and the bias is within 20% for semen concentration. All results within criteria when specimen is 35-45 uL. Thus, the minimum sample volume is 35 uL." |
| Sample Volume (pH) | CV within 10% and bias within 10% | Within criteria for 30-80 µL: "The study results demonstrate the CV is within 10% and the bias is within 10%. All results within criteria when specimen is 30-80 uL. Thus, the minimum sample volume is 30 µL." |
| Operating Temperature & Humidity (Semen) | Bias within 10% | Operates under 15-38°C and 50-90% RH: "The results indicate basis within 10% and conclude that candidate device can operate under the environment conditions 15-38°C (59-100.4°F) and 50-90% relative humidity." |
| Operating Temperature & Humidity (pH) | Bias within 10% | Operates under 15-38°C and 50-90% RH: "The results indicate basis within 10% and conclude that candidate device can operate under the environment conditions 15-38°C (59-100.4°F) and 50-90% relative humidity." |
| Test Strip Stability (Closed Vial) | Stable test cassette strip performance for estimated shelf life | Estimated 2-year shelf life: "The study results should demonstrate stable test cassette strip performance for 8 months under accelerated 40°C condition, which can estimate shelf life of test strips for 2 years at room temperature." (The document states "should demonstrate," implying this was the goal or expectation based on the accelerated conditions, not necessarily a direct report of completion.) |
| System Accuracy & Layuser Performance | Layperson user accuracy and ease of use (via questionnaire) | Demonstrated accuracy and ease of use: "The study results demonstrate that the layperson user accuracy and ease of use (via participant questionnaire scoring) of Candidate device." Excluded findings were addressed in the study report. |
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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