Search Results

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:

These are technical specifications and not acceptance criteria from a clinical performance study. The "Analysis of Differences" column indicates that if the new device's specification is the "Same as" the predicate or reference device, it is considered acceptable for substantial equivalence.

2. Sample size used for the test set and the data provenance:
Not applicable, as no clinical or animal test performance study is reported. The document states "Animal or clinical test: Not applicable for TaiChiB". The listed "Bench Test" and "Hardware and Software Verification and Validation Testing" are conducted in accordance with specified standards and internal procedures, but detailed sample sizes of data used for these engineering tests are not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as no study involving human expert ground truth for clinical cases is reported.

4. Adjudication method for the test set:
Not applicable, as no study involving human adjudication is reported.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable, as no MRMC study or AI component requiring human reader interaction is discussed. The device is a radiation therapy system, not an AI-assisted diagnostic or intervention system in the context of image interpretation.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable, as the document does not describe a standalone algorithm performance study for clinical efficacy or accuracy in diagnosis/treatment planning beyond the general verification and validation of software and hardware.

7. The type of ground truth used:
For the engineering and software validation, the "ground truth" would be the predefined functional and performance requirements derived from the device's design specifications and compliance with international standards (e.g., IEC, ISO). No clinical ground truth (e.g., pathology, outcomes data) is mentioned as it's not a clinical performance study.

8. The sample size for the training set:
Not applicable, as this document does not describe a machine learning model requiring a training set for clinical performance.

9. How the ground truth for the training set was established:
Not applicable.

Ask a specific question about this device