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The S&T Micro Anastomosis Clamp is a hand held surgical instrument that is designed to be used in Microvascular Surgery to either temporarily occlude or approximate blood vessels during the anastomosis process. The clamps are available in three different size ranges and are to be used on vessels that range in size from 0.4mm to 2.25mm. The clamps are used to facilitate surgical procedures that are typically called "free flaps" or replants. Once the micro anastomosis has been completed the micro clamp is removed from the patient.

The S&T Micro Anastomosis Clamp is a hand held surgical instrument.

The provided text is an FDA 510(k) clearance letter for the S&T Micro Anastomosis Clamp. It does not contain any information about acceptance criteria or a study proving the device meets those criteria, nor does it discuss performance metrics of the device.

The document primarily focuses on:

• Confirming that the device is substantially equivalent to a legally marketed predicate device.
• Outlining regulatory requirements and general controls for the device.
• Stating the intended use of the device.

Therefore, I cannot fulfill your request for a table of acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details based on the provided text. This information is typically found in a device's 510(k) summary or clinical study reports, which are not part of this letter.

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The Micrins Micro Anastomosis Clamp is a hand held surgical instrument that is designed to be used in Microvascular Surgery to either temporarily occlude or approximate blood vessels during the anastomosis process. The clamps are available in three different size ranges and are to be used on vessels that range in size from 0.4mm to 2.25mm. The clamps are used to facilitate surgical procedures that are typically called "free flaps" or replants. Once the microanastomosis has been completed the micro clamp is removed from the patient

The Micrins Micro Anastomosis Clamp is a hand held surgical instrument that is designed to be used in Microvascular Surgery to either temporarily occlude or approximate blood vessels during the anastomosis process. The clamps are available in three different size ranges and are to be used on vessels that range in size from 0.4mm to 2.25mm.

This document is a 510(k) premarket notification letter from the FDA regarding the Micrins Micro Anastomosis Clamp (K982278). It confirms substantial equivalence to predicate devices but does not contain information about acceptance criteria or a study proving device performance.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence, not on performance data against predefined acceptance criteria.

Ask a specific question about this device

Ask a specific question about this device