(284 days)
This device is a modular humeral replacement system consisting of head, body and stem segments. These segments can be combined to replace the proximal humerus secondary to extensive bone loss or bone disease. Bone loss may be due to tumor resection, revision arthroplasty or trauma. This device is indicated for use with bone cement.
This device is a modular humeral replacement system consisting of head, body and stem segments. The head and stem segments are manufactured from cobalt-chromiummolybdenum (Vitallium®) alloy. The body segment is manufactured from titanium alloy.
This document is a 510(k) summary for a medical device called the "Howmedica® Modular Proximal Humerus Replacement System." It describes the device, its components, materials, and intended use. However, it does not contain any information about acceptance criteria, performance studies, or details regarding AI algorithms, ground truth, or expert involvement.
Therefore, I cannot fulfill your request for the specific details outlined in your prompt (Table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set information).
This 510(k) summary is purely a regulatory document for device clearance, focusing on substantial equivalence to predicate devices, not on the kind of performance study details you're looking for, especially those related to AI or diagnostic accuracy studies.
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510(k) Summary
510(k) Summary K954559
Device: Howmedica® Modular Proximal Humerus Replacement System
This device is a modular humeral replacement system consisting of head, body and stem segments. These segments can be combined to replace the proximal humerus secondary to extensive bone loss or bone disease. Bone loss may be due to tumor resection, revision arthroplasty or trauma. This device is indicated for use with bone cement.
The head and stem segments are manufactured from cobalt-chromiummolybdenum (Vitallium®) alloy. The body segment is manufactured from titanium alloy.
The Modular Proximal Humerus Replacement System has design features which are equivalent to the features of various marketed products. These equivalent products include: the Proximal Humerus Replacement (Howmedica), Neer II Proximal Humerus (Howmedica), Neer III Modular Proximal Humerus (Kirschner), Select Shoulder (Intermedics), NJ Shoulder (DePuy), PMI Proximal Humeral Segmental System (Biomet), Precision Osteolock™ Femoral Stems (Howmedica), and P.C.A.® E-Series Hip (Howmedica).
For information contact: Margaret F. Crowe
Manager, Regulatory Affairs Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 Telephone: (201) 507-7431 Fax: (201) 507-6870
§ 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.