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The Dynamic MRI Software Option for C-scan, E-scan XQ and E-scan Opera MRI Systems allows the acquisition of MR dynamic image datasets and the post processing display of temporal variations in the acquired datasets, showing changes in contrast over time. Its purpose is to provide time intensity curves that support the diagnostic process. These images when interpreted by a trained physician, yield information that may assist in diagnosis.

The Dynamic MRJ Software Option is a software package intended to be used with the Esaote C-scan. E-scan XO and E-scan Opera MRI systems, cleared via K040877 K032121 and K060956, respectively, The software package allows the acquisition of MR dynamic image datasets and the post processing display of temporal variations in the acquired image datasets, showing changes in image contrast over time.

It provides time intensity data, calculates the interpolation curve of the data, its maximum slope and its asymptotic value. These data, when interpreted by a trained physician, vield information that may assist diagnosis.

C-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.

E-scan XO 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, elbow, upper arm and shoulder, and imaging portions of the leg, including the foot, ankle, calf, knee, thigh and hip.

E-scan Opera is a magnetic resonance (MR) system that produces transversal, sagittal and coronal and oblique cross-section images of the limbs and ioints. It is intended for imaging portions of the arm. including the hand, wrist, forearm, elbow, upper arm and shoulder, and imaging portions of the leg, including the foot, ankle, calf, knee, thigh and hip.

The C-scan, E-scan XO and E-scan Opera MR 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.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Dynamic MRI Software Option for C-scan/E-scan XQ/E-scan Opera.

It's important to note that this 510(k) summary is for a software option that enhances existing MRI systems by enabling dynamic imaging and post-processing of temporal variations. The focus is on demonstrating substantial equivalence to predicate devices rather than a de novo clinical study proving novel diagnostic efficacy. Therefore, typical acceptance criteria and study designs for entirely new diagnostic algorithms might not apply directly in the same way.

Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" for this specific 510(k) is primarily centered around demonstrating substantial equivalence to predicate devices, particularly in terms of indications for use and technological characteristics, without introducing new questions of safety or effectiveness. The reported performance is essentially that the device functions comparably to the predicate devices in its ability to acquire and process dynamic MRI data to produce time-intensity curves.

Given the nature of a 510(k) for a software enhancement to an already cleared imaging system, the "acceptance criteria" are implied through comparison with predicate devices, rather than explicit numerical performance targets like sensitivity/specificity for a diagnostic AI model.

Study Information

Based on the provided 510(k) summary, there is no explicit clinical study described for this specific device. The clearance is based on demonstrating "substantial equivalence" to legally marketed predicate devices, which is a common pathway for modifications or enhancements to existing, cleared medical devices.

The information suggests that the device’s performance is validated through engineering comparisons to predicate devices, confirming that the new software option provides similar functionality without altering the fundamental scientific technology or raising new safety/effectiveness concerns.

Here's why specific sections of your request are not directly addressed in this type of submission:

1. Sample size used for the test set and the data provenance: Not applicable. No "test set" in the sense of a clinical trial dataset is described. The assessment is a comparison of technical specifications and intended use against predicate devices.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" derived from expert consensus on a test set is described. The device leverages existing MRI technology, where "ground truth" is typically established by the inherent diagnostic capabilities of MRI when interpreted by a trained physician.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No clinical test set requiring adjudication is mentioned.
4. 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 is not an AI-assisted diagnostic device in the modern sense, but rather a software feature for dynamic imaging. No MRMC study is mentioned.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is inherently "human-in-the-loop" as it provides data for a trained physician to interpret. It is not an autonomous diagnostic algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not explicitly stated as part of a validation study for this specific software, as its functionality is based on established MRI principles. The "ground truth" concept is inherent in the predicate MRI systems providing diagnositc information when interpreted by a medical expert.
7. The sample size for the training set: Not applicable. This is not a machine learning or AI algorithm that requires a "training set."
8. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) summary demonstrating substantial equivalence for a software feature (dynamic MRI acquisition and post-processing) for existing MRI systems. It relies on the prior clearance of its predicate devices and the established safety and effectiveness of MRI technology itself, rather than presenting a new clinical study with explicit performance metrics against a defined ground truth.

