(91 days)
The Varian Head Frame System is for use with a computed tomography scanner to perform imaging for treatment planning and a charged particle accelerator to perform immobilization of the treatment target for stereotactic radiosurgery or radiotherapy treatments on cranial lesions, tumors and conditions where radiation treatment is indicated.
The Head Frame provides rigid immobilization of a patient's skull by attaching a rigid halo (head frame) to the patient through four invasive contact points (called screws or pins) which penetrate the patient's skin and contact the bone of the skull. The head frame is secured to either the CT table or the treatment table via a bracket which is included in the system. This ensures the patient cannot easily move during imaging or treatment. This level of immobilization is generally used for stereotactic radiosurgery.
This document is a 510(k) premarket notification for the "Varian Head Frame" system. It describes the device, its intended use, and a comparison to a predicate device, but it does not contain the detailed information requested regarding acceptance criteria and a study proving the device meets those criteria, specifically concerning performance metrics like accuracy, sensitivity, or specificity.
The document discusses:
- Device Name: Varian Head Frame
- Intended Use: For immobilization during stereotactic radiosurgery or radiotherapy treatments on cranial lesions.
- Predicate Device: Optical Guidance Platform (K071360)
- Technological Characteristics: Compares features like patient fixation (four pins), materials, sterilization methods, rigid fixation mechanisms, anatomy/head/neck fixation, couch mount degrees of freedom, and positioning/localization features.
- Summary of Performance Testing: States that "Results of verification and validation testing showed conformance to applicable performance requirements specifications and assured hazard safeguards functioned properly." It also mentions biocompatibility and cleaning validation tests were met.
- Standards Conformance: Lists several ANSI/AAMI/ISO and IEC standards related to biocompatibility and medical electrical equipment.
However, the document lacks specific quantitative acceptance criteria for device performance (e.g., maximum displacement, accuracy of targeting) and details of a study proving these criteria are met. It only broadly states that "verification and validation testing showed conformance to applicable performance requirements specifications."
Therefore, I cannot populate the table or answer most of the questions as the required information is not present in the provided text.
Here's an overview of what could be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| (Missing) | (Missing) | (Missing) |
| Example: Immobilization Accuracy | *e.g., |
§ 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.