(42 days)
The Insight Head Coil is a quadrature transmitting and receiving device used to produce magnetic resonance images of the head regions that can be interpreted by a trained radiologist. This device provides a closed, ergonomic package with many patient friendly features including a shorter coil length so that no part of the coil will be over the patient's eyes, nose or mouth.
The Insight Head Coil is a quadrature transmitting and receiving device for use in magnetic resonance imaging of the head regions. This device incorporates advanced radio frequency technology housed in a closed, ergonomic package with many patient friendly features including a shorter coil length so that no part of the coil will be over the patients eyes, nose or mouth. The materials of construction and components are all identical to the predicate devices.
The tubular shaped coil is 13" OD x 9.9" ID x 10" L with a section removed from the bottom that is 60° of the coil circumference and 2" deep. The coil is attached to 2 rails that allow it to slide back and away from the patient, and then to be positioned with the patients head inside the tubular device. The back and sides of the coil will be placed over the center of the ears of the patient while the cut out front edge will be placed parallel with the eye brows.
The outer surfaces of the coil are manufactured from painted plastic polymer materials. These materials have been found to be biologically inert. These materials are routinely used in medical device construction and can be cleaned using mild bleach or alcohol as the customers will be instructed to do so.
The outer surfaces of the coil are manufactured from materials that are routinely used in medical device construction and can be cleaned using mild bleach or alcohol.
Features of the Insight Head Coil:
Imaging
. 2-channel quadrature design uses multiple elements that surround the head tissue
. Optimized for high speed imaging applications
. Compatible with Siemens and GE3T MRI systems
. High SNR
Ergonomics
. Large ID to accommodate a major percentage of patient population
. Ergonomically designed for patient comfort to minimize motion artifact
. Positioning accessories include an adjustable head support and retraction mechanism
. Attachable mirror to reduce patient claustrophobic response
. Complete lack of material in front of the patients face to reduce claustrophobic response.
The provided document is a 510(k) summary for the Insight Head Coil, a magnetic resonance diagnostic device. It does not contain details about acceptance criteria, specific studies, or performance metrics in a way that directly addresses the requested information for AI/device performance evaluation.
The document primarily focuses on establishing substantial equivalence to predicate devices based on design, materials, and intended use. It does not describe a study involving performance acceptance criteria in the context of diagnostic accuracy, sensitivity, specificity, or reader performance improvement.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's an attempt to answer based on the available information, highlighting what is not present:
Acceptance Criteria and Device Performance Study for Insight Head Coil
Based on the provided 510(k) summary, the Insight Head Coil is a hardware device (a head coil for MRI) and not an AI or software-driven diagnostic tool. Therefore, the concept of "acceptance criteria" and "device performance" in terms of diagnostic accuracy (like sensitivity, specificity) or "human reader improvement with AI" as typically applied to AI/CAD devices, is not directly applicable to this submission.
The "acceptance criteria" for this type of device primarily revolve around safety, functional equivalence to predicate devices, and the ability to produce images interpretable by a trained radiologist. The document confirms that the device meets these general criteria by demonstrating substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety: Biologically inert materials, controlled hazards. | "The materials of construction and components are all identical to the predicate devices." "The outer surfaces of the coil are manufactured from painted plastic polymer materials. These materials have been found to be biologically inert." "The potential hazards have been studied and controlled as part of the product development process, including risk analysis, test and design considerations, and planned verification and validation testing processes." |
| Functional Equivalence: Ability to produce diagnostic quality MRI images of the head. | "The Insight Head Coil provides images comparable to the predicate devices." "Used to produce magnetic resonance images of the head regions that can be interpreted by a trained radiologist." |
| Compatibility: With MRI systems. | "Compatible with Siemens and GE3T MRI systems." |
| Image Quality: High Signal-to-Noise Ratio (SNR). | "High SNR" |
| Ergonomics/Patient Features: Improved patient comfort and reduced claustrophobia. | "Ergonomically designed for patient comfort to minimize motion artifact," "Complete lack of material in front of the patients face to reduce claustrophobic response." |
2. Sample size used for the test set and the data provenance:
- Not applicable / Not provided. The document describes a hardware device, not an algorithm requiring a "test set" in the context of diagnostic performance evaluation with patient data. The evaluation is mechanical and functional, comparing its performance to existing predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not provided. Ground truth in the diagnostic sense (e.g., presence/absence of disease) is not established for this device, as it is a coil, not an image interpretation system. The statement "images that can be interpreted by a trained radiologist" refers to the general function of MRI images.
4. Adjudication method for the test set:
- Not applicable / Not provided.
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:
- No, not done. This is a hardware device (MRI coil) and not an AI or CAD system. Therefore, an MRMC study related to human reader improvement with AI assistance is entirely outside the scope of this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a hardware component (MRI head coil), not an algorithm or software. Its performance is evaluated within the larger MRI system, always with a human operator and a human reader (radiologist) interpreting the resulting images.
7. The type of ground truth used:
- Not applicable / Not defined in the context of diagnostic accuracy. The "ground truth" for this device relates to its physical and image-forming properties, and its ability to generate images comparable to other approved MRI coils.
8. The sample size for the training set:
- Not applicable / Not provided. This is a hardware device, not an algorithm that requires a "training set" of data.
9. How the ground truth for the training set was established:
- Not applicable / Not provided.
Summary of the Document's Approach:
The 510(k) submission for the Insight Head Coil relies on the concept of substantial equivalence to predicate devices. This means that instead of presenting a new clinical study with specific acceptance criteria related to diagnostic accuracy, the manufacturer demonstrates that their device has:
- The same intended use.
- Similar technological characteristics.
- Raised no new questions of safety or effectiveness.
The "study" described, implicitly, is a series of tests to ensure the coil produces images comparable to existing coils, operates safely, and functions as intended within an MRI system. This would involve engineering tests, phantom imaging, and potentially some limited human subject imaging to show image quality, but without a focus on diagnostic accuracy metrics like sensitivity or specificity.
§ 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.