Search Results

The Head Coil is indicated for use as diagnostic device extension for a Philips, Siemens or GE 3.0 T MR system to provide cross-sectional 1H and/or any X nucleus images, spectroscopic images and/or spectra in any orientation of the internal structure of the head of the patient. These images when interpreted by a trained physician yield information that may assist in diagnosis.

The Head Coil is used in Magnetic Resonance Imaging and Spectroscopy (MRI, MRS). The Head Coil has been designed to be used on Siemens, Philips or GE 3.0 T MR systems. The Head Coil is a transmit/receive coil to excite and detect radiofrequency (RF) signals of hydrogen (1H) nuclei in combination with either phosphorus (31P), carbon (13C) or sodium (23 Na) nuclei. Excitation of the nuclei is achieved by applying an RF magnetic field. The detected signal is an RF voltage being induced in the Head Coil by the nuclei observed. The Head Coil mainly offers passive antenna technology for linking the MR system to the patient (and reverse).

The provided text is a 510(k) Summary for a medical device (31P/1H Head Coil, 23Na/1H Head Coil, 13C/1H Head Coil). It describes the device, its intended use, and why it is considered substantially equivalent to a previously cleared predicate device.

However, it does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, specifically:

• A table of acceptance criteria and reported device performance. The document mentions "equivalent or better SNR and Image Uniformity performance" but doesn't provide specific quantitative criteria or results in a table format.
• Sample size used for the test set and data provenance. The document states "Nonclinical tests were performed on a phantom" and "Clinical images were acquired," but does not specify the sample size for either (e.g., number of phantoms, number of clinical cases/patients). It also doesn't specify data provenance beyond "in vivo" for clinical images.
• Number of experts used to establish ground truth and qualifications. This information is absent. Ground truth is only mentioned conceptually for image interpretation by a "trained physician" for diagnosis, not for a test set validation.
• Adjudication method for the test set. Not mentioned.
• Multi-reader multi-case (MRMC) comparative effectiveness study. Not mentioned.
• Standalone (algorithm-only) performance. This is not relevant here as the device is a hardware coil, not an AI algorithm.
• Type of ground truth used. For non-clinical tests, physical phantom measurements are the "ground truth." For clinical images, it mentions "images when interpreted by a trained physician," but this isn't a formalized ground truth establishment for a study.
• Sample size for the training set. There's no mention of a training set as this is a hardware device submission, not an AI algorithm.
• How ground truth for the training set was established. Not applicable.

The document primarily focuses on demonstrating substantial equivalence through:

• Comparison of Indications for Use and Intended Use: Stating they are the same or very similar to the predicate.
• Technological Characteristics: Highlighting similarities in coil technology and safety.
• Nonclinical Tests: Phantom studies for SNR and Image Uniformity, showing "equivalent or better" performance, and compliance with NEMA standards (NEMA MS 1-2008 and NEMA MS 3-2008). It also mentions ESD tests per IEC 60601-2-33.
• Clinical Images: Stating that "adequate image quality (SNR, penetration depth, contrast, resolution and robustness against artifacts) as well as scan time and patient comfort are good."

In summary, the provided text describes a medical device (an MRI coil) submission, which relies on demonstrating substantial equivalence to a predicate device through non-clinical performance data and compliance with relevant standards. It does not present a formal clinical study with detailed acceptance criteria, ground truth establishment, or reader studies typical for AI/software-as-a-medical-device (SaMD) submissions.

Ask a specific question about this device

The Endorectal Coil is indicated for use as diagnostic device extension for GE 1.5 T MR Systems and GE 3.0 T MR Systems to produce transverse, sagittal, coronal and oblique images, spectroscopic images and/or spectra, displaying the internal structure of the prostate.

These images when interpreted by a trained physician, yield information that may assist in diagnosis.

