(87 days)
- Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
- Correction of varus, valgus, or posttraumatic deformity.
- Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
The device is a single use implant intended for implantation with bone cement.
The Maxim Accel Knee System is intended to replace the articular portions of the knee joint. The system consists of three femoral components with augmentation pieces and three modular tibial bearings.
The provided text describes a 510(k) premarket notification for the "Maxim Accel Knee System." This document is a summary of safety and effectiveness, and it focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and proving performance through a clinical study for a novel device or AI algorithm.
Therefore, the requested information elements related to acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable in this context.
Here's a breakdown of why these elements are not present and what the document does provide:
- Acceptance Criteria and Reported Device Performance: This device is a traditional medical implant (knee replacement system). Its "performance" is primarily assessed through mechanical testing and comparison to predicate devices, not through performance metrics like accuracy, sensitivity, or specificity found in AI/diagnostic device studies. The document only states "All mechanical testing was done in accordance to 1994- Draft guidance for the preparation of Premarket Notifications (510(j)s) for cemented, semi-constrained total knee prostheses." This indicates compliance with established mechanical testing standards for knee prostheses, but no specific acceptance criteria or reported values are listed in this summary.
- Clinical Testing / Studies: The document explicitly states: "Clinical Testing: None provided as a basis for substantial equivalence." This means no human clinical studies were conducted or submitted for this 510(k) application to prove the device meets specific clinical performance criteria. The device's approval is based on its similarity to previously cleared devices.
- Sample Sizes, Data Provenance, Expert Ground Truth, Adjudication, MRMC, Standalone Performance, Training Set: All of these elements are typically associated with studies involving human data, particularly for diagnostic devices, AI algorithms, or comparative effectiveness studies, none of which were performed for this 510(k) submission.
In summary, the provided document is a regulatory submission for a physical medical implant (knee system) based on substantial equivalence, not a study evaluating an AI algorithm or diagnostic device with defined acceptance criteria and clinical performance metrics.
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.