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The Sentinelle Endo Coil Array is a receive-only MRI coil array which must be used by a qualified medical professional to obtain images of (including spectroscopy images) the prostate, cervix and colon and the surrounding tissues in the pelvis. The Coil Array is a reusable transrectal or transvaginal device that can be high level disinfected. This product is for exclusive use on adult populations with clinically present anus and rectum or vagina. For use with GE, Toshiba and Siemens 1.5T MR systems.

The Endo Coil Array is a reusable, rigid transrectal or transvaginal receive-only MRI coil array similar to other products. The Coil Array housing has a cylindrical shape similar to transrectal and transvaginal ultrasound probes.

The Coil Array is held by an articulating Stabilization Arm that is attached to a Patient Support. The Patient Support is available in both Transporter and Tabletop versions, which dock to the scanner or are placed on top of the scanner's existing couch respectively.

The provided document is a 510(k) summary for the Sentinelle Endo Coil Array for Pelvic Imaging. It describes the device, its intended use, and provides a comparison to predicate devices, but does not include detailed performance study data such as acceptance criteria, specific reported device performance metrics, sample sizes, expert qualifications, or details about standalone/MRMC studies.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can be extracted and what cannot:

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

• Cannot be provided. The document states "Non-clinical performance testing was done to ensure the device performed equivalently to predicates in the areas of SNR comparison, spectroscopy, and image uniformity per NEMA 9:2008 with no additional concerns of safety or effectiveness." However, it does not specify explicit acceptance criteria (e.g., minimum SNR ratio, uniformity percentage) or the quantitative reported performance values of the device against these criteria.

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

• Cannot be provided. The document mentions "Non-clinical performance testing," which typically refers to bench testing rather than clinical study data. It does not provide any information about a "test set" in terms of subject or image samples, nor their provenance.

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)

• Cannot be provided. No information regarding experts or ground truth establishment for a test set is mentioned.

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

• Cannot be provided. No information regarding adjudication methods for a test set is mentioned.

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

• No, an MRMC study was not done. This device is an MRI coil array, not an AI-powered diagnostic tool, so an MRMC study related to AI assistance would not be applicable. The performance testing described is for the coil's physical imaging characteristics.

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

• Not applicable in the context of an "algorithm." As this is an MRI coil, "standalone performance" refers to the coil's physical imaging capabilities in isolation from a human interpreter, which is what the non-clinical performance testing (SNR, spectroscopy, image uniformity) would assess. However, specific results are not provided.

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

• Cannot be provided. No information regarding ground truth used for any testing is mentioned.

8. The sample size for the training set

• Cannot be provided. No information about a "training set" is mentioned as this is not an AI/algorithmic device in the traditional sense that requires training data.

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

• Cannot be provided. No information about a "training set" or its ground truth establishment is mentioned.

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The Sentinelle Vanguard Breast MRI Auxiliary Table/Tabletop with 8/16 Channel Coil Array for GE 1.5T/3T MRI Systems is designed to provide magnetic resonance images of breast anatomy when used in conjunction with a Magnetic Resonance Scanner. These images can be interpreted by a trained physician. When used with a sterile fenestrated plate, this device permits access to the breast anatomy for biopsy and localization procedures that can be performed by a trained physician.

