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Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) of the Musculoskeletal structures, soft tissue and vascular structures of the torso, pelvis, and abdomen.

Model 558GE-64 Torso Array Coil. Compatible with GE Signa EXCITE 1.5T MR Systems.

The provided text describes a 510(k) premarket notification for the "Model 558GE-64 Torso Array Coil" for Magnetic Resonance Diagnostic Devices. This submission focuses on establishing substantial equivalence to a predicate device, rather than performing a novel clinical study for the device itself. Therefore, many of the requested elements for a study proving device performance are not applicable or cannot be extracted from this document as it is a submission for a new coil for an existing MRI system, not a new diagnostic algorithm or AI device.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For this device (an MRI coil), the "acceptance criteria" and "reported device performance" are framed in terms of maintaining the performance and safety characteristics of the MRI system when the new coil is used, and demonstrating equivalence to a predicate device.

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

This document does not describe a clinical study with a "test set" of patient data in the way an AI/diagnostic algorithm would. The evaluation seems to be based on technical specifications and comparison to a predicate device. Therefore, no information on sample size or data provenance in this context can be extracted.

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

Not applicable. As this is not a diagnostic device with a "ground truth" to be established by experts on a test set, this information is not present.

4. Adjudication Method for the Test Set

Not applicable. There is no test set or adjudication method described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This document is for an MRI coil, not an AI-assisted diagnostic tool. No MRMC study or AI performance evaluation is mentioned.

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

Not applicable. This is not an algorithm, but a hardware component (MRI coil).

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

Not applicable. For a hardware component like an MRI coil, "ground truth" would relate to its physical and electromagnetic properties, not diagnostic accuracy in the clinical sense. The "ground truth" here is the established safety and performance of the MRI system with the new coil, which is shown by physical measurements and adherence to technical specifications, along with the substantial equivalence argument.

8. The sample size for the training set

Not applicable. There is no mention of a training set as this is not an AI/ML device.

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

Not applicable. No training set is involved.

Summary of the Study/Evidence Provided (for the MRI coil):

The submission for the "Model 558GE-64 Torso Array Coil" is a technical and substantial equivalence declaration, not a clinical efficacy study. The "study" implicitly referenced is the technical evaluation demonstrating that the new coil, when used with the GE Signa EXCITE 1.5T MR Systems, does not change the safety parameters (Maximum Static Magnetic Field, Rate of Magnetic Field Strength Change, RF Power Deposition, Acoustic Noise Levels, Biocompatibility) or the imaging performance parameters (Specification Volume, Signal-to-Noise Ratio, Image Uniformity, Geometric Distortion, Slice Thickness and Gap, High Contrast Spatial Resolution) compared to the MRI system without the new coil or compared to the predicate device.

The main "proof" is the argument of substantial equivalence to a legally marketed predicate device (Hitachi AIRIS-Elite 0.3T system operated with the identified predicate coil), based on:

• Same intended use.
• Similar technological characteristics (with the implication that the new coil maintains or does not degrade the established performance of the MR system it's compatible with).
• Demonstration that the coil does not affect the system's safety and imaging performance specifications.

The document states that a draft guidance document for MRDDs (issued Nov 14, 1998) clarifies concerns, and the submission summarizes information addressing these concerns, focusing on the lack of change in safety and performance parameters. The device also includes instructions for use, indications, precautions, cautions, contraindications, warnings, and quality assurance testing to assure safe and effective use.

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Magnetic resonance imaging (MRI) of the musculoskeletal structures, soft tissue and vascular structures of the lower extremities.

Model 475 8 Channel T/R Phased Array Lower Extremity Coil. Compatible with GE and Siemens 1.5T and 3.0T MR Systems.

This document is a 510(k) premarket notification for a new MRI coil, the Model 475 8 Channel T/R Phased Array Lower Extremity Coil. It describes the device's characteristics and its substantial equivalence to a predicate device, focusing on safety and imaging performance parameters.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Acceptance Criteria:

The document describes premarket notification (510(k)) as the "study" that proves the device meets the acceptance criteria. This is not a clinical study in the traditional sense, but rather a submission demonstrating "substantial equivalence" to a legally marketed predicate device. The "study" here refers to the engineering and comparative analysis performed by the manufacturer, IGC-Medical Advances Inc., to show that their new coil is as safe and effective as the predicate.

