(156 days)
The iTotal Identity Cruciate Retaining (CR) Knee Replacement System (KRS) is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis.
The Indications for Use include:
• Painful joint disease due to osteoarthritis, traumatoid arthritis, rheumatoid arthritis or osteonecrosis of the knee.
· Post traumatic loss of joint function.
· Moderate varus, valgus or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.
· Failed osteotomies, hemiarthroplasties, and unicondylar, patellofemoral or bicompartmental implants.
· Revision procedures provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.
This implant is intended for cemented use only.
The iTotal Identity® Cruciate Retaining Knee Replacement System (hereafter referred to as the "iTotal Identity CR KRS") is a patient specific tricompartmental faceted posterior cruciate ligament (PCL) retaining knee replacement system. The iTotal Identity CR KRS is a semi-constrained, cemented knee implant which consists of femoral, tibial, and patellar components.
Using patient imaging and a combination of proprietary and off the shelf software, a patient-specific implant is designed that best meets the geometric and anatomic requirements of the specific patient. The femoral component is manufactured from cobalt chromium molybdenum (CoCrMo) alloy. The tibial component includes a metal tray and tray keel stem extension manufactured from titanium (Ti6AL4V-ELI) alloy, a tibial tray keel cap manufactured from polyethylene (UHMWPE), and either one or two polyethylene inserts. These inserts may be manufactured from either UHMWPE or iPoly® XE (a highly cross-linked Vitamin E infused polyethylene). The patellar component is provided in either a round or oval dome shape and may be manufactured from either UHMWPE or iPoly® XE.
For user convenience, and similar to the primary predicate iTotal CR KRS, single-use, patient-specific ancillary orthopedic manual surgical instruments designed for use with the proposed iTotal Identity CR KRS are provided to assist in the positioning of the total knee replacement components intraoperatively and in guiding the cutting of bone. In addition, reusable orthopedic manual surgical instruments are provided separately.
This document describes a 510(k) premarket notification for the "Conformis iTotal Identity Cruciate Retaining Knee Replacement System." It does not contain information about an AI/ML medical device. Therefore, I cannot provide the requested details regarding acceptance criteria, study design, ground truth establishment, or expert involvement for an AI/ML device.
The provided text focuses on demonstrating substantial equivalence of a knee replacement system to legally marketed predicate devices through:
- Intended Use and Indications for Use: Comparing the new device's intended use and indications to those of predicate devices.
- Technological Characteristics: Analyzing the operating principle, design, materials, and sterilization methods.
- Non-clinical Testing: Listing various mechanical and material tests performed (e.g., cadaver testing, fatigue testing, biocompatibility, sterilization validation) to ensure the new device performs similarly and is safe.
There is no mention of a machine learning model, a test set for AI performance, expert labeling, or human-in-the-loop studies.
§ 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.