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The Access Breast Coil 4/SMS is a 4-channel, phased array, receive-only RF coil used in conjunction with a magnetic resonance imager (MRI) to produce diagnostic and interventional images of the breast, chest wall and axillary tissues that can be interpreted by a trained physician. The device is designed to aid the physician in acquiring diagnostic breast MRI studies and interventional breast MRI studies for localization of lesions, biopsies and other interventional procedures.

Access Breast Coil 4/SMS is a 4-channel, phased array breast coil optimized for parallel imaging of the chest wall, breast, and axillary tissue. This device is a dual purpose coil, offering both diagnostic imaging and flexibility in interventional access. The coil's open design allows for flexibility in performing interventional procedures with lateral, medial and cranial-caudal access.

The design of the Access Breast Coil 4/SMS focuses on patient ergonomics, allowing for enhanced comfort during both diagnostic and interventional exams. Positioning accessories, including a headrest, armrest and torso pad, help to relieve pressure on the sternum and provide customized patient positioning during the acquisition of diagnostic and interventional breast MR1 studies.

The coil consists of a supporting base and two insulating coil chambers, one for each breast. Each of the hollow coil chambers houses two coil elements that are insulated from the patient by a rigid plastic housing. The coil housing is made of plastic materials, which are fire rated and have high impact and tensile strength.

The bilateral, open breast coil design offers optimized imaging capabilities and maximum access to aid the physician in localization of lesions during interventional procedures, providing lateral, medial and cranial-caudal access to the breast.

Acceptance Criteria and Study for Access Breast Coil 4/SMS

This document describes the acceptance criteria and the study that demonstrates the Access Breast Coil 4/SMS meets these criteria, based on the provided 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary for the Access Breast Coil 4/SMS does not explicitly state quantitative acceptance criteria or a dedicated performance study with specific metrics. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device. Therefore, the "acceptance criteria" are inferred from the comparison points used to establish substantial equivalence, and the "reported device performance" is a qualitative statement of its comparability.

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

The 510(k) summary does not describe a specific clinical test set with a particular sample size for demonstrating performance. The submission relies on a comparison to a legally marketed predicate device (MRI Devices Corporation's Model OBC-63 Breast Array Coil, K022488) to establish substantial equivalence.

Therefore, there is no mention of data provenance (e.g., country of origin, retrospective/prospective) for a performance test set.

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

Since no specific clinical test set is described, there is no information provided regarding the number or qualifications of experts used to establish a ground truth.

4. Adjudication Method for the Test Set

As there is no described clinical test set, there is no adjudication method mentioned.

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

The provided 510(k) summary does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. Its focus is on demonstrating substantial equivalence of the device's technical specifications and intended use to a predicate device, rather than measuring human reader improvement with or without AI assistance. The device is an RF coil, not an AI diagnostic tool.

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

This is not applicable as the Access Breast Coil 4/SMS is an RF coil, a hardware component for an MRI system, not a standalone algorithm. Its performance is inherent in the image quality it delivers, which is then interpreted by a human physician.

7. Type of Ground Truth Used

Given that the submission relies on substantial equivalence to a predicate device and there is no described clinical performance study, there is no mention of a specific type of ground truth used (e.g., expert consensus, pathology, outcomes data). The "ground truth" implicitly assumed is the established performance and safety of the legally marketed predicate device.

8. Sample Size for the Training Set

The provided 510(k) summary does not describe a training set as this is a hardware device (an RF coil) and not a machine learning or AI-driven diagnostic system that requires training data.

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

As there is no training set described, this point is not applicable.

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The Access Breast Coil is a 7-channel, phased array, receive-only RF coil, used in conjunction with a magnetic resonance scanner to produce diagnostic and interventional images of the breast, chest wall, and axillary tissues that can be interpreted by a trained physician. The device is designed to aid the physician in MR-guided breast biopsy, localization of lesions, and interventional procedures, providing lateral, medial and cranial-caudal access to the breast.

