(269 days)
The Engage™ Partial Knee System is intended for medial unicompartmental knee arthroplasty to treat one or more of the following conditions:
- Moderately disabling joint disease of the knee resulting from painful osteo- or post traumatic arthritis.
- Revision of previous unsuccessful surgical procedures, including prior unicompartmental knee arthroplasty
- As an alternative to tibial osteotomy in patients with Unicompartmental osteoarthritis.
The femoral component and tibial tray are intented fixation. The porous surfaces of both the femoral and tibial tray components provide biological fixation when used in a cementless application. When the tibial tray is implanted without the use of bone cement, the tibial anchor should be used. When the tibial tray is implanted with bone cement, the tibial anchor should not be used.
The Engage™ Partial Knee System is a unicompartmental knee system comprised of tibial trays, tibial inserts, tibial anchors, and femoral components. The implant geometry is optimized for the medial compartment. The Engage™ Partial Knee System permits all sizes of femur to be interchangeable with all sizes of tibial trays and associated tibial insert combinations. The tibial anchor are composed of Ti-6AI-4V alloy, the tibial insert is composed of UHMWPE, and the femoral component is composed of CoCrMo alloy. The tibial tray includes pegs and an engineered porous surface, while the femoral component includes pegs and a sintered porous coating; both of which are intended for biological fixation when used without bone cement and to enhance fixation when used with PMMA bone cement. The Engage™ Partial Knee System is intended for cemented or uncemented replacement of the medial compartment of the knee. The tibial anchors provide for supplemental fixation of the tibial tray when implanted without bone cement. The tibial anchor is not used when the tibial tray is implanted with bone cement.
Based on the provided text, the document is a 510(k) Premarket Notification for a medical device called "The Engage™ Partial Knee System." This document primarily focuses on demonstrating the substantial equivalence of this knee implant system to previously cleared predicate devices.
It does NOT describe an AI/ML-driven device or study that proves an AI device meets acceptance criteria.
Therefore, I cannot extract the requested information regarding acceptance criteria for an AI device, sample sizes for a test set, ground truth establishment by experts, MRMC studies, or training sets. The document details performance testing for a physical orthopedic implant device, not an AI algorithm.
The "Performance Data" section (F. PERFORMANCE DATA) lists pre-clinical performance testing conducted for the physical knee system, adhering to FDA guidance and ASTM/ISO standards. These tests are about the mechanical, biological, and material properties of the implant itself, such as:
- Tibial baseplate fatigue strength
- Range of Motion (ROM), contact pressure, and area of tibiofemoral articulation of UHMWPE inserts
- Constraint testing
- Resistance to dislodgement of the tibial insert
- Biomechanical evaluation under cyclic loading
- Evaluation of porous fixation surfaces
- Validation of additive manufacturing process
- Validation of packaging and shelf life
- Bacterial endotoxins test
- Validation of reusable instrument reprocessing parameters
These are tests for a physical medical device, not an AI/ML algorithm.
§ 888.3535 Knee joint femorotibial (uni-compartmental) metal/polymer porous-coated uncemented prosthesis.
(a)
Identification. A knee joint femorotibial (uni-compartmental) metal/polymer porous-coated uncemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surface. It has no linkage across-the-joint. This generic type of device is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra-high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial baseplate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.