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The intended use of the iLoop Interventional Coil 0.55T is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the human body. Used in a magnetic resonance tomograph, the iLoop Interventional Coil 0.55T is intended to produce transversal, sagittal, coronal and oblique images of the internal structures of the body. This device may be used for interventional procedures.

The iLoop Interventional Coil 0.55T is a 1-channel receiver coil that can be used for MR imaging before, during and after MR-guided interventions with a Siemens MRI System with field strength 0.55T. The iLoop Interventional Coil 0.55T can also be used as a standard diagnostic coil for diagnostic examination of the human body. The iLoop Interventional Coil 0.55T is a coil that can be used on many different regions of the body. Used in conjunction with a sterile, self-adhesive OP-drape, the coil enables the workflow for MR-guided interventions

The provided text is a 510(k) summary for the iLoop Interventional Coil 0.55T, a medical device. It does not describe a study involving an AI or algorithm for medical imaging analysis, nor does it detail acceptance criteria and performance of such a device in the context of diagnostic accuracy (e.g., sensitivity, specificity, AUC).

Instead, this document focuses on the substantial equivalence of a new MR coil to a legally marketed predicate device. The performance testing mentioned (e.g., Image Signal to Noise (SNR), Image Uniformity, Surface heating) is related to the physical and electrical characteristics of the coil itself, rather than the diagnostic interpretive performance of an AI system.

Therefore, I cannot extract the information required for the requested table and study description (e.g., sample size for test/training sets, expert qualifications, MRMC studies, standalone performance, ground truth methods) as they pertain to AI/algorithm-based diagnostic devices, because this document is about a different type of medical device (an MR coil).

The "SUMMARY OF PERFORMANCE TESTING" section (page 5 of the PDF, marked with {5} in your input) outlines engineering and safety tests for the physical coil, not a clinical study to evaluate an AI's diagnostic performance. It states: "J) CLINICAL TESTING: Not required." This explicitly confirms that clinical studies to evaluate diagnostic accuracy were not performed or required for this device's clearance.

Thus, I cannot fill out the requested table or describe such a study based on the provided text.

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The intended use of the Breast Coil is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the female breast. It is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of the female breast. When interpreted by a trained physician, these images provide information that can be useful in determining diagnosis. The included Breast Biopsy Unit permits MR guided breast biopsy and placement of localization-wire by a trained physician. For use with Siemens 0.55T, 1.5T, and 3T systems

These three models are known as specialty MRI coils for use in generating MRI images of the female breast. MRI procedures that include the evaluated device are conducted for clinical purposes at the discretion of the ordering physician. The Breast BI Coil Sets described in this document has been designed, depending upon model type, for use with an MRI system with field strength of 0.55T 1.5T or 3.0T. The coil system consists of pure receiving coils for the reception of high frequency signals from the hydrogen-('H)-nuclei. The hydrogen nuclei are induced into precession by the transmitting coil of the MRI device. The precise magnetization induces potential differences in the Breast Bl Coil Sets which are digitized and further processed in the MRI system. The Breast BI Coil Sets consist of a rigid Coil Frame with Immobilization, Biopsy and Breast Coil System. Imaging is performed with a 7-Channel "phased array" Coil developed and manufactured by the NORAS company. The coils are mounted in the rigid Coil Frame. Interconnection is handled by the software of the MRI. The Breast BI Coil Set 0.55T is an innovative concept designed to offer flexible use to meet the needs of the procedure to be performed in your clinic. It is removable and enables the biopsy device to be used with the respective corresponding coil with the different field strengths. The rigid Coil Frame forms a high resolution, 7-channel "phased array" configuration. The Coil Frame is made of fiberglass-reinforced polycarbonate. The surface has been finished with Alexit biocompatible coating. The breast cushion and the headrest are made of PE

The provided text describes a 510(k) premarket notification for a new set of breast MRI coils. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing extensive clinical trials typical for novel high-risk devices. Therefore, the information provided focuses on engineering and performance testing, largely comparing the new device to existing cleared devices.

