(81 days)
The InkSpace Imaging Small Body Array is a receive-only coil, used for obtaining diagnostic images of general human anatomy in adult and pediatric patients such as cardiac, spine, shoulder, elbow, knee, foot, and prostate in Siemens 3.0T magnetic resonance imaging systems. These images, when interpreted by a trained physician, yield information that may assist in diagnosis.
The InkSpace Imaging Small Body Array is a phased array, receive-only coil intended to work with Siemens 3.0T MRI scanners to provide optimal signal-to-noise ratio and uniformity for high resolution body MR imaging examinations. The coil is comprised of 24 total channels, with two individual flexible pads, each containing 12 individual elements. The elements are optimized to be flexible to conform to patients' anatomies.
The provided text describes the regulatory submission for a medical device, the InkSpace Imaging Small Body Array, and the FDA's "Substantially Equivalent" determination. However, it does not contain a detailed study proving the device meets specific acceptance criteria in the manner described in the prompt (e.g., sample size for test set, expert qualifications, multi-reader multi-case studies, or AI specific details).
The document focuses on demonstrating substantial equivalence to a predicate device (InkSpace Imaging Body Array, K223487) through non-clinical testing and a comparison of technological characteristics. It explicitly states that clinical testing was not required.
Therefore, I cannot fulfill all parts of your request as the provided text does not contain the detailed study information for acceptance criteria related to a performance study on a test set (e.g., a study demonstrating a specific diagnostic accuracy or improvement in human reader performance). The information primarily pertains to device characterization and safety.
Here is what can be extracted and inferred from the text regarding acceptance criteria and performance data, acknowledging the limitations:
Acceptance Criteria and Reported Device Performance (Based on Non-Clinical Testing):
| Acceptance Criteria Category (Non-Clinical) | Reported Device Performance/Conclusion |
|---|---|
| Image Signal to Noise (SNR) | Non-clinical test performed on InkSpace Imaging Small Body Array. (Implicitly, the device met the established specifications for SNR, contributing to the conclusion of safety and effectiveness.) |
| Image Uniformity | Non-clinical test performed on InkSpace Imaging Small Body Array. (Implicitly, the device met the established specifications for uniformity, contributing to the conclusion of safety and effectiveness.) |
| Surface Heating | Non-clinical test performed on InkSpace Imaging Small Body Array. (Implicitly, the device met safety criteria for surface heating.) |
| Decoupling Circuit | Non-clinical test performed on InkSpace Imaging Small Body Array. (Implicitly, the device met intended functionality for decoupling.) |
| EMC - Immunity, Electrostatic Discharge | Non-clinical test performed on InkSpace Imaging Small Body Array. (Implicitly, the device met electromagnetic compatibility standards.) |
| General Electrical/Mechanical Safety | Non-clinical test performed on InkSpace Imaging Small Body Array. (Implicitly, the device met general safety standards.) |
| Acquired Image Quality | Analyzed based on sample clinical images. Reviewed by a board-certified radiologist. (The review confirmed acceptable image quality for diagnostic purposes, contributing to the conclusion of safety and effectiveness and suitability for interpretation by a trained physician as per the Indications for Use.) |
| Biocompatibility Testing | Performed for Cytotoxicity, Sensitization, and Irritation. Initial testing on predicate device deemed applicable, presumably supplemented by additional analysis if needed due to variations. (Implicitly, the device materials are biocompatible for patient contact.) |
| Usability Testing | Testing performed on the predicate device (InkSpace Imaging Body Array) was deemed applicable to the InkSpace Imaging Small Body Array without retesting due to risk analysis. (Implicitly, the device is usable and user-friendly.) |
| Transit Testing | Testing performed on the predicate device (InkSpace Imaging Body Array) was deemed applicable to the InkSpace Imaging Small Body Array without retesting due to risk analysis. (Implicitly, the device can withstand transit conditions.) |
| Overall Conclusion | "The collective results of the nonclinical testing demonstrate that the materials chosen, the manufacturing processes, and design of the InkSpace Imaging Small Body Array meet the established specifications necessary for consistent performance during its intended use. In addition, the collective bench testing demonstrates that the InkSpace Imaging Small Body Array does not raise different questions of safety or effectiveness for MR imaging examinations with Siemens 3.0T MRI Systems when compared to the predicate device." |
Study Details (Inapplicable or Not Provided for a "Performance Study"):
- Sample sized used for the test set and the data provenance: Not applicable in the context of clinical performance testing. The "sample clinical images" used for review of acquired image quality are mentioned but no specific "test set" size is provided, nor is their provenance (country of origin, retrospective/prospective) detailed. The review was part of non-clinical data, not a formal clinical trial with a defined test set size.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: For "acquired image quality," a "board-certified radiologist" reviewed the images. The exact number of radiologists is not specified, but the use of "a board-certified radiologist" (singular) is mentioned. No other ground truth establishment or expert panel for a "test set" is described as it was not a clinical efficacy study.
- Adjudication method: Not applicable/provided, as it was not a study requiring adjudication of diagnostic outcomes.
- 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 document is about an MRI receive-only coil, not an AI-powered diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm, but a hardware device.
- The type of ground truth used: For the "Acquired Image Quality," the ground truth was expert review by a board-certified radiologist of sample clinical images. This is qualitative assessment for suitability, not a quantitative ground truth for diagnostic accuracy (e.g., pathology report).
- The sample size for the training set: Not applicable. This is a hardware device, not an AI model requiring a training set.
- How the ground truth for the training set was established: Not applicable.
Summary of Device and Regulatory Context:
- Device: InkSpace Imaging Small Body Array - a receive-only MR coil.
- Purpose: To obtain diagnostic images of general human anatomy (cardiac, spine, shoulder, elbow, knee, foot, and prostate) in adult and pediatric patients using Siemens 3.0T MRI systems.
- Regulatory Path: 510(k) premarket notification, seeking substantial equivalence to a predicate device (InkSpace Imaging Body Array, K223487).
- Key Change from Predicate: Compatibility with Siemens 3.0T MRI Systems (predicate was for GE 3.0T MRI systems).
- Performance Data: Primarily non-clinical bench testing (SNR, uniformity, heating, etc.) and a qualitative review of sample clinical images by a radiologist. Clinical testing was explicitly stated as not required. The rationale for substantial equivalence is that the changes are minimal and do not raise new questions of safety or effectiveness.
§ 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.