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The Comfort EC710 is a whole-body magnetic resonance imaging (MRI) system intended for general diagnostic use. Transverse, sagittal, coronal and oblique planes may be imaged. MRI images produced by the Comfort EC710 system reflect the spatial distribution for the density of hydrogen nuclei (protons) spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images yield information that can be useful in the determining of a diagnosis.

The Comfort EC710, a 1.5T MRI System, represents a modification to the previously cleared Echostar Comfort 1.5T MRI system (K141945); both utilize a 1.5T superconducting magnet with a 71cm bore, gradients, RF transmission, various sequences and reconstruction algorithms to acquire 2D single slice, multi-slice and 3D volume images, with a data acquisition system supporting multiple coil elements.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Comfort EC710 device by Alltech Medical Systems America, Inc.

Important Note: The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel device with extensive new clinical performance studies. As such, many of the typical elements of an acceptance criteria and study description for a new AI-powered diagnostic device will not be present.

Acceptance Criteria and Study for Comfort EC710 MRI System (K163192)

Based on the provided 510(k) summary, the Comfort EC710 is an update to an existing Magnetic Resonance Imaging (MRI) system (Echostar Comfort 1.5T MRI system, K141945), and the primary focus of the submission is to demonstrate that the changes do not alter fundamental scientific technology or raise new safety concerns. Therefore, the "acceptance criteria" and "study" described are mainly focused on verifying that the modified device still meets established safety and performance standards for MRI systems and performs equivalently to its predicate.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document mentions that "clinical images were obtained to confirm the performance of the knee-foot coil and the new software features" and "sample phantom and clinical images, and test data support the safety of the device."

• Test Set Sample Size: Not explicitly stated. The document refers to "clinical images" and "sample phantom images" generically without providing specific numbers of patients, cases, or scans.
• Data Provenance: Not explicitly stated (e.g., country of origin). The study appears to be retrospective in comparison to the predicate and current clinical images were prospectively/concurrently acquired for verification of new features, rather than as a formal clinical trial for validation.

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

• Number of Experts: Not specified. The document states that "MRI images produced by the Comfort system... When interpreted by a trained physician, these images yield information that can be useful in the determining of a diagnosis." This implies image interpretation by physicians but does not detail how ground truth was established for the specific testing mentioned.
• Qualifications of Experts: Not specified beyond "trained physician."

4. Adjudication Method for the Test Set

Not applicable/Not mentioned. The document primarily focuses on technical safety and performance equivalence, and verification of new features, rather than a diagnostic performance study requiring expert adjudication of results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size of Human Reader Improvement with AI vs. without AI Assistance

• MRMC Study: No. This is not an AI-powered diagnostic device in the sense of providing automated interpretations or assisting human readers for increased diagnostic accuracy or efficiency. It is an MRI imaging system that produces images for human interpretation.
• Effect Size: Not applicable.

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

Not applicable. The Comfort EC710 is an MRI imaging device, not a standalone diagnostic algorithm. Its output (images) is explicitly intended for interpretation by a "trained physician."

7. The Type of Ground Truth Used

For the safety and performance acceptance criteria:

• Standards and Benchmarks: Conformance to recognized NEMA and IEC standards for MRI systems.
• Equivalence to Predicate: Performance that is "equivalent" to the legally marketed Echostar Comfort 1.5T MRI system (K141945).
• Image Quality: Implied ground truth for "confirming performance" of new features would likely involve assessments of image quality, resolution, contrast, artifact reduction, and homogeneity, likely against established benchmarks for diagnostic utility in MRI. However, the specific "type" of ground truth (e.g., pathology, clinical outcomes, expert consensus on image quality) for the "clinical images" is not detailed.

8. The Sample Size for the Training Set

Not applicable. The Comfort EC710 is an MRI system, not a machine learning algorithm that requires a "training set" in the conventional sense. The "software" mentioned refers to operational software, sequences, and reconstruction algorithms that are developed through engineering and testing, not typically "trained" on data in the way an AI model would be.

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

Not applicable, as there is no "training set" for an AI model in this context.

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The Echostar Comfort 1.5T MRI System is a whole-body magnetic resonance imaging (MRI) system intended for general diagnostic use. Transverse, sagittal, coronal and oblique planes may be imaged. MRI images produced by the Echostar Comfort system reflect the spatial distribution for the density of hydrogen nuclei (protons) spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images yield information that can be useful in the determining of a diagnosis.

The Echostar Comfort 1.5T MRI System and Echostar Spica 1.5T MR system are indicated for use as a whole body magnetic resonance diagnostic device (MRDD) that uses transverse, sagittal, coronal and oblique planes to image internal structures or functions of the body including head and extremities. MRI images correspond to the spatial distribution of protons (hydrogen nuclei) that exhibit nuclear magnetic resonance (NMR). The NMR properties of body tissues and fluids are hydrogen density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow dynamics. These images, when interpreted by a trained physician, yield information that can be useful in diagnosis.

