Search Results

The Anatomical Shoulder Inverse /Reverse system is indicated for primary, fracture or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.

The Anatomical Shoulder primary humeral stem is intended for cemented or cementless use. The Anatomical Shoulder revision humeral stem is intended for cemented use only. The Anatomical Shoulder Inverse /Reverse glenoid fixation is intended for cementless, press-fit use. It requires screws for initial fixation.

The Anatomical Shoulder Inverse / Reverse system is a reverse shoulder prosthesis that allows an intra-operative change from a conventional shoulder arthroplasty to a reverse shoulder arthroplasty. The components of the system include a glenoid fixation baseplate, a glenoid head, a humeral cup and a humeral inlay. These components are intended for use with previously submitted polyaxial screws and previously cleared humeral stems.

The provided document (K053274) is a 510(k) premarket notification for a medical device called the "Anatomical Shoulder Inverse / Reverse" system. It describes the device, its intended use, and a comparison to predicate devices, but it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the context of an AI/ML algorithm.

This document pertains to a traditional orthopedic implant, not an AI-powered diagnostic or therapeutic device. As such, the standard information requested for AI/ML device evaluations (such as sample sizes for test and training sets, expert qualifications, ground truth establishment, MRMC studies, or standalone performance) is not applicable or present in this filing.

The document states:

• "Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device." This confirms that a clinical study with human subjects, which would typically involve performance metrics and acceptance criteria, was not required for its clearance.
• "Non-Clinical Performance and Conclusions: Analysis of the glenoid components, the glenoid taper connection, glenoid fixation screw stability, the humeral taper connection, the humeral cup and the connection between the humeral cup and the humeral inlay indicate that all components are adequate for their intended use." This refers to mechanical and material testing of the components, which are common for orthopedic implants, but these are not the "acceptance criteria" in the context of an AI/ML study.

Therefore, I cannot provide the requested table and information, as it is not present in the given 510(k) summary for this type of device.

Ask a specific question about this device