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COPAL® exchange G hip spacer (polymethy)methacrylate / gentamicin) is indicated for temporary use (maximum of 180 days) as a total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. The device is inserted into the femoral medullary canal and acetabular cavity following removal of the existing implant and radical debridement. The device is assigned to be used in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). COPAL® exchange G hip spacer is not intended for use for more than 180 days, at which time it must be explanted, and a permanent device implanted, or another appropriate treatment performed (e.g., resection arthroplasty, fusion etc.). COPAL® exchange G hip spacer is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers, canes) throughout the implantation period.

COPAL® G+V (gentamicin and vancomycin) is a PMMA bone cement intended for fixation of COPAL® exchange G hip spacer to the host bone.

COPAL® exchange G hip spacer is a temporary hip spacer implant as part of two-stage septic endoprosthesis revision based on bone cement. COPAL® exchange G hip spacer contains gentamicin. Gentamicin reduces the risk for bacterial colonization of the device and is released into the fluid surrounding the joint. COPAL® exchange G hip spacer is intended for single-use and is supplied sterile.

COPAL® exchange G hip spacer is made of fully formed polymethyImethacrylate (radiopaque PMMA with gentamicin) and contains an inner stainless steel (AISI 316L) reinforcing structure. The mass used in the filling of the molds (the PMMA unformed resin) is prepared from a powder component and a liquid component. It contains the X-ray contrast medium carbonate. To improve visibility in the surgical field, it has been colored with chlorophyll-copper-complex (E141).

COPAL® G+V is a standard-setting, high-viscosity, radiopaque, poly(methy) methacrylate)-based (PMMA) bone cement, containing gentamicin and vancomycin, designed for fixation of COPAL® exchange G hip spacer to the host bone. COPAL® G+V is intended for single-use and is supplied sterile.

The provided text is a 510(k) summary for the COPAL® exchange G hip spacer and COPAL® G+V. It describes the device, its intended use, and the testing performed to demonstrate substantial equivalence to a predicate device.

However, the document does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/algorithm-driven medical device. The section "VII. PERFORMANCE DATA" primarily focuses on mechanical testing, biocompatibility, packaging, sterilization, and shelf life for a physical medical device (hip spacer and bone cement). It also mentions a "Clinical evaluation" but clarifies it was to "analyze the existing clinical data of predicate device and legally marketed U.S. devices" and "no unknown complications that have not yet been described in the instructions for use were found." Crucially, it explicitly states, "No clinical tests were performed to demonstrate substantial equivalence."

Therefore, I cannot extract the information required to answer your prompt, as the prompt's assumptions (acceptance criteria, test set, ground truth, MRMC study, standalone performance for an algorithm) are not applicable to the content of this 510(k) summary for a physical orthopedic device.

If you have a document describing an AI/algorithm-driven medical device and its performance studies, please provide that document, and I will be happy to attempt to extract the requested information.

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