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The Smart Fit Knee 3.0T coil is designed to be used in conjunction with a Philips 3.0T MR system to produce diagnostic images of the Knee that can be interpreted by a trained physician.

The Smart Fit Knee 3.0T coil is designed to be used in conjunction with a Philips 3.0T MR system to produce diagnostic images of the Knee that can be interpreted by a trained physician.
The Smart Fit Knee 3.0T is a 16-element coil designed for high-resolution imaging of the left or right knee. It is a phased-array, Rx volume coil providing an integrated solution with a base plate, an anterior and a posterior part. Positioning pads are also supplied to support comfortable positioning. The coil can be slightly rotated relative to its base plate to ease coil setup and enhance patient comfort. The coil is used independently and cannot be combined with any other coils. This coil is available for 3.0T MR systems and is compatible with Philips 3.0T MR Scanners.

The provided text describes the Philips Smart Fit Knee 3.0T MRI coil, but it does not contain acceptance criteria for device performance or a detailed study proving the device meets specific performance criteria through clinical effectiveness measures.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (HRK-127-8 KNEE ARRAY COIL K033567) for regulatory clearance. This is primarily done through technological comparisons and compliance with recognized consensus standards.

Here's a breakdown of the information available and what is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: Not explicitly stated as quantifiable performance metrics for clinical effectiveness. The acceptance criteria in this document are implicitly related to compliance with recognized standards and showing similarity to the predicate device in design, intended use, and fundamental scientific technology.
• Reported Device Performance:
  • "The performance test results demonstrate that the proposed Smart Fit Knee 3.0T meets the acceptance criteria and is adequate for its intended use." This is a general statement of compliance, not a report of specific numerical performance metrics.
  • "All clinical images on the proposed coils Smart Fit Knee 3.0T were evaluated by qualified radiologists. No issues with the clinical image quality were seen and images were considered have sufficient quality for diagnostic use." This broadly indicates acceptable image quality based on expert review, but no quantifiable performance metrics (e.g., sensitivity, specificity, SNR values) are provided.

Table based on available information (focused on equivalence and general performance):

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