(183 days)
Osteopal® is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixatio of polymer or metallic prosthetic implants to living bone.
Osteopal® 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.
This document is a 510(k) summary for the medical device OSTEOPAL®, a bone cement. The purpose of a 510(k) summary is to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. This type of submission focuses on comparing the new device's technological characteristics, indications for use, and performance to an existing device rather than presenting extensive de novo clinical trials to establish acceptance criteria and prove its meeting.
Therefore, the provided document does not contain the information requested regarding acceptance criteria and a study proving the device meets them in the format typically found for AI/ML device submissions. Specifically, it lacks:
- A table of acceptance criteria and reported device performance: This document explicitly states that the new device, Osteopal®, is the known Osteopal® marketed by Merck (or Palacos E-Flow by S.-P.) and refers to an existing PMA (P810020). This implies equivalence to a previously approved device, not validation against new performance criteria.
- Sample size, data provenance, number of experts, adjudication method, MRMC comparative effectiveness study results, standalone performance, type of ground truth, training set sample size, and ground truth establishment for the training set: These are all elements typically found in studies for novel devices, especially those incorporating AI/ML, where performance metrics like sensitivity, specificity, or AUC are evaluated against a defined ground truth derived from expert review or pathology. Since this is a 510(k) for a bone cement claiming equivalence, such detailed performance studies with human interpretation or AI assistance are not part of this submission.
In summary, the provided 510(k) summary for OSTEOPAL® is a regulatory submission for a traditional medical device (bone cement) claiming substantial equivalence to a predicate device. It is not an AI/ML device submission and therefore does not contain the information requested about acceptance criteria and associated performance studies as typically understood for such technologies.
§ 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.”