Search Results

Ask a specific question about this device

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.

Ask a specific question about this device

The PA/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 When interpreted by a trained physician, these images provide relaxation time (T2), and flow. information that can be useful in diagnosis determination.

• Head, Body, Spine, Extremities Anatomical Region: Nucleus excited: Proton Diagnostic uses:
• Diagnostic uses:

2D T1- / T2-weighted imaging T1. T2, proton density measurements MR Angiography image processing

• Imaging capabilities:
• 2D, 3D Spin Echo (SE)
• 2D, 3D Fast Spin Echo (FSE)
• 2D Inversion Recovery (IR)
• 2D. 3D Fast Inversion Recovery (FIR)
• 2D,3D Gradient Echo (GE)
• 2D, 3D Steady state acquisition with rewinded GE (SARGE)
• 2D, 3D RF-spoiled SARGE (RSSG)
• 2D, 3D Time-reversed SARGE (TRSG)

MR Angiography (half echo, high resolution/high definition, sloped slab profile, magnetization transfer contrast)

• 2D, 3D TOF
• 2D, 3D TOF RSSG
• ECG, Peripheral Gating
• RF Coil Uniformity

Adaptive Image post-processing

ACR/NEMA/DICOM 3 compliant

• 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 and AIRIS II MRI Magnetic Resonance Diagnostic Devices are being enhanced by one additional RF Coil (PA/QD Shoulder Coil) to increase the clinical utility of the AIRIS and 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, and in the quadrature mode only with the AIRIS. The coil is available in Large and Standard sizes for both MRI systems, to accommodate a wide variety of physical patient sizes, and to achieve maximal coil filling factors.

The provided document is a 510(k) Summary for a new RF Coil (PA/QD Shoulder Coil) for existing MRI systems (AIRIS and AIRIS II). This submission is for an enhancement to an already cleared device, primarily adding a new accessory. Therefore, the document does not contain a comprehensive clinical study with acceptance criteria and performance metrics in the way one would expect for a novel diagnostic algorithm or a new primary imaging modality.

Instead, the submission focuses on demonstrating substantial equivalence to the predicate device, meaning it asserts that the new coil performs similarly and introduces no new safety or effectiveness concerns. The "acceptance criteria" here are implicitly tied to the performance characteristics of the predicate MRI systems and the ability of the new coil to function within those established parameters.

Here's an attempt to answer your questions based on the provided text, acknowledging the limitations of a 510(k) for an accessory:

Acceptance Criteria and Device Performance Study for the PA/QD Shoulder Coil

As this 510(k) submission (K992650) is for an additional RF Coil (PA/QD Shoulder Coil) for existing, cleared MRI systems (Hitachi AIRIS and AIRIS II), the "acceptance criteria" and "study" described are focused on demonstrating that the new coil functions as intended within the established safety and performance envelope of the predicate devices. The submission emphasizes substantial equivalence to the predicate MRI systems and their existing coils, rather than a de novo clinical trial with specific diagnostic performance metrics.

The implicit acceptance criteria are that the new shoulder coil allows the AIRIS and AIRIS II systems to continue to produce high-quality diagnostic images of the shoulder joint, consistent with the performance of the predicate devices for other anatomical regions or with previous coils. The performance is "proven" through the assertion that the device's technological characteristics are identical to the predicate device in terms of fundamental MR physics and imaging capabilities, and that the new coil enhances clinical utility without altering the core functional mechanism or safety profile.

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

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

The document does not describe a specific clinical "test set" or a formal clinical study with patient data in the realm of diagnostic performance. For an accessory like an RF coil, "testing" would typically involve engineering verification and validation (e.g., phantom imaging, signal-to-noise measurements, image uniformity, SAR testing) to ensure it meets technical specifications and functions correctly with the existing MRI system. Such technical data is not detailed in this 510(k) summary, which is a high-level overview. There is no mention of country of origin or retrospective/prospective data.

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

Not applicable. As no clinical "test set" and corresponding ground truth determination are described, there is no mention of experts for this purpose.

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

Not applicable. No clinical test set or adjudication method 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

Not applicable. This submission is for an MRI coil, not an AI-powered diagnostic tool, and no MRMC study or AI component is mentioned.

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

Not applicable. This is for an MRI coil, not a standalone algorithm.

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

Not applicable, as no clinical ground truth determination is described in this summary. The "ground truth" for an MRI coil would be its ability to accurately reflect the NMR properties of the tissue it images, which is assessed through technical performance and image quality.

8. The sample size for the training set

Not applicable. No training set is mentioned as this device is not an AI/machine learning model.

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

Not applicable. No training set or ground truth establishment for a training set is mentioned.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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 Magnetic Resonance Diagnostic Device is being enhanced by the AIRIS II System-level upgrade to increase the clinical utility of the AIRIS in the stationary configuration. The AIRIS II is provided in a stand-alone configuration, and as an upgrade path to existing AIRIS installations.

AIRIS II System-level upgrade enhancements include a new Back End user interface featuring a workstation-based User Console, implementing a graphical user interface operating system and task card-style operations (OpenWindows™). A new Front End provides real-time system control, data acquisition and reconstruction, implements all image acquisition sequences available on current AIRIS, and provides two additional types of image acquisition sequences: TRSG (time-reversed steady-state acquisition with rewinded gradient echo) and RSSG (rf spoiled steady-state acquisition with rewinded gradient echo). Other enhancements include increased gradient strength, a patient physiological gating package, and phased-array RF coils.

This document is a 510(k) summary for the AIRIS II, a Magnetic Resonance Diagnostic Device. It claims substantial equivalence to the Hitachi AIRIS with Version 4.0 Operating System Software. The document describes the device's function, scientific concepts, physical and performance characteristics, intended use, and technological characteristics.

There is no information provided in the given text regarding acceptance criteria, a study proving device conformance, reported device performance, sample sizes, data provenance, ground truth establishment, expert involvement, adjudication methods, or MRMC studies.

The document states that the DEVICE TECHNOLOGICAL CHARACTERISTICS are "Identical to the Predicate Device." This implies that the current submission relies on the predicate device's existing substantial equivalence for its technological characteristics, rather than presenting a new study for the AIRIS II's performance.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details based on the provided text. The document is primarily focused on describing the enhancements of the AIRIS II over the AIRIS, its intended use, and its equivalence to a predicate device for regulatory purposes.

Ask a specific question about this device