Search Results

The Pediatric Head-Spine Coil is a receive-only coil, used for obtaining diagnostic images of pediatric head and spine in magnetic resonance imaging systems. This coil is designed to be used in a Philips Achieva MRI 1.5T system. These images, when interpreted by a trained physician, yield information that may assist in diagnosis.

The Model 0100140201 Pediatric Head and Spine Array Coil1.5T 8ch consists is a single unit with eight coils. Four coils are in the head area and four coils reside in the back portion of the device. This forms a 8-channel phased array, receive-only coil, used for obtaining diagnostic images of head and spine of a pediatric body in magnetic resonance imaging systems. Combination of back part and head part forms an 8-channel phased array, receive-only coil, used for obtaining diagnostic images of the head and spine in magnetic resonance imaging systems. These images when interpreted by a trained physician, yielding information that may assist in diagnosis.

The provided text is a 510(k) summary for a medical device (Pediatric Head and Spine Array Coil), which focuses on demonstrating substantial equivalence to a predicate device. It does not contain information about acceptance criteria or a study designed to prove the device meets specific performance criteria in the way a clinical trial or performance study for a diagnostic AI algorithm would.

Instead, the submission for this type of device (an MRI coil) primarily focuses on:

• Device Description: What the device is and how it works.
• Intended Use: The clinical purpose of the device.
• Substantial Equivalence: Comparing the device to a legally marketed predicate device to show it is as safe and effective. This often means demonstrating similar technical characteristics, materials, and performance specifications (e.g., signal-to-noise ratio, image uniformity), rather than clinical diagnostic accuracy.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to this type of 510(k) submission for an MRI coil.

However, I can extract the relevant information from the document as best as possible, focusing on what is available. It's important to note that the "device performance" in this context refers to the coil's technical imaging capabilities rather than diagnostic accuracy.

Here's a breakdown based on the provided text:

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

The document does not explicitly state "acceptance criteria" in the format of a clinical performance study. For a device like an MRI coil, performance is typically evaluated through technical specifications and comparison to a predicate device. The 510(k) summary asserts "substantial equivalence" based on the device's design and intended use being similar to the predicate.

The closest we can infer for "device performance" is its ability to produce diagnostic images.

Study Proving Device Meets Acceptance Criteria:

The "study" proving the device meets the (inferred) acceptance criteria is the 510(k) premarket notification process itself, demonstrating substantial equivalence to the predicate device K003655 (PHS-63 Pediatric Head Spine Coil, manufactured by MRI Devices Corporation). This typically involves providing technical data and comparisons rather than clinical outcome studies of diagnostic accuracy in the way an AI algorithm would.

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. This submission is for an MRI coil, not a diagnostic algorithm that processes images. There is no "test set" of patient data in the context of diagnostic performance. Performance is evaluated through engineering and technical testing, and comparison to the predicate device's specifications.

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. See point 2. Ground truth for diagnostic performance is not relevant for an MRI coil's substantial equivalence submission. The images produced by the coil "when interpreted by a trained physician, yielding information that may assist in diagnosis." The interpretation is by experts, but the coil itself is not being evaluated for diagnostic accuracy.

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

• Not Applicable. See point 2 and 3.

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 not an AI device.

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

• Not Applicable. This is not an AI algorithm. The device is a "receive-only coil" that produces images for interpretation by a "trained physician."

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

• Not Applicable. See point 2 and 3.

8. The sample size for the training set

• Not Applicable. This device does not involve a "training set" in the context of machine learning.

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

• Not Applicable. See point 8.

Ask a specific question about this device

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.

Ask a specific question about this device

The Knee/Foot/Ankle Coil is a receive-only coil, used for obtaining diagnostic images of knee, foot, ankle and lower leg in conjunction with a PHILIPS 1.5T MRI scanner. These images when interpreted by a trained physician, yielding information that may assist in diagnosis.

The Knee/Foot/Ankle Coil consists of three parts, bottom part with a cable and a base plate, a knee part and a foot part. The combination of the bottom part and knee part forms a 4-channel phased array, receive-only coil, used for obtaining diagnostic images of knee, foot, ankle and lower leg in magnetic resonance imaging systems. Combination of bottom part and foot part forms a 4-channel phased array, receive-only coil, used for obtaining diagnostic images of foot and ankle. These images, when interpreted by a trained physician, vields information that may assist in diagnosis.

Acceptance Criteria and Device Performance Study for CG-KFC18-H150-AP

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

The provided text does not specify the sample size used for the performance testing.
The data provenance (e.g., country of origin, retrospective or prospective) is also not specified.

3. Number and Qualifications of Experts for Ground Truth

The provided text does not mention the use of experts to establish ground truth for the test set. The stated purpose of the images is "when interpreted by a trained physician, yields information that may assist in diagnosis," implying diagnostic interpretation, but details on ground truth establishment are absent.

