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The SPIDER™ (Single Port Instrument Delivery Extended Reach) devices are intended to establish a path of entry for laparoscopic instruments for minimally invasive abdominal surgical procedures.

The SPIDER is a pre-sterilized, single use, disposable, laparoscopic device. These devices are EO sterilized.

The provided text is a 510(k) summary for the TransEnterix SPIDER™ Standard and Advanced laparoscopic device. It details the device's intended use and a comparison to a predicate device, focusing on substantial equivalence. However, the document does not contain the specific information requested about acceptance criteria or a detailed study proving the device meets those criteria.

The document only generally states: "Furthermore, verification and validation testing provided information sufficient to determine that the modifications did not have an effect on safety or effectiveness and demonstrated that the device met pre-determined acceptance criteria based on performance specifications. The testing demonstrated that the modified device is substantially equivalent to the predicate device and performs as well as the predicate device."

Therefore, I cannot provide a table of acceptance criteria, reported device performance, or details about any specific studies (sample size, data provenance, expert qualifications, etc.) as this information is not present in the provided text.

The document is a regulatory submission for premarket notification (510(k)), which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than detailed performance study reports.

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