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510(k) Data Aggregation
(272 days)
CORE Shoulder System
The CORE Shoulder System is a handheld surgical instrument with computer-assisted instrument tracking and is intended to assist the surgeon with placement of the K-wire (central guide pin) used in the preparation of the glenoid and the positioning of the glenoid component during primary Anatomic or Reverse total shoulder arthroplasty. The CORE Shoulder System tracks the live position of the instruments relative to an untracked virtual anatomical model. It does not track the patient anatomy.
The CORE Shoulder System is designed for use with the following LINK Implant systems:
The CORE Shoulder System is a handheld surgical instrument with computer-assisted instrument tracking and is intended to assist the surgeon with placement of the K-wire (central guide pin) used in the preparation of the glenoid and the positioning of the glenoid component during primary Anatomic or Reverse total shoulder arthroplasty. CORE Shoulder assists the surgeon in placing the K-wire according to the preoperatively planned location. The CORE Shoulder System tracks the live position of the instruments relative to an untracked virtual anatomical model. It does not track the patient anatomy.
It allows the surgeon to visually compare the planned and placed position/trajectory of the guide pin (K-wire) by referencing a virtual 3D model of the pre-operative plan and the measured location of the K-wire. The system components include the Workstation (tablet, AC adapter, stand), the handheld COREmote (single-use Power Unit and reusable Sensor Unit), and reusable stainless-steel probes of different sizes.
The provided text is a 510(k) summary for the CORE Shoulder System, a surgical instrument with computer-assisted instrument tracking. It does not describe an AI/ML-based medical device. Therefore, it does not contain the specific information required to answer the prompt regarding AI/ML device performance.
The document focuses on the substantial equivalence of the CORE Shoulder System to a predicate device, based on non-clinical performance testing. It explicitly states that "Clinical performance testing was not required to demonstrate the substantial equivalence of this device." This implies that there was no study proving the device meets acceptance criteria in terms of clinical outcomes or human reader performance with AI assistance, as would be expected for an AI/ML device.
Therefore, I cannot provide the requested information about acceptance criteria for an AI/ML device, the study proving it meets those criteria, sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, training set details, or ground truth establishment for the training set, as these details are not present in the provided 510(k) summary.
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