(25 days)
O-scan is a Magnetic Resonance (MR) system that produces transversal, sagittal, coronal and oblique section images of limbs and joints. It is designed for imaging portions of the arm, including hand, wrist, forearm, and elbow, but excluding the upper part of the arm and portions of the leg, including foot, ankle, calf, and knee, but excluding the thigh. The M.R. images produced by O-scan correspond to the spatial distribution of the protons (hydrogen nuclei) which verify the properties of magnetic resonance and depend on the MR parameters spin-lattice relaxation time (T1), spin-spin relaxation time (T2), nucleus 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 changes performed on the modified O-scan, with respect to the cleared version – O-scan K092469 are due to the upgrade of the software system. These modifications, which do not affect the intended use or alter the fundamental scientific technology of the device, are the following:
- A new Software version (EVO'18) including the following features:
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- AGilExam (automatic slice positioning for the examination of the anatomical regions of knee, ankle and wrist)
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- 3D Viewer; this is an option that starting from the acquired data cube allows the running of a 3D viewer in which to reconstruct the desired 3D series, both using the three projections of the acquired package and generating a special MPR curve as reference. (Previously cleared by FDA via K180592 on G-Scan Brio)
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This FDA 510(k) summary for the Esaote O-Scan device does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in terms of diagnostic accuracy or effectiveness in a clinical setting.
The submission focuses on establishing substantial equivalence to previously cleared devices based on software modifications and compliance with safety standards rather than clinical performance claims.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
No acceptance criteria for diagnostic performance or reported clinical device performance are mentioned in this document. The submission states "No clinical tests are included within this submission."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No clinical tests or test sets are described.
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 applicable. No clinical tests or ground truth establishment for a test set are described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical tests or adjudication methods are described.
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. No MRMC study is mentioned. The software modifications are described as improvements for display, analysis, and comparison, but no quantification of reader improvement is provided. The document mentions "AGilExam (automatic slice positioning for the examination of the anatomical regions of knee, ankle and wrist)" and "3D Viewer," which might relate to AI or image processing, but no comparative effectiveness study with human readers is presented.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. No standalone algorithm performance study is mentioned. The device is an MR system that produces images "When interpreted by a medical expert trained in use of MR equipment."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No ground truth for clinical performance is described.
8. The sample size for the training set
Not applicable. No training set for a clinical performance study is described.
9. How the ground truth for the training set was established
Not applicable. No ground truth for a training set is described.
Summary of what the document does include regarding device evaluation:
The submission focuses entirely on non-clinical tests to demonstrate substantial equivalence:
- Software Verification: The new software version (EVO'18) with AGilExam and 3D Viewer features was evaluated for verification.
- Compliance with Safety Standards: The O-Scan was found to conform to various medical device safety standards, including:
- IEC 60601-1 (Medical electrical equipment - General requirements for basic safety and essential performance)
- IEC 60601-1-2 (Electromagnetic compatibility)
- IEC 60601-1-6 (Usability)
- IEC 60601-2-33 (Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis)
- ISO 14971 (Medical devices - Application of risk management to medical devices)
- ISO 62304 (Medical device software - Software life cycle processes)
- IEC 62366 (Medical devices - Application of usability engineering to medical devices)
- NEMA MS-1 (Magnetic Resonance Terminology)
- NEMA MS-3 (Quality Control Procedures for Magnetic Resonance Imaging Devices)
The conclusion states that "The non-clinical testing demonstrates that the O-Scan is as safe, as effective, and performs as well as or better than the predicate." This "effectiveness" is inferred from compliance with standards and the nature of the software modifications, not from clinical performance data.
§ 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.