(44 days)
Use in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.
DePuy CMW 2 Gentamicin Bone Cement and DePuy CMW 3 Gentamicin Bone Cement are self-curing, polymethylmethacrylate (PMMA) bone cements containing the antibiotic gentamicin (at the rate of 1g active gentamicin in 40g of PMMA bone cement powder), for seating and securing of a metal or plastic prosthesis to living bone.
The provided text is a 510(k) premarket notification summary for medical devices, specifically bone cements. It details the device's description, intended use, and claims of substantial equivalence to previously cleared predicate devices. It does not contain information related to acceptance criteria, device performance metrics, clinical study design (sample sizes, expert qualifications, etc.), or standalone algorithm performance.
Therefore, I cannot fulfill your request for descriptions of acceptance criteria, device performance, or study details such as sample sizes, ground truth establishment, or multi-reader multi-case study results based on the provided text.
The document primarily focuses on establishing substantial equivalence for regulatory clearance, not on reporting detailed performance metrics from a specific study against acceptance criteria.
§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.
(a)
Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”