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The device is indicated to aid in supporting adult and adolescent patients undergoing radiation therapy of the breast and chest region including electron, photon, and proton treatments. Device is also used to position the patient during image acquisition to support treatment planning including in Computed Tomography (CT) and Magnetic Resonance (MR) imaging systems. The device is not intended for use with patients under 12 years of age.

The Breastboard and Overhead Arm Positioner are used to position the patient during external beam radiation therapy. The Breastboard is comprised of a Base, Back Support, and Bottom Stop. The Base serves as the foundation of the assembly and provides a mounting surface for the Back Support, Angle Supports, and the Bottom Stop. The inferior end of the Back Support is mounted to the Base while the superior end of the Back Support is raised/lowered as needed for patient setup using Low Angle Supports. The Bottom Stop is located near the inferior end of the Base and prevents the patient from sliding down the Board. The Low Angle Support is used to position the Back Support at 5°, 7.5°, 10°, 12.5°, and 15° angles. Features on the High Angle Support receive the cutouts on the Low Angle Support and hold the angular position of the Support. The High Angle Support is used to position the Back Support at 17.5°, 20°, 22.5°, and 25° angles. Features on the Base receive the cutouts on the High Angle Support and hold the angular position of the Support. A Lock provides a method of locking the Back Support to the Base at 0° to facilitate easier handling and storage of the Breastboard. The Overhead Arm Positioner provides support for the patient's arms above the head and is attached to the Back Support via a locking assembly. The Overhead Arm Positioner adjusts longitudinally on the Back Support to accommodate a variety of patient sizes. A Hand Grip is mounted on the Overhead Arm Positioner and the location of the Hand Grip is adjustable longitudinally. A Head Support rests on a recessed area of the Overhead Arm Positioner and provides a cushion for positioning of the head of the patient. The Head Support can also be mounted directly on the Breastboard. A Thermoplastic Frame may also be mounted to the Overhead Arm Positioner to enable attachment of a thermoplastic mask for additional patient support. The Breastboard and Overhead Arm Positioner can also be used for supporting and elevating patients undergoing treatment who cannot lay down flat on the table due to their habitus. The Breastboard and Overhead Arm Positioner are reusable devices that are provided nonsterile.

This document is a 510(k) premarket notification for a medical device called the C-Qual M Breastboard and Monarch Overhead Arm Positioner. The notification seeks to add MR (Magnetic Resonance) compatibility to the device's indications for use.

Based on the provided text, there is no study conducted to demonstrate the performance of a device that relies on algorithms or AI assistance, nor is there a study involving human readers or experts to establish ground truth for such a device. The device in question is a physical positioning and immobilization device used in radiation therapy and imaging.

Therefore, many of the typical acceptance criteria and study components requested in your prompt (such as algorithm performance, human-in-the-loop studies, multi-reader multi-case studies, and ground truth establishment for diagnostic/interpretive tasks) are not applicable to this specific device submission.

The "acceptance criteria" for this device relate to its physical safety and compatibility in an MR environment, not to the performance of a diagnostic algorithm.

Here's how to address your points based on the provided document:

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

The acceptance criteria and performance for this physical device are focused on MR safety and biocompatibility, as no AI/algorithmic performance is being evaluated.

Explanation: The device "passed" criteria for magnetically induced torque and displacement force, indicating it is safe for use in 1.5 T and 3.0 T MR fields under these aspects. Image artifact was observed, but this is reported as a known characteristic, and users are informed. Biocompatibility testing confirmed the materials are safe for patient contact under the specified use conditions.

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

As this is a physical device undergoing safety and compatibility testing (rather than an AI/algorithmic performance study), the concept of a "test set" in the context of data points (like images or patient cases) and "data provenance" (country of origin, retrospective/prospective) is not directly applicable.

Instead, the "test set" would refer to the physical device units that underwent testing. The document does not specify the exact number of units tested for MR safety or biocompatibility. However, it states the "device was tested," implying a sufficient number of samples were used to ensure representativeness for regulatory purposes. The testing was conducted in accordance with ASTM and ISO standards, which define the methodologies and often the minimum number of samples.

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

Not applicable. The ground truth for this device's safety and compatibility is established through standardized physical testing protocols (ASTM F2052-15, F2213-06, F2119-07 for MR safety; ISO 10993 standards for biocompatibility), not through expert consensus or interpretation of medical images. Engineering and materials science experts would conduct and interpret these tests, but their role is not that of clinical "ground truth" adjudicators in the typical sense of a diagnostic AI study.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for diagnostic accuracy, where disagreements among human readers or ground truth establishment require a pre-defined resolution process. Since this submission concerns physical device safety and compatibility, such methods are not relevant.

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

Not applicable. This device is a passive physical support and positioning system; it does not involve AI, human readers, or diagnostic interpretation. Therefore, an MRMC study is irrelevant.

