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The Stryker Strykeflow Suction Irrigator Gravity Flow (SIGF) is an irrigation suction device which is provided sterile for single use disposable application. The SIGF accepts a variety of tips for laparoscopic and open general surgery, laparoscopic and open obstetric surgery, laparoscopic and open urologic surgery, endoscopic and open nasal surgery, open otolaryncologic surgery, and open plastic surgery.

The Stryker Strykeflow Suction Irrigator Gravity Flow (SIGF) is an irrigation suction device which is provided sterile for single use disposable application. The SIGF accepts a variety of tips for laparoscopic and open general surgery, laparoscopic and open obstetric surgery, laparoscopic and open urologic surgery, endoscopic and open nasal surgery, open otolaryncologic surgery, and open plastic surgery. The SIGF is validated per AAMI HF18 for electrocautery application. The tips may be sterile packaged and disposable (single-use only) or non-sterile packaged for reusable purposes. The SIGF is constructed of materials which are tested for biocompatibility per ISO 10993 and are safe, effective, and durable for their intended purposes. Gamma irradiation validation is per AAMI standard ST 32, method 1, section 5.2.3.1. The minimum dose for an SAL of 10to is 1.66 Mrads.

This document is a 510(k) summary for a medical device and does not contain the kind of detailed study information (acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, expert qualifications, etc.) that would typically be found in a clinical study report or a more comprehensive efficacy submission.

Therefore, I cannot extract the requested information. The provided text is a regulatory summary focused on substantial equivalence to predicate devices, material safety, and sterilization validation, rather than a performance study with detailed acceptance criteria and results.

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