The Endorectal Coil (1.5T Endorectal Coil O-HLE-015-01899, 1.5T Endorectal Coil O-HLE-015-01946, 3.0T Endorectal Coil O-HLE-030-01900 and ER Coil Support ZUB-01955) is designed for use with a magnetic resonance (MR) system. The coil is designed to work in unison with the Body Coil (BC) of the MR system, which will excite the hydrogen (1H) nuclei with radio frequency (RF) magnetic fields, so that the coil may receive the resultant RF signal from the excited nuclei. The coil is designed as a reusable receive-only coil for high resolution MR examination of the prostate.

The coil housing is minimum sized and drop-shaped for better patient comfort. It features a flat top to minimize the distance of the inside receive coil electronics to the prostate. The coil is receive-only (Rx) and consists of a single loop coil element with an integrated low noise preamplifier and a connector to the GE 1.5 T MR-System or GE 3.0 T MR-System. The coil is fixed tuned and matched to the typical loading condition of a prostate examination at the Larmor frequency of 1H at 1.5 T (63.9 MHz) or 3.0 T (127.7 MHz), respectively. Decoupling circuits are integrated in the single loop element providing a decoupling from the Body Coil of the MR System during transmission of the RF excitation pulse.

It is recommended to employ an Endorectal Coil Model in combination with the additional available ER Coil Support. The ER Coil Support is designed for use with any Endorectal Coil Model (1.5T Endorectal Coil O-HLE-015-01899, 1.5T Endorectal Coil O-HLE-015-01946 and 3.0T Endorectal Coil O-HLE-030-01900). It supports stabilizing the Endorectal Coil in any position required by each individual endorectal MR examination. The ER Coil Support features a collet for acceptance of the Endorectal Coil. The Endorectal Coil is fixated inside the collet by tightening of a knurled screw. It offers five degrees of freedom to align the position of the collet with the required spatial position of the Endorectal Coil housing. Two additional knurled screws allow the lock the ER Coil Support in the desired alignment.

The provided document is a 510(k) summary for MRI Endorectal Coils (1.5T and 3.0T) and an ER Coil Support. This document primarily focuses on establishing substantial equivalence to previously cleared predicate devices rather than providing detailed acceptance criteria and a study report demonstrating the device meets those criteria for clinical AI/ML-based diagnostic devices.

The information sought in your request (acceptance criteria, specific study details with sample sizes, expert qualifications, ground truth, MRMC studies, standalone performance, training set details) is typically found in detailed clinical validation reports for AI/ML diagnostic tools. The submitted document for the Endorectal Coil, being a device accessory used to produce images, focuses on performance metrics like Signal-to-Noise Ratio (SNR) and Image Uniformity, safety standards compliance, and clinical image quality in vivo. It does not describe a study involving an AI algorithm making diagnoses or clinical decisions based on these images.

Therefore, many of the specific questions you've asked about AI/ML device validation cannot be answered from this document. However, I can extract information related to the device's technical performance and the nature of the "tests" conducted to support its substantial equivalence.

Here's an attempt to answer based on the available information, noting the limitations due to the nature of the device and the document:

Acceptance Criteria and Study for RAPID Biomedical Endorectal Coils

This submission pertains to an MRI accessory (endorectal coil), not an AI/ML diagnostic device that provides interpretations or diagnoses. Therefore, the "acceptance criteria" and "study" described are focused on the coil's technical performance, fundamental safety, and generation of adequate image quality for human interpretation, rather than the diagnostic accuracy of an AI algorithm.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Nonclinical Tests (Phantom): No specific number provided for the "sample size" of phantoms or tests conducted. It involved "a phantom" (singular).
• Clinical Tests (In Vivo): No specific number of patients or images provided. The document states "Clinical tests were performed in order to check image quality in vivo." and "Sample clinical images in DICOM format are provided as part of the discussion of the clinical tests submitted." This implies a limited, likely small, number of cases for qualitative assessment.
• Data Provenance: Not explicitly stated, but given the manufacturer (RAPID Biomedical GmbH) is in Germany, and the device is for GE MR Systems, the testing likely occurred in a European or US setting, possibly at GE's facilities or collaborating sites. Retrospective/Prospective is not specified, but in vivo testing would inherently involve prospective patient imaging or use of existing image datasets.

