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The LAP-iX Suction Irrigation provides suction or irrigation to a surgical site during laparoscopic and endoscopic procedures.

The LAP-iX Suction Irrigation provides suction or irrigation to a surgical site during laparoscopic and endoscopic procedures. It delivers sterile irrigation fluids to surgical site and evacuates blood and body fluids from the surgical site to aid visualization. It consists of 4.50 diameter shaft, suction/irrigation buttons and suction/irrigation tubes with hand piece. It has two types of hand piece, pistol and trumpet grip. The subject device is compatible with all suction and irrigation pumps in the market which have the connecting tubes or connectors of Ø10mm (Suction) or Ø7mm(Irrigation). All equipment conforming to this specs can be used. It is provided sterile, for Rx only and single use.

The provided text does not contain information about the acceptance criteria and the study that proves the device meets those criteria in the context of an AI/ML-driven medical device.

The document is a 510(k) clearance letter for a LAP-iX Suction Irrigation device. This is a conventional medical device used in laparoscopic and endoscopic procedures for surgical suction and irrigation.

The "Performance Data" section (page 4, point 7) lists general verification, validation, and testing activities, including:

• Sterilization Validation Test in accordance with ISO11737-1
• Shelf Life Validation Test in accordance with ASTM F 1980
• Biocompatibility Tests in accordance with ISO 10993 (specifically ISO 10993-5 for Cytotoxicity, and ISO 10993-7 for Ethylene Oxide Sterilization Residuals, ISO 10993-10 for Skin Sensitization and Irritation)
• Performance Tests: Air tightness, Suction and Irrigation Test

It states that "The device passed all of the tests based on pre-determined pass/fail criteria." However, it does not provide the specific acceptance criteria that were pre-determined, nor does it detail the results of these tests (e.g., specific values for air tightness, suction, or irrigation performance).

Therefore, I cannot provide the requested information regarding acceptance criteria, reported performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details, as these are typically relevant for AI/ML device evaluations and are not present in this document for a traditional physical medical device.

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