As such, the document does not detail a study that proves the device meets specific performance-based acceptance criteria in a clinical setting related to diagnostic accuracy or AI performance. Instead, it focuses on demonstrating that the new coils are functionally equivalent and equally safe compared to predicate devices through engineering and performance testing.

Therefore, many of the requested details about acceptance criteria for diagnostic performance, sample sizes for medical image analysis, expert ground truth establishment, MRMC studies, or AI performance are not applicable or not provided in this document because the device itself is an MRI coil, not an AI diagnostic algorithm or a device requiring a clinical efficacy study beyond demonstrating image quality and safety.

However, I can extract the information relevant to the performance and safety testing that was conducted according to the document.

Acceptance Criteria and Device Performance (Based on Engineering and Safety Testing):

The acceptance criteria for this device are not defined in terms of diagnostic accuracy metrics (e.g., sensitivity, specificity) as it is an imaging coil, not a diagnostic algorithm. Instead, the performance is assessed based on engineering standards for image quality and safety.

Since the device is an MRI coil and not an AI-powered diagnostic tool, the following sections are largely not applicable or the information is not provided in this type of submission.

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

   • Not Applicable / Not Provided for typical clinical diagnostic test set for AI. The "clinical sample test images" mentioned were likely acquired for qualitative assessment of functional performance (image quality) of the coil itself rather than a diagnostic study with a human-in-the-loop or standalone AI. The sample size for this qualitative assessment is not specified, nor is the provenance of the patients from whom the images were acquired.

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. Ground truth in the context of diagnostic accuracy via expert consensus is not described as the focus is on the performance of the coil itself in generating images, not on interpreting those images for diagnostic accuracy.

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

   • Not Applicable / Not Provided. Similarly, no adjudication method is described as the document does not detail a diagnostic performance study.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • Not Applicable / Not Done. This is an MRI coil, not an AI-assisted diagnostic tool.

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

   • Not Applicable / Not Done. This is an MRI coil, not an AI algorithm.

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

   • Not Applicable / Not Provided. For the image quality assessment, the "ground truth" is adherence to engineering specifications for SNR, uniformity, etc., and qualitative assessment of images ("good coverage, quality, uniformity and SNR") by experienced personnel.

8. The sample size for the training set:

   • Not Applicable / Not Provided. This document is for an MRI coil, not an AI model requiring a training set.

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

   • Not Applicable / Not Provided. As above, this document is for an MRI coil, not an AI model.

In summary, the provided document is a 510(k) submission for a medical device (MRI coils), not an AI algorithm or a device requiring a clinical study for diagnostic efficacy. The acceptance criteria and "study" are therefore focused on demonstrating the device's conformance to established engineering standards for safety and image quality, and proving its substantial equivalence to previously cleared predicate devices.

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The intended medical use of the OR Head Holder LUCY and Head Coil Set 1.57/3T is, in conjunction with a Magnetic Resonance Scanner, intra-operative MR imaging during an open-skull neurosurgery.

The OR Head Holder LUCY is used for safe securing the patient's head during a surgical intervention at the head. It is possible to make an intraoperative assessment during the intervention to determine its progress. In the MR area the Head Coils enable the diagnostic imaging. Using Computed Tomography or C-arm Fluoroscopy, it is mandatory to remove the Head Coils and the device serves as a skull clamp only.

The OR Head Holder LUCY can be used for intra-operative MR Imaging, CT Imaging and C-arm Imaging. In use with the NORAS OR Head Coils 1.5T or 3T, the OR Head Holder LUCY can be applied for intra operative MR imaging during an open skull neurosurgery at human patients.

The NORAS OR Head Holder LUCY is used for safe fixation of the patient's head during neurosurgical procedures on the patient's skull with planning and resection aid for MRI, CT and C-arm Imaging.

One additional feature of the OR Head Holder LUCY is the ability of height adjustment providing an ideal patient positioning in 70 cm MRI (Siemens Magnetom Aera and Skyra and Philips Ingenia 1.5T/3T, Ingenia Ambition 1.5T and Ingenia Elition 3.0T) and in CT- Scanners. Furthermore, the whole set up can be moved parallel to the bore direction (in Z- direction).

