(80 days)
The iTotal® CR Knee Replacement System 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, patello-femoral or bi-compartmental prosthesis. The indications for use include:
Painful joint disease due to osteoarthritis, traumatic 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, hemiarthoplasties, and unicondylar, patello-femoral or bi-compartmental implants. The implant is intended for cemented use only.
The proposed iTotal CR Knee Replacement System (hereafter referred to as the "iTotal CR KRS") is a patient specific tri-compartmental faceted posterior cruciate ligament (PCL) retaining knee replacement system. The iTotal CR KRS is a semi-constrained cemented knee implant which consists of a femoral, tibial and patellar component. The product is designed for bone preservation, with minimal bone resection of the tibia and femur for the treatment of severe pain and/or disability of a knee damaged by osteoarthritis or trauma. The joint restoring design provides for more natural kinematics by maintaining the patient specific femoral sagittal curves, preserving the patient specific femoral offset, preserving the medial and lateral joint lines and having a patient specific fit.
The provided text describes a medical device, the ConforMIS iTotal Cruciate Retaining (CR) Knee Replacement System, and its clearance process. However, it does not contain information related to a study that establishes acceptance criteria for performance metrics of a device, nor does it describe a study involving an algorithm's performance in a diagnostic or image analysis context.
This document is a 510(k) summary for a knee replacement system, which focuses on demonstrating substantial equivalence to predicate devices through mechanical testing and software validation for surgical planning assistance, rather than clinical performance metrics in terms of diagnostic accuracy or reader improvement.
Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving device meets them, as it is not present in the provided text.
Here's why and what information is available:
- Type of Device: This is for a physical medical implant (knee replacement system), not an AI/algorithm-driven diagnostic or image analysis device that would have performance metrics like sensitivity, specificity, or reader improvement.
- Focus of the Document: The document is a 510(k) summary, which aims to demonstrate "substantial equivalence" to already marketed devices. This typically involves:
- Descriptions of the device and its intended use.
- Comparison to predicate devices.
- Non-clinical testing (e.g., mechanical, software validation) to show safety and effectiveness are comparable.
- Crucially, it explicitly states: "Clinical data is not necessary to demonstrate substantial equivalence." This means no patient outcome or diagnostic performance study was provided or required for this clearance.
The document does mention:
- Software validation testing: "Software validation testing of proprietary software" was performed. This implies the software used for designing the patient-specific implant was validated, but details of this validation (e.g., specific metrics, acceptance criteria, sample size, ground truth) are not provided. This validation would likely pertain to aspects like geometric accuracy, consistency, etc., not diagnostic performance.
- Other testing: Patello femoral lateral subluxation testing, Femoral fatigue testing, and Cadaveric testing were performed to establish substantial equivalence. These are mechanical and functional tests for the physical implant components.
§ 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.