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The AIO Solution 3.0 is a positioning and immobilization system to set-up and reproduce the supine and prone position of belly & pelvic patients and the prone position of breast patients during radiation therapy.

The AIO Solution 3.0 with accessories provides the immobilization and positioning system necessary to set-up and reproduce the position of a patient for supine and prone belly & pelvic treatments or prone breast treatments in radiation therapy.

For belly & pelvic treatments, the AIO solution 3.0 base plates (already cleared: K191158) can be used in combination with the green AIO 3.0 belly & pelvic positioning cushions and accessories. Depending on the anatomy of the patient, 2 different sizes of belly inserts are available to make sure the intestines can be pulled out of the treatment area when in prone position. The arms of the patient are positioned above the head to bring them out of the treatment field. A full belly insert should be used in supine position while the arms of the patient can be positioned on the chest to bring them out of the treatment field. The legs of the patient are supported by the grey AIO 3.0 knee & leg positioning cushions and/or the AIO 3.0 indexable feet support (already cleared; K191158). For increased precision, the set-up can be combined with an Orfit thermoplastic EFFICAST mask.

For prone breast treatments, the AIO solution 3.0 base plates (already cleared; K191158) can be used in combination with the yellow AIO 3.0 prone breast positioning cushions and accessories. The arms of the patient are positioned above the head to bring them out of the treatment field. The legs of the patient are supported by the grey AIO 3.0 knee & leg positioning cushions (already cleared; K191158). For increased precision, the set-up can be combined with an Orfit thermoplastic EFFICAST mask.

The provided text describes a medical device, "The AIO Solution 3.0," and its substantial equivalence determination by the FDA. However, the document does not contain any information regarding acceptance criteria or the study details typically associated with AI/ML-driven medical devices, such as performance metrics (e.g., sensitivity, specificity), ground truth establishment, expert adjudication, or training/test set sample sizes.

The "PERFORMANCE DATA" section of the document primarily focuses on:

• Sterilization and Shelf Life: Stating devices are non-sterile and made of durable polymers with low degradation.
• Biocompatibility: Emphasizing that materials are identical to the predicate device, thus no new testing is needed.
• Electrical Safety, EMC, Software, Cybersecurity: Stating the device contains no active components, software, or ports, rendering these categories irrelevant.
• MRI Safety: Confirming material compatibility with MR environments.
• "Performance Testing": This solely refers to dosimetry testing (measurement of radiation attenuation and water equivalent thickness), not clinical performance or diagnostic accuracy. It states, "The test data meets the A/R criteria predetermined for the device," but does not define what those A/R criteria are or what the actual reported performance values were.

Therefore, based only on the provided input, I cannot answer the questions related to AI/ML device performance, acceptance criteria, study design for diagnostic accuracy, or ground truth establishment. The device in question appears to be a physical positioning and immobilization system for radiation therapy, not an AI/ML diagnostic or predictive tool.

If this was a misunderstanding and the request was for a hypothetical AI/ML device, I would need more specific attributes to invent a plausible scenario. However, as per the input, the device's assessment focuses on material properties and physical radiation attenuation, not AI/ML performance.

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The Alta™ Multipurpose Device is intended to immobilize, support, position, and transfer patients undergoing radiotherapy procedures using electrons, protons, including SBRT and SRS; imaging procedures such as x-ray, computed tomography, and magnetic resonance imaging; and other procedures involving transfer of a patient.

The Alta™ Multipurpose Device is designed to interface with the Symphony® Patient Transport System and other positioning devices, such as couch tops, thermoplastic masks, setup-specific treatment devices and adapters, and positioning supports and pads.

Qfix has developed a new device designed to streamline radiotherapy and imaging workflows, the Alta™ Multipurpose Device. The Alta Multipurpose Device is intended to immobilize, support, position, and transfer patients undergoing radiotherapy procedures using electrons, photons, protons, including SBRT and SRS; imaging procedures such as x-ray, computed tomography, and magnetic resonance imaging: and other procedures involving transfer of a patient. The Alta Multipurpose Device is designed to interface with the Symphony® Patient Transport System and other positioning devices, such as couch tops, thermoplastic masks, setup-specific treatment devices and adapters, and positioning supports and pads.

The Alta Multipurpose Device is a versatile device, providing access for a variety of clinical setups for transport, imaging, and treatment on a single device. The proprietary fiber-reinforced composite construction of the Alta Multipurpose Device provides strong and rigid support while remaining lightweight for ease of transport and use. The Alta Multipurpose Device boad-reaching compatibility with a variety of positioning and immobilization devices, including but not limited to:

• Headrests, adapters, and thermoplastics for head and neck applications, including intracranial, whole brain, and stereotactic radiosurgery (SRS),
• MR Coil Holders, ●
• Vacuum cushions for stereotactic body radiation therapy (SBRT), ●
• . Bridges and compression devices for SBRT.
• Supine positioning devices for breast and thorax applications,
• Thoracic and pelvis thermoplastics for thorax and pelvis applications, ●
• Upper and lower extremity positioning devices, like hand grips, arm positioners. ● and knee and foot blocks.

When combined with such other devices through its variety of indexing features, the Alta Multipurpose Device enables a diverse set of clinical applications within the fields of radiotherapy and diagnostic imaging all with the same device, providing significant flexibility, agility, and efficiency for clinicians. Additionally, the Alta Multipurpose Device can optionally be configured to utilize Symphony Air Drive™ technology to facilitate patient transfers with the Symphony Patient Transport System, further enabling more efficient clinical workflows.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It broadly mentions "Non-clinical bench testing was conducted," implying laboratory-based testing rather than studies involving human patients or specific data sets.

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

This information is not provided in the document. The testing described is "non-clinical bench testing," which typically involves engineering and performance evaluations against predefined specifications, not expert-adjudicated ground truth as would be used for image interpretation or diagnostic accuracy studies.

4. Adjudication Method for the Test Set:

This information is not applicable and therefore not provided, as the testing described is non-clinical bench testing against predetermined technical specifications, not human interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document focuses on the technical performance and substantial equivalence of the device, not its impact on human reader performance.

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

Yes, a standalone performance evaluation was done. The "Performance Standards and Testing" section describes "Non-clinical bench testing" conducted to verify hardware specifications, MR safety, compatibility, attenuation characteristics, load rating, workflow, and ergonomics. This testing evaluates the device itself, without human interaction as part of the primary performance metric.

7. Type of Ground Truth Used:

The ground truth for the non-clinical bench testing appears to be based on engineering specifications, industry standards, and predefined acceptance criteria for each test (e.g., specific load capacities, attenuation limits, compatibility requirements). It is not based on expert consensus, pathology, or outcomes data.

8. Sample Size for the Training Set:

This information is not applicable. The Alta™ Multipurpose Device is a physical medical device (immobilization, support, positioning, and transfer device), not an artificial intelligence (AI) algorithm that requires a training set.

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

This information is not applicable as the device is not an AI algorithm and therefore does not have a training set or associated ground truth establishment for a training set.

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