(113 days)
Fraxion™ is intended to be used for immobilisation, positioning and re-positioning during Stereotactic Radiotherapy (SRT) in all parts of the brain and head in a Linear Accelerator environment.
Further Fraxion™ is used to immobilise and position the head during image acquisition to support treatment planning.
Under certain circumstances (e.g. when the patient will not tolerate an invasive frame) Fraxion™ may also be used for Stereotectic Radiosurgery (SRS) in a Linear Accelerator environment.
Fraxion™ is a device for cranial stereotactic radiotherapy and radiosurgery. The major parts of the system include the Fraxion frame, Patient Control Unit, Frontpiece incl. Mouthpiece, vacuum cushion, thermoplastic mask and Stereotactic Frame.
The provided text is a 510(k) summary for the Fraxion™ device. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, the document does not contain information about acceptance criteria, specific study designs, sample sizes for test or training sets, ground truth establishment, or expert qualifications for evaluating device performance. The document refers to a "preparation date" but doesn't mention any specific technical studies or performance data.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance: This information is not present in the provided text. The document is primarily an administrative summary for regulatory clearance, not a performance study report.
- Sample sized used for the test set and the data provenance: Not available.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
- Adjudication method for the test set: Not available.
- 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 available. The device is a physical immobilization and positioning system, not an AI-assisted diagnostic or assistive tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not available.
- The sample size for the training set: Not applicable (not an AI device).
- How the ground truth for the training set was established: Not applicable.
The document discusses the regulatory clearance of a physical medical device (Fraxion™) used for immobilization, positioning, and re-positioning in stereotactic radiotherapy and radiosurgery. It is not an AI/algorithm-based diagnostic or treatment planning system that would typically have the types of performance studies and metrics you are asking about.
§ 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.