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The ECHELON C MRI system is an imaging device, and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The MR system produces transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the head, body, or extremities. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-latticë relaxation time (T1), spin-spin relaxation time (T2), and flow. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination.

ECHELON C Magnetic Resonance Imaging System that utilizes a 1.5 Tesla superconductive short bore gantry design. The design was based on the ECHELON MRI system.

The provided document (K083533) is a 510(k) premarket notification for an MRI system, not a study evaluating software or AI performance against specific acceptance criteria for diagnostic accuracy. The document is primarily focused on demonstrating substantial equivalence to a predicate device based on identical technological characteristics and intended use. Therefore, much of the requested information regarding acceptance criteria and performance studies is not present or applicable.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not available in the provided document. The 510(k) for an MRI system typically assesses technical specifications (e.g., field strength, image resolution, signal-to-noise ratio) and safety, rather than diagnostic accuracy against defined clinical acceptance criteria like sensitivity/specificity for a specific condition. The document states "The technological characteristics of this device are identical to the primary predicate device," implying performance is expected to be equivalent to the predicate.

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

Not applicable. This 510(k) filing does not describe a clinical performance study with a "test set" of patient data in the typical sense of evaluating diagnostic accuracy of an AI or software device. It is a submission for a physical imaging device.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. As no clinical performance study for diagnostic accuracy is detailed, there's no mention of experts establishing ground truth for a test set. The document indicates that images produced by the MR system, when interpreted by a trained physician, provide information useful for diagnosis.

4. Adjudication Method for the Test Set:

Not applicable for the reasons stated above.

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

Not applicable. This is not a software or AI device being evaluated for its impact on human reader performance. It is an MRI hardware system.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. The device is an MRI hardware system, not an algorithm. Its performance is inherent in its ability to produce images, which are then interpreted by a human.

7. Type of Ground Truth Used:

Not applicable. There is no mention of a ground truth in the context of diagnostic accuracy for this submission. The device produces images, and the "ground truth" for the intended use is that these images, when interpreted by a trained physician, provide information useful for diagnosis.

8. Sample Size for the Training Set:

Not applicable. The ECHELON C MRI System is a hardware device; it does not involve a "training set" in the context of machine learning or AI.

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

Not applicable for the reasons stated above.

Summary of the K083533 Document:

This 510(k) submission (K083533) for the ECHELON C Magnetic Resonance Imaging System outlines:

• Device Name: ECHELON C Magnetic Resonance Imaging System
• Intended Use: To provide physiological and clinical information via non-invasive, non-ionizing imaging of the head, body, or extremities. Images reflect spatial distribution of protons, useful for diagnosis when interpreted by a trained physician.
• Device Description: 1.5 Tesla superconductive short bore gantry, based on the ECHELON MRI system.
• Technological Characteristics: Stated to be identical to the primary predicate device (ECHELON Magnetic Resonance Imaging System, K052172). This is the core of its substantial equivalence argument.
• Regulatory Conclusion: FDA determined the device is substantially equivalent to the predicate device.

The document does not contain any information related to clinical performance studies, diagnostic accuracy, or AI evaluation because it is a filing seeking clearance for a new MRI hardware system based on its equivalence to an already cleared hardware system.

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The OASIS MR system is an imaging device, and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The MR system produces transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the head, body, or extremities. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and flow. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination.

The OASIS is a Magnetic Resonance Imaging System that utilizes a 1.2 Tesla superconducting open magnet in an open gantry design was based on the ECHELON MRI system. The OASIS has been designed to enhance clinical utility as compared to the ECHELON by taking advantage of open architecture.

The provided text does not contain information related to specific acceptance criteria or a study proving the device meets those criteria, as typically understood in the context of device performance metrics, clinical trials, or comparative effectiveness studies.

Instead, this document is a 510(k) premarket notification for a Magnetic Resonance Imaging (MRI) system. The core of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving performance against specific quantitative acceptance criteria through a dedicated study.

Here's what can be extracted and inferred from the document:

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

• Acceptance Criteria: Not explicitly stated in terms of performance metrics (e.g., sensitivity, specificity, accuracy). The acceptance criteria for a 510(k) are implicitly met by demonstrating substantial equivalence to a predicate device, which means having the same intended use, similar technological characteristics, and safety and effectiveness that are at least as good as the predicate.
• Reported Device Performance: Not reported in quantitative performance metrics. The document states:
  • "MRI is capable of producing high quality anatomical images without the associated risks of ionizing radiation." (General statement, not specific performance.)
  • "The technological characteristics of this device are similar to the primary predicate device. The primary difference is the 1.2 Tesla superconducting open magnet. The control and image processing hardware and the base elements of the system software are identical to the predicate device." (Focuses on similarity to predicate, not explicit performance.)