The document states: "The GE and Siemens 1.5T and 3.0T MRI systems, operated with the Medical Advances 8 Channel T/R Phased Array Lower Extremity Coil, are substantially equivalent to the GE Signa 1.5T system operated with the legally marketed predicate devices listed in section 4.0, within the Class II definition of Magnetic Resonance Diagnostic Device with respect to the safety parameter action levels..." and "The use of these coils does not affect the GE or Siemens 1.5T and 3.0T system safety parameter specifications."

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

• Sample Size: Not explicitly stated as this is not a clinical trial with a defined 'test set' of patient data in the typical sense. The evaluation is based on technical specifications and comparisons to the predicate device.
• Data Provenance: Not applicable. The "data" here refers to the technical specifications and performance characteristics of the new coil compared to the predicate, likely derived from internal engineering tests and simulations, rather than patient data.

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

This information is not provided in the document. As this is a 510(k) submission focused on technical equivalence to a predicate MRI coil, rather than a diagnostic device that interprets medical images, the establishment of "ground truth" by medical experts for a "test set" of images is not applicable in the way it would be for an AI diagnostic algorithm.

4. Adjudication Method for the Test Set:

This information is not provided and is not applicable to this type of device submission. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies where multiple human readers interpret medical images and their interpretations need to be reconciled to establish a ground truth. This document pertains to the technical performance of an MRI coil, not its diagnostic interpretation by human readers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No. An MRMC study was not done. MRMC studies are used to evaluate the performance of diagnostic imaging devices or AI algorithms by comparing the accuracy of multiple human readers with and without the assistance of a new technology across multiple cases. This submission is for an MRI coil, which is a hardware component, not a diagnostic interpretation tool, and therefore an MRMC study is not relevant.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Not applicable. This device is an MRI coil, a hardware component for image acquisition, not a software algorithm. Therefore, "standalone algorithm performance" is not a relevant concept for this submission.

7. The Type of Ground Truth Used:

Not applicable in the typical sense of diagnostic ground truth. The "ground truth" for this submission is established by the known, legally marketed predicate device's safety and performance characteristics. The new coil's performance is compared against these established technical benchmarks. No pathology, expert consensus on patient outcomes, or other clinical "ground truth" is used in this context. The "truth" is whether the new coil performs at least as safely and effectively as the predicate, or better in some aspects, based on engineering specifications.

8. The Sample Size for the Training Set:

Not applicable. This is a hardware component (MRI coil), not an AI algorithm. Therefore, there is no "training set" in the context of machine learning.

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

Not applicable. As there is no training set for an AI algorithm, the concept of establishing ground truth for it does not apply.

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Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) of the musculoskeletal structures, soft tissue and vascular structures within the anatomic regions from the chest to the pelvic region.

Model 554HI-12 RAPID Body Coil. Compatible with Hitachi AIRIS-Elite MR Systems.

The provided document is a 510(k) Summary of Safety and Effectiveness for the "Model 554HI-12 RAPID Body Coil." This document is part of a premarket notification for a medical device and thus focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a performance study with detailed acceptance criteria and a comprehensive study report for a novel AI/software device.

Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, expert adjudication, and MRMC studies, cannot be found in this document because it pertains to the regulatory review process for a hardware component (an MRI coil) based on substantial equivalence, not a software or AI device's clinical performance study.

However, I can extract the information that is present and explain why other details are absent based on the nature of this document.

Here's a breakdown of the available and unavailable information:

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

The document defines acceptance criteria by stating that the new device has "No change" in specific safety and imaging performance parameters compared to the predicate device. This implies that "no change" is the acceptance criterion for equivalence.

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

• Sample Size for Test Set: Not applicable/not provided. This document describes a new MRI coil seeking clearance through the 510(k) pathway, which relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a new clinical study with a "test set" in the context of an AI/software device. The "testing" would involve demonstrating the new coil functions within the safety and performance limits when paired with a compatible MRI system, and that these parameters are equivalent to those of the predicate.
• Data Provenance: Not applicable/not provided.

