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The Arthro-Surgimat-1500 is a high flow arthroscopic pump intended for fluid distention of the knee, shoulder, elbow, ankle, and wrist joint cavities during arthroscopic procedures.

The Arthro-Surgimat-1500 is a high flow arthroscopic pump intended to distend joint cavities. The Arthro-Surgimat-1500 is a modified version of and substantially equivalent to the device Arthro-Surgimat (K962114) manufactured by W.O.M. GmbH. The Arthro-Surgimat-1500 incorporates the same design features and accessories as the Arthro-Surgimat (K962114). The following modifications have been performed: 1. The device Arthro-Surgimat-1500 incorporates a software filter function referred to as the instrument recognition feature. The instrument recognition feature of the device measures the resistance of the tubing set and instrument being used and regulates the actual pressure accordingly. The instrument recognition feature of the device allows for a more accurate attainment of the desired intraarticular pressure. 2. The device Arthro-Surgimat-1500 incorporates an optional cable remote control for the adjustment of device parameters. Only those parameter which may be adjusted utilizing the user-interface (front panel) and the foot pedal may be adjusted utilizing the cable remote control.

The provided text is a 510(k) Summary for a medical device (Arthro-Surgimat-1500 arthroscopic pump) seeking substantial equivalence to a predicate device. It primarily discusses the device's function, modifications, and references existing literature on arthroscopic techniques. It does not contain information about acceptance criteria, specific device performance studies, sample sizes, expert involvement, or ground truth establishment.

Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance or details about a study demonstrating the device meets those criteria, as this information is not present in the provided document.

The document states:

• The Arthro-Surgimat-1500 is a modified version of and substantially equivalent to the device Arthro-Surgimat (K962114).
• Modifications include a software filter for instrument recognition and an optional cable remote control.
• The utility and safety of arthroscopic techniques using modern electronic high flow pumps are discussed in referenced literature.

The 510(k) submission process for this type of device typically relies on demonstrating substantial equivalence to a predicate device through comparison of technological characteristics and indications for use, rather than conducting new performance studies that would involve acceptance criteria, test sets, experts, or ground truth as described in your request. Clinical performance studies with defined endpoints and statistical analyses are generally reserved for Pre-Market Approval (PMA) applications or when substantial equivalence cannot be demonstrated through non-clinical means.

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