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VitriFreeze Media are intended for ultra-rapid freezing of human blastocysts for Assisted Reproductive Technology (A.R.T.) procedures.

VitriThaw media are intended for the recovery of human blastocysts that have undergone ultra-rapid freezing for Assisted Reproductive Technology (A.R.T.) procedures.

The seven (7) media that comprise the two (2) VitriFreeze and VitriThaw media are all based upon a modified formulation of other media.

The three (3) freeze media in VitriFreeze are intended for use sequentially and are named Pre-incubation medium, VitriFreeze Medium 1 and VitriFreeze Medium 2. These media are used for preparation for and cryopreservation of human blastocysts. Preincubation medium is used to equilibrate the blastocysts. VitriFreeze, Medium 1 is used for the preparation to the vitrification. VitriFreeze, Medium 2 is the actual vitrification medium that is used during cryostorage.

The four (4) thawing media in VitriThaw are also for sequential use in the thawing and recovery of cryopreserved human blastocysts. VitriThaw media includes VitriThaw Medium 1, VitriThaw Medium 2, VitriThaw Medium 3, VitriThaw Medium 4

The provided text describes VitriFreeze Media and VitriThaw Media, which are products used for cryopreservation and recovery of human blastocysts in Assisted Reproductive Technology (ART) procedures. However, the document is a 510(k) premarket notification summary and an FDA clearance letter, focusing on substantial equivalence to a predicate device.

It does not contain the detailed information required to answer your request about acceptance criteria, specific device performance, study design, sample sizes, ground truth establishment, or multi-reader multi-case studies. These types of detailed performance studies are typically part of a Premarket Approval (PMA) application or a more extensive clinical trial report, not generally mandated or included in a 510(k) submission for substantial equivalence.

Therefore, based solely on the provided text, I cannot generate the requested table and study details. The document explicitly states: "The predicates and these devices were compared in the following areas and found to have similar technological characteristics and to be equivalent. Formula Special controls Packaging Performance Testing." This indicates that performance testing was done to show similarity, but the specific metrics, acceptance criteria, and study methods are not detailed here.

To answer your questions, I would need a different type of document, such as a full clinical study report or a detailed technical specification.

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Oil For Tissue Culture is used in covering tissue culture in in-vitro fertilization, embryo culture and micromanipulative procedures such as ICSI and assisted hatching.

Gradient System is used for separation and purification of human sperm for assisted reproduction procedures.

SpermFreeze is intended to be used as a cryopreservation medium for human sperm.

Oil For Tissue Culture is a colorless liquid paraffin.

Gradient System is a solution of silane-coated silica particles in Earle's Balanced Salts Solution (EBSS) with HEPES (pH buffer). Available in 45%, 90% and 100%.

SpermFreeze is a HEPES buffered freezing medium for use with human Sperm. It contains 0.4 % human serum albumin.

I am sorry, but based on the provided text, I cannot provide the requested information. The document focuses on a 510(k) summary for reproductive media devices (Oil for Tissue Culture, Gradient System, and SpermFreeze) and primarily discusses their equivalence to predicate devices and their intended indications for use.

The text does not contain any information about acceptance criteria, device performance metrics, study designs, sample sizes (for test or training sets), expert qualifications, ground truth establishment, or multi-reader multi-case studies.

Therefore, I cannot populate the table or answer the specific questions about the study that proves the device meets acceptance criteria.

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