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The Cytori Lipoplasty System is intended for use in the following surgical specialties when the fragmentation, emulsification, and aspiration of soft tissue is desired:

• · Neurosurgery
• · Gastrointestinal and Affiliated Organ Surgery
• · Urological Surgery
• · Plastic and Reconstructive Surgery
• · General Surgery
• · Orthopedic Surgery
• · Gynecological Surgery
• · Thoracic Surgery
• · Laparoscopic Surgery

The Cytori Lipoplasty System is indicated for use when the fragmentation, and aspiration of subcutaneous fatty tissues for aesthetic body contouring is desired.

The Celase Reagent is intended for use in the fragmentation, disaggregation, and liquefaction of soft tissues and subcutaneous fatty tissues within the Lipoplasty System's Collection Canister.

The Cytori Lipoplasty System with Celase Reagent is provided in two packaged assemblies: 1). Lipoplasty Unit and 2). Celase Reagent. The Lipoplasty Unit is a single-use disposable device designed to utilize house vacuum to create suction within the hollow liposuction cannula and remove subcutaneous fatty tissue from the patient and transport the adipose tissue into the collection canister. The Celase Reagent is a single-use, non-reusable reagent designed to digest the waste tissue in the collection canister as a means to allow the non-reasons rought designed the screen and mitigate down-stream clogging and blockage in the waste system.

The provided text is a 510(k) premarket notification letter and related documentation for the Cytori Lipoplasty System with Celase Reagent. It establishes substantial equivalence to existing predicate devices but does not contain information about acceptance criteria or a study designed to prove the device meets specific performance acceptance criteria.

The document discusses the device's intended use, design characteristics, material composition, and sterility, and it details its equivalence to existing marketed products (MacroPore Lipoplasty System, Flow Laboratories Trypsin, and Oxoid USA Sputasol).

The only mention of "In Vitro Testing" states: "Mechanical testing of the Cytori Lipoplasty System with Celase Reagent demonstrates that the device is substantially equivalent to the predicate." This is a general statement and does not provide specific acceptance criteria, performance metrics, sample sizes, ground truth establishment, or details of a study setup.

Therefore, I cannot provide the requested information.

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