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InteGlobal MicroTips TPLG-130 are used for Denuding, handling blastomeres, oocytes and oocyte stripping. LifeGlobal MicroTips TPLG-180, TPLG-225 and TPLG-275 are used for handling embryos and blastocysts.

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This document does not contain information about acceptance criteria or a study proving that a device meets such criteria.

The provided text is an FDA 510(k) clearance letter for the "LifeGlobal Micro Tips" device. This letter confirms that the device has been found substantially equivalent to a legally marketed predicate device, allowing it to be marketed. It discusses regulatory compliance, labeling requirements, and contact information for further inquiries.

However, it does not include any details on:

• Specific performance acceptance criteria (e.g., accuracy, precision, sensitivity, specificity).
• Any studies (clinical or non-clinical) that were conducted to evaluate the device's performance against such criteria.
• The methodologies for any such studies (sample size, data provenance, ground truth establishment, expert qualifications, adjudication, MRMC studies, standalone performance).
• Any reported device performance metrics.

Therefore, I cannot provide the requested table or answer any of the questions regarding acceptance criteria and studies.

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LifeGlobal® Global® Total® w/HSA: Culture of embryos from zygote to blastocyst, embryo transfer
LifeGlobal® Global® Total® for Fertilization w/HSA: Oocyte culture and fertilization
LifeGlobal® Global® Total® w/HEPES w/HSA: Oocyte and embryo washing, manipulation, fertilization by intracytoplasmic sperm injection (ICSI), embryo transfer

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This document is a 510(k) premarket notification from the FDA, indicating clearance for a medical device. It does not contain information about the device's acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment. These details are typically found in the submission's technical documentation, which is not part of this clearance letter.

Therefore, I cannot provide the requested information based on the provided text. The document confirms regulatory clearance but does not delve into the specific details of performance testing or clinical studies.

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Culture of human embryos from zygote to blastocyst, embryo transfer.

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The provided text from the FDA 510(k) clearance letter for the LifeGlobal Global HP does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

The document is a clearance letter stating that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It outlines regulatory requirements, but it does not include details of a performance study or acceptance criteria.

Therefore, I cannot provide the requested information based on the given text.

To provide this information, I would need access to the full 510(k) submission document, specifically the sections detailing performance data, clinical studies, or non-clinical testing.

Ask a specific question about this device