(17 days)
The [Trade Name] Fiducial Marker is intended to be implanted into the body to accurately visualize and constitute the reference frame for stereotactic body radiosurgery (SBRT) and radiotherapy target localization.
The [Trade Name] Fiducial Marker is a sterile, pyrogen free, single patient use, pyrolytic carbon coated zirconium oxide discrete marker incorporated into lyophilized glucan gel carrier that is visible on kV X-ray, CT, CBCT, mammography, ultrasound, and Magnetic Resonance Imaging (MRI).
The provided text is a 510(k) summary for a medical device called the "[Trade Name] Fiducial Marker." However, it does not contain the specific information required to answer questions 1 through 9 about acceptance criteria and the study that proves the device meets them.
The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices, addressing regulatory requirements like biocompatibility, visibility, MR safety, sterilization, and packaging/shelf-life. It mentions that "A Failure Modes and Effects Analysis (FMEA) was performed in order to assess the risks associated with the modifications introduced," and that "A biocompatibility, visibility, MR safety / compatibility and sterilization and packaging / shelf-life adoption evaluation confirmed that the modified device, [Trade Name] Fiducial Marker, was substantially equivalent to the predicate devices." This implies that some testing was done to ensure basic device functionality and safety, but it does not detail a study with the kind of acceptance criteria, test set, ground truth establishment, or multi-reader studies typically associated with validating an AI/ML-based medical device.
Therefore, based on the provided text, I cannot complete the table or answer the specific questions about acceptance criteria and performance studies. The document describes a traditional medical device (fiducial marker) clearance process, not one for an AI/ML-driven diagnostic or treatment planning system that would involve such performance metrics validated against a ground truth dataset and human expert comparisons.
§ 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.