(261 days)
TaiChiA, is a Medical Linear Accelerator intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
TaiChiA Medical Linear Accelerator, has been designed to deliver radiation treatment in accordance with a prescribed plan. This system utilizes kV image guidance technology (IGRT) to deliver photon based radiation therapy treatments, using an integrated rotating linear accelerator system. TaiChiA is a single energy medical linear accelerator designed to deliver Image Guided Radiation Therapy and Radiosurgery, using 3DCRT, IMRT and VMAT techniques. It consists of the accelerator and patient support within a radiation shielded treatment room and a control console in the control room.
The provided text does not contain explicit acceptance criteria and device performance in a table format, nor does it detail a study proving the device meets specific acceptance criteria using statistical measures (sensitivity, specificity, etc.) typically associated with AI/ML performance. The document describes a medical linear accelerator (TaiChiA) and compares its specifications to predicate and reference devices in tables, asserting substantial equivalence. It confirms various verification and validation tests were performed (electrical safety, EMC, bench tests, hardware/software) to show compliance with relevant standards and specifications.
However, based on the provided text, I can extract and infer information about the device's specifications and the type of testing performed for its regulatory clearance.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a formal table of "acceptance criteria" against which specific "device performance" metrics (like accuracy, sensitivity, specificity for an AI component) are reported. Instead, it presents detailed comparative tables of the TaiChiA's specifications against a predicate device (Varian Halcyon, K181032) and a reference device (Varian TrueBeam, K171733). The "acceptance criteria" here are implicitly the demonstrated equivalence or comparable performance to these legally marketed devices across various physical and functional attributes. The "reported device performance" is the TaiChiA's specifications as listed in these comparison tables.
Below is a summary of key comparative specifications. These essentially serve as the "performance" metrics evaluated for substantial equivalence.
| Attribute/Feature | Predicate Device (Varian Halcyon, K181032) | Proposed Device (TaiChiA Medical Linear Accelerator) | Reference Device (TrueBeam, K171733) |
|---|---|---|---|
| Beam Specification | |||
| Beam energy (MV) | 6MV, FFF | 6MV, FFF | 6/8/10/15/18/20MV (FF), 6/10MV (FFF). (TaiChiA 6MV FFF) |
| Maximum dose rate (cGy/min) | Up to 800 | Up to 1400 | Up to 1400 (6MV FFF) |
| Maximum treatment field (cm) | 28x28 | 40x40 | 40x40 |
| Dmax (cm) | 1.3 +/- 0.2 | 1.5 +/- 0.2 | Not explicitly listed in TrueBeam comparison |
| Percentage dose at 10 cm depth (%) | 63.0 +/- 1.0 | 65.0 +/- 2.0 | Not explicitly listed in TrueBeam comparison |
| Off axis intensity (%) | 79.0 +/- 2.0 | 76.0 +/- 2.0 | Not explicitly listed in TrueBeam comparison |
| Symmetry (%) |
§ 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.