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The AIRIS Elite system is an MR 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 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.

Anatomical Region: Head, Body, Spine, Extremities
Nucleus excited: Proton
Diagnostic uses: 2D/3D T1, T2-weighted imaging
T1, T2 proton density measurements
Diffusion weighted imaging
MR. Angiography
Image processing

The AIRIS Elite is a modification of the AIRIS II MRI System. The AIRIS Elite has been revised to increase the clinical utility as compared to the AIRIS II Magnetic Resonance Imaging System.

This submission is a 510(k) summary for the AIRIS Elite Magnetic Resonance Imaging Device. It claims substantial equivalence to a predicate device, the AIRIS II MRI System. The document does not provide acceptance criteria or a study demonstrating that the device meets such criteria in the way typically expected for a new or modified AI/ML-based medical device.

Instead, this document focuses on demonstrating that the AIRIS Elite is substantially equivalent to existing technology (the AIRIS II MRI System) by comparing their technological characteristics and intended use. The core argument is based on the idea that the modifications (enhanced RF sub-system and gradient sub-systems) do not fundamentally alter the device's function or safety profile, and thus a full performance study with acceptance criteria is not required in the same manner as for a de novo device or a device with a significant change in intended use or technological principle.

Therefore, many of the requested sections (Table of acceptance criteria, sample sizes, expert qualifications, adjudication, MRMC study, standalone performance, ground truth types and establishment methods) are not applicable or not present in this type of submission.

Here's a breakdown based on the information provided and the nature of a 510(k) for an incremental device improvement:

1. Table of acceptance criteria and the reported device performance:

• Not applicable/Not provided in this document. This 510(k) focuses on demonstrating "substantial equivalence" to a predicate device rather than meeting specific quantifiable performance metrics against acceptance criteria for a novel device. The performance is implicitly deemed acceptable because it's equivalent to a device already cleared by the FDA.

2. Sample sized 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 clinical study data is presented for performance evaluation in this 510(k) summary. The submission relies on the established safety and effectiveness of the predicate device and the incremental nature of the changes.

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 ground truth establishment for a specific test set is mentioned.

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

• Not applicable/Not provided.

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/Not provided. This is an MRI system, not an AI-assisted diagnostic tool.

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

• Not applicable/Not provided. This is an MRI system, not an algorithm.

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

• Not applicable/Not provided.

8. The sample size for the training set:

• Not applicable/Not provided. This is an MRI system, not a machine learning model requiring a training set in this context.

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

• Not applicable/Not provided.

Summary of the Acceptance Criteria and "Study" as presented in the Document:

The "acceptance criteria" for the AIRIS Elite, as demonstrated in this 510(k) submission, are centered around the concept of Substantial Equivalence to its predicate device, the AIRIS II MRI System (K001334, K974212).

Here's how the document addresses the "study" and "acceptance criteria":

• Acceptance Criteria (Implicit - Substantial Equivalence): The primary and overarching acceptance criterion is that the AIRIS Elite must be substantially equivalent to the AIRIS II MRI System in terms of:

  • Intended Use: The document explicitly states, "The technological characteristics and intended use are identical to the Predicate Device." (Section 6.0 Conclusions). The intended use is defined as providing physiological and clinical information, obtained non-invasively, producing images that display internal structures of the head, body, or extremities, and useful in diagnosis when interpreted by a trained physician (Section 3.0).
  • Technological Characteristics: The device must be similar enough, such that any differences do not raise new questions of safety or effectiveness. The document notes, "The technological characteristics of this device are similar to the primary predicate device. There has been no change to the magnet design or control system, but the RF sub-system and gradient sub-systems have been enhanced." (Section 5.0).

• "Study" (Comparison and Rationale for Equivalence): The "study" in this context is the comparison presented within the 510(k) itself.

  • Comparison Basis: The submission provides a direct comparison between the AIRIS Elite and its predicate, the AIRIS II.
  • Lack of Clinical Data: The document does not contain a separate clinical study with new performance data. Instead, it argues that the modifications (enhanced RF and gradient subsystems) do not alter the fundamental principles of operation or intended use to such an extent that new clinical performance data is required to establish safety and effectiveness. The enhancements are framed as increasing "clinical utility" rather than changing the diagnostic capability or fundamental safety.
  • Conclusion: Hitachi Medical Systems America concludes, based on the described similarities and enhancements, that the AIRIS Elite is substantially equivalent to the AIRIS II MRI System (Section 6.0). The FDA's letter (K032232) confirms this finding of substantial equivalence.

