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The Extremity Coil is a specialty receive-only RF coil, used to obtain diagnostic images of the knee and foot anatomy in Magnetic Resonance Imaging systems. The indications for use are the same as for standard MR Imaging. The Extremity Coil is designed for use with the Rhapsody 1.0T MRI Scanners manufactured by Siemens Medical Systems, Inc.

The Extremity Coil is a receive-only specialty RF coil, used for obtaining diagnostic images of the knee and foot in Magnetic Resonance Imaging systems. The Extremity Coil is designed for use with the Siemens Rhapsody 1.0Tesla MRI scanner manufactured by Siemens Medical Systems, Inc.

The Siemens Rhapsody MRI system is indicated for use as an NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR signal, (2) depend upon NMR parameters (proton density, spin lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.

The Extremity Coil package consists of a knee coil (two sizes: small and large ) and an attachable foot coil. The electrical circuitry is enclosed in a durable housing assembly made of polyurethane , fiberglass, and ABS/PVC plastic alloy, which are fire rated and have high impact and tensile strength. The Knee Coil is mechanically split into two halves for easier coil handling and more accurate positioning of the patient's knee in the coil. The foot Coil is contoured to accommodate the foot and is mechanically attached to the knee coil.

The document provided is a 510(k) premarket notification for a medical device called "Extremity Coil." This type of submission is for demonstrating substantial equivalence to a predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria as one might find for novel or high-risk devices.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, and ground truth establishment is not applicable or available within this type of regulatory submission document. The device is an accessory (MRI coil) and its safety and effectiveness are established by demonstrating similarity to previously cleared devices.

Here's a breakdown of why each point is not relevant or present in this context:

1. A table of acceptance criteria and the reported device performance

• Not Applicable. For a 510(k) submission of an MRI accessory, specific "acceptance criteria" related to diagnostic performance (like sensitivity/specificity for a disease detection algorithm) are not typically defined or reported. The performance is assessed by demonstrating that the new device functions similarly to predicate devices in terms of image quality and safety characteristics common to MRI coils.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable. There is no mention of a "test set" in the context of clinical images or diagnostic data. The focus is on technical specifications and comparison to predicate devices, not on a study evaluating diagnostic accuracy on a patient cohort.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. As there is no test set in the diagnostic sense, there is no need for experts to establish ground truth.

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

• Not Applicable. No test set or diagnostic performance adjudication.

5. 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

• Not Applicable. This is an MRI accessory, not an AI-powered diagnostic tool. MRMC studies or AI assistance effect sizes are irrelevant here.

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

• Not Applicable. The device is not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• Not Applicable. No ground truth for diagnostic accuracy is established as this is not a diagnostic device in the sense that it interprets images or detects disease.

8. The sample size for the training set

• Not Applicable. This is an MRI coil, not an AI model that requires a training set.

9. How the ground truth for the training set was established

• Not Applicable. No training set for an AI model.

Summary of Safety and Effectiveness (as per the provided document):

The safety and effectiveness of the Extremity Coil are established through comparison to legally marketed predicate devices, specifically the Legend 5000 Knee and Foot Coil (K994040) and the Leo 7000 Quadrature Knee coil (K971246), both manufactured by USA Instruments, Inc.

The document highlights the following features of the Extremity Coil and states their similarity to the predicate devices:

• Intended Use: Knee and Foot Imaging Applications
• Indications for Use: Identical to routine MRI imaging
• Coil Material: Flame retardant Polyurethane, ABS plastic alloy, Fiberglass
• Coil Design: Two-channel receive-only Phased Array Design
• Decoupling: RF Chokes with Switching Diodes
• Prevention of RF Burns: Does not transmit RF Power, Decoupling isolates coil elements from RF fields during RF transmission, Coil elements and circuitry are enclosed in a non-conductive housing.
• Radio Frequency Absorption: Coil is a receive-only coil and does not transmit RF power.
• Formation of Resonant Loops: Decoupling isolates coil elements from RF fields during RF transmission, Length of cable and stiffness does not allow permit looping.

The FDA's review concluded that the device is substantially equivalent to the predicate devices for the stated indications for use, thereby permitting its marketing. This determination is based on the technical and functional similarities, implying that the safety and performance characteristics are consistent with existing, cleared devices.

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