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)

• Number of Experts: Not applicable/not provided.
• Qualifications of Experts: Not applicable/not provided.

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

• Adjudication Method: 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

• MRMC Study: No, this type of study was not performed. The device is an MRI body coil, not an AI-assisted diagnostic tool for human readers.

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

• Standalone Performance: Not applicable. The device is a hardware component (an MRI coil), not a standalone algorithm.

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

• Type of Ground Truth: Not applicable in the context of a clinical performance study with "ground truth" as typically defined for AI/software. The "ground truth" for this device's assessment would be established engineering and safety standards for MRI coils and comparison to the predicate device's established performance specifications. The "ground truth" for the claims of "no change" would be derived from technical measurements and comparisons.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is not an AI/machine learning device.

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

• Ground Truth for Training Set Establishment: Not applicable. This is not an AI/machine learning device.

Summary of Device and Regulatory Context for Understanding:

This document is a 510(k) submission for an MRI coil, which is a hardware accessory for an MRI system. The primary goal of a 510(k) submission is to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device. This typically involves showing that the new device has:

• The same intended use as the predicate device.
• The same technological characteristics as the predicate device, or
• Different technological characteristics that do not raise new questions of safety and effectiveness, and performance data that demonstrates the device is as safe and effective as the predicate device.

In this specific case, the manufacturer is demonstrating that its Model 554HI-12 RAPID Body Coil, when used with the Hitachi AIRIS-Elite 0.3T MRI system, is substantially equivalent to a GE Signa 0.5T system operated with a legally marketed predicate device. The "study" described is a comparison of critical safety and imaging performance parameters, where the finding that there is "no change" in these parameters due to the new coil is the basis for demonstrating equivalence and meeting regulatory requirements. It is not a clinical performance study measuring diagnostic accuracy or reader improvement for a software algorithm.

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Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) of adults and pediatrics of musculo-skeletal structures, soft tissue and vascular structures (mid-abdomen to mid-foot).

Model 675GE-64 Peripheral Vascular Coil consisting of Model 665GE-64 Lower Extremity Flexible Array and Model 538GE-64 Medium General Purpose Flex Coil. Compatible with GE Signa 1.5T MRI systems with Phased Array option.

The provided document is a 510(k) summary for a Magnetic Resonance Imaging (MRI) coil, not a medical device algorithm or AI-powered diagnostic tool. Therefore, many of the requested categories related to algorithm performance, training data, ground truth, and expert evaluation are not applicable.

The document describes the device's technical specifications and asserts its substantial equivalence to a predicate device based on safety and imaging performance parameters. The "acceptance criteria" here refer to meeting the established safety and imaging performance benchmarks of a legally marketed predicate device, rather than a diagnostic performance threshold for an AI model.

Here's a breakdown of the applicable information:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The document states that the GE 1.5T Signa MRI system operated with the IGC-Medical Advances Peripheral Vascular Coil is substantially equivalent to the same system operated with the legally marketed predicate device. This statement implies that testing was conducted to verify that the new coil, when used with the specified MRI system, performs identically or equivalently to the predicate device with respect to the listed safety and imaging parameters. However, details of the specific "study" (e.g., experimental design, number of subjects, quantitative results) are not provided in this summary, as is typical for a 510(k) summary for a physical component like an MRI coil. The "study" here refers to the technical evaluation and comparison performed by the manufacturer to demonstrate substantial equivalence.

Regarding the unapplicable requested information (due to the device being an MRI coil, not an AI/algorithm):

• 2. Sample size used for the test set and the data provenance: Not applicable. There's no "test set" of patient data in the context of an algorithm. Evaluation would involve technical measurements on phantoms and potentially studies on human volunteers/patients to confirm imaging quality, but the specifics are not detailed in this summary.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic performance of an algorithm is not relevant here.
• 4. Adjudication method (e.g. 2+1, 3+1, none) 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 not an AI-assisted device.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this device's performance would be the direct physical measurements of its output (e.g., SNR, uniformity) and its adherence to safety limits.
• 8. The sample size for the training set: Not applicable. This device does not use a training set as it is not an algorithm.
• 9. How the ground truth for the training set was established: Not applicable.

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