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E-scan Opera 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, elbow, upper arm and shoulder, and imaging portions of the leg, including the foot, ankle, calf, knee, thigh and hip.

E-scan Opera MR 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 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.

The system is composed of these main parts:

1. Patient positioning table.
2. Magnetic unit with the display panel.
3. Operating console that consists of the PC unit (including keyboard and mouse), the monitor and the operating table.
4. Electronics box with filter panel.
5. Modular shielding box.

This 510(k) summary (K060956) is for the E-scan Opera, a Magnetic Resonance (MR) diagnostic device. It's important to note that this submission is a Special 510(k), meaning it's for modifications to an already cleared device (E-scan XQ K032121), and the changes do not affect the intended use or alter the fundamental scientific technology of the device.

Therefore, the submission focuses on demonstrating that the modified device remains substantially equivalent to the predicate devices and does not introduce new questions of safety or effectiveness. This type of submission typically relies on a comparison of technological characteristics with predicate devices rather than new clinical performance studies with specific acceptance criteria in the same way a de novo device might.

Based on the provided document, the acceptance criteria and study information typically sought for a new or significantly modified device's performance are not explicitly present or detailed because this is a Special 510(k) for minor modifications to an existing technology. The "study" here is essentially the comparison of technical specifications and demonstrating that the changes do not negatively impact performance or safety.

Here's an attempt to answer your questions based on what's available and the nature of a Special 510(k):

1. Table of Acceptance Criteria and Reported Device Performance

For a Special 510(k) like this, specific "acceptance criteria" and "reported device performance" in terms of clinical metrics (e.g., sensitivity, specificity for a diagnostic task) are generally not required or presented in the same way as for a new device. The "performance" is inherently demonstrated by showing substantial equivalence to the predicate device, which has already established acceptable clinical performance.

The document highlights the changes and compares the technical characteristics of the E-scan Opera to its predicate devices (E-scan XQ K032121 and G-scan K042236, as well as MAGNETOM Vision K945517 for software features). The "acceptance criteria" are implied to be that these changes do not degrade the performance or safety of the device compared to the predicate, and in some cases, improve user experience (e.g., lower patient table).

2. Sample size used for the test set and the data provenance
Not applicable/Not provided for this type of submission. As a Special 510(k) for modifications that do not alter the fundamental scientific technology or intended use, a specific clinical "test set" with a defined sample size for performance evaluation (e.g., diagnostic accuracy) is not typically required or performed. The demonstration of substantial equivalence is based on engineering changes and comparisons to predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not provided. No new clinical performance study requiring expert-established ground truth was detailed in this submission. The device relies on existing MR technology where "medical expert trained in the use of MR equipment" interpret images.

4. Adjudication method for the test set
Not applicable/Not provided. No new clinical performance study requiring adjudication was detailed.

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 device is a basic MR imaging system, not an AI-assisted diagnostic tool. No MRMC study or AI component is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a basic MR imaging system, not an algorithm being evaluated for standalone performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable/Not provided. For an MR imaging device, the "ground truth" for diagnostic purposes is typically pathology, surgical findings, or clinical follow-up as interpreted by human experts. However, no new clinical study requiring the establishment of ground truth for performance metrics was conducted or reported in this Special 510(k).

8. The sample size for the training set
Not applicable/Not provided. This submission does not involve a machine learning or AI algorithm that requires a training set.

9. How the ground truth for the training set was established
Not applicable/Not provided. Since there is no training set mentioned, the establishment of its ground truth is also not applicable.

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E-scan XQ is a magnetic resonance (MR) system that produces transversal, sagittal and coronal and oblique images of the limbs and joints. It is intended for imaging portions of the upper limb, including the hand, wrist, forearm, elbow, upper arm and shoulder, and imaging portions of the lower limb, including the foot, ankle, calf, knee, thigh and hip.

E-scan XQ MR 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.