The Echostar Comfort 1.5T MRI System represents a modification to the previously cleared Echostar Spica 1.5T MR system (K113511); both utilize a superconducting magnet, gradients, RF transmission, various sequences and reconstruction algorithms to acquire 2D single slice, multi-slice and 3D volume images. The data acquisition system supports multiple coil elements including a body coil, head coil, spine coil, cspine (neck) coil, shoulder coil, knee coil, small-4 element torso coil, large-12 element torso coil, wrist coil, medium-8 element torso coil, small flex coil and large flex coil.

This document describes the Echostar Comfort 1.5T MRI System, which is a modification of a previously cleared device (Echostar Spica 1.5T MR system). The submission focuses on demonstrating substantial equivalence to the predicate device rather than presenting a de novo performance study with specific acceptance criteria directly related to clinical diagnostic accuracy.

Therefore, much of the requested information regarding clinical study design, sample sizes, expert adjudication, MRMC studies, and standalone performance for diagnostic tasks is not explicitly available within this 510(k) summary. The summary focuses on engineering and regulatory compliance, ensuring the modified device maintains the same safety and effectiveness as its predicate.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for diagnostic performance (e.g., sensitivity, specificity for a specific condition) for the Echostar Comfort 1.5T MRI System. Instead, the acceptance criteria are based on technical and safety standards compliance and equivalence to the predicate device.

• AAMI ANSI ES 60601-1:2005/(R)2012
• IEC 60601-1-2:2007
• IEC 60601-2-33:2010
• NEMA MS-1 2008
• NEMA MS-2 2008
• NEMA MS-3 2008
• NEMA MS-4 2010
• NEMA MS-5 2010
• NEMA MS-6 2008
• NEMA MS-8 2008 |
  | Image Quality & Functionality | Sample phantom and clinical images, and test reports were presented to demonstrate conformance with standards and equivalent performance with the predicate device. The system can acquire 2D single slice, multi-slice and 3D volume images, and images reflect spatial distribution for hydrogen nuclei density, T1, T2, and flow. |
  | Safety | Nonclinical testing for safety was conducted. No new or additional safety concerns have been raised compared to the predicate device. |
  | RF Coils & System Components | Modifications include:
• Additional RF coils.
• Magnet modifications for a 70+ cm clear bore opening.
• RF transmit components specified for required RF transmit performance.
• Gradient subsystem specified for higher gradient strength and slew rate.
  These modifications are designed to maintain or improve performance while ensuring equivalence. |
  | Software Sequences & Applications | Includes the same software sequences and applications, modified for scan performance improvements. |

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

The document states: "Sample phantom and clinical images, and test reports are presented for the changes, demonstrating conformance with the standard and equivalent performance with the predicate device."

• Sample Size for Test Set: Not specified quantitatively. It mentions "sample phantom and clinical images," implying a limited set used for technical verification rather than a large-scale clinical trial to establish diagnostic accuracy against a ground truth.
• Data Provenance: Not explicitly stated (e.g., country of origin). It mentions "clinical images," suggesting real patient data, but whether it was retrospective or prospective is not detailed. Given the context of a 510(k) for a modified device, it's likely images were collected to demonstrate equivalence, possibly from a mix of retrospective and prospective technical validation scans.

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

This information is not provided. The assessment appears to be primarily technical validation (phantom images, engineering tests) and a comparison of image characteristics to the predicate device, rather than a clinical study requiring expert diagnosis against a clinical ground truth for the new device. The Indications for Use state, "When interpreted by a trained physician, these images yield information that can be useful in the determining of a diagnosis," implying that the interpretation relies on existing medical expertise once the image quality is deemed acceptable.

4. Adjudication Method for the Test Set

Since a formal clinical study with a diagnostic ground truth is not detailed, an adjudication method is not applicable or described in this summary. The assessment focuses on meeting technical standards and demonstrating image quality equivalence.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not done or described. This submission is for an MRI system, not an AI-powered diagnostic algorithm alongside human interpretation.

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

No, a standalone performance study for an algorithm was not done or described. This device is an MRI hardware and basic software system, not an AI or standalone diagnostic algorithm.

7. The Type of Ground Truth Used

For the technical performance aspects, the "ground truth" would be established through:

• Physical Phantoms: Known physical properties and structures within phantoms are used to assess image quality metrics (signal-to-noise ratio, spatial resolution, contrast, uniformity, etc.) according to NEMA standards.
• Predicate Device Performance: The primary "ground truth" for the new device's performance is its substantial equivalence to the performance of the legally marketed predicate device (Echostar Spica 1.5T MR system), which itself would have demonstrated diagnostic capability in general use.
• Clinical Image Evaluation: As mentioned, "clinical images" were presented, which would implicitly be evaluated by qualified personnel for acceptable diagnostic quality, even if not against a specific pathological ground truth within this particular submission.

8. The Sample Size for the Training Set

Not applicable/Not mentioned. This document describes an MRI hardware system, not a device that relies on a trained algorithm or AI model. Therefore, there is no "training set" in the context of machine learning.

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

Not applicable/Not mentioned. As there is no training set for an AI model, this question does not apply to this submission.

