(193 days)
The IMFAST product is intended to calculate a sequence of multi-leaf collimator (MLC) segments. These resulting segments are then written to a file, allowing the V&R system or the RTP system to pick it up for further processing. In the case of SIEMENS' LANTIS and PRIMEVIEW, the file can be imported and the segments can be grouped into intensity modulation groups. The treatment can then be delivered in sequence using SIMTEC and an MLC, thus providing the patient with automated, computer-controlled intensity modulation radiotherapy (IMRT).
IMFAST is a MLC optimization algorithm that sets the MLC jaws for modulated intensity profiles, thereby eliminating the need for BeamShaper like products or compensator blocks. IMFAST takes from the radiotherapy treatment planning (RTP) system an intensity map or a matrix of compensator thickness and calculates a sequence of multi-leaf collimator (MLC) segments. The plan can be reviewed for accuracy and treatment time. These resulting segments are then written to a file, allowing the V&R system or the RTP system to pick it up for further processing. In the case of SIEMENS' LANTIS and PRIMEVIEW, the file can be imported and the segments can be grouped into intensity modulation groups. The treatment can then be delivered in sequence using SIMTEC and an MLC, thus providing the patient with automated, computer-controlled intensity modulation radiotherapy (IMRT).
The provided text describes the Siemens IMFAST device, an MLC optimization algorithm for radiation therapy. However, the document is a 510(k) submission summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed performance study with explicit acceptance criteria.
Therefore, the requested information regarding acceptance criteria, specific study design, sample sizes, expert qualifications, and ground truth establishment is not available within the provided text. The document states that "No applicable performance standards have been established by the FDA under section 514 of the Food, Drug and Cosmetic Act," and Siemens considers IMFAST to be "substantially equivalent" to the predicate device, BeamShaper.
Based on the provided text, I cannot complete the table or answer the specific questions about the device's performance study and acceptance criteria as they are not detailed.
The document primarily focuses on:
- Device Description: IMFAST is an MLC optimization algorithm that calculates sequences of multi-leaf collimator segments for Intensity Modulated Radiation Therapy (IMRT).
- Intended Use: To generate MLC segments from intensity maps or compensator thickness matrices from a radiotherapy Treatment Planning (RTP) system.
- Technological Characteristics: Outputting MLC segments to a file for further processing by V&R or RTP systems, and for grouped intensity modulation with Siemens' LANTIS and PRIMEVIEW, delivered via SIMTEC and MLC for automated IMRT.
- Predicate Device: BeamShaper, 510(k) No. K961902.
- Substantial Equivalence Argument: The configuration and specification differences do not alter the intended use or introduce new safety issues compared to the predicate.
- FDA Clearance: A 510(k) clearance based on substantial equivalence, with a correction to the classification and procode.
In summary, the provided text does not contain the specific performance study details, acceptance criteria, or experimental results you are asking for.
§ 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.