The configuration allows comfortable positioning of the patient in prone, lateral or supine position on the transfer board and allows an exact adjustment of the Head Holder during the positioning of the patient´s head. The system supports awake craniotomy.

Mechanical, the model of the Head Holder allows a slight movement of both posts of the three-point fixation at the Arc with a stable geometry, which minimizes unwanted movements. The patients head will be fixed by three skull pins.

The provided text is a 510(k) summary for the NORAS OR Head Holder LUCY with HeadCoilSet. This document primarily focuses on establishing substantial equivalence to predicate devices based on design, materials, and intended use, rather than presenting a performance study with acceptance criteria in the manner typically seen for AI/ML devices or diagnostic tools.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be fully extracted from the provided text. The document details non-clinical bench testing to demonstrate that "technological changes do not raise any new issues of safety or effectiveness over the predicate," implying a focus on engineering validation rather than clinical performance metrics against specific acceptance thresholds for diagnostic accuracy.

The closest information available pertains to the general safety and effectiveness concerns and non-clinical tests.

Here's what can be extracted and what cannot:

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

• Cannot be fully provided as requested for diagnostic/performance metrics. The document states that "Testing and analysis have been conducted to show that the verification, validation, and safety requirements have been met per the FDA as established standards." It also mentions adherence to NEMA Standards and DIN EN standards (DIN EN 60601-2-33:2017) for safety parameters related to MRI devices. However, specific acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, accuracy) are not listed, nor are numerical results for such performance. The reported "performance" focuses on mechanical and electrical safety, and compatibility with MRI scanners.

  Acceptance Criterion (Inferred from text)	Reported Device Performance (Inferred from text)
  Compliance with NEMA Standards	Met
  Compliance with DIN EN 60601-2-33:2017 (Safety for MRI devices)	Met
  Risk mitigation per DIN EN ISO 14971:2013	Risks controlled via measures in development, testing, and product labeling
  No new issues of safety or effectiveness compared to predicates	Achieved through non-clinical bench testing
  Compatibility with specified MR systems (Siemens 1.5T/3T, Philips 1.5T/3T)	Confirmed through testing

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

• Cannot be provided. The document describes "non-clinical bench testing" and "testing and analysis" but does not specify sample sizes or types of data (e.g., patient images). It does not mention clinical test sets or data provenance (country of origin, retrospective/prospective) in the context of device performance evaluation. The "data" refers to engineering test results, not clinical patient data.

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

• Not applicable/Cannot be provided. Since this is a non-AI/ML device primarily focused on mechanical and electrical safety and physical compatibility, there is no mention of "experts" establishing a "ground truth" for a test set in the diagnostic sense. The expertise involved would be in engineering and regulatory compliance.

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

• Not applicable/Cannot be provided. This concept is relevant for studies involving human readers and complex diagnostic interpretations, which is not the type of study described for this 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 applicable/Not done. This device is a medical accessory (head holder and coil set) for MRI, not an AI/ML diagnostic tool. Therefore, MRMC studies and human-in-the-loop performance metrics are not relevant or described.

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

• Not applicable/Not done. This is not an algorithm or AI device.

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

• Not applicable. For this device, "ground truth" would relate to the physical and electrical properties meeting specified engineering tolerances and safety standards. It does not involve clinical diagnostic ground truth like pathology or outcomes data.

8. The sample size for the training set:

• Not applicable/Cannot be provided. This device is not an AI/ML model that requires a training set of data.

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

• Not applicable/Cannot be provided. As above, no training set information is present.

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The intended use of Breast BI 7 MR Coil 1.5T Mammavention is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the female breast. It is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of the female breast. When interpreted by a trained physician, these images provide information that can be useful in determining diagnosis.

The included Breast Biopsy Unit permits MR guided breast biopsy and wire localization of lesions can be performed by a trained physician.