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

Not applicable. This is not an algorithmic device.

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

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

• Scientific and Engineering Standards: Compliance with recognized international standards (ASTM and ISO) for MR safety and biocompatibility.
• Physical Measurements and Observations: Direct measurement of torque, displacement, and visual assessment of image artifact under controlled MR conditions. Laboratory testing for biocompatibility.

8. The sample size for the training set

Not applicable. There is no AI or machine learning component, so no training set is involved.

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

Not applicable. No training set exists for this device.

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General Positioning Devices: The device is indicated to aid in supporting and positioning adult and pediatric patients undergoing radiation therapy including electron, photon treatments. The device is also used during image acquisition to support treatment planning. Devices include Couchtops, Cushions, Cushions, and Accessories. The following are other positioning devices:

Head. Neck. and Shoulders Device is indicated to aid in supporting, positioning, and/or immobilization of adult and pediatric patients undergoing radiation therapy of the head, brain, neck, and spine including radiosurgery and electron, photon, and proton treatments. The device is also used during image acquisition to support treatment planning. Devices include Overlays, Extensions, Thermoplastic Masks, and Cushions.

Support Garments: The device is indicated to aid in supporting adolescents undergoing radiation therapy including electron, photon treatments. The device is also used during image acquisition to support treatment planning. The device is not intended for use with patients under 12 years of age.

Breast Positioning Devices: The device is indicated to aid in supporting adult and adolescent patients undergoing radiation therapy of the breast and chest region including electron, photon treatments. The device is also used during image acquisition to support treatment planning. The device is not intended for use with patients under 12 years of age.

The CIVCO Positioning and Immobilization devices have been used for many years and were previously cleared under other 510(k) is to have these identical Class II products cleared for use in Proton Therapy environment.

The Head, Neck, and Shoulder Devices are used to treat cancer of the head, neck, brain and spine. Organs that are located in these anatomical regions are applicable.

The General Positioning Devices are used to treat cancer of the spine, thorax, breast, abdomen, pelvis and prostate. Organs that are located in these anatomical regions are applicable.

The Support Garments are used to treat cancer of the breast, thorax and abdominal area. Organs that are located in these anatomical regions are applicable.

The Breast Positioning Devices are used to treat cancer of the breast, thorax and abdominal area. Organs that are located in these anatomical regions are applicable.

The devices are intended for therapeutic treatment (including proton, photon, and electron beam therapy) and diagnostics (including CT and MR as indicated). The devices will be used in a variety of types of external beam radiation therapy including Intensity Modulated Proton Therapy (IMPT), Intensity Modulated Radiation Therapy (IMRT), Pencil Beam Proton Therapy (PBPT), Image Guided Radiation Therapy (IGRT), Volumetric Modulated Arc Therapy (VMAT), Stereotactic Radiosurgery (SRS), Stereotactic Radiotherapy (SRT), Stereotactic Body Radiation Therapy (SBRT), and Craniospinal Treatment.

The intended users of the devices are radiation oncology therapists, medical physicists, and oncologists. The provider selects the appropriate equipment based on a patient's individual clinical goals and unique constraints.

Thermoplastic mask, AccuForm Cushion, and Support Garment devices are single patient use. All devices are non-powered and static.

The subject devices are reusable or disposable as provided in product labeling, provided non-sterile, and are used in a healthcare facility/hospital. The devices are labeled for MR safety, as applicable.

This document is a 510(k) Pre-market Notification for medical devices, specifically Proton Positioning and Immobilization Devices. It is a submission to the FDA to demonstrate substantial equivalence to legally marketed predicate devices, primarily for the modified intended use/indications for use to include proton treatment and pediatric/adolescent use.

The document does not describe a study involving an algorithm or artificial intelligence (AI) with acceptance criteria in the traditional sense of a computer-aided diagnosis (CAD) or AI-driven diagnostic device. Instead, it describes non-clinical performance testing for physical medical devices. Therefore, many of the requested details about acceptance criteria, ground truth establishment, expert consensus, and multi-reader multi-case (MRMC) studies are not applicable to this type of device submission.

Here's an interpretation of the relevant information provided, framed as closely as possible to your request for acceptance criteria and study proof for a medical device:

Device Type: Physical Medical Devices (Positioning and Immobilization for Radiation Therapy)
Purpose of Submission: To expand the Indications for Use of existing, previously cleared devices to include proton treatment and pediatric/adolescent use.

1. Table of "Acceptance Criteria" (Performance Goals) and Reported Device Performance

Given that this is a 510(k) for physical positioning devices, the "acceptance criteria" are not quantitative performance metrics like sensitivity/specificity for an AI algorithm. Instead, they are functional performance goals related to the physical interaction with the proton beam and patient. The "reported device performance" is the confirmation that these functional goals are met.

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