(630 days)
Bone Cement LV and HV are indicated for the fixation of joint prostheses to living bone in orthopedic musculoskeletal surgical procedures for rheumatoid arthritis, sickle cell anemia, osteoarthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe joint destruction secondary to trauma or other conditions and revision of previous arthroplasty.
Bone Cement Genta are intended for the fixation of prosthesis to living bone in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.
The Bone Cement Genta are PMMA, radiopaque bone cements, containing gentamicin designed for the fixation of prosthesis to the living bone. The devices are a traditional bone cement product. The liquid is contained in a vial and the powder in a sachet; these components are packaged in unitary blister with Tyvek lid, which is placed in an aluminum bag. The components are manually mixed immediately prior to use. The devices are sold disposable and sterile. The Bone Cement Genta are available in a low and high viscosity version.
The Bone Cement are PMMA, radiopaque bone cements designed for the fixation of prosthesis to the living bone. The devices are a traditional bone cement product. The liquid is contained in a vial and the powder in a sachet; these components are packaged in unitary blister with Tyvek lid, which is placed in an aluminum bag. The components are manually mixed immediately prior to use. The devices are sold disposable and sterile. The Bone Cement are available in a low and high viscosity version.
The provided text is a 510(k) summary for polymethylmethacrylate (PMMA) bone cements. It details the device's characteristics, intended use, and comparison to predicate devices. However, this document does not contain the specific acceptance criteria or the study results in the format or level of detail requested for the device performance.
The section titled "PERFORMANCE DATA" (starting on page 9) lists the types of performance testing conducted but does not provide quantitative acceptance criteria or the reported device performance. It only states that the performance data demonstrate that the new devices are substantially equivalent to the predicate devices, and meet the requirements of the Special Controls Guidance Document.
Therefore, I cannot complete the table of acceptance criteria and reported device performance from the provided document. Similarly, details about sample sizes, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, or training set specifics for an AI/algorithm are not present as this document pertains to a bone cement, not an AI or imaging device.
If this were an AI/imaging device submission, the provided information would be insufficient to answer most of the requested points.
§ 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.”