Search Results

Halcyon is indicated for the delivery of stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation is indicated for adults and pediatric patients.

Halcyon is a single energy medical linac designed to deliver Image Guided Radiation Therapy and Radiosurgery, using Intensity Modulated and Volumetric Modulated Arc Therapy techniques. It consists of the accelerator and patient support within a radiation shielded treatment room and a control console outside the treatment room.

The provided text does not contain information about acceptance criteria for a device's performance that would require a study to prove it meets those criteria.

Instead, the document is a 510(k) premarket notification for a medical device called "Halcyon," a medical charged-particle radiation therapy system. The FDA's letter (pages 0-1) confirms that the device is substantially equivalent to legally marketed predicate devices.

The "510(k) Summary" (pages 3-4) describes the device, its intended use, indications for use, and differences from a predicate device (Halcyon K170817), as well as non-clinical testing and standards conformance.

Key takeaways from the document regarding testing and validation are:

• Non-clinical testing (hardware and software verification and validation) (page 4) was conducted according to:
  • FDA Quality System Regulation (21 CFR §820)
  • ISO 13485 Quality Management System standard
  • ISO 14971 Risk Management Standard
  • Other FDA recognized consensus standards (e.g., IEC 60601 series, IEC 62304, ISO 10993-1, etc.).
• Software was considered a "major" level of concern, and verification/validation testing was conducted as per FDA guidance.
• Electrical safety and EMC testing was conducted, complying with IEC 60601-1 and IEC 60601-1-2 standards.
• The outcome of non-clinical testing was that the product conformed to defined user needs and intended uses, with no remaining discrepancy reports of "Safety Intolerable" or "Customer Intolerable" priority.
• The manufacturer concludes that Halcyon is safe and effective and performs at least as well as the predicate device.

None of the requested information (acceptance criteria table, sample size, data provenance, expert ground truth, adjudication method, MRMC study, standalone performance, training set size, etc.) can be extracted from the provided text. The document focuses on regulatory compliance, safety, and substantial equivalence rather than performance metrics from a specific comparative study.

Ask a specific question about this device