(88 days)
The Search Evolution Total Knee System is indicated for use in reconstruction of the diseased knee joint caused by osteoarthritis, rheumatoid arthritis, posttraumatic arthritis, the need to revise failed arthroplasties or osteotomies where pain, deformity or dysfunction persist, and for patients suffering from correctable valgus or varus deformity and moderate flexion contracture.
For Posterior Stabilized (PS) Components:
Absent or non-functioning posterior cruciate ligament and severe anteroposterior instability of the knee joint.
The Search Evolution Knee is designed for use with bone cement.
The cemented Search Evolution Knee System is available with two femoral designs, the Posterior Stabilizing (PC) and the Ligament, Cruciate (LC) which retains the ligament (PCL) during implantation. Both designs of the femoral components, and interchangeable tibial plateaus (trays) are manufactured from CoCrMo. The tibial "gliding surfaces" (inserts) and patellas are manufactured from UHMWPE.
The provided text describes the "Search Evolution Total Knee System" (K021313). However, it does not contain information about specific acceptance criteria or a detailed study proving the device meets those criteria in the format requested.
The document is a 510(k) Pre-market Notification summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing performance data against predefined acceptance criteria for a novel device.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
Missing. The document states: "All required testing per 'Draft Guidance for the Preparation of Premarket Notifications (510(k)s) for Cemented, Semi-constrained Total Knee Prostheses' were completed. Biomechanical testing results demonstrate the Search Evolution Knee System is substantially equivalent to other knee systems currently on the market."
This indicates that specific biomechanical tests were performed according to a guidance document, and the results were deemed equivalent to other marketed devices. However, the document does not list the specific acceptance criteria from that guidance (e.g., maximum deflection under load, wear rates, fatigue life) nor does it report the actual numerical performance results of the Search Evolution Total Knee System against these criteria. It only states that the results "demonstrate substantial equivalence."
2. Sample Size Used for the Test Set and Data Provenance
Missing. No information on the sample size for individual tests (e.g., number of knee implants tested for fatigue or wear) or the provenance of any data (e.g., country of origin, retrospective/prospective clinical data) is provided. The document primarily refers to biomechanical testing, which typically involves in-vitro lab tests rather than human subject data for 510(k) clearance of this type of device.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable/Missing. This information is relevant for studies involving expert review (e.g., image analysis, clinical judgment). For a knee implant demonstrating substantial equivalence through biomechanical testing, "ground truth" as typically understood in AI/imaging studies (e.g., expert consensus on a diagnosis) is not applicable. The "ground truth" would be the performance standards set by the guidance document for mechanical properties.
4. Adjudication Method
Not applicable/Missing. See point 3. This is relevant for expert-based assessments, not for demonstrating mechanical properties against a standard.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document does not mention any MRMC study. This type of study is relevant for diagnostic devices that involve human interpretation of outputs (e.g., AI for medical imaging). The Search Evolution Total Knee System is a physical implant.
6. Standalone (Algorithm Only) Performance
Not applicable. The device is a physical knee implant, not an algorithm.
7. Type of Ground Truth Used
For a device like the Search Evolution Total Knee System, the "ground truth" effectively refers to established mechanical and material performance standards and specifications detailed in the "Draft Guidance for the Preparation of Premarket Notifications (510(k)s) for Cemented, Semi-constrained Total Knee Prostheses." The device's performance is compared against these industry-accepted benchmarks and those of legally marketed predicate devices.
8. Sample Size for the Training Set
Not applicable. This device is a physical medical device, not an AI/ML model that requires a training set. The term "training set" is typically used in the context of machine learning model development.
9. How the Ground Truth for the Training Set Was Established
Not applicable. See point 8.
Summary of available information regarding the "study" for K021313:
The "study" or testing conducted for the Search Evolution Total Knee System involved biomechanical testing as required by the "Draft Guidance for the Preparation of Premarket Notifications (510(k)s) for Cemented, Semi-constrained Total Knee Prostheses." The purpose of these tests was to demonstrate substantial equivalence to several predicate devices, including the Scorpio and Gem Knee Systems. The document explicitly states that the "biomechanical testing results demonstrate the Search Evolution Knee System is substantially equivalent to other knee systems currently on the market." This suggests that the performance metrics measured during these biomechanical tests met or were comparable to the performance of the predicate devices and the standards outlined in the guidance document. However, numerical results or specific acceptance criteria are not provided in this summary document.
§ 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.