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The REMEDY Stemmed Knee Spacer, which consists of a modular femoral, tibial and stem extension components, is indicated for temporary use (maximum 180 days) as an adjunct to total knee replacement (TKR) in skeletally mature patients undergoing a two-stage procedure due to a septic process and where gentamicin is the most appropriate antibiotic based on the susceptibility pattern of the infecting micro-organism(s).

The device is applied on the femoral condyles (femoral component) and on the tibial plate (tibial component) following removal of the existing implant and radical debridement. The use of the stem extension component is optional to replace the space occupied by the previous femoral and/or tibial stem (dead space management). Moreover, if necessary, the tibial component could be coupled with the OsteoRemedies REMEDY Tibial Insert Wedge when a large tibial defect is present.

The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).

The REMEDY Stemmed Knee Spacer is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion etc.). Because of the inherent mechanical limitations of the device materials (gentamicin/polymethylmethacrylate), the device is only indicated for patients who will consistently use traditional mobility assist devices (e.g., crutches, walkers, canes) throughout the implantation period, allowing basic joint mobility.

The REMEDY Stemmed Knee Spacer System is a temporary knee spacer system consisting of femoral, tibial, and tibial wedge components, and stem extensions which can be combined to address dead space management following explantation of an infected total knee arthroplasty device. These components are available in different sizes to generally match the sizes of the explanted components and to accommodate variations in patient anatomy.

The stem extension components can be coupled with the femoral and tibial implant components to address dead space management in the femoral and tibial intramedullary canals following removal of infected stemmed prostheses.

The components of the REMEDY Stemmed Knee Spacer System are sterile, single-use devices intended for temporary use (maximum 180 days) as joint replacement. The components are made of fully formed polymethylmethacrylate (PMMA), which is radiopaque and contains gentamicin. The stem components have a stainless steel core.

The REMEDY Stemmed Knee Spacer System provides patients a temporary complete knee implant that allows for a natural range of motion and partial weight-bearing during treatment of the infection, and preserves the soft tissue to prevent further complications, such as muscular contraction, to facilitate the subsequent joint replacement procedure after systemic treatment of the underlying infection. The components of the REMEDY Stemmed Knee Spacer System are protected from bacterial adhesion due to the presence of gentamicin.

The provided text describes a medical device, the REMEDY Stemmed Knee Spacer, and its FDA 510(k) clearance. This type of clearance is based on demonstrating "substantial equivalence" to a predicate device, rather than a full pre-market approval (PMA) which would require extensive clinical efficacy and safety studies.

Therefore, the information you've requested regarding acceptance criteria for an AI/algorithm-based device and the study that proves it meets those criteria is not applicable to this document. This document pertains to a physical medical device (a knee spacer) and its mechanical, material, and biological properties, not a software-based AI device.

The "Performance Data" section describes:

• Sterilization and Shelf Life: Validation of sterilization cycles and stability studies for shelf life.
• Biocompatibility: Evaluation conforming to ISO 10993 and FDA guidance.
• Performance Testing of Subject REMEDY Stemmed Knee Spacer: This specifically mentions "Antibiotic elution testing," "Fatigue behavior of the stem extensions," and "Interconnection strength." These are all physical and chemical performance characteristics of the knee spacer itself.

Since the request asks for details related to AI/algorithm performance and ground truth, which are not relevant to this physical device's clearance, I cannot fill out the requested table or answer the specific questions about AI/algorithm study design using the provided text.

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