(67 days)
PALACOS® fast R+G is indicated for use as bone cement in arthroplasty procedures of the hip, knee and other joints to fix plastic and metal prosthetic parts to living bone when reconstruction is necessary. The cement is indicated for use in the second stage of a two stage revision for total joint arthroplasty after the initial infection has been cleared.
PALACOS® fast R+G is an acrylic bone cement for use in orthopedic surgery. It is formed from powder and liquid by exothermic polymerization. It secures the fixation of the grafted artificial joint improving the transfer of forces at the interface implant - bone. The antibiotic gentamicin sulphate has been added to protect the cured cement and contiguous tissue against contamination by microbes sensitive to gentamicin. PALACOS® fast R+G is available in 51 g packaging size.
The provided text describes the 510(k) premarket notification for a medical device called PALACOS® fast R+G, a radiopaque bone cement with gentamicin. It includes details about the device's classification, indications for use, and a comparison to a predicate device.
However, the document does not contain any information about a study proving the device meets acceptance criteria in the context of an AI/ML medical device. The "Discussion of preclinical tests" section refers to performance testing of the bone cement's physical and chemical properties (e.g., compressive strength, bending strength, bacterial endotoxins), and states that "All obtained data fulfill the pre-defined acceptance criteria." This is for a traditional medical device (bone cement), not an AI/ML product. The document explicitly states "No clinical data was provided."
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI/ML device meets those criteria based solely on the provided text. The questions about sample size, data provenance, expert ground truth establishment, MRMC studies, standalone performance, and training set details are all relevant to AI/ML device validation, but this document is not about an AI/ML device.
§ 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.”