The coil system Breast BI 7 MR Coil 1.5T Mammavention can be used with the following MRI systems:

1.5T: Siemens 1.5T:

Avanto fit, Aera, Amira

The Breast BI 7 MR Coil 1.5T Mammavention described in this document has been designed, depending upon model type, for use with a SIEMENS MRI system with field strength of 3 T. The coil system serves solely as a receiving coil for the reception of high frequency signals from the hydrogen -(1-H) nuclei. The hydrogen nuclei are induced into precession by the transmitting coil of the MRT device. The processing magnetization induces potential differences in the Breast Bl 7 MR Coil 1.5T Mammavention which are digitized and further processed in the MRT system

The provided text describes a 510(k) summary for the NORAS Breast BI 7 MR Coil 1.5T Mammavention. It does not present a study or acceptance criteria for device performance, particularly in terms of diagnostic accuracy or a clinical evaluation with human subjects.

Instead, the summary focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and compliance with recognized safety and performance standards for MR coils.

Here's the breakdown of why the requested information cannot be found in the provided text:

• Acceptance Criteria and Reported Device Performance (Table): This document does not define specific clinical acceptance criteria (e.g., sensitivity, specificity, image quality metrics beyond general "high resolution") or corresponding performance results from a clinical study. The "performance" mentioned refers to compliance with NEMA and IEC standards for MR coils.
• Sample size, data provenance, expert ground truth, adjudication, MRMC study, standalone performance, type of ground truth for test set: No clinical test set is described, because no clinical performance study was conducted or presented to compare the diagnostic output of the device. The 510(k) process for this type of device (an MR coil) primarily focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than a de novo clinical validation study of its diagnostic efficacy in patients.
• Training set sample size and ground truth establishment: Since no machine learning or AI component is mentioned or evaluated in this submission, there is no discussion of a training set or how ground truth for such a set would be established.

Based on the provided information, the answers to your questions are as follows:

1. A table of acceptance criteria and the reported device performance:
   The document does not explicitly define acceptance criteria in terms of diagnostic performance (e.g., sensitivity, specificity). Instead, the acceptance criteria are implicitly related to safety and technological equivalence based on compliance with recognized standards.

   • Acceptance Criteria (Implicit):
     • Conformity with NEMA Standards for measurement of performance and safety parameters.
     • Conformity with IEC standards (IEC 60601-2-33:2011) for safety issues with Magnetic Resonance Imaging Devices.
     • Technological characteristics are substantially equivalent to the predicate device (Breast BI 7 MR Coil 3T Mammavention, K162651).
     • Successful completion of all device testing.
   • Reported Device Performance:
     • "All device testing have been completed successfully before device clearance."
     • "The power tests which have been done by MRI manufacturer for the whole system can be found in 076 Third Party Power Test Breast Bl 7 MR Coil 1.5T.pdf." (The details of these power tests are not provided in this document).
     • "Proton imaging" and "High resolution of breast anatomic regions" are listed as comparable properties to the predicate device.

2. Sample size used for the test set and the data provenance: Not applicable. No clinical test set or data from human subjects is mentioned for performance evaluation in this 510(k) summary. The evaluation focuses on engineering new coil and its compatibility to existing MR scanners and equivalence to a predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set requiring expert ground truth establishment is described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No clinical test set 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 device is an MR coil, not an AI-assisted diagnostic tool, and no MRMC study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an MR coil, not a standalone diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a clinical performance study. The "ground truth" here is the adherence to engineering standards and technical specifications.

8. The sample size for the training set: Not applicable. There is no mention of a training set as this is an MR coil, not an AI or machine learning device.

9. How the ground truth for the training set was established: Not applicable. There is no mention of a training set.

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For Siemens:

The NORAS OR Head Holder Flexibility and the NORAS OR Head Coils 1.5T / 3.0T are used for intra-operative MR imaging during open-skull neurosurgery.

The NORAS OR Head Holder is used for safely securing the patient's head during the intervention.