In essence, for this type of 510(k) submission for an incremental improvement, the regulatory "acceptance" is based on demonstrating that the new device is fundamentally the same as a previously cleared device, and therefore inherits the established safety and effectiveness profile of that predicate device without requiring a new, comprehensive performance study that would generate the detailed data you've asked for.

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The Superopen 0.35T is intended to produce images that 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 determining a diagnosis.

The Superopen 0.35T 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 MRI 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 MRI 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.

Diffusion weighted imaging

MR Angiography

The indications for use are as follows:

Anatomical Region: Head, Body, Spine, Extremities Nucleus excited: Proton T1,T2, proton density weighted imaging Diagnostic uses:

Imaging capabilities:

Imaging processing 2D, 3D Spin Echo( SE ) Short time inversion recovery (STIR) Fluid attenuated inversion recovery (FLAIR) 2D.3D Field Echo (FE) 2D, 3D Field Echo with Spoiler (FESP) 2D FESP Multi-Slice (FESP-MS) 2D and 3D Field Echo Steady State FID with rephasing gradient (FESS-FID) 2D, 3D Fast Spin Echo (FSE) 2D, 3D MRCP MR Angiography 2D, 3D TOF MTC Echo Planar Imaging (EPI) Multi-shot SE / FE Diffusion

The Superopen 0.35T is a 0.35T permanent magnet MRI system. The magnet is mainly made of NdFeB material. The system software based on Windows (TM) is an interactive program with user-friendly interface. Its functions cover scanning control, image reconstruction and image/archive management and maintenance.

The provided text does not contain information about specific acceptance criteria, a study proving device performance against those criteria, or the details about sample sizes, expert involvement, and ground truth establishment typically found in a clinical performance study summary.

Instead, the document is a 510(k) summary for a Magnetic Resonance Imaging (MRI) system (Superopen 0.35T) seeking substantial equivalence to a predicate device (Hitachi AIRIS II and its software).

Here's a breakdown of what the document does provide, and what it lacks in relation to the prompt's request:

Information Present in the Document:

1. Device Description and Intended Use: The document clearly outlines the Superopen 0.35T as a 0.35T permanent magnet MRI system intended to produce images for diagnostic purposes by trained physicians. It lists various imaging capabilities and anatomical regions.
2. Predicate Device: It identifies the Hitachi AIRIS II (K974212) and AIRIS II Version 4.1 Software (K001334) as the predicate devices for substantial equivalence.
3. Substantial Equivalence Statement: The Superopen 0.35T is deemed substantially equivalent based on similar technology, intended uses, and functional components (magnet system, gradient subsystem, RF subsystem, image reconstruction, etc.).
4. Regulatory Information: It includes CFR sections, classification name, product code, device class, applicable standards (IEC, DICOM, NEMA), and manufacturer details.

Information Not Present in the Document (and therefore, cannot be provided in response to the prompt):

• Acceptance Criteria Table and Reported Device Performance: There is no specific table defining performance metrics (e.g., sensitivity, specificity, accuracy, image quality scores) or acceptance thresholds. The document asserts substantial equivalence based on technical and functional similarity, not on a detailed performance study with defined criteria.
• Sample Sizes and Data Provenance for Test Set: No information is provided about a specific "test set" of images or patients used for performance evaluation. The substantial equivalence argument relies on the predicate device's established performance rather than a new clinical study.
• Number of Experts and Qualifications for Ground Truth: Since no independent performance study is detailed, there's no mention of experts establishing ground truth for a test set.
• Adjudication Method: Not applicable as there's no described performance study or ground truth establishment process involving multiple readers.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No MRMC study is mentioned. The submission is for a standalone imaging device, not an AI-assisted diagnostic tool.
• Standalone Performance (Algorithm Only): The device itself is a standalone MRI system, but the prompt's context usually refers to an algorithm's performance. There is no algorithm performance discussed in the AI sense.
• Type of Ground Truth Used: Not applicable in the context of a new performance study.
• Sample Size for Training Set: No information on a training set as this is a medical device submission based on substantial equivalence, not an AI algorithm development and validation.
• How Ground Truth for Training Set Was Established: Not applicable.

Conclusion:

The provided 510(k) summary focuses on demonstrating substantial equivalence of the Superopen 0.35T MRI system to existing legally marketed devices based on technological similarities and intended use. It does not present a clinical study with detailed acceptance criteria or performance metrics for the device itself. Therefore, I cannot construct the requested table or offer the detailed study information as it is not present in the provided text.

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