(189 days)
The Mid-Atlantic Diagnostics Custom Products IVF Workstation is a laminar flow hood that is indicated for use as an accessory to assisted reproduction technologies/in vitro fertilization (ART/IVF) procedures.
The Mid-Atlantic Diagnostics Custom Products IVF Workstation is a laminar flow hood.
The provided document is a 510(k) clearance letter for a medical device: "Custom Products IVF Workstation Models: WKST-24x36, WKST-24x60, WKST-24x60, WKST-24x60, WKST-24x72, and WKST-24x72D."
This type of device, an IVF Workstation, is a laminar flow hood used as an accessory in assisted reproduction technologies. It is a piece of laboratory equipment designed to provide a sterile environment, not a diagnostic or AI-powered device.
Therefore, the document does not contain any information regarding acceptance criteria, device performance metrics (like sensitivity, specificity, or AUC), sample sizes for test or training sets, expert qualifications, ground truth establishment, or any comparative effectiveness studies (MRMC or standalone AI performance) as it pertains to AI or diagnostic algorithms.
The 510(k) clearance for this device is based on substantial equivalence to legally marketed predicate devices, meaning it does not require clinical trials or performance studies that would involve the metrics you've requested. The review focuses on its design, materials, and intended use as a manufacturing/processing aid rather than an AI-driven diagnostic tool.
In summary, all the requested information regarding acceptance criteria and a study proving device performance is NOT applicable to this K030525 clearance letter.
§ 884.6120 Assisted reproduction accessories.
(a)
Identification. Assisted reproduction accessories are a group of devices used during assisted reproduction procedures, in conjunction with assisted reproduction needles and/or assisted reproduction catheters, to aspirate, incubate, infuse, and/or maintain temperature. This generic type of device may include:(1) Powered aspiration pumps used to provide low flow, intermittent vacuum for the aspiration of eggs (ova).
(2) Syringe pumps (powered or manual) used to activate a syringe to infuse or aspirate small volumes of fluid during assisted reproduction procedures.
(3) Collection tube warmers, used to maintain the temperature of egg (oocyte) collection tubes at or near body temperature. A dish/plate/microscope stage warmer is a device used to maintain the temperature of the egg (oocyte) during manipulation.
(4) Embryo incubators, used to store and preserve gametes and/or embryos at or near body temperature.
(5) Cryopreservation instrumentation and devices, used to contain, freeze, and maintain gametes and/or embryos at an appropriate freezing temperature.
(b)
Classification. Class II (special controls) (design specifications, labeling requirements, and clinical testing). The device, when it is a simple embryo incubator with only temperature, gas, and humidity control; a syringe pump; a collection tube warmer; a dish/plate/microscope stage warmer; a controlled-rate cryopreservation freezer; or an assisted reproduction laminar flow workstation is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.