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The Echostar 1.5T and Echostar Spica 1.5 T MR Systems are indicated for use as a whole body magnetic resonance diagnostic device (MRDD) that uses transverse, sagittal, coronal and oblique planes to image internal structures or functions of the body, including head and extremities. MRI images correspond to the spatial distribution of protons (hydrogen nuclei) that exhibit nuclear magnetic resonance (NMR). The NMR properties of body tissues and fluid are hydrogen density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow dynamics. These images, when interpreted by a trained physician, yield information that can be useful in diagnosis. The device is intended for prescription use only.

The Echostar Spica 1.5T MR System is a whole-body magnetic resonance imaging (MRI) system intended for general diagnostic use. Transverse, sagittal, coronal and oblique planes may be imaged. MRI Images produced by the Echostar Spica system reflect the spatial distribution fo the density of hydrogen nuclei (protons) spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and flow. When interpreted by a trained physician, these images yield information that can be useful in the determining of a diagnosis. This device is intended for prescription use only.

The Echostar Spica 1.5 T MR System represents a modification to the previously cleared Echostar 1.5 T (K082100); both utilize a superconducting magnet, gradients, RF transmission, various sequences and reconstruction algorithms to acquire 2D single slice, multi-slice and 3D volume images. The data acquisition system supports multiple coil elements including, a body coil, head coil, spine coil, c-spine (neck) coil, shoulder coil, knee coil, small - 4 element torso coil, large - 12 element torso coil and wrist coil.

The provided 510(k) summary for the Alltech Echostar Spica 1.5 T MR System does not contain the detailed information requested regarding specific acceptance criteria for device performance and the study proving it meets these criteria in the context of diagnostic accuracy. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (Alltech EchoStar 1.5 T) based on technological characteristics and safety.

Here's a breakdown of the available information in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table with explicit acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, accuracy for specific pathologies) nor does it report these metrics for the device. The "performance testing" described refers to engineering and safety verifications rather than clinical diagnostic outcome measures.

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

No information is provided regarding a specific "test set" for evaluating diagnostic accuracy. The performance testing mentioned involves "sample phantom and clinical images." The provenance of these clinical images (e.g., country of origin, retrospective/prospective) is not disclosed, and the sample size is not specified beyond "sample" images.

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

Since no diagnostic accuracy study using a specific test set is detailed, there's no information on the number or qualifications of experts used to establish a ground truth for such a set.

4. Adjudication Method:

Given the lack of a diagnostic accuracy study, there's no mention of an adjudication method (e.g., "2+1", "3+1") for establishing ground truth.

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

No MRMC study comparing human readers with and without AI assistance is mentioned. This device is an MRI system, not an AI-powered diagnostic tool, so such a study would not be applicable in this context.

6. Standalone (Algorithm Only) Performance:

This submission concerns an MRI system, not an AI algorithm. Therefore, "standalone (algorithm only)" performance is not evaluated or reported.

7. Type of Ground Truth Used:

For the performance testing that was conducted (NEMA standards, IEC 60601-2-33), the "ground truth" would relate to quantitative measurements from phantoms and qualitative assessment of image quality from clinical images, rather than a clinical diagnostic ground truth like pathology or outcomes data.

8. Sample Size for the Training Set:

This information is not applicable. The device is an MRI scanner, and the submission does not describe a machine learning algorithm with a training set.

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

This information is not applicable for the same reason as above.

Summary of Device Evaluation in the 510(k):

The 510(k) submission for the Echostar Spica 1.5 T MR System focuses on demonstrating substantial equivalence to a previously cleared predicate device (Alltech EchoStar 1.5 T, K082100). The changes introduced in the Spica system (additional RF coils, removal of amplifier option, optional respiratory gating, magnet manufacturer change, software/sequence updates) are presented as minor and not impacting the fundamental scientific technology, intended use, indications for use, design principles, performance effectiveness, or safety.

The "performance testing" described in the document primarily verifies that the modified device adheres to relevant engineering and safety standards (NEMA standards and IEC 60601-2-33), and that image quality (from "sample phantom and clinical images") remains comparable to the predicate device. This is a typical approach for demonstrating substantial equivalence for modifications to existing medical imaging hardware, where direct clinical diagnostic accuracy studies are often not required if the core technology and intended use remain unchanged.

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The EchoStar 1.5 T MR System is a whole-body magnetic resonance imaging (MRI) system intended for general diagnostic use. Sagittal, coronal and oblique planes may be imaged. MRI images produced by the EchoStar system reflect the spatial distribution of the density of hydrogen nuclei (protons), spin-latice relaxation time (TI), spin-spin relaxation time (T2), and flow. When interpreted by a trained physician, these images yield information that can be useful in the determining of a diagnosis. This device is intended for prescription use only.

The EchoStar 1.5 T MR System is a whole-body magnetic resonance imaging (MRI) system.

I apologize, but the provided text from the FDA 510(k) letter for the "EchoStar 1.5 T MR System" does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets them.

The letter is a regulatory document confirming clearance for marketing based on substantial equivalence to a predicate device. It states the indications for use but does not delve into the specific performance studies, acceptance criteria, or methodological details you've requested.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies based on this document.

To answer your request, I would need access to the full 510(k) submission, specifically the sections related to performance data and testing.

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