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

Model 472GE-128 Quadrature Lower Extremity Coil. Compatible with GE Signa 3.0T MR Systems. Magnetic Resonance Imaging Coil.

This document describes a 510(k) premarket notification for a magnetic resonance imaging (MRI) coil, not an AI/ML device. Therefore, the specific criteria related to AI/ML device performance, such as sample sizes for test and training sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment for AI models, are not applicable to this submission.

The acceptance criteria and study information provided in this document pertain to the substantial equivalence of the new MRI coil to a legally marketed predicate device, focusing on safety and imaging performance parameters relevant to MRI coils.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are demonstrated by its substantial equivalence to a predicate device, specifically the GE Signa 1.5T MR system with its legally marketed lower extremity coil. The new device, the Model 472GE-128 Quadrature Lower Extremity Coil, is intended for use with the GE Signa 3.0T MR system. The parameters assessed for substantial equivalence fall into categories of safety and imaging performance.

Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria

The study demonstrating that the device meets the acceptance criteria is a substantial equivalence evaluation rather than a traditional clinical trial or AI model validation study. The manufacturer, IGC-Medical Advances Inc., performed an analysis and comparison against a legally marketed predicate device (a GE Signa 1.5T system with a comparable lower extremity coil).

The provided text details this comparison: "The GE Signa 3.0T MRI system, operated with the Medical Advances Quadrature Lower Extremity Coil, is substantially equivalent to the GE Signa 1.5T system operated with the legally marketed predicate device 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 GE Signa 3.0T MRI system operated with the Medical Advances Quadrature Lower Extremity Coil addressed in this PMN, has the same intended use and technological characteristics as the GE Signa 1.5T system operated with the identified legally marketed predicate device. The use of this coil does not affect the GE Signa 3.0T system safety parameter specifications."

This evaluation focuses on demonstrating that the new coil, when used with its specified MRI system, maintains the safety parameters and either maintains or improves upon the imaging performance characteristics of the predicate device. The specific improvement noted is a "2 Times Improvement over Predicate Device" in Signal-to-Noise Ratio. Other parameters are stated to have "No change," indicating they meet the equivalence standard by not degrading performance.

Information Not Applicable to This Submission:

As this is a 510(k) for an MRI coil and not an AI/ML device, the following points are not relevant and therefore not addressed in the provided document:

2. Sample size used for the test set and the data provenance: Not an AI/ML device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not an AI/ML device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not an AI/ML device.
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 an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not an AI/ML device. This relates to the performance of the physical hardware (coil) in conjunction with an MRI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not an AI/ML device. Performance is typically assessed through phantom studies, engineering measurements, and potentially comparison of image quality in human subjects or cadavers, but not for "ground truth" as understood in AI/ML.
8. The sample size for the training set: Not an AI/ML device.
9. How the ground truth for the training set was established: Not an AI/ML device.

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Magnetic resonance imaging (MRI) of the shoulder.

Model 415PH-64/42: Phased Array Shoulder Coil With Model 855PH: Synergy MultiConnect. Compatible with a Philips 1.5T/1.0T MRI System. Magnetic Resonance Imaging Coil.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Model 415PH-64/42: Phased Array Shoulder Coil:

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) summary focuses on demonstrating substantial equivalence to existing predicate devices rather than establishing novel performance criteria for a new type of device. Therefore, the "acceptance criteria" are implicitly that the new device performs at least as well as, or identically to, the predicate device in terms of safety and imaging parameters. The "reported device performance" is essentially a statement of no change from the predicate.

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

The provided 510(k) summary does not detail a specific test set, sample size, or data provenance (e.g., country of origin, retrospective/prospective). This type of submission for a coil often relies on engineering testing and comparison to predicate device specifications rather than clinical trials with patient data. The "no change" statements imply that the technical characteristics of the coil were tested and found to be consistent with or within the acceptable range of the existing Philips MRI system and its predicate coils.

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. As this is a submission for a medical device accessory (MRI coil) and not an AI-powered diagnostic algorithm, the concept of "ground truth" established by experts in a clinical context for a "test set" as typically understood for AI algorithms, is largely inapplicable here. The "ground truth" for the technical specifications of the coil would be established by engineering standards and measurements.

