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The device is intended to translate (reposition) the patient manually within a magnetic resonance imaging machine, through the magnet bore, in order to center different regions-of-interest at the center of the magnetic field for either multistation MRA with single dose injection or multistation MRI, using existing system hardware, software and imaging coils.

The "SKIP™" table consists of three major components: two platforms consisting of a multitude of nonferromagnetic wheels, or rollers, which contain glass bearings and one overlying movable table. The matrix of all major components consist of plastic material. The axels of the wheels or rollers are also made of plastic material. Small minor components of the device include several straps attached to plastic connectors which are used to immobilize the patient on the moving table and, finally, a plastic mount for suspending the existing MRI imaging surface coil over the patient.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Stepping Kinematic Imaging Platform (SKIP™) device:

Important Note: The provided 510(k) summary explicitly states "Discussion of Clinical Tests Performed: Not Applicable." This means the device did not undergo dedicated clinical trials to prove its performance against acceptance criteria in the way a diagnostic AI device would. Instead, its substantial equivalence was based on non-clinical tests and comparison to predicate devices. Therefore, many of the requested fields below will reflect this lack of direct clinical performance data.

Acceptance Criteria and Reported Device Performance

Study Details for Performance Evaluation

Given that the document states "Discussion of Clinical Tests Performed: Not Applicable," the following section will address how the device's "performance" was established for 510(k) clearance, which primarily revolves around substantial equivalence rather than a direct clinical performance study.

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not applicable. No clinical test set was used for performance validation in the traditional sense.
   • Data Provenance: Not applicable. The evaluation relied on non-clinical testing and comparison to existing predicate devices.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. As no clinical test set was used, no ground truth needed to be established by experts for performance evaluation.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable. No clinical test set or adjudication process was described or conducted.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No. This device is a mechanical patient positioning platform, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with AI assistance is entirely irrelevant and was not performed.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. The SKIP™ device is a manual mechanical accessory. It does not have an "algorithm" or standalone "performance" in the way an AI diagnostic involves. Its function is to facilitate patient movement.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Not applicable. For this type of device (a manual patient positioning accessory), the "ground truth" for its function is its ability to physically move a patient accurately within the MRI bore without interfering with the imaging or posing a safety risk. This was assessed through non-clinical means (e.g., mechanical design review, material testing, compatibility testing with MRI systems) rather than clinical ground truth derived from expert consensus, pathology, or outcomes.

7. The sample size for the training set:

   • Not applicable. This device is a mechanical accessory, not a machine learning model. Therefore, there is no "training set."

8. How the ground truth for the training set was established:

   • Not applicable. As there is no training set, there is no ground truth establishment for one.

Summary of Approach for SKIP™ Clearance:

The clearance for the Stepping Kinematic Imaging Platform (SKIP™) under 510(k) relied entirely on demonstrating substantial equivalence to predicate devices through:

• Identical Intended Use: The device performs the same function as its predicate.
• Similar Technological Characteristics: While the manual movement differs from the electronic movement of a predicate, the core safety and functional principles (non-ferromagnetic, accessory for patient repositioning) are considered similar.
• Non-Clinical Testing: Compliance with guidance documents for MR diagnostic devices, focusing on properties like lack of ferromagnetism and not interfering with MRI operation. Biocompatibility of materials was also likely considered.
• Lack of New Safety/Effectiveness Questions: The core argument for substantial equivalence is that any differences do not introduce new questions regarding safety or effectiveness that are not already addressed by the predicate devices or standard non-clinical testing for MRI compatibility.

This approach is typical for mechanical accessories where their primary function is to enable or facilitate an existing medical procedure without directly producing diagnostic data or having a complex computational component.

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