4. Adjudication Method

The provided text does not describe any adjudication method used for the test set.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or conducted. The study focused on the technical performance of the MRI coil itself (SNR and uniformity) compared to a predicate device, not on human reader performance with or without AI assistance.

6. Standalone Performance Study

Yes, a standalone (algorithm only without human-in-the-loop performance) study was effectively done. The performance testing focused on the intrinsic characteristics of the device, specifically its Signal-to-Noise Ratio (SNR) and image uniformity in comparison to a predicate device. This evaluates the device's technical capabilities in isolation.

7. Type of Ground Truth Used

The concept of "ground truth" as typically understood in AI/medical device studies (e.g., pathology, expert consensus on disease presence) is not applicable or mentioned in this context. The study assessed the technical image quality metrics (SNR and uniformity) against a predicate device, which serves as the "truth" or benchmark for comparison of physical performance characteristics.

8. Sample Size for Training Set

The concept of a "training set" is not applicable to this device. This is a medical device (an MRI coil), not an AI algorithm that requires training data.

9. How Ground Truth for Training Set was Established

As this is not an AI algorithm, the concept of a training set and its associated ground truth is not relevant.

Ask a specific question about this device

The RF coils when used in conjunction with the MRI systems or RF coils when used with the incubator system and both the incubator and RF coils used in conjunction with the MRI systems provide imaging of the adult head, extremity, neonate head and body. When interpreted by a trained physician, these images provide information that can be useful in the determination of the diagnosis.

Device function is similar to the predicate devices, and in general any RF coil for MRI.

Advanced Imaging Research, Inc. intends to introduce Quadrature, Volume Coils for adult and pediatric MR. Specifically, Improved Adult Head coils, and Neonate Head and Body Volume coils safe for use with MRI compatible incubator systems are enclosed.

Our Improved Adult Head Coils provide enhanced signal-to-noise ratio (SNR), a high degree of RF homogeneity and is "open" to alleviate patient claustrophobia.

Our Neonate Coils are intended to scan pre- and term neonates and are designed for use with MR compatible incubator systems. The Neonate Head coil is intended to scan the newborn brain, whereas the Neonate Body coil is intended to scan the major organs (heart, spine, abdomen, pelvis etc.) in the torso and extremities.

This document is a 510(k) premarket notification for RF coils used in Magnetic Resonance Imaging (MRI). It does not contain acceptance criteria for device performance or a study demonstrating the device meets such criteria. Instead, it asserts that the device's function and technological characteristics are "similar" or "identical" to predicate devices already on the market.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence to existing devices, rather than presenting a performance study with specific acceptance criteria.

Ask a specific question about this device

The AURORA 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, and oblique cross-sectional images that display the internal structure of the extremities (breast tissue, axilla, and chest wall local to the breast). 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 (TI), spin-spin relaxation time (12), and flow. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination.

The AURORA is a dedicated breast MRI system intended to be used as an adjunct to conventional breast screening methods.

The AURORA Magnetic Resonance Diagnostic Device is being enhanced by a "forklift upgrade" to increase the clinical utility of the AURORA in the stationary configuration. With the "forklift upgrade," the AURORA is available in a stand-alone configuration, and as an upgrade path to existing AURORA installations.

The "forklift upgrade" enhancement is an alternate main MRI magnet, operating at a nominal field strength of 0.5T, and improved RF-chain and gradient-chain subsystems. No changes in software or pulse sequences were necessary to support full functionality of these "forkliff upgrade" enhancements.

The provided document is a 510(k) premarket notification for the AURORA Magnetic Resonance Diagnostic Device. It largely focuses on establishing substantial equivalence to a predicate device and does not contain detailed information about specific acceptance criteria, performance studies with quantitative results, or specific expert evaluations beyond general statements of intended use and safety.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a specific table of acceptance criteria or quantitative reported device performance metrics in the way one would typically find for a new, substantially different device or software. The submission focuses on a "forklift upgrade" to an existing device (AURORA K003561) and claims substantial equivalence.

The "performance" described is in terms of its functional capabilities and imaging characteristics, which are implicitly considered 'acceptable' because they are identical to the predicate device.

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

The document does not specify a sample size for a test set or the data provenance (e.g., country of origin, retrospective/prospective). The submission states, "Laboratory and clinical testing to internationally-accepted standards were performed to support this claim of substantial equivalence," implying that such testing occurred, but no details are provided about the datasets used or their characteristics.