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

This is not applicable in the context of this submission. The device is a hardware accessory (an endorectal coil) that produces images; it does not generate a diagnostic output requiring comparison to an expert-established ground truth for performance evaluation in the way an AI diagnostic algorithm would. The "interpretation by a trained physician" is mentioned in the Indications for Use, implying that human experts are the ones making diagnoses from the images produced by the coil, but their role in establishing "ground truth" for the coil's performance itself is not described.

4. Adjudication method for the test set:

Not applicable. There is no diagnostic output from the device itself to adjudicate.

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

No. MRMC studies are typically performed for diagnostic devices (especially AI/ML software) to evaluate the impact of the device on human reader performance. This submission is for an MRI coil, which is hardware for image acquisition.

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

Not applicable. The device is hardware. It is explicitly stated that the images it produces are "when interpreted by a trained physician, yield information that may assist in diagnosis." This indicates a human-in-the-loop workflow for diagnosis, as the device itself is not making a diagnosis.

7. The type of ground truth used:

• Nonclinical (Phantom): The "ground truth" for technical performance (SNR, Image Uniformity) is comparison against established engineering standards (NEMA) and the performance of the predicate device, using objective measurements on a phantom.
• Clinical (In Vivo): The "ground truth" for adequacy of image quality in vivo is likely a qualitative assessment by experienced personnel/physicians as to whether the images show sufficient detail, contrast, and lack of artifacts for diagnostic purposes. This is not "ground truth" in the sense of a confirmed clinical diagnosis (e.g., pathology report) but rather an evaluation of the image's technical and clinical usability.

8. The sample size for the training set:

Not applicable. This is an MRI coil (hardware), not an AI/ML algorithm that requires a "training set."

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

Not applicable. (See #8)

Ask a specific question about this device

The 16Ch Diagnostic Breast Coils are indicated for use as diagnostic imaging device extensions for GE 1.5 T MR Systems and GE 3.0 T MR Systems to produce transverse, sagittal, coronal and oblique images and/ or spectra, and that displays the internal structure of the breast. These images when interpreted by a trained physician, yield information that may assist in diagnosis.

The 16Ch Diagnostic Breast Coil (1.5 T 16Ch Diagnostic Breast Coil and 3.0 T 16Ch Diagnostic Breast Coil) is designed for use with a magnetic resonance (MR) system. The coil is designed to work in unison with the Body Coil (BC) of the MR system, which will excite the hydrogen (1H) nuclei with radio frequency (RF) magnetic fields, so that the coil may receive the resultant RF signal from the excited nuclei. The coil is designed as a receive-only coil for high resolution MR examination of breast.

The coil housing features a curved surface for better adaption to the anatomical region of interest. The coil is receive-only (Rx) and consists of 16 independent single loop coil elements with integrated low noise preamplifiers and a connector to the GE 1.5 T MR Systems or the GE 3.0 T MR Systems. The coil is fixed tuned and matched to the typical load of a breast at the Larmor frequency of 1H at 1.5 T (63.9 MHz) or 3.0 T (127.7 MHz) respectively. Decoupling circuits are integrated in each single loop element providing a decoupling from the Body Coil of the MR System during transmission of the RF excitation pulse. The coil provides both, unilateral and bilateral images (Left, Right and Both) of the anatomy of interest.

The provided document is a 510(k) premarket notification for a magnetic resonance breast coil accessory, not a detailed study report for an AI device. As such, it does not contain the specific information requested in the prompt regarding acceptance criteria and a study proving a device meets them in the context of an AI/ML clinical validation.

