(226 days)
General: The LinkSymphoKnee System is intended for primary and revision total knee replacement in skeletally mature patients with the following conditions. This device is intended for cemented use only unless a cementless modular stem is indicated for use. Indications: Primary degenerative arthritis / osteoarthritis Secondary arthritis resulting from rheumatoid arthritis Fracture
The LinkSymphoKnee System is available in multiple versions with different applications, characteristics, and materials. The LinkSymphoKnee Cruciate Retaining (CR) Fixed Bearing (FB) (cemented) consists of a cemented femoral component for crucial retaining applications made from CoCrMo, a cemented tibial component for fixed bearing (FB) applications made from CoCrMo as monoblock or modular with a modular stem or a taper cap, and an articulating surface for crucial retaining and fixed bearing applications made from cPE or X-LINKed Vit-E PE (E-Dur). The LinkSymphoKnee Posterior Stabilized (PS) Fixed Bearing (FB) (cemented) consists of a cemented femoral component for posterior stabilized applications made from CoCrMo, a cemented tibial component for fixed bearing applications made from CoCrMo as monoblock or modular with a modular stem or a taper cap, and an articulating surface for posterior stabilized and fixed bearing applications made from cPE or X-LINKed Vit-E PE (E-Dur). Additonally, the tibial components can also be replaced by an All-Poly tibial component made from cPE. The LinkSymphoKnee Posterior Stabilized Plus (PS+) Fixed Bearing (FB) (cemented) consists of a cemented femoral component for posterior stabilized applications made from CoCrMo, a cemented tibial component for fixed bearing applications made from CoCrMo as monoblock or modular with a modular stem or a taper cap, and an articulating surface for posterior stabilized plus and fixed bearing applications that provides more stability than the standard PS. The articulating surface PS+ provides a constraint from 0 to 3 degrees of varus/valgus and from 0 to 3 degrees of internal/external rotation and is made from cPE or X-LINKed Vit-E PE (E-Dur). The LinkSymphoKnee Condylar Constrained (CCK) Fixed Bearing (FB) consists of a cemented femoral component for condylar constrained applications made from CoCrMo with a cemented modular stem made from CoCrMo or with a cementless modular stem made from TiAl6V4 (Tilastan), a cemented modular tibial component for fixed bearing applications made from CoCrMo with a cemented modular stem (CoCrMo with or without LINK PorEx (TiNbN) modification) or with a cementless modular stem made from TiAl6V4 (Tilastan), and an articulating surface for condylar constrained (CCK) and fixed bearing (FB) applications made from cPE or X-LINKed Vit-E PE (E-Dur). The femoral components can be used with distal, posterior, and L-shaped femoral augments made from TiAl6V4 (Tilastan). The modular tibial components can be used with tibial augments made from TiAl6V4 (Tilastan). The femoral and tibial components are also available in LINK PorEx (TiNbN) coated version. Additionally a 3-peg patella can be used with the LinkSymphoKnee System. It is made from cPE or X-LINKed Vit-E PE (E-Dur). The LinkSymphoKnee System is compatible with previously cleared Tibial and Femoral Cones of Waldemar Link GmbH & Co. KG (K200113 and K201364).
The provided text describes a medical device, the LinkSymphoKnee System, and its clearance process with the FDA. However, it does not include information about performance criteria or a study that evaluates a device's performance against such criteria.
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed performance study data against acceptance criteria. The "Performance Testing" section explicitly states that "Non-clinical performance testing and analysis were provided" and lists various mechanical tests (e.g., Range of Motion, Wear analysis, Fatigue testing). It concludes that "The results of non-clinical performance testing demonstrate that the device is suitable for its intended purpose and substantially equivalent to the predicates." Importantly, it also explicitly states, "Clinical performance testing was not required to demonstrate the substantial equivalence of this device."
Therefore, based only on the provided text, I cannot extract the following information:
- A table of acceptance criteria and the reported device performance: No specific acceptance criteria or quantitative performance results related to a study are provided. The document generally states suitability and substantial equivalence.
- Sample size used for the test set and the data provenance: No test set or data provenance mentioned for a performance study. Only mentions "non-clinical performance testing."
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no such test set or ground truth establishment is described.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a knee replacement system, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The document mainly focuses on providing information about the device, its indications for use, comparison to predicate devices, and the types of non-clinical tests performed to demonstrate substantial equivalence (e.g., mechanical testing, wear analysis). It does not provide the detailed performance study information typically associated with AI/software devices or clinical performance 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.