The Vanguard Breast MRI Auxiliary Table/Tabletop with 8/16 Channel Coil Array for GE 1.5T/3T MRI Systems is a receive-only MRI imaging coil and interventional system for the breast anatomy. The system consists of a table base and/or a tabletop supports the patient, the imaging coils and means for modest compression/immobilization of the breast, as well as a means of enabling interventional device guidance. The table base (optional) is used to support and transport the tabletop. The tabletop, like other breast coils provides an aperture to admit the breasts. A corresponding aperture in the table base maximizes physician access to the breast(s) when the tabletop is at the home position. This table aperture is useful for guidance of interventional devices (such as biopsy needles), especially when it is desired to perform a biopsy from a medial approach. The tabletop's compression system facilitates immobilization of the breast for imaging and interventional procedures and serves to hold the individual imaging coils in proximity to the breast(s). Compression plates provided with the system are held in compression frames which may be positioned in the left-right and anterior-posterior directions and fixed in place to gently immobilize one or both breasts for interventional procedures. When performing a stereotactic interventional procedure (such as biopsy or wire localization), one or more compression plates may be interchanged for a sterile, single use, disposable fenestrated plate cleared under FDA 510(k) number: K060873. The fenestrated plate has apertures that permit the physician to access the breast for intervention, while minimizing tissue motion. When performing biopsy and/or imaging of a single breast, the system may be used with two compression plates immobilizing that breast. The contralateral breast support prevents the contralateral breast from interfering with medial-approach interventions. When imaging both breasts, a medial coil element is used between the breasts in conjunction with two lateral coils. The tabletop's receive-only coil system acts to passively collect RF emissions from the nuclei excited by the MRI. The function of the tabletop is substantially equivalent to predicate devices used for breast MRI maging and intervention, including our legally marketed device 510(K) Number: K060873. The Vanguard phased array coil set consists of 8 or 16 RF coil elements in a phased array design. The 16 channel coil array may be interchanged with a 10 or 2-channel coil array. The coil elements and electronics are enclosed in a rigid housing that is resistant to fluid ingress and is fire retardant. The coils are positioned close to the patient's breast during imaging. This receive-only coil is designed to give an improved signal-to-noise ratio, image resolution and image acquisition over that of a standard body coil.

This document describes the Sentinelle Vanguard Breast MRI Auxiliary Table/Tabletop with 8/16 Channel Coil Array for GE 1.5T/3T MR Systems, designed to provide magnetic resonance images of breast anatomy and facilitate biopsy and localization procedures.

Important Note: The provided document is a 510(k) Premarket Notification summary, which focuses on device description, intended use, and substantial equivalence to a predicate device. It does not contain a detailed study report with specific acceptance criteria, device performance results, or extensive statistical analysis typically found in full clinical or performance studies. The information below is extracted based on what is available in the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission and not a detailed performance study, explicit, quantitative acceptance criteria and corresponding reported device performance values like sensitivity, specificity, accuracy, or reader agreement are not present in the provided text for the new device.

The submission focuses on the device's functional equivalence and improvements over an existing predicate device. The "performance" described is in terms of the intended benefits for image quality and acquisition time, which are qualitative improvements rather than specific, measurable performance metrics against a defined ground truth.

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

The provided 510(k) summary does not contain information about a dedicated "test set" with a specific sample size, data provenance (country of origin, retrospective/prospective), or a formal study design for evaluating the new device's performance against ground truth.

510(k) submissions primarily demonstrate substantial equivalence to a legally marketed predicate device rather than presenting new clinical study data with test sets, especially for accessories like MRI coils. The improvements mentioned (SNR, acquisition time) are inherent to the coil design (e.g., more channels, phased array design) and are generally accepted principles in MRI technology, often supported by engineering tests and phantom studies, rather than large-scale patient test sets.

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

Since a formal "test set" or clinical study with ground truth establishment is not detailed in this 510(k) summary, this information is not provided.

4. Adjudication Method for the Test Set

As no specific test set or clinical study requiring adjudication is detailed in this 510(k) summary, this information is not provided.

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

An MRMC comparative effectiveness study was not mentioned or described in the provided 510(k) summary. This device is an MRI coil system, not an AI or CAD (Computer-Aided Detection) software, so an MRMC study comparing human readers with and without AI assistance would not be relevant to this product.

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

This question is not applicable as the device is a hardware component (MRI coil system), not a standalone algorithm or software.

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

Since a formal clinical study with ground truth is not detailed, the type of ground truth used is not specified in the provided 510(k) summary. The "ground truth" for demonstrating substantial equivalence primarily involves showing the new device functions similarly and safely to the predicate device, with described improvements being technical characteristics rather than diagnostic performance metrics against a clinical gold standard.

8. The Sample Size for the Training Set

The provided 510(k) summary does not describe a "training set" in the context of an algorithm or AI development. This device is a hardware component; therefore, the concept of a training set as used in AI is not applicable.

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

As there is no described training set, the method for establishing its ground truth is not applicable and therefore not provided in the document.