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

This information is not provided in the document. Given that the submission focuses on hardware upgrades and claims "identical" technological characteristics to a predicate device, it's possible that a formal ground truth establishment process with multiple experts for novel diagnostic performance was not deemed necessary for this specific 510(k) submission.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method for a test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not applicable and not provided. The AURORA device described here is an MRI system, not an AI-powered diagnostic algorithm designed to assist human readers. Thus, an MRMC study comparing human readers with and without AI assistance would not be relevant to this submission.

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

This information is not applicable and not provided. The AURORA is a complete MRI system, not a standalone algorithm.

7. The Type of Ground Truth Used

The document does not specify the type of ground truth used for any performance evaluation. As noted, the submission emphasizes substantial equivalence based on the hardware upgrade and existing predicate device characteristics, rather than a novel diagnostic performance claim requiring extensive new clinical ground truth establishment.

8. The Sample Size for the Training Set

This information is not provided and is not applicable in the context of this submission. The AURORA is an MRI system; it is not an AI/ML algorithm that is "trained" in the conventional sense with a distinct training set. The "software or pulse sequences" are mentioned as being unchanged, implying they were developed and validated prior to this upgrade, but no training set details are given.

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

This information is not provided and is not applicable. As explained above, this submission is for an MRI hardware upgrade and does not involve an AI/ML algorithm with a training set and corresponding ground truth.

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 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.

Identical to the AIRIS and MRP-7000 with Version 4.0 Operating System software (Cf. K971279), and the AIRIS and MRP-7000 with Version 4.0D Operating System software as described in a memo-to-file document, dated September 22, 1997.

The AIRIS Operating System Software is revised to Version 5.0 to increase the clinical utility of the AIRIS in the stationary configuration. The MRP-7000 Operating System Software is revised to Version 5.0 to increase the clinical utility of the MRP-7000 in both stationary and mobile configurations.

Version 5.0 Operating System revisions include additional image acquisition sequences (3D SG TOF MRA, high SNR MR Fluoroscopy sequence, 3D FSE/FIR sequences, additional T1-weighted 2D FSE sequence, and addition of 2D RF-spoiled SARGE sequence). Image acquisition sequence enhancements include improvement in fat suppression for STIR and Fast STIR, addition of Dual Slice function to 2D GE/ GR, addition of small FOV FSE sequence, addition of rephase to FIR sequence, addition of ECG-gating to 2D SG sequence (currently available only for 2D SE. GE and GR sequences), and addition of off-resonance MTC to 3D TOF, SE, GE and GR sequences (currently only on-resonance MTC available). A raw data filter is additionally available to reduce truncation artifacts.

This submission describes a software update (Version 5.0 Operating System Software) for existing Hitachi AIRIS and MRP-7000 Magnetic Resonance Diagnostic Devices. The 510(k) summary indicates that the device has the "same intended use" and "identical technological characteristics" as the predicate devices (Hitachi AIRIS with Version 4.0 Operating System Software and Hitachi MRP-7000 with Version 4.0 Operating System Software).

Therefore, the submission does not contain information about acceptance criteria or a dedicated study proving the device meets specific performance criteria. The substantial equivalence relies on the fact that the updated software introduces new imaging sequences and enhancements but operates within the established principles and capabilities of MR imaging, as demonstrated by the predicate devices.

Specifically, the document states:

• FUNCTION: "Identical to the AIRIS and MRP-7000 with Version 4.0 Operating System software (Cf. K971279)..."
• DEVICE TECHNOLOGICAL CHARACTERISTICS: "Identical to the Predicate Device."
• DEVICE INTENDED USE: The description of the intended use is broad and consistent with general MR imaging devices.

Because this is a submission for a software update deemed substantially equivalent to a predicate device, a new clinical performance study with specific acceptance criteria, sample sizes, expert ground truth establishment, or comparative effectiveness studies (MRMC or standalone) is not typically required or included in such a 510(k) summary. The FDA's 510(k) clearance process for devices like this primarily focuses on demonstrating that the modified device is as safe and effective as a legally marketed predicate device, rather than requiring a detailed de novo performance study.

Therefore, I cannot provide the requested table or specific study details because they are not present in the provided 510(k) summary document. The provided document focuses on describing the device, its functions, scientific concepts, and receiving FDA clearance based on substantial equivalence.

Ask a specific question about this device

The QD C-Spine Coil provides imaging of the cervical spine anatomy; dependent upon patient Inc Q & Epil sensitivity may additionally image upper thoracic and lower cranial structures.