The DPA Shoulder Coil is to be used with the E-scan XQ magnetic resonance imaging system. It is a receiving coil and is the result of the combination of two different coils. The first is a coil designed to be "worn" by the patient and connected in a series with 4 tuning capacitors positioned under the primary coil and is composed of 3 turns designed to improve the image homogeneity and having spatially complementary sensitivity with respect to the primary coil. The coil allows for imaging of both the left and right shoulder, due to the symmetrical mechanical connection between its base and the magnet.

The provided text is a 510(k) premarket notification summary for the E-scan XQ MRI System, specifically addressing the addition of a DPA Shoulder Coil. This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with performance criteria. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment is largely absent from this document.

Here's an analysis based on the provided text, highlighting the information that is and is not available:

1. Table of Acceptance Criteria and Reported Device Performance

Not available. The document does not specify quantitative acceptance criteria or provide performance metrics such as sensitivity, specificity, or accuracy of the device for diagnostic tasks. The focus is on the "technological characteristics" of the new shoulder coil being "similar" to the predicate, and producing diagnostically useful images when interpreted by a medical expert.

2. Sample Size for the Test Set and Data Provenance

Not available. The document describes the device and its intended use but does not mention any specific test set of cases, their size, or their origin (country, retrospective/prospective). This is typical for a 510(k) submission where substantial equivalence is demonstrated through engineering and functional comparisons, not necessarily new clinical performance data for diagnostic accuracy.

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

Not applicable/Not available. Since no specific test set or diagnostic performance study is described, there's no mention of experts establishing ground truth for such a study. The document generally states that images provide "diagnostically useful information" when "interpreted by a medical expert trained in the use of MR equipment." This is a general statement about the expected use of an MR system, not a specific study methodology.

4. Adjudication Method for the Test Set

Not applicable/Not available. As no test set for diagnostic performance is detailed, no adjudication method is described.

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

No. The document does not describe any MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated. The device itself is an MRI system and coil, not an AI-assisted diagnostic tool.

6. Standalone Performance Study (Algorithm only without human-in-the-loop performance)

No. The device is an MRI system. By its nature, it requires a human expert ("a medical expert trained in the use of MR equipment") to interpret the images. There is no mention of an algorithm-only standalone performance study.

7. Type of Ground Truth Used

Not available. Since no specific performance study with a test set is detailed, the type of ground truth used to evaluate diagnostic accuracy is not mentioned. The document focuses on the physical properties of the MR images (spatial distribution of protons, relaxation times, etc.) rather than diagnostic outcomes.

8. Sample Size for the Training Set

Not applicable. The E-scan XQ MRI System is a hardware device; it does not appear to employ machine learning or AI that would require a "training set" in the computational sense.

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

Not applicable. As there is no training set for a machine learning algorithm, there is no description of how ground truth would be established for it.

Summary of what is present in the document:

• Device Description: The DPA Shoulder Coil for the E-scan XQ MRI system is a receiving coil connected in series with tuning capacitors. It's designed to be "worn" by the patient and improve image homogeneity and Signal-to-Noise Ratio (SNR).
• Intended Use: The E-scan XQ MR system, with the DPA Shoulder Coil, is intended for imaging portions of the upper and lower limbs, specifically mentioning the shoulder. It produces transversal, sagittal, coronal, and oblique images corresponding to the spatial distribution of protons.
• Technological Characteristics (Comparison to Predicate): The document affirms that the "technological characteristics of the DPA 7 Shoulder coil are similar to the characterisitics of the predicate device DPA receiving coils." It lists physical dimensions for various coils (Knee, Hand, Foot/Ankle) for both the predicate and the modified E-scan XQ, highlighting the addition of the Shoulder coil.
• Predicate Device: Esaote E-Scan (K990968, K001894), Esaote Hip Coil (K012728), Esaote E-Scan XQ (K020164, K032121).
• Regulatory Conclusion: The FDA determined the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market subject to general controls.

This 510(k) largely relies on demonstrating that the new shoulder coil does not raise new questions of safety and effectiveness compared to existing, cleared MRI coils and systems, rather than presenting new clinical performance data for diagnostic accuracy.

