(90 days)
The Competitor Unicondylar Tibial Baseplate Components are indicated for restoring either compartment of a knee that has been affected by the following:
- Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or . avascular necrosis;
- . correction of functional deformity;
- 트 revision procedures where other treatments or devices have failed; and
- treatment of fractures that are unmanageable using other techniques
The baseplate components are single use only and are intended for implantation only with bone cement.
New unicondylar knee tibial baseplate components have been designed and developed by Smith & Nephew Orthopaedics. The subject devices are metal-backed tibial baseplates that are designed to be used with specific articular inserts. The overall designs of the components are based upon the existing Genesis Unicompartmental tibial implants subject of K912735.
The provided document is a 510(k) summary for a medical device: "Smith & Nephew Competitor Unicondylar Tibial Baseplate Components." This type of submission focuses on demonstrating substantial equivalence to a previously legally marketed device, not on proving clinical effectiveness or efficacy through acceptance criteria and detailed clinical studies as would be required for a PMA (Premarket Approval) application or a de novo classification.
Therefore, the document does not contain the information requested regarding:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for test and training sets, data provenance, ground truth establishment, or expert qualifications.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
The 510(k) summary states that "The Smith & Nephew Competitor Unicondylar Tibial Baseplate Components are similar to the following commercially available devices regarding design features, overall indications, and materials: Smith & Nephew Genesis Unicompartmental Knee System (K912735) and Smith & Nephew Unicondylar Femoral Component (K030301)."
This statement is the "study" and "acceptance criteria" in the context of a 510(k). The acceptance criterion is that the new device is "substantially equivalent" in design, indications, and materials to the predicate devices. The "proof" is the detailed comparison submitted by the manufacturer (which is not fully contained in this summary document) demonstrating this substantial equivalence.
In summary, the information requested is not applicable or available in this 510(k) submission document. This document is for a medical implant (knee prosthesis components), not an AI/software device that would typically involve the types of performance metrics and studies you've asked about (e.g., sensitivity, specificity, reader studies).
§ 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.