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The MAGNETOM ESSENZA with syngo MR D14 is indicated for use as magnetic resonance diagnostic devices (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremities. Depending on the region of interest, contrast agents may be used. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

The MAGNETOM ESSENZA may also be used for imaging during interventional procedures when performed with MR compatible devices such as, in room display and MR-safe biopsy needles.

The MAGNETOM ESSENZA is being upgraded with software syngo MR D14. The MAGNETOM ESSENZA is a 1.5T, whole body scanner designed for economical optimized reasons. Siemens intends to modify the cover, gradient coil, Physiological Measurement Unit (PMU), Measurement and Reconstruction System (MaRS), update the software and add two new coils for the existing MAGNETOM ESSENZA Magnetic Resonance System.

The provided document is a 510(k) summary for the Siemens MAGNETOM ESSENZA 1.5T System with syngo MR D14 software. This document primarily focuses on demonstrating substantial equivalence to a predicate device and adherence to regulatory standards for a Magnetic Resonance Diagnostic Device (MRDD).

Crucially, this document does NOT contain information about acceptance criteria or a study that proves the device meets specific performance criteria related to the diagnostic accuracy (e.g., sensitivity, specificity) of an AI-powered diagnostic algorithm.

The 510(k) submission for the MAGNETOM ESSENZA with syngo MR D14 is for an imaging hardware system (a 1.5T MRI scanner) with updated software, coils, and mechanical components. It is not for an AI/algorithm-driven diagnostic aid. Therefore, the types of studies and acceptance criteria typically associated with AI-powered diagnostic devices (e.g., MRMC studies, sensitivity/specificity targets, expert adjudication for ground truth) are not applicable to this specific submission and are consequently not present in the provided text.

The document indicates that the device's substantial equivalence is based on:

• Its intended use being the same as the predicate (K071925).
• The fact that it is an upgrade to an existing, cleared MRI system.
• Conformity to applicable FDA-recognized and international IEC, ISO, and NEMA standards for performance and safety.
• Risk management in compliance with ISO 14971:2007.

Therefore, I cannot populate the requested table or answer the specific questions related to AI acceptance criteria and performance studies based on the provided text.

To reiterate, the provided document describes a magnetic resonance diagnostic device (MRI scanner), not an AI-driven diagnostic algorithm. The "performance" discussed in this context relates to the safety and functionality of the imaging system itself, not the diagnostic accuracy of an AI interpreting images.

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The Sentinelle Breast MRI tabletop with 16 Channel Coil Array for Siemens 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 are interpreted by a trained physician. When used with a disposable sterile plate (biopsy grid), the device permits access to breast anatomy for biopsy and localization procedures.

The Sentinelle Breast MRI Tabletop with 16 Channel Coil Array for Siemens 1.5/3T MRI Systems is a receive-only MRI imaging coil and interventional system for breast anatomy. The system consists of a tabletop which supports the patient and imaging coils which provide a means of enabling interventional device guidance. The tabletop, like other breast coils provides an aperture to admit the breasts and provides the physician access to the breast(s). This aperture enables the guidance of interventional devices (such as biopsy needles), when performing a biopsy. 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 (also referred to as immobilization plates) provided with the system are held in frames, which may be positioned in the left-right and anteriorposterior 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 (also referred to as biopsy grid) cleared under FDA 510(k) Number: K060873. The biopsy grid contains 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 Sentinelle phased array breast coil set consists of 2, 10 or 16 RF coil elements in a phased array design. 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.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: Sentinelle Breast MRI Tabletop with 16 Channel Coil Array for Siemens 1.5/3T MRI Systems

1. Table of Acceptance Criteria and Reported Device Performance

The provided document defines acceptance criteria primarily through a comparison to a predicate device and extensive verification and validation testing, ensuring safety and performance are substantially equivalent. The acceptance criteria are implicit in the comparison to the predicate and the successful completion of a comprehensive set of tests. The reported device performance is indicated by the successful completion of these tests and a finding of substantial equivalence.

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

The document does not explicitly state a numeric "sample size" in terms of patient cases for clinical studies for the "test set" in the traditional sense of AI/clinical trial studies. Instead, the testing involved:

• Phantoms: Used for various technical and performance evaluations (e.g., SNR, gMap, detuning, field distortions, noise).
• Volunteers: Used for "Volunteer Imaging" tests (VAR-02350 for 1.5T, VAR-02363 for 3T).

Data Provenance:

• The tests were conducted in-house by trained testing personnel.
• The use of contrast agent was not used in obtaining the images.
• The tests were performed on the proposed device.
• The nature of the testing (phantom and volunteer imaging for technical parameters) suggests this is prospective data collection specifically for device verification.
• Country of origin is not explicitly stated for individual tests but the manufacturer is based in Canada.

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

The document does not mention the use of experts to establish "ground truth" for the test set in the context of diagnostic accuracy, as this is a device for image acquisition, not for diagnostic interpretation. The "ground truth" here is implied by objective physical measurements (e.g., signal-to-noise ratios, field distortions) and the observed performance of the device against engineering specifications and NEMA standards.

The phrase "These images are interpreted by a trained physician" in the Indications for Use refers to the subsequent clinical use of the images, not the validation of the device itself.

4. Adjudication Method for the Test Set

Given that the testing focuses on technical performance parameters of an MRI coil rather than diagnostic interpretation, an adjudication method for a diagnostic test set is not applicable and therefore not mentioned. The tests are objective measurements (e.g., SNR values, signal measurements, scout image quality).

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study focuses on the diagnostic performance of human readers and is not relevant for the type of device (an MRI coil) described in this submission, which is about image acquisition and quality, not interpretation assistance.

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

The entire set of tests performed (Tables 4 and 5) can be considered a standalone study of the device's technical performance. These tests evaluate the coil directly, independent of a human interpreter's diagnostic ability. For example, "SNR Evaluation," "gMap," "Heating and Performance Output," "Passive Detuning Test," "Field Distortions Test," "RF Noise Test," etc., are all standalone performance metrics of the hardware.

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

The "ground truth" for this device's validation is based on:

• Engineering Specifications/Standards: Performance measured against NEMA standards and internal functional requirements.
• Physical Measurements: Quantifiable data from phantoms (e.g., SNR ratios, field distortion measurements).
• Visual Assessment: For aspects like "Body Scout" images and "Volunteer Imaging," the "ground truth" is the expected image quality and appearance generated by a properly functioning MRI coil.

No pathology or outcomes data is used as the device is for imaging and intervention guidance, not for diagnosis itself.

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of an AI algorithm because the device is a hardware component (an MRI coil) and not an AI-powered diagnostic algorithm.

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

As there is no AI algorithm or training set discussed in the document, this question is not applicable.

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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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