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The Cofield Modular Shoulder System is indicated for the following use: Proximal Humeral Prosthesis - 1. Complex, acute fractures or fracture-dislocations of the humeral head (e.g., the four-part injuries in the Neer classification, or headsplitting, or head impression fractures). 2. Complex, chronic fractures or fracture-dislocations of the humeral head with malunion, nonunion of a small osteoporotic head fragment, or chronic dislocation with loss of humeral head cartilage, or large impression fractures. 3. Avascular necrosis with intact glenoid cartilage. 4. Selected patients with arthritis who do not have adequate scapular bone to support a glenoid component or who must engage in moderately heavy activities. Total Shoulder Arthroplasty - Severe destruction of the glenohumeral articular surfaces with intractable chronic pain in rheumatoid arthritis, juvenile rheumatoid arthritis, osteoarthritis, traumatic arthritis, cuff tear arthroplasty, ancient septic arthritis, avascular necrosis with secondary glenoid changes, radiation necrosis, and other failed reconstructive procedures. The device is intended only for use with bone cement and is a single use device.

The Cofield Modular Shoulder System consists of the following components: Stem component Head component Glenoid UHMWPE component The humeral components are fabricated from Co-Cr-Mo. The porous coating on the undersurface of the collar of the stem is fabricated from Co-Cr-Mo beads. The glenoid component is manufactured from UHMWPE.

The provided text from K955767 does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the manner requested (i.e., performance metrics, sample sizes, ground truth establishment, expert involvement, or MRMC studies).

The document is a "Summary of Safety and Effectiveness" for a premarket notification (510(k)) submission for the Cofield Modular Shoulder System. It focuses on demonstrating substantial equivalence to previously marketed devices.

The only mention of "acceptance criteria" or "device performance" in a testing context is:

"Mechanical testing was performed according to the requirements of FDA guidance documents and met or exceeded acceptable performance."

This statement is very general and does not provide the specific details requested in the prompt. Therefore, I cannot complete the table or answer the specific questions based on the provided text.

The document indicates that the safety and effectiveness are based on the "long history of use of these devices in the market place," implying that the substantial equivalence argument, rather than a specific clinical performance study, is the primary basis for regulatory clearance.

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