(229 days)
PALABOND 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.
Palabond® 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 provided text is a 510(k) summary for the Palabond bone cement. It does not describe an AI medical device or a study involving acceptance criteria for AI performance. Instead, it focuses on the substantial equivalence of Palabond to an existing bone cement (Palacos R) based on chemical identity and mechanical performance.
Therefore, I cannot extract the information requested about acceptance criteria, study details, ground truth, or training sets for an AI device from this document.
The document indicates:
- Device Trade Name: PALABOND®
- Classification Name: Bone Cement
- Intended Use: Fixation of prostheses in the bone (partial or total hip joint replacement at the hip, knee or other joints).
- Comparison: Palabond® is chemically identical to Palacos® R, with the only difference being the addition of bigger particles (granules) of copolymer to the powder.
- Performance Claim: The mechanical performance is equivalent (see test report).
The "test report" mentioned in the last point would contain the actual mechanical performance data and acceptance criteria used to establish equivalence, but this report is not included in the provided text.
§ 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.”