(82 days)
The Modular Replacement Elbow System is intended for use in Oncology patients requiring extensive reconstruction of the distal humerus, including the elbow joint and total humeral replacement, necessitated by extensive bone loss due to tumor resection. These prostheses are intended for use with bone cement as a means of intramedullary fixation.
The Modular Replacement Elbow System is also intended for use in patients requiring extensive reconstruction of the distal humerus necessitated by trauma, failed previous prosthesis, distal humeral fracture and/or dislocation, and disabling joint disease of the elbow resulting from degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis.
This submission is a line extension to the Howmedica Modular Replacement Systems for reconstruction of the humerus and ulna. Humeral components will be based on the design of the Howmedica Modular Proximal Humerus Replacement System and ulna components will be derived from the Osteonics® Total Elbow System.
This 510(k) summary describes a medical device, the Modular Replacement Humeral and Ulna, and its substantial equivalence to predicate devices. It does not contain information about a study that measures device performance against specific acceptance criteria. This submission is for a line extension of existing products and relies on an "engineering analysis" to establish substantial equivalence in strength to predicate devices, rather than a clinical performance study with defined acceptance criteria.
Therefore, I cannot provide the requested information from the provided text, as the document does not describe such a study.
Here's why and what kind of information is missing:
- Acceptance Criteria & Reported Performance: The document does not define any specific performance metrics (e.g., accuracy, sensitivity, specificity, or specific mechanical thresholds) or corresponding acceptance criteria for the device. It only states that an "engineering analysis was conducted to compare the strength of the subject modular replacement components to the predicate components," and that "The results demonstrate that the subject components are substantially equivalent in strength to the predicate components." No quantitative results or predefined thresholds are given.
- Study Details (Sample Size, Data Provenance, Ground Truth, Experts, Adjudication, MRMC, Standalone): Because no performance study in the traditional sense (e.g., a clinical or in-vitro study evaluating diagnostic or prognostic accuracy) is described, all these sections are not applicable. The engineering analysis would involve material testing and simulations, not patient data, experts, or ground truth in the medical imaging/AI sense.
- Training Set Information: This is irrelevant as the device is a mechanical prosthesis, not a software algorithm requiring a training set.
In summary, the provided document is a 510(k) summary for a mechanical orthopedic implant, where "substantial equivalence" is established primarily through design comparison and engineering analysis, not through a clinical or performance study that would typically generate the kind of data you've requested (e.g., accuracy, sensitivity, expert-adjudicated ground truth).
§ 888.3690 Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.
(a)
Identification. A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium-molybdenum. It has an intramedullary stem and is intended to be implanted to replace the articular surface of the proximal end of the humerus and to be fixed without bone cement (§ 888.3027). This device is not intended for biological fixation.(b)
Classification. Class II.