(282 days)
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, %)
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Progressive motility (%)
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Non-Progressive motility (%)
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(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.
§ 864.5220 Automated differential cell counter.
(a)
Identification. An automated differential cell counter is a device used to identify one or more of the formed elements of the blood. The device may also have the capability to flag, count, or classify immature or abnormal hematopoietic cells of the blood, bone marrow, or other body fluids. These devices may combine an electronic particle counting method, optical method, or a flow cytometric method utilizing monoclonal CD (cluster designation) markers. The device includes accessory CD markers.(b)
Classification. Class II (special controls). The special control for this device is the FDA document entitled “Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA.”