(296 days)
The PTS is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.
The device corresponds to the previously cleared IBA proton therapy system (K101508) with the addition of a compact Gantry Beam line designed to produce and deliver a proton beam from various directions in a range of 220° for the treatment of patients.
The provided text describes a 510(k) premarket notification for a modification to the IBA Proton Therapy System - Proteus 235, specifically the introduction of a Compact Gantry Beam Line (CGBL). This document is primarily focused on demonstrating substantial equivalence to a predicate device rather than a comprehensive study report with detailed acceptance criteria and performance data from clinical trials.
Therefore, many of the requested sections about specific study methodologies, sample sizes, expert qualifications, and comparative effectiveness (MRMC) cannot be fully addressed from the provided text. The document focuses on comparing technological characteristics and functionality to establish equivalence.
Here's an attempt to extract the information based on the provided text, with significant limitations due to the nature of the document:
1. A table of acceptance criteria and the reported device performance
The document presents a comparison of the modified device (Compact Gantry Beam Line) against the predicate device (360° Gantry Beam Line) for various characteristics. In the context of a 510(k), the "acceptance criteria" are implied by the predicate device's performance, meaning the new device must meet or be substantially equivalent to these values.
| Characteristic | Acceptance Criteria (from 360° Gantry Beam Line) | Reported Device Performance (Compact Gantry Beam Line) |
|---|---|---|
| Angular position range | 360° | 220° |
| Isocenter accuracy (mechanical sphere of confusion radius) | 1 mm | 1 mm |
| Maximum rotation speed | 1 rpm | 1 rpm |
| Angle to get max speed | ≤30° | ≤30° |
| Maximum braking angle | 5° | 3° |
| Mechanical Angular repeatability | 0.25° | 0.25° |
| Brakes | Fail Safe | Same (Fail Safe) |
| Control for treatment mode | Multiple Access Point | Same (Multiple Access Point) |
| Motion modes | Goto, Jog | Goto, Jog, Trajectory |
| Treatment volume brought at isocenter | 100 cm X 50 cm X 40 cm | 100 cm X 50 cm X 40 cm |
| Collision prevention | By PPS load cell & proximity detection algorithm | By PPS load cell, proximity detection algorithm and sensors |
| Beam Range in Patient (Tissue depth) | Pencil Beam Scanning: 0.5 to 32 cm | Pencil Beam Scanning: 0.5 to 32 cm |
| Field size | 30 cm x 40 cm | 24 cm x 20 cm |
| Beam Distal Fall Off | ≤0.25 g/cm² above the physical limit | Same |
| Spot Size | ≤ 15 mm on the range of energies | Same |
| Spot Position accuracy | ≤ 15 % of beam sigma or |
§ 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.