Summary of Study Context (Based on 510(k) Submission):

The document is a 510(k) Premarket Notification, which primarily aims to demonstrate substantial equivalence to a previously cleared predicate device (K060873), rather than presenting a de novo clinical study with detailed performance metrics. The improvements highlighted (increased SNR, decreased acquisition time) are technical advancements in the coil design (more channels, phased array) that are inherent to the physics of MRI and are generally accepted to enhance image quality and efficiency. The FDA's clearance indicates that the device met the regulatory requirements for safety and effectiveness through demonstration of substantial equivalence.

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This device provides two and three-dimensional image review, manipulation, and analysis tools to assist users in screening, diagnosis, planning and performing image-guided interventional procedures. Supported imaging modalities include Magnetic Resonance (MR), Ultrasound (US), Single Photon Emission Computed Tomography (SPECT), Computed Tomography (CT), Positron Emission Tomography (PET), Fluoroscopy and Endoscopy. Images and data are received from various imaging systems and other sources such as calibrated spatial positioning devices.

This device provides the capability to overlay annotations on 2D or 3D medical image displays. These annotations may represent the position of instruments including but not limited to biopsy needles, guidance wires, imaging probes or other tracked devices.

This device is intended to assist skilled medical professionals in clinical screening and interventions, for anatomical structures where imaging is currently used for visualizing such structures, including head and neck, breast, thoracic, and abdominal applications (including pelvis).

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using a FDA approved monitor that offers at least 5 MPixel resolution and meets other technical specifications reviewed and accepted by the FDA.

Aegis Navigation and Aegis Pelvic Application products are line-extensions to Sentinelle's medical image software product Aegis. These are also referred to below as (Aegis) plug-ins.

The products are designed to assist with multi-modality (including MRI, US, SPECT, CT, PET, Fluoroscopy, Endoscopy and others) imaging and guidance of screening and interventional procedures for anatomical structures such as head and neck, thoracic, breast, abdominal and pelvis(including prostate).

Aegis Pelvic Application is a software tool intended for analyzing multi-modality images. This plug-in also identifies where and how deeply, a biopsy or localization needle should be inserted into a region of interest (including prostate and surrounding structures) to strike a target or region of interest. Registration of target anatomy with an interventional device can be performed manually or automatically based on fiducial markers. This in turn provides a calculation of the location and depth of the targeted region of interest.

Similarly, Aegis Navigation is a software tool intended for analyzing multi-modality images. This plug-in also identifies where an imaging device (e.g. an ultrasound transducer), interventional tool (e.g. a biopsy or localization needle) or other tracked instrument should be placed in order to visualize or strike a target or region of interest. In addition, Aegis Navigation provides the user with the option to view previously acquired DICOM data (e.g. MRI data) alongside of a separate imaging modality such as Ultrasound (US) or a fluoroscopic device. In the context of US, a 3-D tracking system provides positional data regarding the transducer, which is used to guide the real-time reformatting of DICOM data to match the current US image. Interventional and imaging device operation and manipulation remains under the manual control of the trained medical professional at all times.

Additional applications of Aegis Navigation include:

• The ability to display the position of a tracked probe or instrument, overlaid on DICOM . (e.g.MR or CT) data
• The ability to track the position of an US transducer as it collects data, then retrospectively display reformatted DICOM (e.g. MR/CT) data slices oriented to match the previously acquired ultrasound images.

Here's a breakdown of the acceptance criteria and the study information for the Sentinelle Aegis Navigation and Pelvic Application, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a table format. Instead, it refers to fulfilling functional requirements and meeting or exceeding specified accuracy criteria. The performance is gauged by comparison to the predicate device.

2. Sample Size and Data Provenance

• Test Set Sample Size: Not explicitly stated. The document mentions "targeting locations within a phantom" and "volunteers," but does not quantify the number of phantoms, volunteers, or the specific cases used in the accuracy and verification tests.
• Data Provenance: The tests were conducted "in-house by trained personnel in a simulated work-environment using phantoms or volunteers." This implies prospective data collection specifically for these tests. The country of origin of the data is Canada (where Sentinelle Medical Inc. is located).

3. Number of Experts and Their Qualifications for Ground Truth

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The document states "trained personnel" conducted the testing but does not elaborate on their clinical or expert qualifications for establishing ground truth for the device's accuracy.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. Ground truth establishment appears to be based on the direct observation and measurement of the device's output against the known properties of the phantoms or volunteer setups, rather than an expert consensus process requiring adjudication.

