(168 days)
The device is intended to be used for immobilization, positioning and re-positioning during Stereotactic Radiotherapy (SRT) and Stereotactic Radiosurgery (SRS) in all parts of the brain, head, and neck during external beam radiation therapy. The device is also used to immobilize and position the head during image acquisition to support treatment planning including in Computed Tomography (CT) and Magnetic Resonance (MR) imaging systems.
The Head Immobilization System is intended for head and neck immobilization. The device is used as an aid in positioning and re-positioning of the patient during diagnostic and therapeutic treatments including radiation therapy. The fundamental component of the system is the trUpoint ARCH™ comprised of an arch, frame arm, bite assembly arm, and nasion assembly arm. A nasion cushion and bite cup also comprise the system. A storage plate is used to store the trUpoint ARCH™ and a Base Lock Replacement Kit is available to replace the base lock in the trUpoint ARCH™. Accessories to the proposed device that are manufactured by CIVCO Medical Solutions include the individual head support, thermoplastic mask, and baseplate. Accessories to the proposed device that not manufactured by CIVCO Medical Solutions include a bite tray, impression putty, and putty dispenser. The proposed devices are sold non-sterile. The nasion cushion and bite cup are single patient use devices whereas the trUpoint ARCH™ may be reused for multiple patients. The proposed devices are non-implanted devices that are large in size and manufactured of non-magnetic and plastic materials.
Here's a breakdown of the acceptance criteria and study information for the CIVCO Medical Solutions trUpoint ARCH™ Head Immobilization System, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document primarily focuses on demonstrating the device's safety and compatibility in an MR environment and its efficacy in patient immobilization.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance and Remarks |
|---|---|---|
| MR Safety | RF Heating: Must pass relevant ASTM standards (F2182-11a, F2119-07, F2052-06e1, F2213-06).Magnetic Induced Torque: Must pass relevant ASTM standards.Magnetically Induced Displacement Force: Must pass relevant ASTM standards. | The devices passed the acceptance criteria for RF heating, magnetic induced torque, and magnetically induced displacement force, demonstrating safety for use in the MR environment. Modifications were made to accommodate the large size and external use of the devices. |
| Image Artifacts | Must be localized and documented, if present, with information on location and size included in Instructions for Use. | Image artifact was observed but was localized. Information regarding location and size has been included in the Instructions for Use. |
| Biocompatibility | Patient contacting materials must be biocompatible. | Biocompatibility testing was completed for patient contacting materials. |
| Intrafraction Immobilization | Patients must be immobilized within 1 mm during treatment. | Documented that the device immobilizes patients within 1 mm during treatment (intrafraction). |
| Interfraction Patient Shifts (Equivalence to competitor) | When comparing CT simulation images to daily image matching, the device should be equivalent to a competitor system regarding interfraction patient shifts. | Documented that the trUpoint ARCH™ device is equivalent to a competitor system with respect to interfraction patient shifts. |
2. Sample Size Used for the Test Set and Data Provenance
- MR Safety/Compatibility Testing: Not explicitly stated, but implies a sufficient number of devices were tested to meet ASTM standards.
- Immobilization Efficacy Data (Zurich White Paper):
- Sample Size: Not explicitly stated in the provided text. It mentions data was "collected by the University Hospital Zurich" and analyzed in a "white paper."
- Data Provenance: Prospective (implied, as it was "collected by the University Hospital Zurich") from Switzerland. "Zurich's data" is referenced, indicating real-world patient data likely collected at an academic institution.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- MR Safety/Compatibility Testing: Not applicable. Ground truth for these tests is based on established engineering and materials science standards (ASTM).
- Immobilization Efficacy Data: Not specified. The "ground truth" for intrafraction immobilization (within 1 mm) and interfraction shifts (equivalence to competitor) would likely be derived from high-resolution imaging modalities (e.g., CT, MR) and established clinical protocols for assessing patient movement during radiation therapy. The expertise would be in radiation oncology, medical physics, and imaging sciences, typically associated with a university hospital setting performing such studies.
4. Adjudication Method for the Test Set
- MR Safety/Compatibility Testing: Not applicable. Automated measurements and compliance with engineering specifications are the primary evaluators.
- Immobilization Efficacy Data: Not explicitly stated. For a study conducted at a university hospital, it would typically follow established clinical research protocols, potentially involving independent review of imaging data by medical physicists or radiation oncologists if subjective assessments were part of the data collection (though the metrics mentioned seem objective).
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 physical head immobilization system, not an AI-powered diagnostic or treatment planning tool that would involve human readers interpreting images with or without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical device, not an algorithm.
7. The Type of Ground Truth Used
- MR Safety/Compatibility: Engineering specifications and established ASTM standards for material properties and interaction with MR fields.
- Immobilization Efficacy (Zurich Data): Objective measurements from imaging data (e.g., CT, daily image matching) to quantify patient movement and shifts during diagnostic and therapeutic procedures. This would fall under outcomes data in the sense of measured performance related to the device's function.
8. The Sample Size for the Training Set
- Not applicable. This is a physical device, not a machine learning algorithm requiring a training set.
9. How the Ground Truth for the Training Set was Established
- Not applicable. This is a physical device.
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.