(503 days)
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.
| Parameter | Acceptance Criteria (Implied) | Reported Device Performance (SQA-iO vs. SQA-V) |
|---|---|---|
| Concentration, M/mL | Slopes between 0.9 and 1.2, Y-intercepts near zero, r ≥ 0.8 | Intercept: -1.5 (CI: -2.0 to -0.7), Slope: 1.0 (CI: 1.0 to 1.0), Correlation: 1.0 (CI: 0.98 to 0.99) |
| Motility, % | Slopes between 0.9 and 1.2, Y-intercepts near zero, r ≥ 0.8 | Intercept: -3.0 (CI: -3.1 to -1.7), Slope: 1.0 (CI: 1.0 to 1.0), Correlation: 1.0 (CI: 0.95 to 0.97) |
| Progressive Motility, % | Slopes between 0.9 and 1.2, Y-intercepts near zero, r ≥ 0.8 | Intercept: -0.8 (CI: -1.0 to 0.0), Slope: 0.9 (CI: 0.9 to 1.0), Correlation: 1.0 (CI: 0.97 to 0.98) |
| Rapidly Progressive, % | Slopes between 0.9 and 1.2, Y-intercepts near zero, r ≥ 0.8 | Intercept: 0.1 (CI: 0.0 to 0.3), Slope: 1.0 (CI: 0.9 to 1.0), Correlation: 0.9 (CI: 0.90 to 0.94) |
| Slowly Progressive, % | Slopes between 0.9 and 1.2, Y-intercepts near zero, r ≥ 0.8 | Intercept: -0.8 (CI: -1.0 to 0.0), Slope: 1.0 (CI: 0.9 to 1.0), Correlation: 0.9 (CI: 0.86 to 0.93) |
| Non-Progressive, % | Slopes between 0.9 and 1.2, Y-intercepts near zero, r ≥ 0.8 | Intercept: -1.9 (CI: -3.0 to -1.0), Slope: 1.2 (CI: 1.0 to 1.3), Correlation: 0.8 (CI: 0.71 to 0.83) |
| Immotile, % | Slopes between 0.9 and 1.2, Y-intercepts near zero, r ≥ 0.8 | Intercept: 3.0 (CI: 1.0 to 5.0), Slope: 1.0 (CI: 1.0 to 1.0), Correlation: 1.0 (CI: 0.95 to 0.97) |
| MSC, M/mL | Slopes between 0.9 and 1.2, Y-intercepts near zero, r ≥ 0.8 | Intercept: -0.9 (CI: -1.7 to -0.6), Slope: 1.0 (CI: 1.0 to 1.0), Correlation: 1.0 (CI: 0.98 to 0.99) |
| PMSC, M/mL | Slopes between 0.9 and 1.2, Y-intercepts near zero, r ≥ 0.8 | Intercept: -0.4 (CI: -0.7 to -0.3), Slope: 1.0 (CI: 0.9 to 1.0), Correlation: 1.0 (CI: 0.99 to 1.00) |
| Rapid PMSC, M/mL | Slopes between 0.9 and 1.2, Y-intercepts near zero, r ≥ 0.8 | Intercept: 0.0 (CI: -0.1 to 0.0), Slope: 1.0 (CI: 1.0 to 1.0), Correlation: 1.0 (CI: 0.96 to 0.98) |
| Slow PMSC, M/mL | Slopes between 0.9 and 1.2, Y-intercepts near zero, r ≥ 0.8 | Intercept: -0.1 (CI: -0.4 to -0.1), Slope: 1.0 (CI: 0.9 to 1.0), Correlation: 1.0 (CI: 0.98 to 0.99) |
| Morphology, % (n = 155) | Slopes between 0.9 and 1.2, Y-intercepts near zero, r ≥ 0.8 | Intercept: 0.0 (CI: 0.0 to 0.1), Slope: 1.0 (CI: 0.9 to 1.0), Correlation: 1.0 (CI: 0.96 to 0.98) |
| FSC, M/mL (n = 155) | Slopes between 0.9 and 1.2, Y-intercepts near zero, r ≥ 0.8 | Intercept: -0.1 (CI: -0.1 to 0.0), Slope: 0.9 (CI: 0.9 to 1.0), Correlation: 1.0 (CI: 0.97 to 0.99) |
| Conclusion from results | All criteria met | The data demonstrate slopes between 0.9 and 1.2, Y-intercepts near zero, and a correlation coefficient ("r") ≥ 0.8, indicating the device meets the criteria for substantial equivalence to the predicate device. |
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.
§ 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.”