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 crosssectional 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-lattion 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 T1-/T2-weighted imaging; T1, T2, proton density measurements; MR Angiography
Imaging capabilities: 2D Spin Echo (SE); also with rephase; 2D Gradient Field Echo (GE); also with rephase (2D GR); 2D Inversion Recovery (IR); 2D Fast Spin Echo (FSE); 2D Dual Slice acquisition (SEDS); 3D Spin Echo (SE); 3D Gradient Field Echo (GE); also with rephasing; 3D Steady-state Acquisition with Rephased Gradient Echo (SG); MR Angiography (2D TOF, 3D TOF, half echo, high resolution/high definition); RF Coil Uniformity; Adaptive Image post-processing; ACR/NEMA/DICOM 3 compliant

The MRP-5000 MRI Magnetic Resonance Diagnostic Device is being enhanced by one additional RF Coil (QD C-Spine Coil) to increase the clinical utility of the MRP-5000 in both mobile and stationary configurations.

MRP-5000 software did not need to be revised in order to support full functionality of these coils.

Magnetic Resonance (MR) is based on the fact that certain atomic nuclei have electromagnetic properties which cause them to act as small spinning bar magnets. The most ubiquitous of these nuclei is hydrogen, which makes it the primary nucleus used in current imaging experiments in magnetic resonance. When placed in a magnetic field, there is a slight net orientation or alignment of these atomic nuclei with the magnetic field. The introduction of a short burst of radiofrequency (RF) excitation of wavelength specific to the magnetic field strength and to the atomic nuclei under consideration can cause a reorientation of the proton's magnetization vector. When the RF excitation is removed, the proton relaxes and returns to its original orientation. The rate of relaxation is exponential, and varies with the character of the proton and its adjacent molecular environment. This reorientation process is characterized by two exponential relaxation times called T1 and T2 which can be measured.

These relaxation events are accompanied by an RF emission or echo which can be measured and used to develop a representation of these emissions on a three dimensional matrix. Spatial localization is encoded into the echo by varying the RF excitation and by appropriately applying magnetic field gradients in x, y, and z directions, and changing the direction and strength of these gradients. Images depicting the spatial distribution of NMR characteristics of the nuclei under consideration can be constructed by using image processing techniques similar to those used in CT.

For magnetic fields up to 1.5T. the RF frequencies commonly used range up to 65MHz. The RF fields have pulse powers from several watts to greater than 10 kilowatts, and repeat at rates from once every few seconds to greater than fifty per second. The time-varying magnetic gradient fields have a typical duration of sub-millisecond to several milliseconds.

The provided text is a 510(k) summary for a medical device (QD C-Spine Coil for an MRI system) and a clearance letter from the FDA. It does not contain information about acceptance criteria or a specific study proving the device meets acceptance criteria in the format requested. The document primarily focuses on demonstrating substantial equivalence to a predicate device and outlining the device's intended use and technical characteristics.

Therefore, I cannot extract the requested information to fill in the table and answer the study-related questions. The document does not describe a performance study with detailed acceptance criteria, sample sizes, expert involvement, or comparative effectiveness.

The document states: "MRP-5000 software did not need to be revised in order to support full functionality of these coils." and "5.0 DEVICE TECHNOLOGICAL CHARACTERISTICS: Identical to the Predicate Device." This suggests that the clearance was based on the substantial equivalence to existing technology rather than a specific performance study against defined acceptance criteria for the new coil itself.

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 TREX MRI system produces cross-sectional images:

• Anatomical Region: General body anatomy, including head, spine, forso, and extremities
• Nucleus excited: 1H nuclei (Proton)
• Diagnostic uses: Images correspond to the distribution of 1H nuclei exhibiting nuclear magnetic resonance, with image intensity dependent upon NMR parameters, including spin-lattice relaxation time (T1) spin-spin relaxation time (T2) density of nuclei (p) flow velocity chemical shift (δ)
• Clinical use: Images may be interpreted by a trained physician to yield information that can be useful in the determination of a diagnosis.

The TREX MRI 0.15T Elliptical MRI Magnetic Resonance Diagnostic Device is being enhanced by three additional RF Coils (Head Coil [quadrature], C-Spine Coil [quadrature], and Knee Coil [linear]) to increase the clinical utility of the TREX MRI in the stationary configuration.

The new quadrature Head Coil (Field Effects P/N 96530-01) will have a smaller diameter of 19 cm. The reduction in diameter will allow for improved coil fill factor, increasing SNR, while maintaining optimal coil uniformity. This new coil will replace the original Head Coil.

The new C-Spine Coil Field Effects P/N 96529-01) is substantially re-designed from the original coil, optimized for Cervical Spine imaging, and reducing the potential for patient anxiety and claustrophobia. This new coil utilizes a proprietary multiple receiver coil design, and will replace the original C-Spine/Knee Special Purpose Coil.

The new Knee Coil (Field Effects P/N 96629-01) utilizes a proprietary solenoid receiver coil design optimized for knee and extremity anatomies, improving coil fill factor, and increased S/N Ratio.

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

Below is a summary of the requested information based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

Ask a specific question about this device