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The Smith & Nephew ACCORD Cable System is indicated for use in general orthopaedic repair procedures including general cerclage of the femur, trochanteric reattachment, fixation of fractures in conjunction with intramedullary prosthesis (i.e., femoral stem) and screw fixation techniques.

The ACCORD Cable System includes cables (with or without clamps), trochanteric grips, and plates. (K223762).
The Smith & Nephew ACCORD Cable System consists of Cobalt Chrome cables (without clamps) to be used with the ACCORD Titanium trochanteric grips or ACCORD Titanium plates and also Stainless Steel and Cobalt Chrome cables with clamps to be used alone. These materials are identical to the material that has been previously cleared in K223762, K031162, and K993106.
The implants within this system are single-use and are Gamma sterilized.

The provided document is an FDA 510(k) clearance letter and an accompanying 510(k) summary for the Smith & Nephew ACCORD Cable System. It does not describe a study that proves the device meets specific acceptance criteria in the context of an AI/ML medical device.

Instead, this submission is for labeling updates to an existing, previously cleared medical device (ACCORD Cable System). The core assertion is that there are no significant changes in design, technological characteristics, function, sterilization, or packaging as a result of these labeling updates. Therefore, no performance testing (bench, animal, clinical) was required for this specific 510(k) submission (K233949).

Consequently, I cannot extract the information required to answer your prompt, as the prompt is designed for a study demonstrating the performance of a new or significantly modified device, particularly one involving AI/ML and associated acceptance criteria. The document explicitly states:

• "There is no significant change in design, technological characteristics, function, sterilization or packaging of the devices as a result of this submission."
• "The subject Smith & Nephew ACCORD Cable System devices are identical in function, design features, materials, packaging, sterilization, manufacturing methods and operational principles to what was previously 510(k) cleared (K223762, K031162). These labeling updates do not affect the safety and effectiveness of the subject devices when used as labeled."
• "Therefore, since there are no changes to the design features, or manufacturing methods of the subject ACCORD Cable System devices, no performance testing (bench, animal, clinical) was required."

This 510(k) relies on the substantial equivalence to its predicate devices (K223762, K031162, K993106), which would have had their own studies to demonstrate safety and effectiveness at the time of their clearance. However, those studies are not detailed in this document.

Therefore, I cannot provide the requested information based on the provided text. The document describes a regulatory filing for a non-AI/ML device that did not require new performance studies due to the nature of the submission (labeling updates only).

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The Smith & Nephew Cabling System of the Smith & Nephew ACCORD™ Cable System is indicated for general orthopaedic repair procedures including patellar fractures, general cerclage, trochanteric reattachment, femoral and tibial fractures, prophylactic banding, olecranon fractures, ankle fractures, fixation of spiral fractures in conjunction with intramedullary nail and screw fixation techniques.

Trochanteric reattachment whenever the trochanter is osteotomized in any of the procedures listed below:

• Primary total hip arthroplasty. .
• Revision total hip arthroplasty. .
• . Any procedure using anterolateral or lateral approaches.

The ACCORD™ Titanium Plates of the Smith & Nephew ACCORD™ Cable System are indicated for adult or pediatric patients as indicated for pelvic, small, and long bone fracture fixation. Indications for use include fractures of the tibia, fibula, femoral condyle, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, middle hand and middle foot bones; treatment of the calcaneal; hip arthrodesis, and provisional hole fixation.

The purpose of this Traditional 510(k) is to add MR safety information to the labeling and update the information within the labeling, including the package insert for the subject Smith & Nephew ACCORD™ Cable System. The technological characteristics, function of the devices, packaging and sterilization remain unchanged. No modifications have been made to the materials, sterilization, or the manufacturing processes of the previously cleared devices due tothe addition of MR labeling for this subject 510(k). The Smith & Nephew ACCORD™ Cable System consists of the following previously cleared devices:

• . The ACCORD™ Titanium Plates: Bone plates of various sizes to accommodate the individual requirements of patient anatomy, cleared under K993106.
• The Smith & Nephew Cabling System: Cables with or without clamps and . trochanteric grips, cleared under K031162.

This document does not contain information about acceptance criteria and a study that proves the device meets the acceptance criteria. It is a 510(k) premarket notification for the Smith & Nephew ACCORD™ Cable System, focusing on adding MR safety information to the labeling and updating existing information.

The key points from the provided text are:

• Device: Smith & Nephew ACCORD™ Cable System.
• Purpose of Submission: To add MR safety information to the labeling and update other labeling information.
• No Changes to Core Device: The technological characteristics, function, materials, packaging, sterilization, and manufacturing processes of the device remain unchanged from previous clearances.
• Predicate Devices: The device is deemed substantially equivalent to two previously cleared Smith & Nephew devices: the Bone Plate System (K993106) and the Orthopaedic Cabling System (K031162).
• Performance Data: Performance data is mentioned only in the context of Magnetic Resonance Imaging (MRI) compatibility testing, conducted according to specific ASTM standards and FDA guidance.
• Engineering Analysis: Engineering analysis and dynamic tensile strength testing were performed to demonstrate substantial equivalent mechanical performance of the plates and cables to the predicate devices.

Therefore, I cannot provide the requested table or answer the specific questions regarding acceptance criteria, sample sizes for test/training sets, ground truth, expert qualifications, or MRMC studies, as this information is not present in the provided text. The document is a regulatory filing for an update, not a clinical study report or a detailed performance and validation study.

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