(67 days)
S-scan is a Magnetic Resonance (MR) system that produces transversal, sagittal, 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, imaging the temporomandibular joint and imaging the cervical, the thoracic and the lumbosacral 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 spinlatice relaxation time (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and "chemical shift". When interpreted by a medical expert trained in use of MR equipment, the images can provide diagnostically useful information.
The change performed on the modified S-scan, with respect to the cleared version, S-scan K153039, is due to the improvement of the system performance. This modification, which does not affect the intended use or alter the fundamental scientific technology of the device, is the introduction of the Shoulder Coil 20 code 130000014. The Shoulder Coil N.20 is a three channels receiving coil. Its intended use is for shoulder examination on the S-scan. The Shoulder Coil is a wearable rigid coil equipped with an adaptor for fast placement in the patient table. The same adaptor matches for patient laterality (left /right shoulder).
This document, K161238, is a Special 510(k) submission for the ESAOTE S.p.A. S-scan Magnetic Resonance (MR) system, specifically regarding the addition of a new Shoulder Coil 20. The submission states that no clinical tests were performed to prove the device meets acceptance criteria. Instead, the submission relies on the concept of substantial equivalence to a previously cleared device (S-scan K153039) and non-clinical testing.
Therefore, many of the requested details related to acceptance criteria, device performance, and clinical study specifics are not available in this document.
However, based on the provided text, here's what can be extracted and inferred regarding the "study" that proves the device meets "acceptance criteria" through non-clinical means:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria with specific performance metrics for the device itself or the new shoulder coil. Instead, the "acceptance criteria" are implied to be adherence to recognized safety and performance standards and demonstrating improved image quality/performance of the new coil compared to the previous one.
| Acceptance Criteria (Implied) | Reported Device Performance (for Shoulder Coil 20) |
|---|---|
| Biocompatibility | Evaluated; found to conform to ISO10993-1 |
| Electrical safety | Evaluated; found to conform to IEC 60601-1, IEC 60601-1-2, IEC 60601-2-33 |
| Electromagnetic compatibility (EMC) | Evaluated; found to conform to IEC 60601-1-2 |
| Mechanical safety | Evaluated; found to conform to IEC 60601-1 |
| Software lifecycle process | Evaluated; found to conform to IEC62304 |
| Usability/Human factors | Evaluated; found to conform to IEC62366 |
| Risk management | Evaluated; found to conform to ISO 14971-2 |
| Image Quality: Signal-to-Noise Ratio (SNR) | Increased (compared to 2Ch Shoulder Coil 7) as per NEMA MS-1 standards. |
| Image Quality: Uniformity | Evaluated as per NEMA MS-3 standards. (Specific performance not detailed, but implied to be acceptable) |
| Increased number of possible patient examinations (due to coil size) | Designed to allow this |
| Increased receiving channels | 3 channels (compared to 2 channels in the previous coil) |
| Substantial Equivalence to Predicate Device (S-scan K153039) | Claimed and accepted by FDA. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as no clinical tests were performed with human subjects. The "test set" here refers to non-clinical evaluations against engineering standards and specifications within the manufacturer's testing environment.
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)
This information is not applicable as no clinical data or expert consensus was used for ground truth in this non-clinical submission. The "ground truth" for the non-clinical tests would be the established engineering and safety standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as no clinical data requiring expert adjudication was involved.
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, a multi-reader, multi-case comparative effectiveness study was not done. This submission is for an MR system, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The S-scan is a diagnostic imaging system, not an algorithm. Its performance is evaluated based on its ability to produce diagnostically useful images when interpreted by a medical expert. The "standalone" performance here refers to the engineering validation of the system and its components.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests, the "ground truth" was based on established engineering and safety standards and specifications. For example, the Signal-to-Noise Ratio (SNR) was determined according to NEMA MS-1, and image uniformity according to NEMA MS-3. These standards define the acceptable performance characteristics for MR devices.
8. The sample size for the training set
This information is not applicable. There is no "training set" in the context of this submission, as it does not involve machine learning or artificial intelligence.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set.
§ 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.