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Device-Specific Indications for Use/Intended Use: This device is intended for use as part of the AirDrive system to facilitate diagnostic and image guided procedures including under fluoroscopy, X-ray, CT, MR, other imaging procedures, and other procedures involving transfer of a patient.

System Indications for Use/Intended Use: The Qfix® Symphony Patient Transport System is indicated to aid in the support, positioning, and transfer of a patient for procedures involving imaging, including MRI; and external beam radiation therapy treatment with electrons, photons; and other procedures requiring transfer of a patient. The Symphony is designed to interface with other positioning devices, such as couchtops, inserts, thermoplastic masks, and positioning pads.

Qfix has made a modification to its previously cleared Symphony Patient Transport System (cleared in K160627). This modification introduces a new transfer device variant compatible with the Symphony Patient Transport System – the Iris AirShuttle is designed to be used with an AirDrive source, such as the AirDrive Trolley or AirDrive Caddie, to provide a solution for a complete patient transport system. With the Iris AirShuttle, the system is capable of being used in multimodal imaging and treatment environments, including interventional radiology procedures and workflows involving fluoroscopy, angiography, and magnetic resonance imaging. To facilitate these workflows, user configurable accessory rails have been added to the design, allowing easy transfer of essential railmounted equipment with the patient. Additionally, the Iris AirShuttle allows for patient transfer on soft and hard surfaces. Device pads have been included in the modification to maximize patient comfort while minimizing the distance between the patient and the spine coil of MR machines for optimal image quality. Alternative integrated transfer handles have also been included to allow for transfers with or without air power and without installation of the removable transfer handles. Qfix intends to market the subject device for use with the AirDrive Trolley and the AirDrive Caddie. This creates an improved efficient workflow while reducing the risk of injuries related to manually lifting patients for transport in various treatment environments, including multimodal imaging and treatment workflows involving fluoroscopy, angiography, and magnetic resonance imaging.

The Iris AirShuttle is a modification to the previously cleared Symphony Patient Transport System (K160627). It's designed to be used with an AirDrive source (like an AirDrive Trolley or Caddie) to facilitate patient transfer in various medical environments, including multimodal imaging (fluoroscopy, X-ray, CT, MR, angiography) and external beam radiation therapy.

Here's an analysis of the acceptance criteria and study information provided:

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 explicit sample sizes for the "test set" in terms of patient data or a particular number of units tested for all performance aspects.
• The studies were described as "bench testing and analysis," "analysis of mechanical components," "verification of MRI compatibility," and "radiographic property analysis."
• "Usability studies" were conducted, but the number of participants or duration is not stated.
• Data Provenance: The studies were conducted by the manufacturer (Qfix) as part of their verification and validation processes. No mention of data provenance in terms of country of origin or retrospective/prospective clinical data is relevant, as no clinical studies were performed.

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 no clinical studies were performed that would typically require expert ground truth establishment for a test set. The performance validation relies on engineering and physical testing, and usability assessments. The intended users are healthcare professionals, but they weren't necessarily establishing ground truth for a diagnostic task.

4. Adjudication Method for the Test Set

• This information is not applicable as no clinical studies were performed that would involve adjudication of a test set.

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

• No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical or animal studies were completed to support the subject device and substantial equivalence argument." Therefore, there is no effect size of human readers improving with AI vs. without AI assistance.

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

• Not applicable. The Iris AirShuttle is a patient transport device, not an AI or algorithm-based device. Its performance is assessed through physical, mechanical, and usability testing, not algorithmic performance.

7. The Type of Ground Truth Used

• For the physical and functional aspects of the device, the "ground truth" was established by engineering specifications, recognized physical standards (e.g., ASTM F2503-20 for MR compatibility, ISO 14971:2019 for risk management), and validated mechanical test methods.
• For usability, "ground truth" typically comes from user feedback and observations during usability studies, measured against predefined usability criteria.

8. The Sample Size for the Training Set

• Not applicable. The Iris AirShuttle is a physical medical device, not an AI/machine learning algorithm. Therefore, there is no "training set" in the computational sense.

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

• Not applicable. As a physical device, there is no training set. Design and manufacturing adhere to established engineering principles, material science, and quality system regulations (e.g., CFR 21 Part 820) and standards (e.g., ISO 14971), which form the basis for its development and "ground truth" adherence to specifications.

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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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The Encompass™ 15 Channel Head Coil is intended to be used in conjunction with a Magnetic Resorance Scanner for the MR examination of the human brain just before, during, and at the end of brain surgery. The Encompass™ 15 Channel Head Coil can also be used as a standard diagnostic examinations and fMRI (Functional Magnetic Resonance Imaging). When used with magnetic resonance imaging systems, it is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of the head. When interpreted by a trained physician, these images provide information that can be useful in determining diagnosis.

