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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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