(90 days)
The Duracon® CS (Condylar Stabilizing) Lipped Extra Small Tibial Insert is intended to be used with Duracon® Extra Small Universal and Cruciform tibial baseplates, Duracon® Cruciate Retaining femoral components and Duracon® patellar components as part of a total knee system in primary cemented total knee arthroplasty. These inserts are intended to be used in cases where there is destruction of the joint surfaces with or without bone deformity, where the cruciate ligaments are inadequate, not present, or cannot be preserved during the operative procedure, especially when anterior-posterior stability is impaired due to absence of the patella. The collateral ligaments should be intact if this insert is utilized. This tibial insert may also be used in situations where the posterior cruciate ligament is present - its geometry will accommodate that ligament. More specific indications and contraindications are listed below:
Indications
- Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis or avascular necrosis,
- Rheumatoid arthritis,
- Correction of functional deformity,
- Post-traumatic loss of joint anatomy, particularly when there is patello-femoral erosion, dysfunction or prior patellectomy; and,
- Irreparable fracture of the knee
Contraindications
Absolute contraindications include:
- Overt infection.
- Distant foci of infections (which may cause hematogenous spread to the implant site),
- Rapid disease progression as manifested by joint destruction or bone absorption apparent on roentgenogram,
- Skeletally immature patients
- Cases where there is poor bone stock which would make the procedure unjustifiable,
Conditions presenting an increased risk of failure include:
- Uncooperative patient or patient with neurological disorders who is incapable of following instructions.
- Osteoporosis,
- Metabolic disorders which may impair bone formation,
- Osteomalacia, and
- Previous arthrodesis
The subject Duracon® Extra Small CS Lipped Tibial Insert is an ultra-high molecular weight polyethylene tibial insert designed to be used with the femoral, tibial, and patellar components of the Duracon® Total Knee System. This insert is available in an extrasmall size in the following thicknesses: 9mm, 11mm, 13mm, and 16mm. The subject insert has a dished articulating surface geometry to provide anatomic rollback, flexionextension and internal-external rotation. The subject tibial insert features a raised anterior eminence designed to provide greater anterior constraint in situations where the posterior cruciate ligament is not present or not functional. This anterior eminence is designed to provide substitution for the posterior cruciate ligament if it is not present or cannot be preserved.
The subject insert does not feature a support post. This allows the Duracon® CS Lipped Extra Small Tibial Insert to be used with the Duracon® Condylar Femoral Components. These condylar femoral components do not require the removal of additional bone from the distal surface of the femur. Because this insert does not feature a support post, it may also be used in situations where the posterior cruciate ligament is present. The geometry of the insert will accommodate the PCL if it is present.
The subject Duracon® CS Lipped Extra Small Tibial Insert features the same locking mechanism as the previously released Duracon® Condylar and AP Lipped Tibial Insert.
Engineering analyses were presented to characterize the function of the subject tibial insert, and to demonstrate substantial equivalence to other legally marketed devices.
The provided document describes a medical device, the Duracon® CS Lipped Extra Small Tibial Insert, which is a component of a total knee arthroplasty system. It is a 510(k) premarket notification for this device.
However, the document does not contain information regarding acceptance criteria, device performance metrics (such as sensitivity, specificity, accuracy, etc.), or details of any studies (like clinical trials, standalone algorithm performance studies, or MRMC studies) that would typically be conducted for AI/software-as-a-medical-device (SaMD).
Instead, this document focuses on:
- Device Identification: Proprietary name, common name, classification, and product code.
- Intended Use: Specific types of patients and conditions for which the device is designed.
- Indications for Use: Detailed medical conditions the device addresses.
- Contraindications: Conditions under which the device should not be used.
- Device Description: Physical characteristics and design features (e.g., ultra-high molecular weight polyethylene, dished articulating surface, raised anterior eminence, locking mechanism).
- Substantial Equivalence Claim: The primary basis for 510(k) clearance, stating that engineering analyses were presented to characterize the function and demonstrate substantial equivalence to other legally marketed devices. This implies comparison to existing, already cleared knee replacement components, rather than a novel AI system.
- FDA Clearance Letter: Confirmation from the FDA that the device is substantially equivalent to a legally marketed predicate device.
Therefore, I cannot fulfill your request for: "A table of acceptance criteria and the reported device performance" or information regarding "the study that proves the device meets the acceptance criteria" because this type of information is not present in the provided text for this specific device.
The questions you've asked (about sample sizes, data provenance, ground truth, experts, adjudication, MRMC, standalone performance, and training sets) are highly relevant to AI/SaMD submissions, which often involve extensive performance testing and clinical validation. This document, however, is for a physical orthopedic implant and does not describe such studies. The "engineering analyses" mentioned likely refer to biomechanical testing, wear testing, and material characterization to ensure the physical properties and mechanical performance of the implant are safe and effective and comparable to existing devices.
§ 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.