(160 days)
The ZyMot ICSI Sperm Separation Device is intended for preparing motile sperm from semen for use in the treatment of infertile couples by intracytoplasmic sperm injection (ICSI) procedures.
The ZyMot Multi Sperm Separation Device is 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 ZyMōt ICSI Sperm Separation Device and ZyMōt Multi Sperm Separation Device (850μl, 3ml) are used to prepare motile sperm for assisted reproductive technology (ART) procedures. They separate motile sperm from the semen based on the mobility (i.e., swimup nature) of motile sperm.
The ZyMōt ICSI Sperm Separation Device has five micro-channels, each accommodating 2ul of semen and processes up to five separations from one semen sample. Each channel has an inlet port for applying the semen sample and an outlet port for collecting the motile sperm. The ports are connected by a fluid-filled micro-channel in which separation occurs.
The ZyMōt Multi Sperm Separation Device has two processing volumes, 850µl and 3ml. Each version has an inlet port that communicates with the lower sample chamber. The sample chamber is separated from the upper collection chamber by a microporous filter. Untreated semen is added through the inlet port. After incubation, the separated motile sperm are collected from the upper chamber through the outlet port.
The subject devices are radiation-sterilized devices with a sterility assurance level (SAL) of 10-6. They are individually packaged and for single-use only.
The document describes the non-clinical performance testing for the ZyMōt ICSI Sperm Separation Device and ZyMōt Multi Sperm Separation Device (850µl, 3ml).
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criterion | Reported Device Performance |
|---|---|---|
| Human sperm survival assay (HSSA) | ≥80% of control motility at 24 hours after 30 minutes exposure | Not explicitly stated, but implies met (study supports SE) |
| Performance Testing (Motile Sperm) | Not explicitly stated as a numerical acceptance criterion. Implied acceptable separation of motile sperm. | |
| ZyMōt ICSI (motile sperm separation) | N/A (implied improvement) | 29.7% / 87% (before/after separation) |
| ZyMōt Multi 850µl (motile sperm separation) | N/A (implied improvement) | 67% / 83.6% (before/after separation) |
| ZyMōt Multi 3ml (motile sperm separation) | N/A (implied improvement) | 67% / 86.5% (before/after separation) |
| Performance Testing (Progressively Motile Sperm) | Not explicitly stated as a numerical acceptance criterion. Implied acceptable separation of progressively motile sperm. | |
| ZyMōt ICSI (progressively motile sperm separation) | N/A (implied improvement) | 26.3% / 74.2% (before/after separation) |
| ZyMōt Multi 850µl (progressively motile sperm separation) | N/A (implied improvement) | 44.7% / 68.6% (before/after separation) |
| ZyMōt Multi 3ml (progressively motile sperm separation) | N/A (implied improvement) | 44.7% / 75.4% (before/after separation) |
2. Sample size used for the test set and the data provenance:
- Human sperm survival assay (HSSA): "Donor sperm" were used. The exact number of donors or samples is not specified. Data provenance is not explicitly stated (e.g., country of origin), nor is it specified if it was retrospective or prospective.
- Performance testing: "Each version of the subject device was used to separate motile sperm from donor semen samples." The exact number of donor semen samples or individual tests is not specified. Data provenance is not explicitly stated, nor is it specified if it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The tests performed are laboratory-based assays (HSSA and performance testing determining sperm motility percentage), which typically rely on standardized laboratory protocols and instrumentation rather than expert consensus for ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable as the tests are laboratory assays, not reliant on expert adjudication.
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:
This information is not applicable. The device is a sperm separation device, not an AI-powered diagnostic tool requiring human reader interpretation. No MRMC study was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable. The device is a physical sperm separation device, not an algorithm.
7. The type of ground truth used:
- Human sperm survival assay (HSSA): The ground truth was established by comparing the rate of motile sperm after exposure to the device and incubation to that of a control sample (no exposure to the device). This relies on a direct measurement of motility.
- Performance testing: The ground truth for motility and progressively motile sperm percentages was established through direct measurement of these parameters in the input (before separation) and output (after separation) semen samples.
8. The sample size for the training set:
This information is not applicable. The device is a physical sperm separation device, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established:
This information is not applicable as there is no training set for this type of device.
§ 884.6160 Assisted reproduction labware.
(a)
Identification. Assisted reproduction labware consists of laboratory equipment or supplies intended to prepare, store, manipulate, or transfer human gametes or embryos for in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures. These include syringes, IVF tissue culture dishes, IVF tissue culture plates, pipette tips, dishes, plates, and other vessels that come into physical contact with gametes, embryos or tissue culture media.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, and clinical testing). The device, when it is a dish or plate intended for general assisted reproduction technology procedures, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.