4. Adjudication Method for the Test Set

This information is not provided and is not typically relevant for a 510(k) submission of an MRI coil, which focuses on technical performance and safety rather than diagnostic accuracy requiring expert consensus.

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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is an MRI coil, not an AI-powered diagnostic tool, therefore, the concept of "human readers improve with AI" is not applicable.

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

No, a standalone algorithm-only performance study was not done. This device is hardware (an MRI coil), not a software algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's performance is based on engineering measurements and technical specifications compared against established standards for MRI system safety and imaging quality. This would involve measurements of static magnetic fields, RF power deposition, signal-to-noise ratios, image uniformity, geometric distortion, etc., rather than clinical ground truth derived from pathology or expert consensus on diagnostic images.

8. The Sample Size for the Training Set

This information is not applicable as this is a hardware device (MRI coil) and not an AI/machine learning algorithm that requires a training set.

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

This information is not applicable for the same reasons as #8.

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Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) of the Head: Magical lobes (hippocampus), internal auditory canals, orbits and anterior optic pathways, I chiporal loocs (inppooaliffalo), interesonance angiography (MRA). Upper Neck: Skull base, Cranio-cervical junction, cervical carotid artery. Upper Extremities: Shoulder, Craino-cavicular (AC) joint, elbow, peripheral nerves. Lower Extremities: Knee, ankle and Achilles tendon, foot. Pediatric applications.

Model 235GE-64: Multi Purpose Flex Array Coil. Compatible with GE Signa 1.5T MRI systems with Phased Array option.

The provided documentation details a 510(k) summary for the Model 235GE-64: Multi Purpose Flex Array Coil, a magnetic resonance specialty coil. This submission aims to demonstrate substantial equivalence to legally marketed predicate devices, primarily focusing on safety and imaging performance.

Here's an analysis of the acceptance criteria and the study characteristics:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Model 235GE-64 coil are based on demonstrating "no change" compared to the predicate device when used in conjunction with the GE 1.5T Signa MRI system. This implies that the device's performance should be equivalent to that of the predicate, and not degrade the existing system's capabilities.

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

The document does not specify the sample size used for any test set (e.g., number of patients, number of images). It also does not provide information on data provenance (e.g., country of origin, retrospective or prospective nature). The evaluation appears to be based on engineering and performance testing against established MRI system specifications rather than clinical data from a specific test set.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not mention the involvement of experts to establish a ground truth for a test set. This type of FDA submission (510(k) for a coil) typically relies on technical specifications and comparisons rather than expert-derived ground truth from a clinical study.

4. Adjudication Method for the Test Set

As no specific test set requiring expert ground truth is described, there is no mention of an adjudication method.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or described in this 510(k) summary. The study focuses on the coil's technical performance and safety equivalence, not on comparing human reader performance with and without AI assistance.

6. Standalone (Algorithm Only) Performance Study

This device is a magnetic resonance imaging coil, not an AI algorithm. Therefore, a standalone (algorithm only) performance study was not performed.

7. Type of Ground Truth Used

The "ground truth" for this submission is implicitly the performance specifications and safety limits of the predicate MRI system and its existing coils. The goal is to demonstrate that the new coil does not degrade these established parameters. There is no mention of pathology, outcome data, or expert consensus used as ground truth in a clinical sense.

8. Sample Size for the Training Set

Since this is a physical medical device (an MRI coil) and not an AI algorithm, there is no concept of a "training set" in the context of machine learning.

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

As there is no training set, this question is not applicable.

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Magnetic resonance imaging (MRI) of the knee, ankle, foot, and associated structures.

Model 473PH-64 Quadrature Lower Extremity Coil. Compatible with Philips Gyroscan ACS-NT 1.5T MRI System.

The provided 510(k) summary for the K99724 "Model 473PH-64 Quadrature Lower Extremity Coil" is focused on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria for algorithm performance.

