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The ARROW Off-Centred Humeral Insert is designed for the following indications: REVERSE PROSTHESIS (POROUS GLENOID IMPLANT) The ARROW Reverse Shoulder Prosthesis is indicated for patients with severe shoulder arthropathy and a grossly deficient rotator cuff or a previously failed shoulder joint replacement with a grossly deficient rotator cuff. A functional deltoid muscle and adequate glenoid bone stock are necessary to use this device. The humeral stem is intended for cemented or cementless application while the porous glenoid baseplate is intended for cementless application with the addition of bone screws for fixation.

The ARROW Off-Centered Humeral Insert is used for reverse shoulder prosthesis, with implants of Arrow Reverse Shoulder System (K112193 and K150568), similar to the standard version. This is a modification of the standard ARROW reverse prosthesis (K122193), with the purpose of reducing lateralization of the prosthesis, increase the range of motion, and provide better adaptation for patient anatomy. The ARROW Off-Centered Humeral Insert is made up of four components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI) per ASTM F-136/ISO 5832-3, polyethylene UHMWPE per ASTM F648/ISO 5834-1, and stainless steel 316L per ASTM F138/ISO 5832-1, identical to the previous ARROW Humeral Insert cleared in the 510(k) file ARROW Reverse Shoulder System (K112193). All components are provided sterile via gamma irradiation.

The provided document is a 510(k) summary for the ARROW Off-Centred Humeral Insert, a medical device. It focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical performance testing and adherence to various ISO standards, rather than clinical performance (e.g., diagnostic accuracy of an AI algorithm).

Therefore, the document does not contain the specific information required to answer the questions about acceptance criteria and study proving device performance as typically applied to a diagnostic AI device or other devices requiring clinical performance metrics.

The document describes pre-market testing relevant to an orthopedic implant, such as:

• Mechanical performance testing: Connections between stem and humeral insert (ASTM F2009), Range of Motion for reverse prosthesis (ASTM F1378).
• Sterilization: ISO 11137
• Packaging: ISO 11607
• Biocompatibility: ISO 10993-1
• Bacterial Endotoxin: LAL validation

These tests are to demonstrate that the new device performs "as well as or better than the predicate devices" and "does not raise new questions about safety and effectiveness," fulfilling the criteria for substantial equivalence.

Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria, ground truth, expert adjudication, or MRMC studies for a diagnostic or AI-driven device, as this information is not present in the provided text.

The provided text describes a physical medical implant, not a software-driven or AI-based diagnostic device. The "study" referenced in the text is mechanical performance testing and compliance with material, sterilization, and packaging standards, not a clinical study involving human readers or AI algorithm performance against ground truth.

If your intention was to ask about a different type of device or a different kind of performance study, please provide the relevant document.

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