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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.

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O-scan is a Magnetic Resonance (MR) system that produces transversal, sagittal and coronal and oblique cross-section images of the limbs and joints. It is intended for imaging portions of the arm, including the hand, wrist, forearm and elbow, but excluding the upper arm, and imaging portions of the leg, including the foot, ankle, calf and knee, but excluding the thigh.

O-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.

O-scan is a Magnetic Resonance (MR) system, which produces images of the internal structures of the patient's limbs and joints.

The system comprises three main parts:

1. Magnetic unit, containing a permanent magnet

2. Electronic unit

3. Console, comprising a PC, Keyboard, mouse, monitor and operating table.

4. Patient seat

5. Receiving coils

This 510(k) summary for the O-Scan MR System does not contain detailed acceptance criteria or a specific study proving the device meets acceptance criteria in the manner typically expected for AI/ML-driven medical devices. Instead, it focuses on demonstrating substantial equivalence to predicate devices for a conventional MRI system.

Here's an analysis based on the provided text, highlighting what is present and what is absent:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "Non-clinical testing of the O-Scan system demonstrated that it met performance requirements and is as safe and effective as the predicate devices."

This is a general statement of compliance, but no specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or detailed reported device performance metrics are provided. For a traditional MRI system, "performance requirements" would typically refer to image quality parameters, signal-to-noise ratio, spatial resolution, field homogeneity, etc., but these are not explicitly listed or quantified in this summary.

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

Not specified. The document mentions "non-clinical testing," which usually refers to phantom studies, engineering tests, and bench testing, rather than studies on patient data with a defined "test set" in the context of AI/ML evaluation.

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

Not applicable/Not specified. For a conventional MRI system's substantial equivalence review, a dedicated "test set" with expert-established ground truth for diagnostic accuracy (as would be needed for an AI algorithm) is not typically detailed in this type of summary. The images are to be "interpreted by a medical expert trained in the use of MR equipment" for diagnostic information.

4. Adjudication Method for the Test Set:

Not applicable/Not specified. As there's no defined "test set" for diagnostic accuracy evaluation in the AI/ML sense, no adjudication method is mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. This document describes a conventional MRI system, not an AI-assisted diagnostic tool. Therefore, an MRMC study to show human reader improvement with AI assistance is not relevant and was not performed.

6. Standalone Performance Study:

No. The O-Scan is a diagnostic imaging device that produces images. Its performance is inherent in the image quality it generates for human interpretation, not in an automated diagnostic output from an algorithm operating in a standalone mode.

7. Type of Ground Truth Used:

Not applicable/Not specified. For evaluating the O-Scan as a diagnostic imaging system, the "ground truth" would ultimately be the patient's clinical outcome or other diagnostic modalities, as interpreted by a medical expert. However, the 510(k) summary doesn't detail a study where diagnostic accuracy against a specific ground truth was performed or quantified for the O-Scan itself. Its approval is based on substantial equivalence to existing MRI systems.

8. Sample Size for the Training Set:

Not applicable. The O-Scan is a hardware device (MRI scanner), not a machine learning algorithm. Therefore, there is no "training set" in the AI/ML context.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As there is no training set for an AI algorithm, this information is not relevant.

Summary of what is available from the 510(k) in relation to the request for AI/ML device criteria:

The provided 510(k) summary is for a traditional Magnetic Resonance (MR) imaging system (a hardware device), not an AI/ML-driven diagnostic software. Consequently, most of the requested information, which pertains to the rigorous evaluation of AI/ML algorithms, is not present because it is not applicable to the type of device being described.

The "performance data" section is very brief, simply stating that "Non-clinical testing of the O-Scan system demonstrated that it met performance requirements and is as safe and effective as the predicate devices." This is typical for demonstrating substantial equivalence for a conventional medical imaging device, focusing on engineering specifications and comparison to existing, cleared devices rather than a detailed clinical performance study with specific diagnostic accuracy metrics or AI algorithm validation.

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