Here's an analysis based on the information provided:

Acceptance Criteria and Study Details

This submission does not describe a study involving an algorithm or artificial intelligence. Instead, it details a comparison of a new medical device (an MRI coil) against an existing MRI system without that specific coil. The "acceptance criteria" are therefore framed in terms of maintaining the safety and imaging performance parameters of the predicate MRI system.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criterion for each of these parameters is implicitly "No change" or "equivalent to the predicate device performance." The reported device performance indicates that the new coil does not affect these parameters.

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

Not applicable. This is a medical device (MRI coil) submission, not an AI/algorithm submission. There is no "test set" of patient data in the typical sense for an AI study. The evaluation is based on the technical specifications and expected performance of the MRI system with the new coil.

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

Not applicable. Ground truth for patient data is not established in this type of submission. The safety and performance parameters are typically assessed through engineering tests, phantom studies, and adherence to established standards for the MRI system.

4. Adjudication Method for the Test Set

Not applicable. There is no test set of patient data being adjudicated by experts.

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 not for an AI device.

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

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

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

Not applicable in the context of diagnostic performance evaluation of an AI. For the device itself, the "ground truth" for its performance is its physical and operational characteristics measured against engineering specifications and the established safe operating parameters of the compatible MRI system.

8. The sample size for the training set

Not applicable. This is not an AI/algorithm submission.

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

Not applicable. This is not an AI/algorithm submission.

Summary of the document's purpose:

This 510(k) submission demonstrates that a new MRI coil (Model 473PH-64 Quadrature Lower Extremity Coil) is substantially equivalent to an existing MRI system (Philips Gyroscan ACS-NT 1.5T MRI System) without the new coil. The core argument is that the addition of this coil does not negatively impact the established safety and imaging performance parameters of the predicate MRI system. It's a hardware submission, not a software/AI submission, hence the lack of data-driven performance metrics typically associated with AI.

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Magnetic resonance imaging (MRI) of the hand and wrist.

Model 445PH-64 Quadrature Wrist Coil. Compatible with Philips Gyroscan ACS-NT 1.5T MRI system.

This document describes the 510(k) summary for the Medical Advances, Inc. Model 445PH-64 Quadrature Wrist Coil, submitted on April 21, 1999 (K991434). This device is a Magnetic Resonance Imaging (MRI) coil intended for diagnostic imaging of the hand and wrist.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria in this submission are framed around demonstrating substantial equivalence to the predicate device (the Philips Gyroscan ACS-NT 1.5T MRI system operated without the Medical Advances Quadrature Wrist Coil). The key performance parameters are assessed by showing "No change" compared to the predicate device, indicating that the addition of the new coil does not adversely affect these fundamental MRI system capabilities. No specific quantitative numerical acceptance thresholds are provided in this summary.

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

The provided 510(k) summary does not specify a separate "test set" in the context of clinical studies with human subjects or detailed performance evaluations for the Quadrature Wrist Coil. The submission relies on demonstrating that the new coil, when integrated with an existing, legally marketed MRI system (Philips Gyroscan ACS-NT 1.5T), does not alter the system's safety and imaging performance parameters.

The data provenance is implied to be from engineering and technical testing of the coil's compatibility and performance characteristics within the specified MRI system, rather than a clinical study with patient data. No information on country of origin or whether it's retrospective/prospective is given, as it's not a clinical data-driven submission in the modern sense.

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

Given the nature of the submission, which focuses on demonstrating substantial equivalence through technical specifications rather than clinical diagnostic accuracy, no information is provided regarding experts used to establish ground truth for a test set. This type of submission does not involve a diagnostic accuracy study where ground truth would be established by medical experts for a set of cases.

4. Adjudication Method for the Test Set

As there is no specified test set involving human subject data or diagnostic interpretations, there is no mention of an adjudication method.

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

No MRMC comparative effectiveness study was performed by the device manufacturer, as this submission is for an MRI coil and focuses on technical equivalence rather than comparing diagnostic efficacy with and without AI assistance. The device itself is an accessory to an MRI system, not an AI-enabled diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

No standalone performance study was done as the device is a passive MRI coil and does not incorporate an algorithm that operates independently.

