(183 days)
The patient should be skeletally mature to receive a knee replacement. The Rx Knee System is indicated for temporary use (maximum 180 days) as an adjunct to total knee replacement (TKR) in 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 intended for use in conjunction with systemic antimicrobial therapy (standard treatment approach to an infection).
The device is intended for use with the gentamicin-loaded cement. Palacos® G.
The Rx Knee System 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.).
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 Rx Knee System is a temporary knee device consisting of femoral, all polyethylene tibial and patellar components, with femoral and tibial augments and a tibial or universal stem to accommodate for variants in patient anatomy. The femoral component is available in posterior stabilised and cruciate retaining variants intended for use with corresponding all polyethylene tibia variants that have been previously cleared as part of Signature Orthopaedics' World Knee System via K181530. The femoral and tibial components have been previously cleared as part of Signature Orthopaedics' World Knee System via K181530, K220737 and K223062. All Rx Knee System components are intended for use with FDA-cleared gentamicin-loaded bone cement.
The device is intended to be used for patients undergoing a two-stage revision procedure for infection of a total knee implant. The Rx Knee System components are sterile, single-use devices intended for temporary use as a total knee replacement.
Materials: Cast Cobalt Chromium (CoCr) alloy (ASTM F75 and ISO 5832-4) for the femoral component, Wrought Titanium-6Aluminium-4Vanadium ELI Alloy (Ti6Al4V ELI, ASTM F136-13) for femoral and tibial augment components, tibial stem, stem extension adapter and locking screw, Ultra-High-Molecular-Weight Polyethylene (UHMWPE) or Vit-E HXLPE for the femoral and tibial components and All-poly tibial components previously cleared as part of predicate World Knee System, and titanium nitride (TiN) diamond-like carbon (DLC) for coating femoral components which is the subject of FDA device master file no. 1647.
This document is an FDA 510(k) Premarket Notification review for a medical device, the "Rx Knee System". It details the device's description, indications for use, comparison to predicate devices, and performance testing conducted to demonstrate substantial equivalence.
However, the document does not contain specific acceptance criteria, or details of a study that proves the device meets those criteria, in the format typically used for studies validating AI/ML medical devices. The performance testing outlined here is primarily engineering evaluations and comparisons to existing predicate devices, not clinical studies with human participants against a defined ground truth for a diagnostic or predictive AI/ML model.
Therefore, I cannot extract the requested information regarding acceptance criteria, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to an AI/ML device validation.
The information provided pertains to a traditional medical device (knee prosthesis), and the "performance testing" described focuses on mechanical performance, biocompatibility, sterility, and antibiotic elution to demonstrate substantial equivalence to existing devices, which is the standard for 510(k) clearances. It does not describe a study that validates an AI/ML algorithm's performance against a clinical "ground truth".
§ 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.