(30 days)
The Identity Imprint CR Total 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, patellofemoral or bicompartmental 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, 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 CS insert option should be utilized when additional anterior-posterior constraint is desired.
The subject device, Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Insert, 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 of bone. In addition, reusable orthopedic manual surgical instruments are provided separately.
This submission also seeks clearance of Cruciate Sacrificing (CS) Insert to be used with the cleared (secondary predicate) Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS).
The provided text describes the Conformis Inc. Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Insert. However, it does not contain the level of detail requested for acceptance criteria and the study proving a device meets those criteria, particularly for a software-driven device or AI model.
The document is a 510(k) Premarket Notification summary for a medical device, which focuses on demonstrating substantial equivalence to a legally marketed predicate device. The "Non-Clinical Performance Evaluation" section for this orthopedic implant lists only:
- Virtual Range of Motion (ASTM F2083)
- Verification/Validation Bioskills Lab
These are typical performance tests for a physical implant, not a software or AI device. The document does not provide information on:
- Specific acceptance criteria metrics (e.g., sensitivity, specificity, accuracy, error rates)
- Reported device performance against such metrics
- Sample sizes for test sets (beyond general "patient imaging (either CT or MR scans)" for design selection)
- Data provenance (country of origin, retrospective/prospective)
- Number and qualifications of experts for ground truth
- Adjudication methods
- Multi-reader multi-case (MRMC) comparative effectiveness studies
- Standalone algorithm performance
- Type of ground truth used (beyond design rules based on patient imaging and anatomical requirements)
- Training set sample size
- How ground truth was established for the training set
Therefore, I cannot populate the requested table and answer the detailed questions based on the provided text, as this information is not present for this particular medical device submission. The device described is a physical knee replacement system, not an AI/software device that would typically have the acceptance criteria and study details requested.
§ 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.