Qfix and NORAS MRI products GmbH have jointly developed a head coil designed to enable MRI for diagnosis and to inform additional clinical actions, the Encompass™ 15 Channel Head Coil, 3T. The Encompass 15 Channel Head Coil is a diagnostic imaging device for use in 3T environments for obtaining diagnostic MR images to be used to inform procedures which use MR imaging to guide interventional procedures and other treatments. The Encompass™ 15 Channel Head Coil has been specifically designed to interface with the Encompass™ SRS Immobilization System (cleared with K152321 December 4, 2015).

The Encompass™ 15 Channel Head Coil is a ridged receive only coil featuring a 7 Channel Top Coil, an 8 Channel Bottom Coil, and an optional mirror holder. Imaging is performed with a 15-Channel "phased array" co-developed by Qfix and NORAS and manufactured by NORAS. The coils are mounted in a rigid Coil Frame and connection to the MRI is managed by the applicable MRI software. The Encompass™ 15 Channel MRI Head Coil has been designed for use with Siemens Healthineers MAGNETOM 3T systems e.g. MAGNETOM Skyra.

Encompass™ 15 Channel Head Coil has been optimized for use with the Encompass™ SRS Immobilization System. The use of the Encompass™ 15 Channel Head Coil together with the Encompass™ SRS Immobilization System allows immobilization of the patient while obtaining diagnostic MR images to be used to inform procedures which use MR imaging to guide interventional procedures and other treatments.

This FDA 510(k) summary describes the Qfix Encompass™ 15 Channel Head Coil, 3T, which is an MRI head coil. The document primarily focuses on demonstrating substantial equivalence to a predicate device (NORAS OR Head Coil 3T) through non-clinical performance and safety testing. It does not present an independent study with acceptance criteria involving specific performance metrics like sensitivity, specificity, or AUC for an AI/device's diagnostic accuracy.

Therefore, many of the requested elements for an AI/device performance study (like test set sample size, expert ground truth, effect size with AI assistance, standalone performance, training set details) are not applicable to the information provided in this 510(k) summary.

However, based on the provided text, I can infer the general acceptance criteria and describe the general study approach used to demonstrate substantial equivalence for this type of medical device (an MRI coil).

Here's the breakdown:

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

For an MRI coil, "acceptance criteria" and "reported device performance" are typically framed around safety and technical imaging performance, often compared to a predicate device, rather than diagnostic accuracy metrics.

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

• Sample Size: Not applicable in the context of an "AI/device test set." This document describes testing for an MRI coil. The "test set" would primarily refer to technical performance measurements on imaging systems. There's no mention of a defined "test set" of patient images or specific clinical cases for evaluating diagnostic accuracy in the way an AI algorithm would be evaluated.
• Data Provenance: Not applicable for a typical AI/device test set. The performance data comes from non-clinical bench testing conducted by Qfix and NORAS. It indicates testing on "3T Siemens Healthineers MAGNETOM MRI scanners."

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

• Not applicable. No expert review for establishing ground truth on a 'test set' of patient data for diagnostic accuracy is mentioned. The "interpretation by a trained physician" is mentioned in the Indications for Use, which is standard for diagnostic imaging, but this is not part of a study to establish ground truth for algorithm performance.

4. Adjudication method for the test set

• Not applicable. No adjudication method is mentioned as there's no diagnostic accuracy study described involving a test set and experts.

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 comparative effectiveness study was not performed. This document is for an MRI head coil, not an AI-powered diagnostic device, so AI assistance is not a component.

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

• Not applicable. This device is an MRI head coil, not an algorithm. Its performance is inherent to its physical design and interaction with the MRI scanner. It does not perform a standalone diagnostic function akin to an algorithm.

7. The type of ground truth used

• For an MRI coil, "ground truth" relates to the accuracy and quality of the image acquisition, not diagnostic findings from patient cases. The "ground truth" (or reference standard) in this context would be:
  • Engineering specifications and standards: Adherence to NEMA standards for MRI performance (e.g., SNR, uniformity).
  • Safety standards: Compliance with IEC 60601-1 series and ISO 14971.
  • Predicate device performance: Functional equivalence and demonstrated improvements over the NORAS OR Head Coil 3T.

8. The sample size for the training set

• Not applicable. This device is hardware (an MRI coil), not an AI algorithm, so there is no "training set."

