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The Joint Motion Devices are an accessory to MRI diagnostic devices, including the Hitachi AIRIS™, Siemens Magnatom™, Toshiba OPART™ Picker Outlook™, Fonar, and GE Medical Systems Open MRI systems. In addition, the devices may be used in any MRI system where the physical limits of the bore size is not a constraint.

The devices are built from plastics and nonferromagnetic materials, and hold patients securely during MRI imaging sequences. The devices also constrain joint motion to one of several user-designated planes of rotation, dependant upon the joint to be imaged, and emulate the natural motion of the joint.

The Joint Motion Devices increase the clinical utility of MRI systems to provide high quality, repeatable imaging and constraint for the knee, cervical spine, ankle, wrist, lumbar spine, hip and shoulder anatomies to enable fixed position imaging, and kinematic (incremental stepped) motion of the knee, cervical spine, ankle, wrist, lumbar spine, hip and shoulder anatomies, and dynamic (continuous) motion of the knee, cervical spine, ankle, wrist , lumbar spine, hip and shoulder joint anatomies.

The devices will enable the physician to evaluate the anatomy of the knee, cervical spine, ankle, wrist, lumbar spine, hip and shoulder anatomies, in a static mode as well as to evaluate the dynamic interaction of the different tissues (ligaments, cartilage, bone, muscle, fat). Such functional interaction may be useful in diagnosis.

The Joint Motion Devices provide constraint for the knee, cervical spine, ankle, wrist, lumbar spine, hip and shoulder anatomies to enable fixed position imaging, and kinematic (incremental stepped) motion of the knee, cervical spine, ankle, wrist, lumbar spine, hip and shoulder anatomies, and dynamic (continuous) motion of the knee, cervical spine, ankle, wrist , lumbar spine, hip and shoulder joint anatomies. Form, fit and function, as well as a determination that the devices do not adversely affect the magnetic field for imaging has been tested.

The Joint Motion Devices add clinical utility to all known open MRI diagnostic devices, including the Hitachi AIRISTM, Siemens Magnatom™, Toshiba OPART™, and Picker, Fonar, Phillips and GE Medical Systems Open MRI systems. In addition, several of the devices have use in higher tesla magnets where bore size is not a constraint.

The devices are manually operated by the user. No active components (i.e. motors) are used and there are no ferromagnetic materials that could affect the scan field.

This document is a 510(k) premarket notification for a medical device called "Joint Motion Devices." It does not contain information about acceptance criteria or a study proving that the device meets those criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device, which is a different regulatory pathway than proving performance against specific acceptance criteria.

The key points from the document are:

• Device: Joint Motion Devices (for various joints like knee, cervical spine, ankle, wrist, lumbar spine, hip, and shoulder)
• Intended Use: To provide constraint for specific anatomies during MRI imaging for fixed-position, kinematic (incremental stepped), and dynamic (continuous) motion studies. This allows physicians to evaluate anatomy in static mode and dynamic interaction of tissues.
• Predicate Device: K953918, manufactured by CHAMCO, Inc. (the same company submitting this 510(k)). The submission states the devices are identical to the predicate device.
• Regulatory Pathway: 510(k) premarket notification, which emphasizes substantial equivalence to a legally marketed predicate device rather than de novo demonstration of safety and effectiveness against explicit performance criteria.

Therefore, I cannot provide the requested information because the provided text describes a 510(k) submission based on substantial equivalence, not a study demonstrating adherence to specific acceptance criteria.

Here's why the specific questions cannot be answered from the provided text:

1. Table of acceptance criteria and reported device performance: This document does not establish specific acceptance criteria for performance; it relies on the predicate device's established safety and effectiveness.
2. Sample size, data provenance: No new study data is presented, as the claim is one of identity to a predicate device.
3. Number of experts, qualifications: Not applicable, as there's no independent ground truth establishment for a new study.
4. Adjudication method: Not applicable.
5. MRMC comparative effectiveness study: Not conducted or reported.
6. Standalone performance study: Not conducted or reported in this document. The device is an accessory to MRI diagnostic devices.
7. Type of ground truth: Not applicable, as no new study is detailed.
8. Sample size for training set: Not applicable, as no AI/machine learning model is being described or validated.
9. How ground truth for training set was established: Not applicable.

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