(57 days)
A pre-processing registration tool for use with other stereotactic surgical and neurosurgical treatment planning systems.
The above system is a pre-processing registration (fusion) software for CT, MR and PET scans. The software provides QA tools for the user to evaluate the fusion results. The results are used with other Integra Radionics applications. The software can be used on a HP UNIX or Linux workstation.
This submission does not contain information about acceptance criteria or a study that proves the device meets acceptance criteria. The provided documents are a 510(k) summary and the FDA's clearance letter for the Integra Radionics ImageFusion 3.
Here's a breakdown of what is and is not in the provided text:
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What's present:
- Device Name: Integra Radionics ImageFusion 3
- Predicate Device: Radionics ImageFusion 2, 510(k), K990071
- Intended Use/Indications for Use: "A pre-processing registration tool for use with other stereotactic surgical and neurosurgical treatment planning systems." and "registering (fusing) stereotactic and non-stereotactic scans."
- Technological Characteristics: Stated as "the same or similar to those found with the predicate devices."
- Regulatory Information: 510(k) number (K063230), regulation number, product code, regulatory class.
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What's missing (information needed to answer the request):
- A table of acceptance criteria and reported device performance.
- Details of any study (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods).
- Information on MRMC comparative effectiveness studies or standalone performance.
- Training set details (sample size, ground truth establishment).
To answer your request thoroughly, a performance study report or verification and validation documentation would be needed, which is not included in this 510(k) summary. 510(k) summaries primarily focus on demonstrating substantial equivalence to a predicate device rather than detailing specific performance studies with acceptance criteria, especially for devices where clinical performance might be inferred from the predicate and technological similarity.
§ 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.