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

• Not applicable. As there is no training set for an AI algorithm.

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The Encompass™ SRS Headframe provides noninvasive stereotactic head and neck immobilization by using a patient specific thermoplastic mask that conforms to the patient's features to provide accurate, reproducible positioning. repositioning, and immobilization. The Encompass™ SRS Headframe allows the patient to undergo diagnostic imaging in the same position as that of the treatment position enabling more accurate radiation therapy.

Qfix, has made a modification to its previously cleared Encompass™ SRS Immobilization System (cleared in K152321). In this modified variant of the Encompass™ SRS Immobilization System, the essential geometry of the head portion of the Encompass™ SRS Standalone Device is isolated to create a separate attachment which can be affixed to patient positioning devices that accept S-type thermoplastic masks, such as Qfix's Portrait™ Intracranial, Head and Neck Device (a device for use with S-type thermoplastics). Ofix intends to initially market the subject device for use with the Encompass™ SRS Fibreplast® System with optional IntegraBite™ (also cleared in K152321) and its devices which share a hole pattern and geometry with its Portrait™ Intracranial, Head and Neck Device. Examples of such devices include the kVue™ Portrait™ Intracranial. Head and Neck Insert and the Symphony® Portrait™ Transfer Device (cleared in K160627). This creates a flexible solution for a variety of imaging and radiotherapy treatment applications using stereotactic radiosurgery, such as radiation oncology and the treatment of noncancerous conditions and malformations such as trigeminal neuralgia.

The provided text is a 510(k) summary for the Qfix Encompass™ SRS Headframe, a medical device for patient immobilization during radiation therapy. It claims substantial equivalence to a previously cleared predicate device rather than presenting a novel AI/software-as-a-medical-device (SaMD) study. Therefore, the information typically requested about AI/SaMD acceptance criteria, test set details, expert ground truth, MRMC studies, and training set information is not present in this document.

However, I can extract information related to the device's performance claims and general testing.

Here's a breakdown of what can be extracted based on the provided text, and what cannot be extracted because it's not an AI/SaMD submission:

Acceptance Criteria and Device Performance (General Device Performance):

The document does not provide a table of explicit, quantifiable acceptance criteria with corresponding performance data in the typical sense of a SaMD validation study. Instead, it makes a general claim about performance relative to its predicate device.

• Verification of hardware specifications
• Accuracy validation via motion studies
• Ease of use/ergonomics assessments
• Verification of aluminum equivalence
• Verification of compatibility with optical tracking systems |

Information NOT available in the provided text (typical for AI/SaMD studies):

2. Sample size used for the test set and the data provenance: Not applicable to this device type and submission. The document mentions "testing using healthy volunteers" for non-clinical bench testing but does not specify a sample size for these volunteers.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical immobilization device is typically established through direct measurement (e.g., motion studies, calibration) rather than expert interpretation of images or data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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, as this is not an AI-assisted device for diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this physical device, ground truth for accuracy claims would be based on physical measurements (e.g., displacement measurements during motion studies) rather than expert interpretation or pathological findings.
8. The sample size for the training set: Not applicable, as this is not an AI/machine learning device.
9. How the ground truth for the training set was established: Not applicable, as this is not an AI/machine learning device.

Summary of Device and Study Type:

This 510(k) submission is for a physical medical device (Encompass™ SRS Headframe) used for patient immobilization during radiation therapy. The submission relies on demonstrating substantial equivalence to a previously cleared predicate device (Encompass™ SRS Immobilization System, K152321). Therefore, the "study" described is primarily non-clinical bench testing and testing with healthy volunteers to ensure the modified device maintains the performance characteristics (e.g., sub-millimetric accuracy, compatibility) and safety profile of the predicate device, rather than a clinical trial or AI/SaMD validation study with diagnostic endpoints.

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Device-Specific Intended Use: The Qfix® Abdominal/Thoracic Motion Control System is intended to apply abdominal compression for managing internal body motion during respiration while maintaining maximum comfort to the patient. The Qfix® Abdominal/Thoracic Motion Control System is also intended to promote shallow breathing in radiation therapy or radiology.

System Intended Use: The Qfix® Abdominal/Thoracic Motion Control System can be used as part of the Qfix® SBRT Solution and Accessories including, Ofix's kVue™, Stradivarius™, VacQFix™ and DoseMax™ inserts, overlays, and standalone devices which are intended to immobilize, position patients undergoing radiation therapy including SBRT.

