(90 days)
The ABC Elbow Prothesis is indicated for use in Rheumatoid Arthritis, Non-Inflammatory Degenerative Joint Disease including osteoarthritis and avascular necrosis, correction of severe functional deformity, revision procedures where other treatments or devices have failed, and treatment of acute or chronic fractures with humeral epicondyle involvement which are unmanageable using other treatment methods.
This device is a single use implant. It is intended for use with bone cement.
The ABC elbow is a total elbow prothesis. The implant consists of two components, an ulna and a humeral component.
The ulna is made up of two elements, the polyethylene articulating surface and the titanium stem. The polyethylene is compression molded onto the substrate. The articulating section is formed like part of a cylinder, the inner part being the polyethylene bearing and the outer being the substrate. The ulna component is designed to match the existing trochlea anatomy. This conserves bone and will improve the ease of implant alignment and fixation.
The substrate is roughened to enhance fixation to the cement interface. The stem is shaped to approximate to the internal geometry of the proximal ulna at the trochlea. The stem may be coated with a titanium plasma spray to provide additional cement fixation. The inner surface of the implant, the polyethylene bearing, is radiused in both axes.
The humeral component is a one piece cobalt chrome casting. The barrel is open ended and this matches the bone cut on the distal anterior humerus. The open section has been thickened internally to compensate for mechanical weakening caused by the removal of the closing section of the barrel. The transition from the barrel has been profiled to match the natural anatomy of the olecranon fossa. The support of the inside of the barrel and the gradual transition from barrel to stem ensure the mechanical strength of the barrel is not compromised. It requires less bone removal to implant the humeral component and the stem is designed to match the natural anatomy of the olecranon fossa and the surrounding borders.
This document, K972691, is a 510(k) premarket notification for a medical device called the "ABC Total Elbow Prothesis." It focuses on establishing substantial equivalence to previously marketed devices rather than presenting a study demonstrating the device meets specific acceptance criteria based on performance metrics.
Therefore, the requested information regarding acceptance criteria and a study proving the device meets them cannot be extracted from this document. The 510(k) process is primarily a regulatory pathway to demonstrate that a new device is "substantially equivalent" in safety and effectiveness to a legally marketed predicate device, not necessarily to prove performance against pre-defined acceptance criteria through a clinical or performance study in the way a PMA (Premarket Approval) might require.
The document mainly covers:
- Device Description: Details about the ABC Total Elbow Prothesis (ulnar and humeral components).
- Intended Use: The medical conditions for which the device is indicated.
- Potential Risks: General risks associated with joint replacement.
- Substantial Equivalence: A list of predicate devices to which the ABC Total Elbow Prothesis is compared.
- FDA Communication: The FDA's letter granting clearance based on the determination of substantial equivalence.
There is no mention of:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets or data provenance.
- Number of experts or their qualifications for ground truth.
- Adjudication methods.
- MRMC comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth used (pathology, outcomes data, etc.).
- Training set sample size or how its ground truth was established.
§ 888.3160 Elbow joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. An elbow joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an elbow 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 consist of a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a radial 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.