(18 days)
The AIO Solution 3.0 is a positioning and immobilization system to set-up and reproduce the supine and prone position of belly & pelvic patients and the prone position of breast patients during radiation therapy.
The AIO Solution 3.0 with accessories provides the immobilization and positioning system necessary to set-up and reproduce the position of a patient for supine and prone belly & pelvic treatments or prone breast treatments in radiation therapy.
For belly & pelvic treatments, the AIO solution 3.0 base plates (already cleared: K191158) can be used in combination with the green AIO 3.0 belly & pelvic positioning cushions and accessories. Depending on the anatomy of the patient, 2 different sizes of belly inserts are available to make sure the intestines can be pulled out of the treatment area when in prone position. The arms of the patient are positioned above the head to bring them out of the treatment field. A full belly insert should be used in supine position while the arms of the patient can be positioned on the chest to bring them out of the treatment field. The legs of the patient are supported by the grey AIO 3.0 knee & leg positioning cushions and/or the AIO 3.0 indexable feet support (already cleared; K191158). For increased precision, the set-up can be combined with an Orfit thermoplastic EFFICAST mask.
For prone breast treatments, the AIO solution 3.0 base plates (already cleared; K191158) can be used in combination with the yellow AIO 3.0 prone breast positioning cushions and accessories. The arms of the patient are positioned above the head to bring them out of the treatment field. The legs of the patient are supported by the grey AIO 3.0 knee & leg positioning cushions (already cleared; K191158). For increased precision, the set-up can be combined with an Orfit thermoplastic EFFICAST mask.
The provided text describes a medical device, "The AIO Solution 3.0," and its substantial equivalence determination by the FDA. However, the document does not contain any information regarding acceptance criteria or the study details typically associated with AI/ML-driven medical devices, such as performance metrics (e.g., sensitivity, specificity), ground truth establishment, expert adjudication, or training/test set sample sizes.
The "PERFORMANCE DATA" section of the document primarily focuses on:
- Sterilization and Shelf Life: Stating devices are non-sterile and made of durable polymers with low degradation.
- Biocompatibility: Emphasizing that materials are identical to the predicate device, thus no new testing is needed.
- Electrical Safety, EMC, Software, Cybersecurity: Stating the device contains no active components, software, or ports, rendering these categories irrelevant.
- MRI Safety: Confirming material compatibility with MR environments.
- "Performance Testing": This solely refers to dosimetry testing (measurement of radiation attenuation and water equivalent thickness), not clinical performance or diagnostic accuracy. It states, "The test data meets the A/R criteria predetermined for the device," but does not define what those A/R criteria are or what the actual reported performance values were.
Therefore, based only on the provided input, I cannot answer the questions related to AI/ML device performance, acceptance criteria, study design for diagnostic accuracy, or ground truth establishment. The device in question appears to be a physical positioning and immobilization system for radiation therapy, not an AI/ML diagnostic or predictive tool.
If this was a misunderstanding and the request was for a hypothetical AI/ML device, I would need more specific attributes to invent a plausible scenario. However, as per the input, the device's assessment focuses on material properties and physical radiation attenuation, not AI/ML performance.
§ 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.