Search Results

The general-purpose magnetic resonance imaging (MRI) device is designed to scan any targeted area of the body, to collect, display and analyze MR images and other real-time imaging procedures.

Imaging portions of calf, knee, ankle, foot, thigh, hand, wrist, forearm, elbow, arm, shoulder, hip, lumbar column, sacral column, cervical column, thoracic spine, pelvis, temporomandibular joint (included only for "Open" configuration), head (included only for "Open" configuration).

MRI provides better soft tissue contrast than CT and can differentiate better between fat, water, muscle, and other soft tissue than CT (CT is usually better at images provide information to physicians and can be useful in diagnosing a wide variety of diseases and conditions.

The new Magnifico EVO 23 employs the same fundamental scientific technology as its predicate device, the first version of Esaote Magnifico, cleared via K212419.

The modifications, do not affect the intended use or alter the fundamental scientific technology of the device.

The software, used on the proposed Magnifico system has been modified, from EVO 21 to include the

• LSDWI sequence for brain examination

• · MR Angiography
  · Maximum Intensity Projection (MIP)

• and to support:
  · Additional multi-channel technology coil for body

• · Enhancement of PC board with new processor
  Maqnifico keeps all the other technological characteristics of the first cleared, version, as the 0.4T permanent Magnet, based on NdFeB (neodymium), C-shape.

The provided text indicates that the device in question is the Magnifico Open (100009900) and Magnifico MSK (100009910) MRI systems, specifically focusing on the new EVO 23 software release.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with numerical targets. Instead, it describes general categories of testing and qualitative conclusions. The reported device performance is described as meeting these criteria.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a numerical sample size for the test set. It mentions "Sample clinical images for the new features were reviewed."

The data provenance (country of origin, retrospective/prospective) is not specified in the provided text.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Number of Experts: One expert.
• Qualifications: An "ACR registered radiologist." The document does not specify their years of experience.

4. Adjudication Method for the Test Set

The adjudication method is not explicitly stated as a formal process like 2+1 or 3+1. Given that only one expert (an ACR registered radiologist) reviewed the sample clinical images for new features, it appears to be a single-reader review rather than a consensus or adjudicated process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study comparing human readers with and without AI assistance was not mentioned in the provided text. The study focuses on the substantial equivalence of the device itself and the diagnostic quality of its output.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

The device is an MRI system, not an AI algorithm performing diagnostic tasks independently. The "software" modifications refer to new sequences (LSDWI, MR Angiography) and features (MIP), which are integrated into the MRI system to produce images, and these images are then assessed by a human expert. Therefore, a standalone algorithm-only performance study in the context of diagnostic AI is not applicable here. The software verification and validation, along with image quality tests, implicitly evaluate the system's standalone performance in generating medically relevant images.

7. The Type of Ground Truth Used

The ground truth for evaluating the "diagnostic quality" of the sample clinical images for new features was expert consensus/opinion. Specifically, it was the opinion of a single "ACR registered radiologist."

8. The Sample Size for the Training Set

The document does not provide any information about a training set since the device is an MRI system with new imaging sequences and features, not a machine learning model that requires a distinct training phase. The software changes involve implementation of established imaging techniques and display methods.

9. How the Ground Truth for the Training Set was Established

As no training set is mentioned or applicable in the context of the described device and its modifications, this information is not provided.

Ask a specific question about this device

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:
  • 1. AGilExam (automatic slice positioning for the examination of the anatomical regions of knee, ankle and wrist)
  • 2. 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)

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.

Ask a specific question about this device