(218 days)
TaiChiB Digital Radiotherapy System is a teletherapy device equipped with two radiation beam delivery units within an enclosed gantry.
(1) The electron linear accelerator producing 6MV photon beam is indicated to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
(2) The rotating focused gamma beam emitting unit with multiple Cobalt-60 sources is indicated to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions in the brain and head where radiation treatment is indicated.
TaiChiB Digital Radiotherapy System integrates medical linear accelerator technology and rotating gamma technology for precision radiotherapy and stereotactic radiosurgery.
TaiChiB contains a gantry with a slip ring, 6 MV X-ray Beam Generation Module (BGM), Beam Shaping Module (BSM), Rotating Gamma Subsystem (RGS), Image Guidance System (IGS), Patient Support System (PSS), Treatment Control System (TCS).
The provide text is a 510(k) summary for the TaiChiB Digital Radiotherapy System. This document focuses on demonstrating substantial equivalence to predicate devices rather than detailing a specific study designed to meet pre-defined acceptance criteria for the new device's performance.
Therefore, the requested information regarding acceptance criteria, a study proving the device meets them, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a specific performance evaluation is not available within this document.
The document primarily highlights the device's technical specifications and compares them to predicate devices, stating that "The TaiChiB system is as safe and effective as the predicate device and reference device." and "The verification and validation testing demonstrated that TaiChiB has met its specifications, demonstrated substantially equivalent performance to the predicate and met its intended use."
The "PERFORMANCE DATA" section lists various electrical safety, EMC, and bench tests conducted according to relevant IEC and ISO standards. It also mentions "Hardware and Software Verification and Validation Testing" where test results showed TaiChiB conforms to applicable requirements and assures hazard safeguards functioned properly. However, these are general compliance statements and not specific performance metrics with acceptance criteria for the device's clinical efficacy or accuracy in the context of diagnostic or treatment capabilities. No clinical or animal studies were performed.
Summary of available information from the provided text:
1. A table of acceptance criteria and the reported device performance:
This information is not explicitly provided in the format of acceptance criteria for clinical performance and device performance results. The document instead presents a table comparing the new device's features and specifications to those of its predicate and reference devices, implying that matching or being similar to these established devices constitutes acceptable performance.
Excerpts from the "Detailed Comparisons" table representing device specifications that could be considered performance characteristics:
| Feature | New Device (K210921) | Predicate Device (K193207) | Reference Device (K203250) | Analysis of Differences |
|---|---|---|---|---|
| Initial Dose rate at the focal spot¹ | ≥3.5Gy / min | NA | ≥3.5Gy / min | Same as the reference device. |
| Radiologic accuracy |
§ 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.