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The Cryopette is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human blastocyst stage embryos.

The Cryopette consists of a cryostraw manufactured from polycarbonate-Lexan OQ-3820. This straw has a displacement bulb attached to one end of the cryostraw whose function is to aspirate and dispense the sample contained in the vitrification media in and out of the opposite (open) end of the cryostraw. The cryostraw is the only sample contacting portion of the Cryopette. The metering sheath provides structural rigidity for the Cryopette. The support ring provides a backstop and seal for the displacement bulb. The outer case encases the displacement bulb to provide a surface for labeling. The sealing mark, distal storage border and proximal storage border reference lines are found on the outside of the cryostraw.

The provided text describes the acceptance criteria and performance data for the Cryopette device. Here's a summary of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

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The transfer of the removed blastomere from a holding vessel to a transport vessel. This device is NOT intended for blastomere biopsy from an embryo.

Stripper PGD® Micropipette and associated tip

This document is a 510(k) clearance letter from the FDA for a medical device called "Stripper PGD® Micropipette and associated tip." It states that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain the information requested in the prompt regarding acceptance criteria, device performance, study details, or ground truth.

The letter is a regulatory approval document and focuses on the administrative aspects of device clearance rather than the detailed technical performance or the studies that would demonstrate compliance with acceptance criteria.

Therefore, I cannot extract the requested information from this provided text.

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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.

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"THE STRIPPER®" MICROPIPET FAMILY'S INDICATION FOR USE IS T0 MANIPULATE AND TRANSFER ZYGOTES AND EMBRYOS DURING IVF AND ICSI PROCEDURES.

"THE STRIPPER®" MICROPIPETS ARE USED IN THE TISSUE CULTURE TECHNIQUES PERFORMED BY EMBRYOLOGISTS WHEN PREPARING OOCYTES FOR IVF, ICSI AND ASSISTED HATCHING TECHNIQUES PRIOR TO RE-IMPLANTATION.

"THE STRIPPER®" MICROPIPETS ARE TOOLS USED IN PROCEDURES THAT HAVE BEEN DEVELOPED TO AID INFERTILE COUPLES ACHIEVE PREGNANCY.

REMOVES CUMULUS AND CORONA CELLS FROM OOCYTE FOR CONFIRMATION OF FERTILITY DURING IVF.

REMOVES CUMULUS AND CORONA CELLS FROM OOCYTE PRIOR TO ICSI PROCEDURES.

USED TO TRANSFER EMBRYOS AND OOCYTES THROUGH VARIOUS MEDIA AND SOLUTIONS DURING THE IVF PROCEDURE.

"THE STRIPPER®" micropipetter is a hand held device used to create the vacuum necessary for "THE STRIPPER®" micropipetter tips to aspirate and dispense fluid and cellular material. Its' components include an aluminum barrel that houses a stainless steel plunger and spring, an aluminum plunger shaft with finger pad, o-rings, washer and collet for securing "THE STRIPPER®" tips.

"THE STRIPPER®" micropipette tips are fabricated from polycarbonate tubing wherein one end of the tube is pulled to a much smaller dimension to produce tips of varying internal dimensions.

The provided document describes the "THE STRIPPER®" Micropipetter and Micropipetter Tips, a device used in In Vitro Fertilization (IVF) and Intracytoplasmic Sperm Injection (ICSI) procedures. The document includes information on the device's testing procedures and, by extension, its acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance:

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