(29 days)
Identity Imprint CR KRS
The Identity Imprint 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 unicondylar, patellofemoral or bicompartmental prosthesis.
The Indications for Use include:
· Painful joint disease due to osteoarthritis, traumatoid 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.
Identity Imprint PS KRS
The Identity Imprint PS 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 unicondylar, patellofemoral or bicompartmental prosthesis.
The Indications for Use include:
· Painful joint disease due to osteoarthritis, traumatoid arthritis, polyarthritis, polyarthritis or osteonecrosis of the knee.
· Post traumatic loss of joint function
- · Moderate varus, valgus or flexion deformity
· Failed osteotomies, hemiarthroplasties, and unicondylar, patellofemoral or bicompartental implants
· Revision procedures provided that the 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 subject device. Identity Imprint Knee Replacement System, is a knee replacement system including standardized implant sizes combined with standard and patient-specific ancillary surgical instrumentation. As with all Conformis Knee Replacement Systems (KRS), the Identity Imprint Knee Replacement System is semi-constrained knee implants which consist of a femoral, tibial, and/or patellar components. The products are intended for treatment of severe pain and/or disability of the knee damaged by osteoarthritis or trauma.
Using patient imaging (either CT or MR scans), a standard implant is selected that best meets the geometric and anatomic requirements of the specific patient. The femoral components of the subject devices are manufactured from cobalt chromium molybdenum (CoCrMo) alloy. The tibial component includes a metal tray manufactured from titanium alloy and polyethylene inserts. The patellar components are manufactured from UHMWPE.
For user convenience, single-use, standard and patient-specific ancillary orthopedic manual surgical instruments designed for use with the selected Identity Imprint implants 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.
The provided text is a 510(k) summary for a knee replacement system. It details the device description, indications for use, and a comparison to predicate devices, focusing on a change in packaging configuration. It does not contain information about the performance of an AI/ML device, nor does it provide acceptance criteria or a study proving that a device meets such criteria in terms of analytical or clinical performance.
Therefore, I cannot extract the information required to populate the table of acceptance criteria and reported device performance, or to answer the subsequent questions regarding sample sizes, expert involvement, ground truth, or MRMC studies.
The document discusses the substantial equivalence of the "Identity Imprint Knee Replacement System" based on its technological characteristics and intended use being identical to a predicate device, with the specific modification being an alternate packaging configuration. The "Non-Clinical Performance Evaluation" section explicitly states:
"The proposed packaging configuration has been previously verified/validated and cleared for use with the Conformis iTotal Hip Replacement System (K192198). A rationale (TD-05001) for the proposed packaging configuration for use with the Identity Imprint Inserts summarizes packaging testing, sterilization adoption justification, bioburden test results, and EO residual test results. This rationale supports that the proposed packaging configuration for use with the subject device are as safe, effective, and perform as well or better than the predicate device(s) packaging configuration. No new issues of safety or efficacy were raised."
This content relates to packaging and sterilization validation, not AI/ML model performance or clinical outcomes related to diagnostic accuracy or effectiveness which would typically involve the requested criteria.
§ 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.