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THE NORTECH OMNIFLATOR® 7640 SHALL BE USED FOR GAS DISTENTION OF THE ABDOMEN FOR DIAGNOSTIC AND / OR OPERATIVE LAPAROSCOPY.

The Omniflator® Model 7640 CO, Gas Insufflator incorporates front panel controls similar to our current Omniflator® Model #6630/6600. The 7640 has an adjustable gas flow rate from 0-40 LPM. The unit shall have direct patient pressure monitoring which can be used by attaching the direct patient monitoring tubing set to the Omniflator's® patient monitoring connector and subsequently into a cannula or trocar after initial insufflation has been achieved. The user has an option to utilize CO, from a central supply or E-Cylinder tank.

The provided text is a 510(k) summary for the Nortech Omniflator® 7640 Laparoscopic Insufflator. It describes the device, its intended use, and states that it is substantially equivalent to legally marketed predicate devices.

However, this document does not contain information about:

• Specific acceptance criteria for device performance (numerical thresholds for accuracy, precision, etc.).
• A study proving the device meets acceptance criteria.
• Sample sizes for test or training sets.
• Data provenance.
• Number/qualifications of experts or ground truth establishment methods.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance studies.
• Type of ground truth used.

The document is a regulatory submission demonstrating substantial equivalence to existing devices, which is a different type of evaluation than a study proving performance against specific acceptance criteria. The substantial equivalence relies on the device being similar in design, materials, and intended use to previously cleared devices.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study proving the device meets them based on the provided text.

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