(46 days)
For cranial fixation during CT scanning and treatment with the TomoTherapy HiArt System.
The Interfix Patient Adapters consists of two adapters, the InterFix™ CT Adapter which attaches to the CT scanner tabletop and the InterFix™ Tabletop Adapter for attachment to the TomoTherapy HiArt System tabletop. The adapters are designed to accept the Integra Radionics headrings, such as the Gill-Thomas-Cosman relocatable headring. Universal Compact Head Ring (UCHR), Intubation Headring Assembly (HRA-IM), and Tarbell-Loeffler Cosman (TLC) Pediatric Frame. The purpose of the Interfix system is to hold a patient securely and in the same position during the diagnostic CT scan and TomoTherapy HiArt Treatment. The adapters can be used to aid the user in aligning the patient to the lasers; however, the prescan is still required to ensure that the patient is in the correct position.
This device is for mechanical fixation and does not involve AI or algorithms, therefore, most of the requested information is not applicable.
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Cranial fixation during CT scanning and treatment with the TomoTherapy HiArt System. | The device accepts various headrings (Integra Radionics headrings, Universal Compact Head Ring (UCHR), Intubation Headring Assembly (HRA-IM), and Tarbell-Loeffler Cosman (TLC) Pediatric Frame) for secure patient positioning during CT scanning and TomoTherapy HiArt treatment. The device aids in aligning the patient to lasers, with prescan still required to ensure correct positioning. |
Study Information (Not Applicable for this mechanical device):
- Sample size used for the test set and the data provenance: Not applicable. This is a mechanical fixation device, not a diagnostic or AI-driven system that processes data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a mechanical fixation device is typically based on mechanical stability and fit, not expert interpretation of outputs.
- Adjudication method for the test set: Not applicable.
- 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 is not an AI-assisted device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device does not have an algorithm.
- The type of ground truth used: For a mechanical device like this, the "ground truth" would be objective measurements of stability, reproducibility of positioning, and compatibility with the specified headrings and equipment (CT scanner, TomoTherapy HiArt System). The provided text implies that these functional requirements were met for the device to be cleared.
- The sample size for the training set: Not applicable. There is no training set for a mechanical device.
- How the ground truth for the training set was established: Not applicable.
§ 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.