Ofix has developed an improved device. the Ofix® Abdominal/Thoracic Motion Control System, to promote shallow breathing in patients undergoing radiation therapy including electron, photon, and proton treatments and general radiology and imaging applications including MR and CT image acquisition. The Ofix® Abdominal/Thoracic Motion Control System is intended to be used either independently or in conjunction with a number of existing devices and accessories in the Ofix portfolio to create a comprehensive solution for stereotactic body radiation therapy.

The Ofix® Abdominal/Thoracic Motion Control System features belts and paddles of varying size, an air bladder, and a hand pump with gauge. The belts come in multiple sizes to accommodate wide range of patient girths. The rigid foam paddles are designed with geometry that conforms to the region beneath the xibhoid process, in order to provide relatively comfortable compression that does not compress the ribs themselves. The paddles also feature embedded fiducial markers, providing another means of positional localization.

Compression is achieved via a bladder attached to the paddles, designed to maintain a flat profile even when fully inflated in order to achieve uniform pressure on the paddle through the course of the procedure. The bladder, which is inflated with a detachable small hand pump with gauge, features a pressure-holding valve and a quick release at the junction of the pump and the inflation tubing. This allows the Abdominal/Thoracic Motion Control System to reliably hold its pressure without the pump in place, enabling more flexibility and versatility in studies and procedures. At the time of this submission. the Ofix® Abdominal/Thoracic Motion Control System is patent pending.

The Qfix® Abdominal/Thoracic Motion Control System can be used in conjunction with other devices already in the Qfix Product Portfolio to achieve further body immobilization or greater degrees of compression with the Qfix® SBRT Solution and Accessories. It combines a rigid, low attenuating support structure in the form of a couchtop insert or overlay with a series of interchangeable devices such as supportive cushions, compression devices, and other immobilization devices, including the Qfix® Abdominal/Thoracic Motion Control System, allowing clinicians to provide superior immobilization customized to the unique treatment plan of each patient.

The provided text describes the Qfix® Abdominal/Thoracic Motion Control System, a device intended to apply abdominal compression for managing internal body motion during respiration and promoting shallow breathing in radiation therapy and radiology. The submission focuses on demonstrating substantial equivalence to a predicate device and includes details on non-clinical testing.

However, the provided document is a 510(k) summary for a physical medical device (Abdominal/Thoracic Motion Control System), not an AI/Software as a Medical Device (SaMD). Therefore, many of the requested elements pertaining to AI/SaMD studies (e.g., test set sample size, expert ground truth, MRMC studies, training set details) are not applicable to this submission and are not present in the document.

The document describes performance testing to show the device meets its intended use, but it's not in the context of an AI/SaMD acceptance criteria table. I will extract the relevant information from the document as best as possible, focusing on the described performance testing and what could be interpreted as "acceptance criteria" for a physical device.

Here's an attempt to structure the information based on the provided text, while acknowledging the limitations due to the nature of the device:

Device: Qfix® Abdominal/Thoracic Motion Control System

Primary Intended Use (relevant to performance testing): To apply abdominal compression for managing internal body motion during respiration while maintaining maximum comfort to the patient, and to promote shallow breathing in radiation therapy or radiology.

Acceptance Criteria and Reported Device Performance

The document describes non-clinical bench testing and customer preference validation. The "acceptance criteria" for a physical device like this are typically derived from its functional requirements and safety standards. The document implicitly states meeting these through the testing results.

Study Details (as inferable from the document)

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

  • MR Safety and Compatibility Testing: No specific number of samples (devices) or tests is provided, but it states methodology from ASTM F2119-07 and F2052-15 was used. The provenance of the data is internal non-clinical bench testing.
  • Shallow Breathing Efficacy: "Healthy volunteers." The exact number is not specified in the document. The data provenance is internal testing with human subjects.

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

  • Not applicable directly. For a physical device like this, "ground truth" establishment isn't in the sense of expert annotation of images. For the shallow breathing study, ground truth would be objectively measured physiological parameters (inspiratory capacity, tidal volume). For MR safety, ground truth is established by physics principles and standards.

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

  • Not applicable. This concept typically applies to subjective assessments or disagreements in AI model output or human reader performance. The testing mentioned is objective measurement or adherence to standards.

• 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, not performed. This is an AI/SaMD specific study type and not relevant for this physical device submission.

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

  • Not applicable. This device does not involve an algorithm for standalone performance. The device's "performance" is its mechanical and physiological effect.

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

  • For the shallow breathing efficacy, the ground truth was physiological measurements (inspiratory capacity and tidal volume) obtained from healthy volunteers.
  • For MR safety and compatibility, the ground truth was based on physical standards and objective testing (e.g., quantifying magnetic displacement force, checking for artifact generation).