The NORAS OR Head Holder Flexibility together with the NORAS OR Head Coil 1.5T / 3.0T are suitable for use with the MR system MAGNETOM Aera / Skyra and the Combi-Dockable-Table together with Trumpf OR Tables TrueSystem 7500 (EU/US Version) and as well as together with Maquet OR Tables Magnus (EU/US Version) and Alpha Maquet Plus (EU/US Version).

For Philips:

The NORAS OR Head Holder Flexibility and the NORAS OR Head Coils 1.5T / 3.0T are used for intra-operative MR imaging during open-skull neurosurgery.

The NORAS OR Head Holder is used for safely securing the patient's head during the intervention.

The NORAS OR Head Holder Flexibility together with the NORAS OR Head Coil 1.5T / 3.0T are suitable for Philips MR system Ingenia 1.5T/3T in combination with Maquet Transfer Board together with Maquet OR table.

The NORAS OR Head Holder and the NORAS OR Head Coil 1.5T / 3.0T combine the functions of a head holder for neurosurgical interventions and an MR receiving coil for intra-operative surgery.

The NORAS OR Head Holder without the NORAS OR Head Coil 1.5T / 3.0T can be used for stabilizing the patient's head. It can also be used in combination with the body coil.

The Head Frame of the NORAS OR Head Holder allows adjustment to heads varying in size. For optimal access to the area of intervention, the Head Frame can be swiveled and rotated.

The provided document pertains to the 510(k) premarket notification for the NORAS OR Head Holder Flexibility. The device is a "Magnetic Resonance Diagnostic Device" and is intended for use in intra-operative MR imaging during open-skull neurosurgery, primarily for safely securing the patient's head.

Based on the document, here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The document does not explicitly present a table of acceptance criteria in terms of specific performance metrics (e.g., accuracy, sensitivity, specificity) that a diagnostic device would typically have, nor does it report specific performance values for the device in such a format. This is because the NORAS OR Head Holder Flexibility is primarily a support and positioning device for MR imaging, rather than an active diagnostic algorithm.

Instead, the acceptance criteria are implicitly related to:

• Safety and Mechanical Integrity: Ensuring the device can safely secure a patient's head and function properly within an MR environment without posing new risks.
• Compatibility: Ensuring it works as intended with specified MR systems and operating tables.
• Substantial Equivalence: Demonstrating that it is as safe and effective as a legally marketed predicate device.

Here's an interpretation of the implied acceptance criteria and the device's reported performance based on the provided text:

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 specify a "sample size" in terms of patient data or a "test set" in the context of diagnostic algorithm validation. The testing described is primarily focused on engineering and safety standards conformance for the device's mechanical and electrical properties.

• The testing involves "external tests done by VDE" and "internal evaluations" concerning mechanical aspects (e.g., Z-joint meeting IEC 60601-1 clause 9.8).
• Conformance to NEMA and IEC 60601-2-33:2002 standards is stated for safety and performance in an MR environment.

These types of tests are typically conducted in a laboratory or engineering testing facility setting rather than with a "test set" of patient data. Therefore, concepts like data provenance (country of origin, retrospective/prospective) are not applicable in the usual sense for this type of 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)

This information is not applicable to this device. As explained above, the device is a piece of hardware for patient positioning, not an AI/diagnostic algorithm that requires ground truth established by medical experts on patient data. The "ground truth" here is adherence to engineering and safety standards, verified by testing bodies and internal evaluations.

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

This information is not applicable to this device, as there is no "test set" of medical images or patient data requiring expert adjudication.

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

This information is not applicable to this device. An MRMC study is relevant for evaluating the impact of an AI-powered diagnostic tool on human reader performance, which the NORAS OR Head Holder Flexibility is not.

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

This information is not applicable to this device. It is a hardware device, not a standalone AI algorithm. It acts as a component within a human-in-the-loop imaging workflow (neurosurgeon, MR technologist, radiologist, etc.).

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

The concept of "ground truth" as typically used in diagnostic algorithm validation (e.g., pathology, clinical outcomes) is not applicable here. The "ground truth" for this device's acceptance is its conformance to established international and FDA-recognized engineering and medical device safety standards (e.g., IEC 60601-1, IEC 60601-2-33, NEMA standards). The truth is established by meeting these pre-defined technical and safety requirements through testing.