Here's an analysis of what can be extracted and what information is missing:

Information Extracted:

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

   • Acceptance Criteria (Implicit from regulatory standards): The device adheres to safety and performance parameters outlined in the FDA Guidance Document "Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices, issued on Nov. 18, 2016." It also conforms to specific international standards for medical electrical equipment (AAMI/ANSI ES60601-1, IEC 60601-2-33) and NEMA standards for MRI coil performance (MS 6-2008, MS 9-2008).
   • Reported Device Performance:
     • Nonclinical Tests (Loading phantom): "Test results show an enhanced SNR performance of the subject device, while determined Image Uniformity compares well to the results from the predicate device."
     • Clinical Tests (Volunteers): "Clinical test show that the subject device provides adequate image quality (SNR, penetration depth, contrast, resolution and robustness against artifacts) as well as scan time and patient comfort are good."

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

   • Sample Size: Not specified for non-clinical (phantom) or clinical (volunteer) tests.
   • Data Provenance: Clinical tests were performed on "volunteers." No country of origin is specified. The tests appear to be prospective, as they were "performed... in order to check image quality in vivo."

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

   • Not applicable/not provided. This device is an MRI coil, not an AI diagnostic algorithm, so there's no mention of "ground truth" derived from expert consensus for diagnostic accuracy. The "indications for use" state images "when interpreted by a trained physician, yield information that may assist in diagnosis," but this refers to the end-user, not experts establishing ground truth for a study.

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

   • Not applicable/not provided for the reasons stated above.

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 MRMC study was mentioned. The device is a breast coil, not an AI assistance tool.

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

   • Not applicable. This is not an AI algorithm.

7. The type of ground truth used:

   • Not applicable in the typical sense of AI/ML validation (e.g., pathology, outcomes data). The evaluation criteria for this MRI coil focused on technical image quality parameters (e.g., SNR, uniformity, contrast, resolution, artifacts) and patient comfort.

8. The sample size for the training set:

   • Not applicable; this is not an AI/ML device requiring a training set.

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

   • Not applicable; no training set.

Summary of Missing Information for AI/ML Context:

The document is a premarket notification for an MRI coil, a hardware accessory. The information requested in the prompt, such as "number of experts," "adjudication method," "MRMC study," "standalone performance," "training set," and "ground truth establishment" (in the context of diagnostic accuracy), are standard requirements for the validation of Artificial Intelligence/Machine Learning (AI/ML) powered diagnostic devices or software. This document is not for such a device, and therefore these details are not present.

Ask a specific question about this device

The P-140-Flex Coil, Na-140-Flex Coil and C-140-Flex Coil are indicated for use as diagnostic device extensions for Philips 3.0 T MR Systems to produce cross-sectional spectroscopy images and/or spectra in any orientation of the internal structure of the whole body, e.g. of the calf, liver or heart. These images when interpreted by a trained physician, yield information that may assist in diagnosis.

The P-140-Flex Coil, Na-140-Flex Coil and C-140-Flex Coil are single tuned surface type transmit and receive coils for usage in magnetic resonance systems, the operating frequency and interface being adapted for usage on Philips 3.0 T MR Systems. The coils are for transmit and receive (T/R) and provide the required magnetic RF field for excitation of the spins and receive the MR signal of 31P, 23Na or 13C spins. This is used for axial, sagittal, coronal and oblique imaging, spectroscopic imaging and/or spectroscopy, which display the internal structure and/or function of the human anatomy, e.g. of the calf, liver or heart.The coils are optimized for local examinations of human subjects. The housing is flexible for better adaption to the anatomical region of interest. The coils consist of a single loop (linear) with a diameter of 14 cm, RF routing (T/R switch), a low noise preamplifier and a connector to the Philips 3.0 T MR Systems. The coils are fixed tuned and matched to the typical load of human tissue at the Larmor frequency of 31P (51.7 MHz), 23Na (33.8 MHz) or 13C (32.1 MHz) at 3.0 T. There is no detuning or switching mechanism in the loops. The loops are tuned permanently to the working frequencies of 31P, 23Na or 13C while being decoupled from the 1H body coil at the 1H frequency.

