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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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The E-scan 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, coronal 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 is a magnetic resonance diagnostic device. The Multipurpose Flexible Receiving Coil improves the system performance and does not alter the fundamental scientific technology of the cleared device.

The provided 510(k) summary does not contain the detailed information typically required to describe acceptance criteria and a study proving a device meets them in the context of an AI/ML medical device submission. This document pertains to an MRI system (E-Scan) and a new receiving coil, filed in 2001, long before the widespread use and regulatory frameworks for AI/ML in medical devices.

Therefore, many of the requested fields cannot be directly extracted from the provided text. I will address what information is available and explain why other fields are missing or not applicable.

Here's an analysis based on the provided text:

Acceptance Criteria and Study for E-Scan MRI System (Receiving Coil)

The submission focuses on establishing substantial equivalence to a predicate device, primarily through demonstrating that the addition of a "Multipurpose Flexible Receiving Coil" does not alter the fundamental scientific technology of the cleared device (Esaote E-Scan K001894). The acceptance criteria are implicitly tied to maintaining the safety and effectiveness profile of the predicate device.

1. A table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified. The document does not describe a clinical study or test set in the way an AI/ML validation would. It primarily focuses on the technical characteristics of the new coil and its intended use.
• Data Provenance: Not applicable. There's no mention of specific data used for a test set that would have provenance like country of origin or whether it was retrospective/prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The submission states that images, "If interpreted by a medical expert, these images can provide diagnostically useful information," but doesn't detail their role in a specific test for the coil.

4. Adjudication method for the test set:

• Adjudication method: Not applicable. No specific test set or adjudication process is 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:

• MRMC Study: No, an MRMC study was not done.
• Effect Size of AI assistance: Not applicable. This submission is for an MRI system and a mechanical coil, not an AI/ML algorithm.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Standalone Performance: Not applicable. This is not an AI/ML algorithm. The device produces images that "If interpreted by a medical expert, these images can provide diagnostically useful information," clearly indicating human interpretation is part of its intended use.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Type of Ground Truth: Not explicitly stated as part of a formal validation study. For an MRI system, the "ground truth" for image quality and diagnostic utility is typically established by comparing the images produced to established anatomical knowledge, clinical expectations, and the ability of human experts to make diagnoses from them. No specific methodology for establishing such ground truth in the context of this specific submission (for the new coil) is detailed beyond its intended use for diagnostic imaging.

8. The sample size for the training set:

• Sample Size: Not applicable. This is not an AI/ML algorithm that required a training set.

9. How the ground truth for the training set was established:

• Ground Truth Establishment: Not applicable. This is not an AI/ML algorithm that required a training set.

Summary of what can be gleaned about the "study" for this device:

The "study" for this 510(k) submission primarily involved demonstrating that the new Multipurpose Flexible Receiving Coil is consistent with the established safety and effectiveness of the predicate E-Scan MRI system (K001894). The key "performance" claim is that the new coil "improves the system performance and does not alter the fundamental scientific technology of the cleared device," and that it can be used for various anatomical regions, including those that might be challenging with other coils (e.g., painful or plastered limbs). This substantial equivalence argument is based on technical specifications and comparison to existing devices rather than a formal clinical trial or AI/ML validation study.

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The E-Scan is intended for diagnostic nuclear magnetic resonance imaging of the hip, leg, knee, ankle, foot, shoulder, elbow, forearm, wrist and hand. The device produces transverse, sagittal, coronal 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 system preliminarily named "Artoscan S" is going to be commercialized under the trade name "E-Scan". The changes performed, with respect to the cleared version, are due to the optimization process of the system, in particular in relation to an improvement of the accessibility inside the gantry and therefore toward a greater patient comfort. The intended use of the modified device has not changed as a result of the modifications nor such modifications alter its fundamental scientific technology.

The E-Scan is a Magnetic resonance diagnostic device. It is a System, Nuclear Magnetic Resonance Imaging. The changes performed, with respect to the cleared version (Artoscan S), are due to the optimization process of the system, in particular in relation to an improvement of the accessibility inside the gantry and therefore toward a greater patient comfort.

Here's an analysis of the provided K990968 document, focusing on acceptance criteria and supporting studies.

It's important to note that this document is a 510(k) summary for a Magnetic Resonance Diagnostic Device (E-Scan) from 1999. The submission focuses on demonstrating substantial equivalence to a predicate device (Artoscan S), rather than presenting a performance study with detailed acceptance criteria as one might expect for a modern AI/software device. Therefore, many of the requested categories for AI device studies will not be directly applicable or present in this type of submission.

Acceptance Criteria and Device Performance (Based on Substantial Equivalence)

The acceptance criteria here are implicitly based on demonstrating that the E-Scan device is substantially equivalent to its predicate device, the Artoscan S. The performance metrics are relative to the predicate, showing that the E-Scan maintains or improves upon the predicate's capabilities.

Study Information (Based on the K990968 Submission):

The provided document is a 510(k) summary, which for a device like an MRI, primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device. It typically does not include a detailed, prospective clinical performance study with the types of metrics and specific methodologies you'd find for a novel AI diagnostic device.

Here's an attempt to answer the questions based on what can be inferred from this type of submission, or noting what is not applicable:

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Not Applicable / Not Provided. This 510(k) submission does not describe a clinical test set or study in the way an AI/software device would. The "study" here is essentially a technical comparison demonstrating that the modifications to the Artoscan S (to become E-Scan) do not alter the fundamental safety or effectiveness and that the new specifications are within acceptable ranges or represent improvements.
   • There is no mention of patient data, retrospective or prospective studies, or country of origin for such data.

2. 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. Since no specific test set and ground truthing process for diagnostic performance are described, this information is not provided. The intended use states that images, "If interpreted by a medical expert, these images can provide diagnostically useful information," implying that medical experts (like radiologists) would interpret the output, but this is not part of a performance study setup in this document.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not Applicable. No test set or related adjudication is described.

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:

   • No, this was not done. This is a 1999 submission for an MRI hardware device, not an AI-powered diagnostic tool. The concept of "human readers improve with AI" is not relevant here.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

   • Not Applicable. This is an MRI scanner, not an algorithm. Its performance is inherent in the image quality and physical specifications.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • Not Applicable. No explicit ground truth for diagnostic performance is mentioned. The implicit "ground truth" for the substantial equivalence claim is the performance and specifications of the predicate device (Artoscan S).

7. The sample size for the training set:

   • Not Applicable. This device is an MRI machine; it does not utilize a "training set" in the context of machine learning.

8. How the ground truth for the training set was established:

   • Not Applicable. As there is no training set for a machine learning model, this question does not apply.

Summary of this 510(k) Submission:

This 510(k) for the E-Scan MRI machine is a request for clearance based on substantial equivalence to a previous version of the device (Artoscan S). The "study" involves a side-by-side technical comparison of specifications and features, demonstrating that the E-Scan either maintains the same capabilities as the predicate, offers minor improvements (like patient comfort or ease of use for certain anatomical regions), or has minor technical differences (e.g., slices per echo, homogeneity figures) that don't negatively impact safety or effectiveness for the stated intended use. A formal clinical study with patient data, ground truth establishment, or reader performance metrics, as would be expected for a modern AI medical device, is not part of this type of submission.

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