(16 days)
S-scan is a Magnetic Resonance (MR) system that produces transverse, sagittal and coronal and oblique cross-section images of the limbs, joints and spinal column. It is intended for imaging portions of the upper limb, including the hand, wrist, forearm, elbow, arm and shoulder, imaging portions of the lower limb, including the foot, ankle, calf, knee, thigh and hip and imaging the cervical spine and the lumbar spine sections as portions of the spinal column.
S-scan images correspond to the spatial distribution of protons (hydrogen nuclei) that determine magnetic resonance properties and are dependent on the MR parameters, including spin-lattice relaxation time (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and "chemical shift". When interpreted by a medical expert trained in the use of MR equipment, the images can provide diagnostically useful information.
S-scan is a Magnetic Resonance (MR) system, which produces images of the internal structures of the patient's limbs and joints.
This 510(k) is to add the 4-channels Lumbar Spine coils 17 and 18. These are a four channels receiving coils, shaped for suitability to the areas under examination and designed to be matched to the patient's lumbo-sacral vertebrae; the coils are also morphologically adapted to the examined area to obtain a good Signal-to-Noise Ratio.
The provided text is a 510(k) Summary for the 4-channels Lumbar Spine Coils 17 and 18 for the Esaote S-scan MRI system. It describes the device, its intended use, and its technological characteristics. However, it does not contain information regarding detailed acceptance criteria, a specific study proving the device meets those criteria, or any performance metrics like sensitivity, specificity, or reader improvement with AI assistance.
The document states: "Non-clinical testing of the S-scan system with the addition of the 4-channels Lumbar Spine Coils 17 and 18 demonstrated that it met performance requirements and is as safe and effective as the predicate devices." This is a high-level statement and does not provide the specifics requested in your prompt.
Therefore, I cannot populate the table or answer most of your questions based on the provided text.
Here's an assessment based on the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in text | "met performance requirements and is as safe and effective as the predicate devices." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not specified in the text. The document mentions "non-clinical testing" but does not detail the size or nature of the test set, nor its provenance.
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 specified in the text.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified in the text.
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 document describes an MRI coil, not an AI-powered device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This pertains to an MRI coil, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not specified in the text. The assessment of "performance requirements" would implicitly involve some form of ground truth or comparison, but the method is not described.
8. The sample size for the training set
- Not applicable. This is an MRI coil, not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This is an MRI coil, not an AI or machine learning model.
§ 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.