The provided text is a 510(k) summary for MRI coils. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, this document does not contain information about acceptance criteria or a study proving the device meets specified performance criteria through a human-in-the-loop or standalone AI study.

The document discusses:

• The indications for use of the P-140-Flex Coil, Na-140-Flex Coil, and C-140-Flex Coil as diagnostic device extensions for Philips 3.0T MR Systems to produce cross-sectional spectroscopy images and/or spectra.
• The device description, noting they are single-tuned surface transmit and receive coils.
• Comparisons to a predicate device (Philips P-140 Coil), highlighting improvements like flexible housing for better patient comfort without detrimental effects on safety, reliability, or other performance topics.
• Conformity to IEC standards (60601-1 and 60601-2-33) to assure safe and effective performance.
• A brief statement that "Testing was performed to support this claim of substantial equivalence and to show that the modifications do not raise any new questions pertaining to safety and effectiveness."

Based on the provided text, I cannot answer the specific questions about acceptance criteria for device performance, the study design, sample sizes for test/training sets, ground truth establishment, or human reader performance with/without AI assistance, as this information is not present. The document focuses on demonstrating substantial equivalence to a predicate device based on similar technology, intended use, and compliance with general safety standards for MR coils, rather than a clinical performance study with defined acceptance criteria for image interpretation or diagnostic accuracy.

Ask a specific question about this device

The Dual Tuned Head Coils 3T are indicated for use as a diagnostic imaging device accessory to produce transverse, sagittal, coronal and oblique images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

The Dual Tuned Head Coils 3T are transmit/receive volume coils to detect radiofrequency (RF) signals of hydrogen (1H) nuclei in combination with either phosphorus (31P), carbon (13C) or sodium (23Na) nuclei. Each coil consists of two single quadrature resonators, one of which is always tuned to the proton frequency, the other being tuned to either phosphorus, carbon or sodium frequency.

The device in question is a component of an MRI system (Dual Tuned Head Coils 3T) and as such, its acceptance criteria and performance are focused on its technical contribution to image quality and safety, rather than diagnostic accuracy like an AI algorithm. Therefore, many of the requested points regarding diagnostic performance, ground truth, experts, and human-in-the-loop studies are not applicable.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that "the results presented in this submission show that they are equivalent with the predicate devices" for several performance parameters. This implies the acceptance criterion was to demonstrate equivalence to the predicate devices based on established NEMA standards or other tests.

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

• Sample Size: Not explicitly stated. The tests conducted were laboratory-based performance tests on the device itself, rather than clinical studies involving human patients or a specific "test set" of images/data in the typical sense of an AI study.
• Data Provenance: The tests were conducted in a laboratory setting by the manufacturer, Rapid Biomedical GmbH, in Germany. The data is thus internal to the manufacturer, from device testing.

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

• Not Applicable. This device is a hardware component (MRI coil). The "ground truth" here is the physical performance and safety metrics of the coil itself, measured through standardized tests (e.g., NEMA standards) on a phantom or test object, not clinical interpretations by human experts.

4. Adjudication Method for the Test Set

• Not Applicable. As per point 3, there was no "test set" requiring adjudication by human experts for diagnostic accuracy. The assessment was based on objective, quantifiable engineering and physics measurements.

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

• Not Applicable. This is a hardware device (MRI coil), not an AI algorithm. No MRMC study was performed as it's not relevant to demonstrating the safety and effectiveness of an MRI coil.

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

• Not Applicable. This is a hardware device (MRI coil), not an algorithm. Performance tests were done on the standalone device.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance relies on objective physical measurements against established standards (e.g., NEMA MS 1-2008, NEMA MS 3-2008, NEMA MS 5-2003, NEMA MS 8-2008) and comparison to the performance of predicate devices. For safety parameters (like static field, acoustic noise), the ground truth is adherence to general safety guidelines or the fact that modifications did not affect these parameters.