8. The sample size for the training set

This information is not applicable to this device. There is no AI algorithm being trained, so there is no "training set."

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

This information is not applicable to this device, as there is no training set or AI algorithm involved.

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The intended use of the Noras OR Head Coil 3T 7230-PH is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the human brain just before, during and at the end of the brain surgery in the operating room. The coil can also be used as a standard diagnostic head coil for diagnostic examinations and fMRI (Functional Magnetic Resonance Imaging).

Used in the 3T Philips Achieva Systems, it is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of the head.

When interpreted by a trained physician, these images provide information that can be useful in determining diagnosis.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA to Moras MRI Products GmbH for their Noras OR Head Coil 3T. This document is a regulatory approval letter and does not contain the results of a study or detailed acceptance criteria for a device.

Therefore, I cannot extract the information required by your request about acceptance criteria and the study proving the device meets them, because this information is not present in the provided text.

The document states that the FDA reviewed the 510(k) premarket notification and determined the device to be "substantially equivalent" to legally marketed predicate devices. This regulatory pathway typically relies on demonstrating equivalence to an already approved device rather than presenting new clinical study data with specific acceptance criteria and performance metrics in the same way a Premarket Approval (PMA) application might.

The indications for use are provided, but these are not the acceptance criteria or device performance data.

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The intended use of the Noras OR Head Coil 3T is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the human brain just before, during and at the end of the brain surgery in the operating room. The coil can also be used as a standard diagnostic head coil for diagnostic examinations and fMRI (Functional Magnetic Resonance Imaging).

Used in the 3T MAGNETOM Systems, it is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of the head.

When interpreted by a trained physician, these images provide information that can be useful in determining diagnosis.

The Noras OR Head Coil 3T is an 8-channel phased array coil. The coil is divided into a bottom and a top array of 4 channels each. Each-channel is tuned to the Larmor frequency of the 1H spin in a magnetic field of 3T, 123.2 MHz. Each coil is connected to the MAGNETOM system by a separate cable.

The provided document describes a 510(k) premarket notification for a medical device, the Noras OR Head Coil 3T, which is an MRI coil. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with specific acceptance criteria and performance metrics for the new device.

Therefore, many of the requested details, such as specific acceptance criteria, detailed device performance metrics, sample sizes for test and training sets, and information about expert-established ground truth, are not available in the provided text.

Here is an analysis based on the information that is present:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The submission focuses on demonstrating substantial equivalence to a predicate device through technological characteristics and conformity to general safety and performance standards, rather than proving performance against specific acceptance criteria.

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

This information is not provided as there is no mention of a clinical test set or data from human subjects for performance evaluation specific to this device. The assessment relies on conformity to NEMA and IEC standards, which are likely tested with phantoms or in controlled laboratory environments.

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

This information is not provided as there is no mention of a test set with expert-established ground truth in the context of this 510(k) submission.

4. Adjudication Method for the Test Set

This information is not provided as there is no mention of a test set requiring adjudication.

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

This information is not applicable/provided. The device is an MRI head coil, not an AI-powered diagnostic tool. Therefore, an MRMC study related to AI assistance would not be relevant.

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

This information is not applicable/provided. The device is an MRI head coil, not an algorithm. Performance assessment is based on its physical and electrical characteristics and ability to produce images, not on standalone algorithm performance.

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

This information is not provided as there is no specific "ground truth" mentioned in the context of a clinical performance study for this device. The document emphasizes conformity to recognized standards (NEMA, IEC) for performance and safety parameters. These standards often rely on objective physical measurements using phantoms rather than clinical "ground truth" from patients.

8. The Sample Size for the Training Set

This information is not provided as there is no mention of a "training set" in the context of the device's development or evaluation. As an MRI coil, it does not involve machine learning algorithms that would typically require a training set.

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

This information is not provided and is not applicable, as there is no mention of a training set.

Based on the provided document, the study demonstrating that the device meets (implicitly, rather than explicitly stated acceptance criteria) is the conformity to recognized standards and substantial equivalence to a predicate device.