7. Type of Ground Truth Used

The "ground truth" in this context is the established performance and safety specifications of the predicate Philips Gyroscan ACS-NT 1.5T MRI system when operating without the Medical Advances Quadrature Wrist Coil. The new coil is demonstrated to not alter these established parameters. This is based on technical specifications and engineering measurements rather than expert consensus, pathology, or outcomes data from a diagnostic study.

8. Sample Size for the Training Set

There is no mention of a training set as this device is a passive MRI coil and does not employ machine learning or AI algorithms requiring a training set.

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

Since there is no training set, this question is not applicable.

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Magnetic resonance imaging (MRI) of the musculoskeletal structures and soft tissue of the Wrist and surrounding joints.

Model 414GE-09 Linear Wrist Coil. Compatible with GE Signa Profile 0.2 T MRI Systems. Magnetic Resonance Imaging Coil.

The provided text describes a 510(k) submission for a medical device, a linear wrist coil for MRI. The submission focuses on establishing substantial equivalence to a predicate device, rather than proving a new device's independent performance against defined acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria and a study proving their fulfillment is not directly applicable or available in this document.

However, I can extract and infer some information based on the document's content. The "acceptance criteria" here are essentially the demonstration of "no change" in key safety and imaging performance parameters when the new coil is used with the specified MRI system, compared to the predicate device.

Here's a breakdown of the requested information, addressing what's present and what's not:

1. Table of acceptance criteria and the reported device performance

Study that proves the device meets the acceptance criteria:

The document describes the basis for proving substantial equivalence, which is the "study" in this context. The study is a comparison of the new device (Medical Advances Linear Wrist Coil) with a legally marketed predicate device when both are operated with the GE Signa Profile 0.2 T MRI system.

The core of the study is to demonstrate that the new coil "has the same intended use and technological characteristics" as the predicate and "does not affect the GE Signa Profile 0.2T system safety parameter specifications." This implies that testing was conducted to verify that the performance of the system with the new coil remained consistent with its performance with the predicate coil in terms of the listed safety and imaging parameters.

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

• Sample size used for the test set: Not explicitly stated. The document indicates a comparison with a predicate device, but doesn't specify how many instances or types of images were used for comparison. This is a 510(k) summary, which typically focuses on demonstrating equivalence rather than providing detailed clinical trial methodologies.
• Data provenance: Not explicitly stated, but it would have been collected from testing the GE Signa Profile 0.2 T MRI system with both the new coil and the predicate coil. The origin of the data would likely be from an engineering/testing environment rather than patient data, given the nature of the parameters being assessed (e.g., SNR, uniformity, geometric distortion are often measured using phantoms). It is a "new device" submission and not a clinical study.

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

Not applicable. The "ground truth" here is not established by human experts in a clinical context (e.g., radiologists diagnosing a condition). Instead, it's based on quantitative measurements of physical and performance characteristics, likely against established engineering specifications or the performance of the predicate device.

4. Adjudication method for the test set

Not applicable. There's no human-based adjudication described as the evaluation criteria are objective physical and performance measures.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence of a component (the coil) to a predicate, not on the comparative clinical effectiveness of the entire system (MRI + coil) or the improvement of human readers.

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

Yes, in a sense. The "study" described is entirely standalone in that it assesses the physical and functional performance of the device itself (the coil) and its interaction with the MRI system, without involving human interpretation of images for diagnostic purposes. This is an engineering/performance assessment, not a clinical trial of diagnostic accuracy.

7. The type of ground truth used

The "ground truth" is the established safety and imaging performance specifications of the GE Signa Profile 0.2 T MRI system when operated with its original or a legally marketed predicate coil. The new coil's performance is compared against these established technical benchmarks. It's based on objective measurements of physical parameters rather than pathology, outcomes data, or expert consensus.

8. The sample size for the training set

Not applicable. This device is an MRI coil, a hardware component. There is no "training set" in the context of machine learning, as this is not an AI/algorithm-driven device.

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

Not applicable, as there is no training set for this type of device.

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