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CDR Systems Precision Patient Positioning System is indicated to assist in the proper positioning of patients for radiation therapy and radiosurgery simulation and treatment including electron, photon and proton treatments. Place a clean sheet over the device to ensure a clean device from patient to patient.

The CDR Systems Precision Patient Positioning System consists of several options that may be purchased individually or as a complete system.

1. The CDR Systems Freedom SBRT Immobilization System is designed to provide an easy to use means to immobilize, position and reposition patients undergoing stereotactic radiation therapy. The SBRT Immobilization System is manufactured from Vinvl skinned flexible polyurethane foam and carbon fiber/epoxy components.
2. The CDR Systems Couch Overlay and Couch Extension are manufactured from carbon fiber/epoxy over a foam core providing a rigid radio-translucent platform to immobilize and position the Head, Neck and Shoulders of a patient.
3. The CDR Systems Belly Board System has a generally rectangular contour with a firm base that provides patient support and locations for softer modules that provide additional support for a patient's pelvis and head. The indexing bars ensure secure fixation of the Belly Board to the treatment couch.
4. The CDR Systems Prone Breast Patient Positioning System is generally rectangular in shape with firm base and soft cushions with a specific location for, pelvis, head and breasts. An interchangeable left or right contra-lateral breast support provides support for the breast not requiring radiation treatment. The breast opposite to the contralateral breast is intentionally unsupported and is allowed to hang providing unobstructed treatment access.
5. The CDR Systems Prone Head and Neck Immobilization System is a headboard that attaches to a base plate that locates onto a couch tabletop, onto a Couch Overlay or Couch Extension and provides adjustable positive and negative tilt for patient's head. The Prone Head and Neck Immobilization System can be used for support of a patient's head in supine or prone position.
6. The CDR Systems InstaForm Foam is designed to provide an easy to use means to stabilize, position and reposition patients undergoing radiation therapy on a treatment couch. Shortly after the foam has completed expanding inside a plastic bag it becomes rigid, resulting in a customized mold of the patient's anatomy for accurate positioning and stabilization for subsequent patient setups requiring the same initial position.
7. The CDR Systems Vacuum Cushion is constructed from vinyl coated nylon material that is filled with small polystyrene beads to immobilize the patient. Once evacuated, the Vacuum Cushion holds a rigid shape over the course of a specific patients radiation therapy treatment.
8. The CDR Systems Indexing Bar is designed for the indexing of patient immobilization devices onto a treatment couchtop.

The provided text is a 510(k) summary for the CDR Systems Precision Patient Positioning System, a medical device used to position patients for radiation therapy. This document primarily focuses on establishing "substantial equivalence" to predicate devices based on intended use and technological characteristics, particularly beam attenuation.

Crucially, this document does NOT contain information about a study proving the device meets acceptance criteria related to AI or a "human-in-the-loop" performance study. The device described is a physical patient positioning system, not an AI software or a device that would require such studies for its performance. The "performance testing" mentioned is "Bench (Tab 12) indicates that CDR devices attenuate a 6 MeV radiation beam by less than 3%." This is the only direct performance metric stated.

Therefore, I cannot provide details on the following as they are not present in the provided text:

• A table of acceptance criteria for AI performance and reported device performance.
• Sample size used for an AI test set or data provenance.
• Number of experts used to establish ground truth for an AI test set or their qualifications.
• Adjudication method for an AI test set.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
• Standalone (algorithm only) performance study.
• Type of ground truth used for AI (expert consensus, pathology, outcomes data, etc.).
• Sample size for an AI training set.
• How ground truth for an AI training set was established.

**Based on the provided text, the only "acceptance criteria" discussed are related to the device's physical properties and its substantial equivalence to predicate devices, specifically:

1. Acceptance Criteria and Reported Device Performance (as stated for this physical device):

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

• Sample Size: Not applicable in the context of AI or clinical performance for this physical device as described. The "performance testing" cited refers to bench testing (attenuation of a radiation beam), not a study with a "test set" of patient data.
• Data Provenance: Not applicable. The performance data is from laboratory/bench testing of materials, not patient data.

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 an AI model is not relevant here as this is a physical medical device.

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. This device is not an AI system.

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

• Not applicable. This device is not an AI system or an algorithm.

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

• Not applicable. The performance evaluation here is based on physical properties (beam attenuation) measured through bench testing against a specified threshold.

8. The sample size for the training set:

• Not applicable. There is no training set for a physical patient positioning device.

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

• Not applicable.

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The Zephyr "x-series" Patient Positioning and Transfer 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, as well as other procedures requiring transfer of a patient.

The Zephyr "x-series" Patient Positioning and Transfer System functions as an accessory to support a patient and positioning devices during imaging and radiation therapy procedures, and other procedures requiring the transfer of a patient. The Zephyr "x-series" Patient Positioning and Transfer System utilizes forced air as a low-friction bearing to transfer patients from one flat surface to another, eliminating the need to manually lift the patient.

The Diacor Zephyr "x-series" Patient Positioning and Transfer 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, as well as other procedures requiring transfer of a patient.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set: Not applicable as this submission details bench testing rather than a clinical study with a patient test set.
• Data Provenance: The data is from bench testing conducted by Diacor Inc. The country of origin for this testing is not explicitly stated, but Diacor Inc. is based in West Valley City, UT, USA.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not applicable. Ground truth in this context (bench testing) is established through physical measurements and scientific methodologies rather than expert consensus on medical images or diagnoses.

4. Adjudication Method for the Test Set

• None. Adjudication is not relevant for bench testing where objective physical measurements are performed.

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

• No. An MRMC study was not conducted as this device is a patient positioning and transfer system, not an imaging or diagnostic AI device that would involve human readers interpreting cases.

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

• Yes, in the context of device function. The "standalone" performance here refers to the device's physical and material properties (attenuation, build-up, MR safety) as measured during bench testing, independent of human interaction beyond operating the testing equipment. There is no algorithm involved in the "standalone" sense of an AI device.

7. Type of Ground Truth Used

• Physical Measurements and Scientific Standards:
  • Attenuation and Build-up: Measured using a Unidose-E electrometer with specific chambers (Farmer Chamber FC65-G, PTW Advanced Markus Plane Parallel Chamber) in solid water, based on established physics principles for radiation dosimetry.
  • MR Safety: Assessed by observing the physical interaction (attraction/pull) of the device components with a magnet and a hand-held metal detector, adhering to MR safety guidelines.

8. Sample Size for the Training Set

• Not applicable. This submission describes a physical medical device, not an AI/machine learning algorithm, so there is no "training set" in that context.

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

• Not applicable. As there is no AI algorithm training set, this question is not relevant.

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