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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 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:

2. Sample Sizes Used for the Test Set and Data Provenance:

• Mouse Embryo Bioassay: The text states "microdrops" are used, and embryos are added to "both the test and control medium." It does not specify the exact number of embryos per microdrop or the total number of embryos tested per lot. The data provenance is implied to be prospective as each "lot of micropipettes" is tested. The country of origin of the data is not specified but is implicitly from Mid-Atlantic Diagnostics, Inc. in the USA.
• Sterility Testing: The sterilization validation program follows the United States Pharmacopeia 23 (71) procedure. The document mentions "every lot being validated for sterility." The exact sample size (number of devices per lot tested) is not specified. Data provenance is prospective per lot.
• Endotoxin Testing: "Each lot of micropipettes is also tested." The specific number of devices tested per lot is not stated. Data provenance is prospective per lot.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

The document does not mention the use of experts to establish the ground truth for the device's performance tests. The tests (mouse embryo bioassay, sterility, endotoxin) are laboratory assays with objective, measurable outcomes, not requiring expert human interpretation for ground truth establishment in the described context.

4. Adjudication Method for the Test Set:

Not applicable. The described tests are laboratory assays with predefined quantitative thresholds for acceptance, not requiring an adjudication method involving human interpretation.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not conducted. The provided document focuses on the safety and performance characteristics of "THE STRIPPER®" itself through laboratory testing, not on comparing the effectiveness of human readers with and without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Yes, a standalone study was done. The performance evaluation presented is entirely based on the device's intrinsic characteristics through laboratory assays (mouse embryo bioassay, sterility testing, endotoxin testing). There is no "human-in-the-loop" component to these performance measurements.

7. Type of Ground Truth Used:

The ground truth for the performance evaluations is based on:

• Biological/Empirical Outcomes: For the mouse embryo bioassay, the ground truth is the observable development of mouse embryos to the blastocyst stage after exposure to the device extract, compared to a control.
• Quantitative/Analytical Measurements: For sterility, the ground truth is the absence of microbial growth as determined by validated microbiological methods to a specified Sterility Assurance Level. For endotoxin, the ground truth is the measured concentration of endotoxins in EU/ml as determined by the Limulus Amebocyte Lysate assay.

8. Sample Size for the Training Set:

Not applicable. This device is a manual micropipetter and tips, not an AI/ML algorithm. Therefore, there is no "training set" in the context of an algorithmic model.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for this type of device.

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