8. The Sample Size for the Training Set

• Not Applicable. This is a hardware device, not a machine learning model. There is no concept of a "training set" in this context.

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

• Not Applicable. As per point 8, there is no training set for this hardware device.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study involved a series of laboratory tests designed to evaluate the safety and performance of the Dual Tuned Head Coils 3T. These tests included:

• RF Power Deposition (SAR) determination: Performed according to NEMA MS 8-2008.
• Imaging Performance:
  • Signal to Noise Ratio (SNR) tests according to NEMA MS 1-2008.
  • Image Uniformity tests according to NEMA MS 3-2008.
  • Slice Profile tests according to NEMA MS 5-2003.
• Spectroscopy Performance:
  • SNR tests.
  • Spectral Resolution tests.
  • Decoupling tests.

Additionally, biocompatibility was addressed by confirming that no new patient-contacting materials were used, thus precluding the need for new biocompatibility tests. Other general safety and performance parameters (Maximum Static Field, Rate of Change of Magnetic Field, Acoustic Noise Level, Geometric Distortion, High Contrast Spatial Resolution, Spatial Localization Accuracy, Peak Assignment Accuracy, Solvent Suppression) were deemed "unaffected by the modifications."

The results of these laboratory tests demonstrated "equivalence with the predicate devices," thereby supporting the manufacturer's claim of substantial equivalence and showing that the technological differences did not raise new questions pertaining to safety and effectiveness, as required for 510(k) clearance.

Ask a specific question about this device

The Dual Tuned Surface Coils 3T are surface type transmit/receive coils dual tuned on l H (proton) and either 31P (phosphorus), 23Na (sodium) or 13C (carbon) nuclei. The coils are indicated for use as a diagnostic imaging device accessory to Siemens MAGNETOM Trio, A Tim System 3T and MAGNETOM Verio 3T magnetic resonance diagnostic devices to produce transverse, sagittal, coronal and oblique images, spectroscopic images and/or spectra, and that display the internal structure and/or function of the head or extremities. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

The Dual Tuned Surface Coils 3 T are transmit/receive surface coils to detect radiofrequency (RF) signals of hydrogen (1H) nuclei in combination with either phosphorus (31P), carbon (13C) or sodium (23Na) nuclei. Each coil consists of two single concentric loops, one of which is always tuned to the proton frequency, the other being tuned to either phosphorus-31P, carbon-13C or sodium-23Na frequency. Additional components are housed in a separate interface housing box.

Here's a breakdown of the acceptance criteria and study information for the Dual Tuned Surface Coils 3T, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission acts as a 510(k) summary, aiming to demonstrate substantial equivalence to a predicate device rather than explicitly defining and meeting specific quantitative acceptance criteria in a pass/fail manner. Instead, the submission outlines parameters considered and states that the new device's performance results in these areas are "equivalent with the predicate devices."

Note: The document does not provide specific numerical values for the performance metrics, only stating equivalence to the predicate device or that tests were performed.

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

The provided text does not explicitly state a "test set" in the context of human subject data. The testing described appears to be primarily bench testing or phantom testing on the device itself and its interaction with MR systems. Therefore, there is no mention of human subject sample sizes or data provenance (country of origin, retrospective/prospective). The tests were performed on "the Siemens MAGNETOM Trio a Tim System" which is an MR scanner.

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

Not applicable. This device is an accessory (surface coil) for an MR diagnostic device. The ground truth for its performance tests (e.g., SNR, image uniformity, spectral resolution) would be derived from quantitative measurements based on standardized test methods (like NEMA standards), not expert interpretation of images/spectra for diagnostic accuracy.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the performance is assessed through quantitative measurements, not expert adjudication of diagnostic outcomes.

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

Not applicable. This submission is for a hardware accessory (MR coil), not an AI-powered diagnostic software.

