(175 days)
The SpermAlign Sperm Separation Device is intended for preparing motile sperm from semen for use in the treatment of infertile couples by intracytoplasmic sperm injection (ICSI) and in vitro fertilization (IVF) procedures.
SpermAlign is a sperm separation device used to prepare motile sperm for assisted reproductive technology (ART) procedures. Separation is achieved through a fluid filled microstructure which guides the motile sperm to the central collection outlet isolating it from the remaining sample. The device utilizes a total processing volume of 180ul of liquefied semen added in 30ul aliquots to each of the six outer wells and sperm washing media added to the central well. Following incubation for 30 minutes, the concentrated motile sperm is withdrawn from the central well and may be used directly in intracytoplasmic sperm injection (ICSI) or in vitro fertilization (IVF) procedures.
SpermAlign is sterilized using X-Ray irradiation and has a sterility assurance level (SAL) of 10-6. The devices are individually packaged and for single use only.
The provided document is a 510(k) summary for the SpermAlign Sperm Separation Device, indicating substantial equivalence to a predicate device. While it details several non-clinical performance tests, it does NOT contain the specific information requested about the acceptance criteria and study proving device meets acceptance criteria for an AI/ML medical device, particularly regarding test sets, expert adjudication, MRMC studies, or standalone algorithm performance. The device described appears to be a physical labware device, not an AI/ML software device.
Therefore, I cannot extract the requested information (acceptance criteria, study details for AI/ML performance, sample sizes for AI/ML test/training data, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to AI/ML) directly from this document.
However, I can extract information regarding the non-clinical performance studies conducted for this physical device:
A table of acceptance criteria and the reported device performance (for physical device tests):
| Test | Acceptance Criterion | Reported Performance |
|---|---|---|
| Sterilization Validation | Sterility Assurance Level (SAL) of 10⁻⁶ | Met SAL of 10⁻⁶ |
| Endotoxin Testing |
§ 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.