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E-scan XQ 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 the arm, including the hand, wrist, forearm, elbow, upper arm and shoulder, and imaging the leg, including the foot, ankle, calf, knee, thigh and hip.

E-scan XQ MR images correspond to the spatial distribution of protons (hydrogen nucle) that determine magnetic resonance properties and are dependent on the MR parameters, including spin-latice relaxation time (TI), 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.

The E-scan XQ is a magnetic resonance (MR) system. The modified system is composed of a patient positioning table, magnetic unit, operating console (PC unit, keyboard, mouse, monitor, operating table), electronics box with filter panel, and modular shielding box. The modifications from the cleared version (K020164) include a modified system configuration, new operating tables, upgrading of the electronics, and a new software release. These modifications are stated to not affect the intended use or alter the fundamental scientific technology of the device.

This document is a 510(k) premarket notification for modifications made to the E-Scan XQ MRI system. It's not a study report proving a device meets acceptance criteria through clinical or technical performance testing with a specific outcome measure like diagnostic accuracy. Instead, it demonstrates substantial equivalence to a previously cleared device (E-Scan XQ K020164) based on similar technological characteristics and unchanged intended use.

Therefore, many of the requested categories (acceptance criteria, reported performance, sample size, ground truth, expert consensus, MRMC study, standalone performance) are not applicable (N/A) in the context of this type of submission. The comparison is primarily against the specifications of the predicate device, not clinical performance metrics against a defined standard.

However, I can extract the information provided regarding the modification and the comparison to its predicate.

Here's a summary of the relevant information:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) amendment for modifications, the "acceptance criteria" are implicitly the maintenance of, or improvement upon, the technological characteristics of the predicate device, while ensuring the intended use is not altered. The "reported device performance" is a comparison of the modified device's technical specifications against the predicate.

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The E-scan XQ is intended for diagnostic nuclear magnetic resonance imaging of the hip, knee, ankle, foot, shoulder, elbow, wrist, hand, calf, thigh, arm and forearm. The device produces transverse, sagittal, coral and oblique cross-sectional images, displaying the internal structure of the limbs and joints being imaged. The images that are produced correspond to the spatial distribution of protons (hydrogen nuclei) that check the magnetic resonance properties and depend upon the MR parameters (spin-lattice relaxation time (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and chemical shift). If interpreted by a medical expert, these images can provide diagnostically useful information.

The E-Scan MRI system is substantially equivalent to the currently available E-Scan system cleared via K012728.

The provided 510(k) summary for the E-Scan XQ Magnetic Resonance Diagnostic Device does not contain information regarding acceptance criteria or a study proving the device meets specific performance criteria beyond substantial equivalence to predicate devices.

The document focuses on:

• Submitter Information: Details of the manufacturer and contact person.
• Device Identification: Trade name, common name, classification, and product code.
• Predicate Devices: Lists similar devices previously cleared by the FDA.
• Intended Use: Description of the device's diagnostic purpose and areas of the body it images.
• Technological Characteristics: States that the device is "substantially equivalent" to an existing cleared E-Scan system.
• FDA Clearance Letter: Confirms substantial equivalence to predicate devices.

Therefore, it is not possible to fill out the requested table or provide details about a performance study, sample sizes, expert qualifications, or ground truth based solely on the provided text.

Explanation for the absence of requested information:

510(k) submissions primarily focus on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through extensive clinical performance studies. While the device's output (images) is intended to be interpreted by a medical expert for diagnostically useful information, the 510(k) summary itself does not detail a specific study proving the device's diagnostic accuracy or performance against pre-defined acceptance criteria. The FDA's clearance is based on the device being "substantially equivalent" in terms of intended use, technological characteristics, and safety and effectiveness to existing predicate devices.

To obtain the requested information, one would typically need to review a more detailed technical file, design validation reports, or clinical study reports that might have been submitted to the FDA as part of the overall 510(k) submission, but this information is not present in the provided summary.

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