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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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The AIRIS II Magnetic Resonance Diagnostic Device with the CTL Phased Array Coil P/N MR-CTL-51 provides for continuous imaging of the cervical, thoracic, and lumbar spine and adjacent anatomies.

The 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.

Aids in the performance of minimally invasive, diagnostic, and therapeutic procedures of the head, body and extremities which may be facilitated by real-time MR guidance. Such procedures must be performed with MRI-compatible instrumentation, as selected and evaluated by the clinical user.

The AIRIS II MRI Magnetic Resonance Diagnostic Device is being enhanced by one additional RF Coil (CTL Phased Array Coil) to increase the clinical utility of the AIRIS II in the stationary configuration.

The CTL Phased Array Coil P/N MR-CTL-51 provides for continuous imaging of the cervical, thoracic, and lumbar spine and adjacent anatomies, and utilizes a proprietary multiple receiver coil configuration (8 elements) operating in the phased array mode. The coil operates in three modes: C, T/L, and L. A multi-position switch is used to select between the modes, by routing a current through PIN diode-activated high impedance tanks.

The C-spine section of the coil is nearly identical in design to the USAI QD C-spine coil P/N MR-QCS-51, and features a removable nosepiece bridge. The T/L and L sections are combinations of flat elements in the coil's base and removable loop sections, connecting to mounting blocks at the edge of the coil.

AIRIS II software did not need to be revised in order to support full functionality of this CTL Phased Array Coil.

The provided document, K994378, describes a 510(k) submission for an "Additional RF Coil for AIRIS II (CTL Phased Array)" and does not contain detailed information about acceptance criteria or a specific study proving the device meets acceptance criteria in the manner typically seen for AI/ML-based medical devices.

Instead, this submission is for a hardware enhancement (a new RF coil) for an existing Magnetic Resonance (MR) diagnostic device. The regulatory review process for such a device at the time (late 1990s) focused on demonstrating substantial equivalence to a predicate device, primarily through technical specifications, functional descriptions, and indications for use, rather than extensive performance studies with acceptance criteria as one might expect for a diagnostic or AI-driven software.

Based on the provided text, here's what can be extracted and what information is not present:

Missing Information:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone AI performance, or how ground truth was established for a performance study. These types of studies are not described because this submission is not for a new diagnostic algorithm.

Information Extracted from the Document:

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

   • This document does not provide a table of acceptance criteria or reported device performance in the context of diagnostic accuracy, sensitivity, or specificity.
   • The "performance" described is related to the physical and functional characteristics of the new RF coil and its compatibility with the existing AIRIS II MRI system.
   • The submission focuses on demonstrating that the new CTL Phased Array Coil, when added to the AIRIS II, still functions as an MR diagnostic device and provides continuous imaging of the cervical, thoracic, and lumbar spine and adjacent anatomies, similar to the predicate device and the existing AIRIS II capabilities. The performance is implied by its ability to perform these imaging tasks.

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

   • Not applicable. This is a hardware modification (RF coil) for an existing MRI system. The document does not describe a "test set" of patient data for evaluating a diagnostic algorithm.
   • The "testing" mentioned would be related to engineering validation of the coil's electrical and mechanical performance, and its integration with the MRI system, not clinical diagnostic accuracy based on a patient dataset.

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

   • Not applicable. This is not a study requiring expert ground truth for diagnostic accuracy.

4. Adjudication method for the test set:

   • Not applicable.

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 is a hardware component for an MRI system, not an AI/ML-based diagnostic aid.

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

   • Not applicable. This is a hardware component, not a standalone algorithm.

7. The type of ground truth used:

   • Not applicable.

8. The sample size for the training set:

   • Not applicable. This is a hardware component, not an AI/ML system requiring a training set.

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

   • Not applicable.

Summary based on the K994378 document:

The K994378 submission for the CTL Phased Array Coil for the AIRIS II MRI system is a 510(k) Pre-market Notification seeking to demonstrate substantial equivalence to a previously cleared device (the Hitachi AIRIS II, K974212 and the USAI QD C-spine coil P/N MR-QCS-51).

The "study" for this type of submission is essentially the demonstration that the new coil performs its intended function (providing continuous imaging of the cervical, thoracic, and lumbar spine and adjacent anatomies) and integrates seamlessly with the existing AIRIS II system without altering its fundamental scientific concepts, physical, or performance characteristics in a way that would raise new questions of safety or effectiveness.

The document implicitly "proves the device meets acceptance criteria" by stating its technological characteristics are "Identical to the Predicate Device" (Section 5.0) and describing its function as an enhancement that "provides for continuous imaging of the cervical, thoracic, and lumbar spine and adjacent anatomies," which aligns with the predicate device's capabilities. The FDA's clearance letter (MAR - 7 2000) confirms that the agency found the device "substantially equivalent" for its stated indications for use, thereby implicitly accepting that it meets the necessary criteria for safe and effective operation as an MRI coil.

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By providing in-suite scan control and viewing of MR images, the AIRIS II with the Interventional MR Package aids in the performance of minimally invasive, diagnostic, and therapeutic procedures of the head, body and extremities which may be facilitated by real-time MR guidance. Such procedures must be performed with MRI-compatible instrumentation, as selected and evaluated by the clinical user.

