`INEAR WRIST COIL, MODEL 440GE-09 by MEDICAL ADVANCES, INC.

The provided text describes a 510(k) submission for a medical device, a linear wrist coil for MRI. The submission focuses on establishing substantial equivalence to a predicate device, rather than proving a new device's independent performance against defined acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria and a study proving their fulfillment is not directly applicable or available in this document.

However, I can extract and infer some information based on the document's content. The "acceptance criteria" here are essentially the demonstration of "no change" in key safety and imaging performance parameters when the new coil is used with the specified MRI system, compared to the predicate device.

Here's a breakdown of the requested information, addressing what's present and what's not:

1. Table of acceptance criteria and the reported device performance

Category	Acceptance Criteria (from text)	Reported Device Performance (from text)
Safety Parameters
Maximum Static Magnetic Field	No change from predicate	No change
Rate of Magnetic Field Strength Change	No change from predicate	No change
RF Power Deposition	No change from predicate	No change
Acoustic Noise Levels	No change from predicate	No change
Imaging Performance Parameters
Specification Volume	No change from predicate	No change
Signal-to-Noise Ratio (SNR)	No change from predicate	No change
Image Uniformity	No change from predicate	No change
Geometric Distortion	No change from predicate	No change
Slice Thickness and Gap	No change from predicate	No change
High Contrast Spatial Resolution	No change from predicate	No change
General Safety and Effectiveness Concerns	Instructions for use, indications, precautions, cautions, contraindications, warnings, and quality assurance testing	Device includes these elements to assure safe and effective use.

Study that proves the device meets the acceptance criteria:

The document describes the basis for proving substantial equivalence, which is the "study" in this context. The study is a comparison of the new device (Medical Advances Linear Wrist Coil) with a legally marketed predicate device when both are operated with the GE Signa Profile 0.2 T MRI system.

The core of the study is to demonstrate that the new coil "has the same intended use and technological characteristics" as the predicate and "does not affect the GE Signa Profile 0.2T system safety parameter specifications." This implies that testing was conducted to verify that the performance of the system with the new coil remained consistent with its performance with the predicate coil in terms of the listed safety and imaging parameters.

2. Sample size used for the test set and the data provenance

Sample size used for the test set: Not explicitly stated. The document indicates a comparison with a predicate device, but doesn't specify how many instances or types of images were used for comparison. This is a 510(k) summary, which typically focuses on demonstrating equivalence rather than providing detailed clinical trial methodologies.
Data provenance: Not explicitly stated, but it would have been collected from testing the GE Signa Profile 0.2 T MRI system with both the new coil and the predicate coil. The origin of the data would likely be from an engineering/testing environment rather than patient data, given the nature of the parameters being assessed (e.g., SNR, uniformity, geometric distortion are often measured using phantoms). It is a "new device" submission and not a clinical study.

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

Not applicable. The "ground truth" here is not established by human experts in a clinical context (e.g., radiologists diagnosing a condition). Instead, it's based on quantitative measurements of physical and performance characteristics, likely against established engineering specifications or the performance of the predicate device.

4. Adjudication method for the test set

Not applicable. There's no human-based adjudication described as the evaluation criteria are objective physical and performance measures.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence of a component (the coil) to a predicate, not on the comparative clinical effectiveness of the entire system (MRI + coil) or the improvement of human readers.

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

Yes, in a sense. The "study" described is entirely standalone in that it assesses the physical and functional performance of the device itself (the coil) and its interaction with the MRI system, without involving human interpretation of images for diagnostic purposes. This is an engineering/performance assessment, not a clinical trial of diagnostic accuracy.

7. The type of ground truth used

The "ground truth" is the established safety and imaging performance specifications of the GE Signa Profile 0.2 T MRI system when operated with its original or a legally marketed predicate coil. The new coil's performance is compared against these established technical benchmarks. It's based on objective measurements of physical parameters rather than pathology, outcomes data, or expert consensus.

8. The sample size for the training set

Not applicable. This device is an MRI coil, a hardware component. There is no "training set" in the context of machine learning, as this is not an AI/algorithm-driven device.

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

Not applicable, as there is no training set for this type of device.

Summary

Regulation Number and Section

§ 892.1000 Magnetic resonance diagnostic device.

(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.