(60 days)
The InkSpace Imaging Pediatric Body Array is a receive-only coil, used for obtaining diagnostic images of pediatric cardiac and body in GE 3.0T magnetic resonance imaging systems. These images, when interpreted by a trained physician, yield information that may assist in diagnosis.
The InkSpace Imaging Pediatric Body Array is a phased array, receive-only coil intended to work with GE 3.0T MRI scanners to provide optimal signal-to-noise ratio and uniformity for high resolution pediatric body MR imaging examinations. The size and layout of individual channels of the InkSpace Imaging Pediatric Body Array were designed specifically to fit the pediatric population for body imaging. The coil is comprised of 24 total channels, with two individual flexible pads, intended to be placed anterior and posterior to the patient, containing 12 individual elements. The elements are optimized to be flexible to conform to a pediatric patient's anatomy.
The InkSpace Imaging Pediatric Body Array is a receive-only coil for pediatric cardiac and body imaging in GE 3.0T MRI systems. Its acceptance criteria and performance are based on non-clinical testing.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Image Performance | Signal to Noise (SNR) meets specifications | Testing conducted, results suggest specifications met |
| Image Uniformity meets specifications | Testing conducted, results suggest specifications met | |
| Acquired Image Quality is clinically acceptable | Analyzed based on sample clinical images; found acceptable by board-certified radiologist | |
| Safety | Surface Heating within acceptable limits | Testing conducted, results suggest limits met |
| Decoupling Circuit functions as intended | Testing conducted, results suggest proper function | |
| EMC Immunity, Electrostatic Discharge meets standards | Testing conducted, results suggest standards met | |
| General Electrical/Mechanical Safety meets standards | Testing conducted, results suggest standards met | |
| Biocompatibility | No Cytotoxicity | Testing (ISO 10993) conducted, results suggest no cytotoxicity |
| No Sensitization | Testing (ISO 10993) conducted, results suggest no sensitization | |
| No Irritation | Testing (ISO 10993) conducted, results suggest no irritation | |
| Usability | Device is usable | Usability Testing conducted |
| Durability/Transit | Device withstands transit | Transit Testing conducted |
Study Proving Acceptance Criteria:
The device's acceptance criteria were proven through a series of nonclinical tests conducted in accordance with the FDA Guidance Document entitled, "Magnetic Resonance (MR) Receive-only Coil – Performance Criteria for Safety and Performance Based Pathway," issued December 11, 2020.
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: The document does not specify a numerical sample size for "test sets" in the traditional sense of a clinical trial with patient data. The testing primarily involved bench testing and technical evaluations of the device itself. For "Acquired Image Quality," sample clinical images were analyzed.
- Data Provenance: Not explicitly stated as "country of origin" for patient data, since the primary testing was non-clinical. The "sample clinical images" used for image quality analysis would presumably be from a clinical setting, but no details on their origin (e.g., country, specific institution, retrospective/prospective collection) are provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: One expert.
- Qualifications of Experts: "A board-certified radiologist."
4. Adjudication method for the test set:
- The document mentions "a review of their clinical quality by a board-certified radiologist" for the acquired image quality. This implies a single-reader adjudication for the image quality assessment. There is no mention of a multi-reader, consensus, or other adjudication methods.
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, an MRMC comparative effectiveness study was not done. This device is a hardware component (MRI coil), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, in essence, standalone performance was assessed through the nonclinical bench testing. The "device performance" metrics (SNR, uniformity, heating, electrical safety, etc.) were evaluated for the coil itself, independent of human interpretation or interaction beyond its operational use in an MRI system. The image quality analysis, while reviewed by a radiologist, evaluated the device's output (the images) when compared to clinical expectations, not the radiologist's performance with or without the device.
7. The type of ground truth used:
- For the technical performance aspects (SNR, uniformity, heating, electrical safety, biocompatibility, etc.), the "ground truth" was established by engineering specifications, recognized industry standards (e.g., ISO 10993), and regulatory guidance documents (FDA Guidance Document for MR Receive-only Coil).
- For "Acquired Image Quality," the ground truth was based on the clinical interpretation and judgment of a board-certified radiologist regarding the diagnostic utility of the sample images produced by the device.
8. The sample size for the training set:
- Not applicable. This device is a hardware component (MRI coil); it does not involve machine learning or an "algorithm" in the sense of requiring a training set for model development.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set for this hardware device.
§ 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.