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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:

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The system is a teletherapy device intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions in the brain and head where radiation treatment is indicated.

TaiChiC Rotating Gamma System has been designed to deliver radiation treatments in accordance with a prescribed plan. This system is a stereotactic radiotherapy equipment developed by applying the principle and mature technology of Cobalt-60 rotary focusing. It is suitable for brain and head lesions and tumors requiring radiotherapy, and provides image guided stereotactic radiosurgery and precision radiotherapy.

TaiChiC consists of a gantry with a slip ring, a focusing gamma ray treatment head, image guidance subsystem, couch, power supply and electrical cabinet, main cover and treatment bore etc. TaiChiC combines gamma beam stereotactic radiation therapy technology with contemporary advanced image guidance technology (IGRT) to provide image guided stereiotactic radiotherapy and precision radiotherapy.

The provided text describes the TaiChiC Rotating Gamma System, a teletherapy device for stereotactic radiosurgery and precision radiotherapy, and its substantial equivalence determination by the FDA. However, the document does not contain specific acceptance criteria, reported device performance metrics in a quantitative manner, detailed study designs, or information about human expert involvement for establishing ground truth.

The performance data section broadly states:

• Electrical Safety and Electromagnetic Compatibility (EMC): Compliance with IEC 60601-1 and IEC 60601-1-2 standards.
• Bench Test: Conformance to various IEC standards (60601-2-11, 60601-1-3, 60601-2-68, 61217, 62274, 62366-1, 60601-1-6), RT2, ISO 15223-1, and ISO 10993-1.
• Hardware and Software Verification and Validation Testing: Conducted according to 21 CFR §820, ISO 13485, ISO 14971, and FDA guidance for software in medical devices. The software was considered "major" level of concern.
• Animal or clinical test: Not applicable.

The conclusion states that verification and validation testing demonstrated that the device "met its specifications, demonstrated substantially equivalent performance to the predicate and met its intended use." One quantitative metric mentioned is "Radiologic accuracy

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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.

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