(214 days)
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.
| Parameter Category | Test Type | Acceptance Criteria (Implicit from conclusion) | Reported Device Performance (Summary) |
|---|---|---|---|
| Precision (Control Material) | Repeatability (Within-run), Between-day, Between-operator, Between-site, Total Imprecision | StDev and %CV met the acceptance criteria (specific values not provided in extract). | All reported SDs and %CVs for Controls Level 1, Level 2, and Negative Control were low, indicating high precision. For example, Total %CV for Control Level 1 was 1.84%, and for Level 2 was 4.01%. Total SD and %CV for Negative Control were 0.00%. |
| Precision (Native Samples) | Repeatability (Within-run), Between-operator, Total Imprecision | StDev and %CV met the acceptance criteria for all reported parameters (specific values not provided in extract). | All reported SDs and %CVs for Sperm Concentration, MSC, PMSC, Morphology, Motility, Progressive Motility, Non-Progressive Motility, and Immotile were reported, with the conclusion that they "met the acceptance criteria." For instance, Total %CV for Sperm Concentration ranged from 1.5% to 14.1%, for MSC 0.0% to 41.6%, for PMSC 4.0% to 173.2% (with some very high %CVs for low-level samples), for Morphology 6.5% to 244.9% (with some very high %CVs for low-level samples), for Motility 4.2% to 11.0%, for Progressive Motility 6.1% to 261.7% (with some very high %CVs for low-level samples), for Non-Progressive Motility 6.4% to 76.7% (with some high %CVs for low-level samples), and for Immotile 1.8% to 10.4%. The conclusion states all met acceptance criteria, suggesting that higher %CV for low-level samples was considered acceptable within the context of clinical relevance for those low values. |
| Method Comparison | Passing-Bablok Regression: Intercept, Slope, Correlation Coefficient | Slopes, y-intercepts, and correlation coefficients, along with the 95% confidence intervals, demonstrated clinical equivalence to the predicate device (specific ranges not provided in extract). | CONCENTRATION: Intercept 0.05 (-0.4799 to 0.2610), Slope 0.98 (0.9718 to 0.9836), Correlation 1.0 (0.9974 to 0.9982). |
| MOTILITY: Intercept 2.1 (1.2174 to 3.0000), Slope 0.9 (0.9189 to 0.9565), Correlation 0.96 (0.9493 to 0.9659). | |||
| PROGRESSIVE MOTILITY: Intercept -0.7 (-1.4516 to 0.0000), Slope 1.0 (0.9286 to 0.9677), Correlation 1.0 (0.9683 to 0.9787). | |||
| NON-PROGRESSIVE MOTILITY: Intercept -0.3 (-1.0000 to 0.0000), Slope 1.3 (1.2500 to 1.4000), Correlation 0.7 (0.6944 to 0.7850). | |||
| IMMOTILE: Intercept 4.0 (3.0417 to 5.0000), Slope 0.9 (0.9200 to 0.9583), Correlation 0.9 (0.9130 to 0.9411). | |||
| MORPHOLOGY: Intercept -1.0 (-1.0000 to -0.0455), Slope 1.0 (0.9091 to 1.0000), Correlation 1.0 (0.9563 to 0.9706). | |||
| MSC: Intercept 0.3 (0.05708 to 0.5580), Slope 0.9 (0.9344 to 0.9571), Correlation 1.0 (0.9889 to 0.9925). | |||
| PMSC: Intercept -0.3 (-0.5450 to -0.0968), Slope 0.9 (0.9149 to 0.9364), Correlation 1.0 (0.9894 to 0.9929). |
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.
§ 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.”