• 8. The sample size for the training set:

  • Not applicable. This device is not an AI/machine learning model, so there is no "training set."

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

  • Not applicable. See point 8.

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The Qfix® Symphony Patient Transport System is indicated to aid in the support, positioning, and transfer of a patient for procedures involving imaging, including MRI; and external beam radiation therapy treatment with electrons, photons or protons; and other procedures requiring transfer of a patient. The Symphony is designed to interface with other positioning devices, such as couchtops, inserts, thermoplastic masks, and positioning pads.

Qfix, has developed the Symphony™ Patient Transport System to seamlessly move patients among multiple imaging modalities such as MR and CT to treatment modalities, such as those utilizing photon or proton and other procedures requiring the transfer of a patient. The Symphony™ Patient Transport System is designed to utilize a low-friction air bearing to transfer patients from one surface to another, eliminating the need to manually lift the patient. Additionally, the design enables clinicians to set up a patient on the Symphony™ for subsequent transfer and immobilization throughput in cancer treatments and other procedures. Qfix intends to market the Symphony™ Patient Transport System which consists of the Symphony™ trolley and several transfer surfaces including; a standard transfer surface, a head/neck transfer surface, and a brachytherapy solution which are compatible with existing patient positioning devices. The Symphony™ Patient Transport System is designed to optimize workflow efficiencies and improve patient outcomes.

The provided document describes the Qfix® Symphony™ Patient Transport System and its safety and effectiveness information. However, it does not contain the detailed information required for a comprehensive answer regarding acceptance criteria and a specific study proving the device meets those criteria.

Here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

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The Encompass™ SRS Immobilization System provides noninvasive stereotactic head and neck immobilization by using a patient specific thermoplastic mask that conforms to the patient's features to provide accurate, reproducible positioning. a pationing and immobilization. The Encompass™ SRS Immobilization System allows the patient to undergo diagnostic imaging in the same position as that of the treatment position enabling more accurate radiation therapy.

The Encompass™ SRS Immobilization System is a highly advanced, non-invasive immobilization solution designed for precisely targeted brain, head and neck treatments. The Encompass™ SRS Immobilization System consists of a posterior support of either a Fibreplast™ thermoplastic mask, or a Moldcare cushion which rests on a contoured surface. The Encompass™ SRS Immobilization System features the IntegraBite™, which reduces motion allowing for maximum dose to the tumor while minimizing radiation delivered to the surrounding healthy tissue. The Integrated Shim System™ enables quick and seamless 0.5 mm height adjustments of the thermoplastic mask for a fully customizable patient setup. The Encompass™ SRS Immobilization System is designed to optimize workflow efficiencies and improve patient outcomes.

The provided text describes the Encompass™ SRS Immobilization System and its performance studies to support its substantial equivalence to a predicate device. However, it does not explicitly define "acceptance criteria" in the way one might expect for a diagnostic or AI-driven medical device (e.g., sensitivity, specificity thresholds). Instead, the performance studies assess immobilization and workflow.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

As explicit acceptance criteria with numerical targets are not stated, I will infer them from the "verification, validation and safety requirements" and the "conclusions" of the studies.

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

• Sample Size for Test Set:
  • Motion Studies: Healthy volunteers (number not specified).
  • Intrafractionation Studies: Not specified, but conducted "at a clinical site."
  • Workflow Studies: Not specified.
• Data Provenance: The text does not explicitly state the country of origin. The motion studies were conducted on "healthy volunteers," implying a prospective study. The intrafractionation studies were conducted "at a clinical site," also suggesting prospective data collection.

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

There is no mention of experts establishing ground truth in the context of diagnostic accuracy for this immobilization system. The "ground truth" for immobilization performance appears to be directly measured via tracking systems. For workflow studies, the assessment is observational.

4. Adjudication Method for the Test Set

Not applicable. The performance studies described involve direct measurement of physical parameters (motion, time), not subjective interpretation requiring adjudication among experts.

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

No, an MRMC comparative effectiveness study was not done. This device is an immobilization system, not a diagnostic imaging interpretation tool where human readers and AI would be compared. The study focused on the physical performance of the device itself.

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

Not applicable. The device is a physical immobilization system, not an algorithm. Its performance is inherent in its design and physical properties, tested in conjunction with human interaction (mask formation, patient use).

7. The Type of Ground Truth Used

• Motion Studies: Direct measurement of motion using tracking systems.
• Intrafractionation Studies: Direct measurement of intrafractionation motion, likely using external tracking or imaging.
• Workflow Studies: Timed observations of the mask-making process.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a "training set."

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

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

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