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Reprocessed Arthroscopic Shavers are intended for resecting tissue and bone found in articular body cavities during orthopedic, maxillofacial, hand, foot and plastic surgery in patients requiring arthroscopic or orthopedic surgery.

Reprocessed Arthroscopic Burs are indicated for use in orthopedic surgical procedures of the joints, jaw or sinuses where the cutting and removal of soft and hard tissue or bone is needed in patients requiring orthopedic surgery.

Arthroscopic shavers can be used to abrade, cut and excise tissue and bone; remove loose fragments; and shave away debris in arthroscopic surgeries, as well as surgeries of the jaw and sinuses.

The arthroscopic shaver components reprocessed by Alliance Medical Corporation include a Bur or blade at the end of a long rod that rotates within a long hollow stain- less steel housing. The housing has a window cut out on one side of the distal end, allowing the Bur to cut one structure while the adjacent one is still protected by the housing on the opposite side of the bur on blade. This system attaches to a motorized handpiece that drives the internal bur or blade inside the outer housing and provides suction to pull the cut tissue away from the surgical site

The provided document K012652 is a 510(k) summary for "Reprocessed Arthroscopic Burs" and does not describe an AI/ML device. Therefore, it does not contain information related to acceptance criteria or studies proving device performance typical for AI/ML devices, such as those involving sensitivity, specificity, or human expert performance.

Specifically, the document focuses on demonstrating substantial equivalence of reprocessed medical devices to predicate devices. The performance data mentioned relates to:

• Biocompatibility
• Validation of reprocessing
• Function Test(s)

The conclusion states that performance testing demonstrates that Reprocessed Arthroscopic Burs perform as originally intended, implying that they meet the same performance standards as new, unreprocessed devices, which are the predicate devices.

Since this is not an AI/ML device submission, the requested information elements such as a table of acceptance criteria vs. reported AI performance, sample size for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable and are not present in the provided text.

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