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

Not applicable. This is a hardware device. Its "performance" is inherently "standalone" in that it produces raw data/images/spectra, which are then interpreted by a human. The coil itself is not an algorithm.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" for the device's performance tests would be established through quantitative measurements against recognized industry standards (e.g., NEMA standards) or engineering specifications. For example, SNR would be measured directly from phantom images, spectral resolution from known chemical phantoms, etc. This is not a diagnostic device where pathology or expert consensus would establish ground truth for clinical decision-making.

8. The Sample Size for the Training Set

Not applicable. This is a hardware device, not a machine learning algorithm that requires a "training set."

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

Not applicable. As above, this is a hardware device.

Ask a specific question about this device

The 16 Ch AI Breast Coil 1.5 T and the 16 Ch AI Breast Coil 3 T are indicated for use as a diagnostic imaging device accessory to produce transverse, sagittal, coronal and oblique images, spectroscopic images and/or spectra, and that displays the internal structure of the breast.

The 16 Ch AI Breast Coil 1.5 T and the 16 Ch AI Breast Coil 3 T are receive only MR coils for imaging the human breast. Both coils consist of 16 coil elements. Two housing halves each contain eight independent coil elements. Seven of each are arranged in a cylindrical geometry while one element is positioned in a horizontal plane at top of the cylinder faced outwards.

The provided document describes the K083253 510(k) submission for the "16 Ch AI Breast Coil 1.5 T" and "16 Ch AI Breast Coil 3 T." This submission is for an accessory to an existing Magnetic Resonance Diagnostic Device, specifically a specialized coil for breast imaging. It claims substantial equivalence to a previously cleared predicate device, the "CP Breast Array Coil."

The document details safety and performance characteristics that were considered during the evaluation for substantial equivalence but does not describe a clinical study or specify acceptance criteria in the context of device performance metrics with numerical targets and achieved results. Instead, it focuses on laboratory testing to demonstrate equivalence based on certain technical parameters.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table with explicit acceptance criteria (e.g., "SNR must be > X dB") and corresponding reported device performance values. It states that "Signal to Noise Ratio (SNR) and image uniformity tests according to IEC 62464-1 were performed... and the results presented in this submission show that they are equivalent with the predicate devices." This implies that the acceptance criterion was likely equivalence to the predicate device's performance for these metrics, rather than a specific numeric threshold.

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

The document only mentions "Laboratory testing" and does not specify a sample size for a test set in the context of human subjects or clinical data. The tests performed ("Signal to Noise Ratio (SNR) and image uniformity tests according to IEC 62464-1" and "spectroscopic tests on SNR and spectral resolution") are typically conducted on phantoms or test objects rather than human subjects for pre-market clearance of an MR coil accessory. Therefore, "data provenance" (country of origin, retrospective/prospective) is not applicable in the usual sense of clinical trial data.

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

Not applicable. The evaluation was based on laboratory engineering tests (e.g., SNR, image uniformity, spectral resolution) rather than clinical interpretation requiring expert ground truth.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical test set requiring adjudication.

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

No. The document describes laboratory performance testing of an MR coil accessory, not a comparative effectiveness study involving human readers and AI assistance for diagnostic interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

Yes, in a sense. The testing described focuses on the intrinsic performance characteristics of the coil itself (e.g., its SNR, uniformity). This can be considered "standalone" as it evaluates the device's physical capabilities independently of human interaction for interpretation. However, it's not "algorithm only" as there's no diagnostic algorithm being evaluated.

7. Type of Ground Truth Used

The "ground truth" for the laboratory tests mentioned would be the physical properties and measurements obtained from test phantoms or standard measurement protocols (e.g., IEC 62464-1). It's not expert consensus, pathology, or outcomes data.

8. Sample Size for the Training Set

Not applicable. This device is an MR coil, not an AI or machine learning algorithm that requires a training set of data.

9. How Ground Truth for the Training Set Was Established

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

Ask a specific question about this device