Access is a 7-channel, phased array breast coil optimized for parallel imaging of the chest wall, breast and axillary tissue. Access is a dual purpose coil, offering both diagnostic imaging and flexibility in interventional access. The coil's open design allows for flexibility in performing interventional procedures with lateral, medial and cranial-caudal access.

The design of the Access breast coil focuses on patient ergonomics, allowing for enhanced comfort during both diagnostic and interventional exams. Positioning accessories, including a headrest, armrest and torso pad, help to relieve pressure on the sternum and provide customized patient positioning during the acquisition of breast MRI studies and interventional procedures.

The coil consists of a supporting base and two insulating coil chambers, one for each breast. Each of the hollow coil chambers houses two coil elements that are insulated from the patient by a rigid plastic housing. The coil housing is made of plastic materials, which are fire rated and have high impact and tensile strength.

The bilateral, open breast coil design offers optimized imaging capabilities and maximum access to aid the physician in MR-guided breast biopsy, localization of lesions, and interventional procedures, providing lateral, medial and cranial-caudal access to the breast.

Features of the Access Breast Coil:

Imaging

• 7-channel phased array design uses multiple elements that surround . the breast tissue
• t Optimized for parallel imaging applications
• Supports both unilateral and bilateral imaging exams .
• Compatible with Siemens 1.5T MRI systems .
• 40 cm field of view .
• Extensive coverage of chest wall and axilla ●
• High SNR t

Ergonomics

• Large apertures to accommodate a major percentage of patient . population
• Ergonomically designed for patient comfort to minimize motion . artifact

Interventional Access

• Coil design allows lateral, medial and cranial-caudal interventional . access
• Lighting is integrated into the coil for interventional procedures . that demand a well lit area
• Compatible with SureLoc software to support interventional MRI .

This document describes a 510(k) submission for the "Access Breast Coil" and primarily focuses on establishing substantial equivalence to existing legally marketed devices, rather than a detailed study proving the device meets specific acceptance criteria in the way a new AI/software device would. Therefore, many of the requested data points are not directly available or applicable in the provided text.

Based on the nature of this submission (a medical device coil for MRI), the "acceptance criteria" discussed are largely related to safety, performance comparable to predicate devices, and meeting regulatory standards for a Class II magnetic resonance diagnostic device. The "study" mentioned is more accurately described as a validation process during development and comparison to predicate devices.

Here's an analysis based on the provided text, addressing the points where information is available or inferable:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a "test set" in the context of human subject data or image datasets with a defined sample size for performance evaluation. The submission relies on engineering validation, verification, and comparison to predicate devices. There is no mention of a clinical study with a specific sample size of patients or images used to prove the device's diagnostic or interventional performance in a statistical sense beyond what is assumed by comparison to predicate devices. Therefore, sample size for a test set and data provenance (country, retrospective/prospective) are not provided.

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

This information is not provided as the submission does not detail a formal study involving expert review of a test set. The interpretation of images from the device is stated to be by a "trained physician," but this is a general statement about usage, not a specific ground truth establishment for a study.

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

This information is not provided, as there is no described test set or expert ground truth establishment and review process that would involve 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

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is more common for evaluating AI/software performance with human readers. This submission is for an MRI coil, a hardware device, and thus does not involve AI or human reader improvement with AI assistance.

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

No. This is a hardware device (an MRI coil), not an algorithm or software. Therefore, a standalone performance evaluation of an algorithm without human-in-the-loop is not applicable.

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

The document does not describe a specific type of ground truth used for a formal performance study in the way one would for evaluating a diagnostic algorithm. The implicit "ground truth" for demonstrating equivalence is that the images produced by the Access Breast Coil are considered "comparable to the predicate devices" when interpreted by a trained physician, which suggests a general equivalence of image quality and diagnostic utility, rather than a specific clinical validation against pathology or outcomes.

8. The sample size for the training set

This information is not applicable/not provided. This is a hardware device, not a machine learning model, so there is no training set in that context.

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

This information is not applicable/not provided. As a hardware device, there is no training set that requires ground truth establishment.

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