The MR system is an imaging device, and is intended to provide the plysician 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 AIRIS II MRI Magnetic Resonance Diagnostic Device is being enhanced by optional hardware to aid in the performance of minimally invasive, diagnostic, and therapeutic procedures of the head, body, and extremities which may be facilitated by real-time MR guidance. Such procedures must be performed with MRI-compatible instrumentation, as selected and evaluated by the clinical user. Additional hardware includes QD Interventional Body Coil (IBC), in-suite image display and scanner control, physician kneelers, directed gantry illumination, and surgical drapes to provide a sterile field. The Latchable Joint/Large Extremity Coil, P/N MR-JCL-52, currently in commercial distribution supports imaging of the head and neck during interventional procedures of those anatomies.

AIRIS II software did not need to be revised in order to support full functionality of this additional hardware. MR Fluoroscopy was not made as an explicit marketing claim of the AIRIS II 510(k) K974212, however, the capabilities were available at the time of the submission (Cf. K974212, Attachment F, Functional Specification, 2D/3D SG and 2D/3D SG (RSSG) images acquisition sequences).

The provided text is a 510(k) summary for the Hitachi AIRIS II Interventional MR Package. It primarily focuses on demonstrating substantial equivalence to a predicate device and describing the technical characteristics and intended use of the MR system.

Crucially, this document does not contain any information about a performance study, acceptance criteria, or specific performance metrics for the device.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, study details, sample sizes, expert qualifications, or ground truth methods from the provided text.

The document states:

• "Identical to the AIRIS II 510(k) K974212." for device function.
• "Identical to the Predicate Device." for technological characteristics.
• The FDA letter confirms substantial equivalence based on the indications for use.

This implies that the device is considered equivalent to existing, legally marketed devices, and no new performance study data with specific acceptance criteria is presented in this summary for the "Interventional MR Package". The primary purpose of this 510(k) appears to be to introduce optional hardware that enhances the capabilities of an already-cleared MRI system, rather than to demonstrate novel performance characteristics requiring a new, detailed clinical performance study.

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The QD Shoulder Coil provides imaging of the shoulder articular anatomy and other large joints.

The 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 AIRIS II MRI Magnetic Resonance Diagnostic Device is being enhanced by one additional RF Coil (Shoulder Coil) to increase the clinical utility of the AIRIS II in the stationary configuration. The Shoulder Coil can operate either in the quadrature mode or in the phased array mode with the AIRIS II.

AIRIS II software did not need to be revised in order to support full functionality of these coils.

This appears to be a 510(k) summary for a new RF coil (Shoulder Coil) for an existing MRI system (Hitachi AIRIS II), not a study evaluating the performance of a new medical device in the typical sense of AI/image analysis. The document details the technical characteristics and intended use of the coil, emphasizing its substantial equivalence to a predicate device.

Therefore, many of the requested items (acceptance criteria, device performance metrics, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, standalone performance, etc.) are not applicable in the context of this specific regulatory submission.

Here's why and what information can be extracted:

Reasoning for Non-Applicability:

• Device Type: The device is an accessory RF coil for an MRI system, not a software algorithm, diagnostic AI tool, or a novel imaging modality requiring extensive clinical endpoint studies.
• Regulatory Pathway: A 510(k) submission for an accessory like this primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device. This typically involves technical comparisons (e.g., design, materials, performance specifications) rather than new clinical trials with detailed performance metrics against ground truth.
• Nature of the Document: This is a summary of safety and effectiveness, outlining the device's characteristics and intended use, not a detailed scientific report of a performance study.

Information that can be extracted or inferred:

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

• Acceptance Criteria: For an RF coil, the acceptance criteria are generally focused on technical performance and safety, demonstrating that it functions as intended and does not introduce new risks compared to the predicate device. These are implicitly assumed to be met for 510(k) clearance based on the substantial equivalence argument.
  • Implicit Acceptance Criteria (based on 510(k) of an MR accessory):
    • RF Coil Uniformity (mentioned as an imaging capability)
    • Compatibility with AIRIS II MRI system software and hardware.
    • Ability to produce diagnostic quality images of the shoulder and other large joints.
    • Safety standards for MR coils (e.g., SAR limits, heating, noise).
    • Performance comparable to legally marketed predicate devices.
• Reported Device Performance: The document does not report specific performance metrics from a study in the way an AI algorithm might report sensitivity/specificity. Instead, it states that:
  • "The QD Shoulder Coil provides imaging of the shoulder articular anatomy and other large joints."
  • It operates "either in the quadrature mode or in the phased array mode."
  • "AIRIS II software did not need to be revised in order to support full functionality of these coils."
  • It is "Identical to the Predicate Device" in technological characteristics.

Table (Best Effort based on available info):

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

• Not Applicable. This document does not describe a clinical performance study with a test set of patient data to evaluate a diagnostic algorithm. The clearance is based on technical specifications and substantial equivalence.

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

• Not Applicable. See point 2. Ground truth establishment for diagnostic performance is not relevant for this type of regulatory submission.

4. Adjudication method for the test set

• Not Applicable. See point 2.

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 is an RF coil, not an AI or diagnostic algorithm. No MRMC study was performed or is relevant for this type of device.

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

• Not Applicable. This is an RF coil, not a standalone algorithm.

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

• Not Applicable. Ground truth for diagnostic performance is not relevant for this type of device and submission. The "ground truth" for an RF coil is its physical and technical performance specifications and its ability to consistently produce images as expected.

8. The sample size for the training set

• Not Applicable. This is an RF coil, not a machine learning model. No training set is involved.

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

• Not Applicable. See point 8.

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