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

• Was an MRMC study done? No. The document does not mention any MRMC study comparing human readers with and without AI assistance. The testing focuses on the device's standalone accuracy and functionality.
• Effect Size of Human Reader Improvement: Not applicable, as no MRMC study was performed.

6. Standalone (Algorithm Only) Performance Study

• Was a standalone study done? Yes. The entire testing described in the document (registration accuracy, needle verification, and functional tests) describes the performance of the Aegis Navigation and Aegis Pelvic Application software itself, independent of a human operator, to verify its accuracy and functionality.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the accuracy tests was established using phantoms or volunteers with known anatomical structures and target locations. This provides a measurable, objective ground truth against which the device's calculations and guidance were compared. Specifically, "targeting locations within a phantom and confirming that the selected target location/needle location based on the registration calculation is within the same tolerance range or better than the Aegis predicate device."

8. Sample Size for the Training Set

• Training Set Sample Size: Not applicable. The document describes a software plug-in whose functionality is inherited from an approved device (Sentinelle Aegis) and combines features of several predicate devices. There is no mention of a machine learning or AI model being trained, thus no explicit training set. The performance evaluation is based on verifying its compliance with specifications and equivalence to predicate devices, not on a new learning algorithm.

9. How Ground Truth for the Training Set Was Established

• Ground Truth for Training Set: Not applicable, as there is no mention of a training set for a machine learning model.

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Aegis is a software application that is intended for use in analyzing magnetic resonance imaging (MRI) medical images as well as other multi-modality images. Its primary goal is to identify where and how deep a biopsy or localization needle should be inserted into an imaged breast in order to strike a targeted lesion or region of interest, as chosen by a trained medical professional. Aeris receives images and data from various sources (including but not linited to CT, MR, US, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways or imaging sources). Aegis can be used to communicate, process, and display medical images. Users have access to various image processing and measurement tools to assist them in viewing images. These user-defined post-processing functions include image subtractions, multiplanar reformats, maximum intensity projections, and segmenting of regions based on enhancement characteristics.

The digitized mammographic images and/or ultrasound images displayed by Aegis on the laptop display (or on any display not approved by the FDA for such purposes) must not be used for primary diagnostic interpretation.

Typical users of Aegis are trained medical professionals, including but not limited, to radiologists, technologists and clinicians. When interpreted by a skilled user, this device provides information that may be useful in screening and diagnosis. Patient management decisions shoulding be made solely on the results of Aegis analysis.

Aegis is one of the components of a PACS (Picture Archiving and Communications System), Aegis is visualization software designed for breast imaging and intervention procedures. Aegis receives DICOM 3.0 images over a medical imaging network where its primary goal is to identify where and how deep a biopsy needle should be inserted into an imaged breast in order to strike a targeted lesion or region of interest, as chosen by a trained medical professional.

This 510(k) submission (K070244) for Aegis does not contain specific acceptance criteria or details of a study proving the device meets acceptance criteria in the provided document. The submission focuses on device description, indications for use, and comparison to a predicate device to demonstrate substantial equivalence, which is typical for 510(k) submissions.

Therefore, I cannot populate the table or provide details for the requested points based solely on the provided text.

The document states: "The potential hazards have been studied and controlled as part of the product development validation houring risk analysis, test and design considerations, and planned verification and validation testing processes. Aegis provides images and functionality comparable to the breadicate device." This indicates that some validation and verification testing was performed, but the specifics of these tests, acceptance criteria, and results are not included in this summary.

Information not available in the provided document:

• A specific table of acceptance criteria and reported device performance.
• Sample sizes used for any test sets.
• Data provenance (country of origin, retrospective/prospective).
• Number and qualifications of experts for ground truth.
• Adjudication method for test sets.
• Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
• Results of a standalone (algorithm only) performance study.
• Type of ground truth used (pathology, expert consensus, outcomes data).
• Sample size for the training set.
• How ground truth for the training set was established.

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The Sentinelle Vanguard Breast MRI Auxiliary Table with 8 Channel Coil array is designed to provide magnetic resonance images of breast anatomy when used in conjunction with a Magnetic Resonance Scanner. These images can be interpreted by a trained physician. When used with the disposable sterile plate the Sentinelle Vanguard Breast MRI Auxiliary Table with 8 Channel Coil array permits access to the breast anatomy for biopsy and localization procedures that can be performed by a trained physician.