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 / Not provided. No specific test set or associated data is mentioned for performance evaluation. This submission relies on demonstrating similarity to a predicate device.

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 / Not provided. No test set requiring expert ground truth is described. The "ground truth" for this submission is established by the accepted performance and safety of the predicate device.

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

• Not applicable / Not provided. No 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

• No. An MRMC study was not done. This device is an MRI system itself, not an AI-assisted diagnostic tool for readers.

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

• No. This is an MRI system, not an algorithm.

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

• Implicitly the established safety and effectiveness of the predicate device. The "ground truth" for this application is that the predicate device (ECHELON Magnetic Resonance Imaging System, K052172) is considered safe and effective for its intended use, and the new device is substantially equivalent.

8. The sample size for the training set

• Not applicable / Not provided. There is no mention of a training set for an algorithm or model.

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

• Not applicable / Not provided. No training set is discussed.

In summary: This 510(k) submission for the OASIS MRI system is a "substantial equivalence" claim. It does not present a study with explicit acceptance criteria, performance metrics, or data from a test set as would be found for a novel diagnostic algorithm or software. Its acceptance is based on demonstrating that it is as safe and effective as a previously cleared device with similar intended use and technological characteristics.

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The Hitachi Echelon MR Spectroscopy Package is intended for use as a non-invasive diagnostic device that provides information based on relative concentrations of metabolites in body tissues. This NMR data in the form of spectra or spectral images reflect the NMR properties of proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and chemical shift. When interpreted by a trained medical practitioner, these spectral data provide information that can be useful in making a diagnosis.

This package is indicated for use as follows:

Anatomical Region: Head, whole body 1H Nuclei Excited:

MR Spectroscopy is an imaging and analysis feature that can provide unique information about tissue within a human body. Spectroscopy can be used to complement or augment information and images obtained through other MR imaging and analysis techniques.

The acquisition of spectroscopic information is fundamentally the same as for other MR imaging techniques. For example, a modified spin echo sequence is used to collect data for one or more voxels of tissue. This data collection utilizes existing MR hardware and software, for example, the main magnetic field, gradient coils, RF transmitter, RF receiver coils, and memory or "K-Space".

The analysis of the collected data is what differentiates MR Spectroscopy from other more conventional MR imaging and analysis techniques. The data that is collected from the MR pulse sequence as described above is processed through MR spectroscopy algorithms. After computation and analysis on this data, information is displayed for the operator/reviewer. Spectroscopy data may be displayed in multiple ways, for example as data, graphs or images.

The provided 510(k) summary (K071506) for the Hitachi Echelon MR Spectroscopy Package does not contain information about acceptance criteria or a study that proves the device meets specific performance acceptance criteria.

The submission focuses on establishing substantial equivalence to a predicate device (Picker MR Spectroscopy Package K991568) based on intended use and similar technology, rather than presenting a performance study with defined acceptance criteria.

Therefore, I cannot extract the requested information from the provided text.

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Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) of the musculoskeletal structures, soft tissue and vascular structures in various anatomic regions.

The HHF Echelon Multi-purpose Coil (hereby referred to as GP coil) is a receive only RF coil for obtaining diagnostic images of the abdominal region, in an open Magnetic Resonance Imaging (MRI) system.

The General-purpose coil consists of two independent parts A and B. The two parts can be used individually or together. The main body of each coil is housed in a flexible structure to conform to the body. The coil consists of a single element. The signal output of each part is independently processed by the system to enhance performance.

This document (K061950) is a 510(k) premarket notification for the HHF1™ Echelon™ Multi-purpose Coil, a component of an MRI system, not a standalone AI device. Therefore, the provided text does not contain the information requested regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methods for an AI or imaging diagnostic algorithm.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (T/R Body coil cleared in HHF1 Echelon MRI System, Cf. K052172).

Here's why the requested information is absent:

• No AI/Algorithm: The device is a "receive-only" radiofrequency (RF) coil for an MRI system. It detects MR signals. It is not an imaging algorithm or an AI-powered diagnostic device.
• Substantial Equivalence: The 510(k) submission seeks to demonstrate that the new coil is "substantially equivalent" to an already legally marketed predicate device. This typically involves showing similar technological characteristics and intended use, rather than conducting new performance studies that would generate the kind of data you're asking for.
• Performance Data Type: While the document describes the scientific concepts of MRI, it does not present performance metrics (like sensitivity, specificity, AUC) that would be relevant for an AI diagnostic tool. It describes the physical and functional characteristics of the coil.

Therefore, it is not possible to fill in the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, experts, or ground truth based on the provided text. The document does not describe a study proving the device meets acceptance criteria in the context of an AI-driven diagnostic.

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