• Acceptance Criteria (Implied):

  • Conformity to FDA recognized NEMA Standards for the measurement of performance and safety parameters.
  • Conformity to IEC standards for safety issues with Magnetic Resonance Imaging Devices, specifically IEC 60601-2-33:2002.
  • Substantial equivalence to predicate devices (Noras OR Head Coil 1.5T and MRI Devices Corporation High Resolution Head Coil Model HRH-63-8) in terms of intended use, technological characteristics, and safety/effectiveness.

• Study That Proves the Device Meets the Implied Acceptance Criteria:

  • "The NEMA Tests were done on software platform version VB15A." (Page 3) This statement indicates that specific tests outlined by NEMA (National Electrical Manufacturers Association) standards were performed. These tests would evaluate various performance characteristics of the MRI coil, such as signal-to-noise ratio, uniformity, spatial resolution, etc.
  • Conformity Statements: The document explicitly states, "The Noras OR Head Coil 3T will conform to the FDA recognized NEMA Standards for the measurement of performance and safety parameters and the IEC standards for safety issues with the Magnetic Resonance Imaging Devices, IEC 60601-2-33:2002." (Page 3). This serves as the primary evidence provided for meeting safety and performance expectations through adherence to established industry standards.
  • Substantial Equivalence Argument: The core of the 510(k) submission is the argument that the Noras OR Head Coil 3T is "substantially equivalent" to predicate devices (Noras OR Head Coil 1.5T and MRI Devices Corporation High Resolution Head Coil Model HRH-63-8). This implies that its performance and safety are comparable to devices already cleared for market.

In summary, the document does not contain details of a specific clinical study with explicit acceptance criteria and performance results for the Noras OR Head Coil 3T. Instead, it relies on demonstrating compliance with recognized industry standards (NEMA, IEC) and establishing substantial equivalence to previously cleared devices to prove its safety and effectiveness.

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The intended use of the Noras CPC is, in conjunction with a Magnetic Resonance Scanner, Body-imaging for diagnostic with a MRI system.

It is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of special regions of the human body. When interpreted by a trained physician, these images provide information that can be use in determining diagnosis.

The application area shouldn't be bigger than 20 cm because of the depth of 10 om per coll. The outcome of this is diagnostic images of toes, feet, ankle, knee, finger, hand, wrist, elbow, shoulder, carotid artery, inner ear and other parts of the body with sumilar structure can be taken.

The CPC is a multifuntional coil for 1 5T and 3T MRI-systems, with 2x4-channel phased array receive only colls. The coils are pre-tuned in the fixed load and no further tuning or matching is required for the user.

The coll is divided into two spherical parts. Each half contains a 4 channel receive only array. The coils were used together with a parallel imaging procedure.

Each coll has its own plug. The plug is specific to the MRI-system and can't be mixed up with a not designated MRI-system.

The base plate is flat and is suitable on each Siemens MRI-system table.

This document is a 510(k) summary for a medical device called the "CPC Multipurpose Coil." It is a submission to the FDA seeking clearance to market the device, demonstrating its substantial equivalence to previously cleared devices.

Based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria in the way typically expected for an AI/CADe device. This document describes an MRI coil, which is a hardware component, not a software algorithm that would produce performance metrics like sensitivity or specificity.

Here's why the requested information cannot be found in this document:

• Device Type: The "CPC Multipurpose Coil" is an MRI coil, which is a physical component of an MRI system used to acquire images. It is not an AI/CADe device that performs diagnostic interpretation or analysis.
• Regulatory Pathway: This is a 510(k) premarket notification. For hardware devices like MRI coils, the 510(k) process focuses on demonstrating substantial equivalence to existing legally marketed predicate devices. This typically involves showing that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness. It does not generally require clinical performance studies with acceptance criteria based on diagnostic accuracy (e.g., sensitivity, specificity, AUC) against a ground truth, as would be expected for an AI algorithm.
• "Acceptance Criteria" for Hardware: For a hardware device like this, "acceptance criteria" generally refer to engineering specifications, safety standards compliance, and performance metrics relevant to image acquisition (e.g., signal-to-noise ratio, uniformity, field of view), not diagnostic accuracy.