The Vanguard Breast MRI Auxiliary Table with 8 Channel Coil Array is an MRI imaging coil and interventional system for breast. The system consists of a table base and a table top. The tabletop supports the patient, the imaging coils and means for modest compression/immobilization of the breast, as well as a means of enabling interventional device guidance. The table base is used to support and transport the tabletop. The table base is substantially equivalent to the table provided by General Electric with their GE Signa ® MRI machines.

The tabletop, like other breast coils provides an aperture to admit the breasts. A corresponding aperture in the table base maximizes physician access to the breast(s) when the tabletop is at the home position. This is useful for guidance of interventional devices (such as biopsy needles), especially when it is desired to perform a biopsy from a medial approach.

When performing a stereotactic interventional procedure (such as biopsy or wire localization), one or more compression plates may be interchanged for a sterile, single use, disposable fenestrated plates. The fenestrated plate has apertures which permit the physician to access the breast for intervention. No biopsy needles are included with or packaged with the system.

The tabletop's receive-only coil system acts to passively collect RF emissions from the nuclei excited by the MRI. The function of the tabletop is substantially equivalent to predicate devices used for breast MRI imaging and intervention.

The Vanguard phased array coil set consists of 8 RF coil elements in a phased array design. The 8 coil array may be interchanged with a four coil array. The coil elements and associated circuitry are enclosed to prevent exposure to the patient or the environment. The coil electronics are enclosed in a rigid housing that is resistant to fluids and is fire retardant. The coils are positioned close to the patient's breast during imaging. This receive-only coil is designed to give an improved signal-to-noise ratio, image resolution and image acquisition over that of a standard body coil.

This system is for use with GE Signa ® (3X-LX, Echo Speed, TwinSpeed) 1.5T Scanners. This system is compatible with GE Signa ® Excite platforms.

The presented document is a 510(k) summary for the "Vanguard Breast MRI Auxiliary Table with 8 Channel Coil Array for GE Signa™ systems." It details the device's characteristics and its comparison to predicate devices, focusing on demonstrating substantial equivalence rather than fulfilling specific acceptance criteria in the context of a typical AI/ML device study.

Therefore, many of the requested fields related to acceptance criteria, ground truth establishment, sample sizes for training/test sets, expert adjudication methods, and MRMC comparative effectiveness studies are not applicable to this type of submission for an MRI coil accessory. The submission focuses on technical performance and safety comparisons to predicate devices.

Here's a breakdown of the information that can be extracted from the provided text according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document mentions "volunteers" for additional comparison in Attachment 9 and imaging phantoms for the primary performance tests. However, it does not specify the sample size for either the phantom tests or the volunteer study.

• Data Provenance: Not explicitly stated, but given the company location (Toronto, Ontario, Canada) and the submission to the FDA, the testing was likely conducted in Canada or the USA. The data is prospective as it describes performance testing conducted for the submission.

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

This is not applicable to this submission. The device is an MRI coil accessory, and the "ground truth" for its performance is assessed through technical measurements like Signal-to-Noise Ratio (SNR) and image uniformity using phantoms, rather than expert interpretation of complex clinical cases that would require a ground truth established by experts. The indications for use state "These images can be interpreted by a trained physician," but this pertains to the use of the device in clinical practice, not to the testing of the device itself for FDA clearance.

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

This is not applicable as there were no subjective interpretations requiring adjudication. Performance was measured using objective technical metrics on phantoms.

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 is not applicable. This submission is for an MRI coil, not an AI/ML diagnostic aid. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.

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

This is not applicable. This is not an algorithm or AI device.

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

The "ground truth" in this context refers to objective physical measurements using imaging phantoms according to NEMA standards. For the volunteer study, the "ground truth" would be the direct physical properties of the volunteers being imaged, again assessed through objective imaging metrics. There is no mention of expert consensus, pathology, or outcomes data being used to establish a ground truth for the device's performance.

8. The sample size for the training set

This is not applicable. The device is hardware (an MRI coil and table), not a software algorithm that requires a training set.

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

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

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