(76 days)
Synthes Epoca Shoulder Prosthesis System is intended for use as a hemi or total shoulder replacement. It is a single use device for reconstruction of the glenohumeral joint in the presence of complex fractures (i.e. 3 and 4 part), revision of failed fixation or arthroplasty, post-traumatic mal-union and disabled, painful shoulder joints resulting from various forms of arthropathy such as osteoarthritis, rheumatoid arthritis, traumatic arthritis or avascular necrosis and other pathologies where arthrodesis is not acceptable. The Press-fit Titanium Plasma Sprayed Humeral Stems are for cementless use only.
The Synthes Epoca Shoulder Prosthesis System is intended for partial or total replacement of the shoulder joint. The Synthes Epoca Shoulder Prosthesis System consists of metallic cemented and uncemented fixation stems, humeral heads, an eccenter offset adjustment mechanism, and UHMWPE glenoid components. The components are available in a variety of sizes for primary and revision applications. The components are manufactured from CoCrMo Alloy, Titanium, and Ultra-High Molecular Weight Polyethylene (UHMWPE).
The provided text from K072578 is a 510(k) summary for the Synthes Epoca Shoulder Prosthesis System. This document is a notification of intent to market a medical device, where the manufacturer demonstrates that the new device is "substantially equivalent" to a legally marketed predicate device.
It is important to note that a 510(k) submission generally focuses on demonstrating substantial equivalence to a predicate device, and thus typically does not include extensive clinical studies or acceptance criteria tables in the same way a PMA (Premarket Approval) application or a de novo submission would.
The information requested in your prompt (acceptance criteria, specific study results, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set details) are typically associated with performance evaluations and clinical trials for novel or higher-risk devices, or for AI/ML-driven devices.
Based on the provided text, there is no information regarding the specific acceptance criteria, a study proving device performance against those criteria, sample sizes, ground truth, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance for the Synthes Epoca Shoulder Prosthesis System.
The 510(k) summary focuses on:
- Device Description: What the device is and its components.
- Intended Use: For what purposes the device is designed.
- Predicated Device: The existing device(s) to which the new device is being compared for substantial equivalence.
- Substantial Equivalence: A statement that the information presented supports substantial equivalence.
Therefore, I cannot populate the table or answer the specific questions as the relevant data is not present in the provided document. The 510(k) process for this type of device (a shoulder prosthesis) relies heavily on comparing the new device's design, materials, manufacturing processes, and sometimes bench testing results to those of already approved predicate devices to demonstrate that it is as safe and effective. It does not typically involve the type of clinical performance study details you are asking for, especially concerning "algorithm performance" as this is a mechanical prosthetic, not an AI/ML-driven diagnostic tool.
§ 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.