Therefore, I cannot provide the requested information. The document focuses on:

• General Information: Importer, manufacturer, contact person.
• Device Name and Classification: Trade name, common name, classification, CFR number, device class, product code.
• Device Description: Multi-channel phased array receive-only coils for 1.5T and 3T MRI systems, pre-tuned, designed for specific MRI systems.
• Intended Use: Body-imaging for diagnostic purposes with an MRI system, to produce images of internal structures for determining diagnosis. Specifies application areas like toes, feet, ankle, knee, etc.
• Substantial Equivalence: Lists several predicate MRI coils the device is compared against.
• Technological Characteristics: Highlights comfortable access to the region of interest.
• General Safety and Effectiveness Concerns: States adherence to IEC 60601-1 and 60601-2-33 standards, and NEMA standards for performance and safety. Mentioned testing on a Siemens Avanto system.
• Conclusion: Affirms substantial equivalence.

The FDA's letter (Page 4-5) confirms the substantial equivalence determination, allowing the device to be marketed under general controls.

In summary, this document does not contain the type of AI/CADe performance study data you are asking for because the device is an MRI coil, not an AI algorithm.

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The intended use of the Noras MR-BI320-PA 1.5T is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the female breast. It is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of the female breast. When interpreted by a trained physician, these images provide information that can be useful in determining diagnosis.

The included Breast Biopsy Unit Bl160-2 permits MR guided breast biopsy, wire localization of lesions that can be performed by a trained physician.

The MR-BI320-PA 1.5T is a patient rest with a immobilization- and biopsy unit and a 4-channel phased array receive only coil.

The coil is factory pre-tuned to the fixed load and no further tuning or matching is required for the patient.

The coil is divided into two spherical parts. Each half contains a 2 channel receive only arrav.

The upper coil is connected with a cable and a plug with the insertion coil. The insertion plate coil is connected to the scanner with a cable connection.

The insertion plate coil is designed to enable insertion of immobilization and biopsy system and is inserted into the patient rest.

The upper coil (patient pad coil) serves as a positioning pad for the patient at the same time.

The provided text describes a 510(k) summary for the Noras MR-BI320-PA 1.5T device, a patient rest with an immobilization- and biopsy unit and a 4-channel phased array receive-only coil for MR examination of the female breast.

However, the document does not contain information about specific acceptance criteria, a study proving the device meets these criteria, or details regarding device performance metrics (such as sensitivity, specificity, accuracy), sample sizes for test/training sets, expert qualifications, ground truth establishment, or multi-reader multi-case studies as requested in your prompt.

The document focuses on:

• Device Description: What the device is and its components.
• Intended Use: How the device is meant to be used (MR examination of the female breast, MR-guided breast biopsy and wire localization).
• Substantial Equivalence: Comparing the device to legally marketed predicate devices (MRI Devices Corporation Breast Array Coil, Noras Immobilization and Biopsy Units).
• Technological Characteristics Comparison: Highlighting improvements and capabilities compared to predicates.
• Safety and Effectiveness Concerns: Stating conformity to harmonized standards (IEC 60601-1, NEMA MS 6-2001, IEC 60601-2-33:2002) and testing on a Siemens Avanto system to ensure safety and performance with Siemens 1.5T systems.
• Conclusion of Substantial Equivalence.

The only mention of a "test protocol" is in the context of technological comparison, stating "The dedicated 4 channel 1.5T breast coil enables a MR guided biopsy under comparable picture quality as the MRI OBC coil (see Appendix C Test Protocols, due to Standard NEMA MS 6-2001)." This refers to a standard for measuring performance and safety parameters, not a specific clinical or performance study with acceptance criteria and results.

Therefore, I cannot populate the requested table or answer most of the prompt's specific questions based on the provided text. The document is a regulatory submission for substantial equivalence, not a detailed study report.

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