(152 days)
AccuSoft is intended to be used for the computation, display, evaluation, and output documentation of radiation dose estimations that are to be submitted for independent clinical review and verification by a physicist or physician prior to use.
The application provides output data in the form of displays or hardcopy printouts to guide a physician in selecting the optimum patient treatment plan. It is intended to provide a report to be used by a competent health professional such as a radiation oncologist, medical physicist, radiation therapist or dosimetrist.
AccuSoft is a radiation treatment planning system. It consists of a software package that executes accepted algorithmic approaches to produce radiation dose estimations and of extensive verification and quality assurance (QA) procedures to enable the proper system and patient setup and adequate radiation delivery. It includes the same image acquisition, localizing, delineation and beam planning techniques. AccuSoft is designed with stationary or "static" radiation beams. These beams can be shaped with a shaping device, a Micro-Multi-Leaf Collimator (MMLC), such that the shape of the radiation beam conforms to the irregular shape of the lesion. The ability to shape the radiation beam enables the user to treat irregularly shaped lesions, maximizing the radiation dose to the lesion, while minimizing the radiation dose to the surrounding normal tissue and critical structures.
The provided text is a 510(k) summary for a medical device called AccuSoft, a radiation treatment planning system. However, the document does not contain any information regarding specific acceptance criteria, study data, sample sizes, ground truth establishment, or multi-reader multi-case (MRMC) studies.
The summary focuses on:
- Administrative details: Applicant information, contact, trade name, classification, predicate device, and performance standards.
- Compliance with general standards: Guidance documents for software, electrical safety, risk analysis, and failure mode analysis.
- Intended Use: For computation, display, evaluation, and documentation of radiation dose estimations for clinical review and verification.
- Device Description: Software package for radiation dose estimations, verification, QA procedures, and beam planning techniques (static beams, MMLC).
- Substantial Equivalence claim: Based on validations and performance testing results (without providing details).
- FDA Clearance Letter: Confirming the substantial equivalence determination for marketing the device.
Therefore, based solely on the provided text, I cannot complete the requested tables and answer the questions. The information requested (acceptance criteria, device performance, study details, sample sizes, ground truth, expert qualifications, adjudication, MRMC studies, standalone performance, training set details) is not present in this document.
§ 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.