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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.

The study described is essentially the collection of various tests and comparisons to demonstrate substantial equivalence to predicate devices, thus meeting regulatory acceptance for market clearance.

2. Sample size used for the test set and the data provenance
The document discusses "bench tests" and "hardware and software verification and validation testing" according to various international standards (IEC, ISO). However, it does not specify sample sizes for these tests in terms of patient data or a specific number of testing scenarios. The nature of these tests are for device performance and safety, not for diagnostic accuracy on a clinical dataset. The data provenance is not specified beyond the device being manufactured by "OUR UNITED CORPORATION" in Xi'an, China. It appears to be device-level testing rather than clinical study data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. The tests described are engineering and regulatory compliance tests, not clinical performance evaluations requiring expert-established ground truth on patient data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided as the described tests do not involve human adjudication of clinical outcomes or images.

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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a medical linear accelerator for radiation therapy, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This refers to a standalone performance of an AI algorithm. The device, TaiChiA, is a physical medical linear accelerator, not an AI algorithm for image analysis or diagnosis. Therefore, this question is not applicable in this context. The document describes traditional device verification and validation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the described bench tests, electrical safety, EMC, and hardware/software verification, the "ground truth" would be the specifications and requirements defined by the relevant international standards (e.g., IEC 60601 series, IEC 61217, ISO 13485) and the device's design specifications. There's no mention of clinical ground truth (like pathology or outcomes data) as this is not a diagnostic device evaluated for disease detection.

8. The sample size for the training set
This information is not provided and would not be relevant for a physical medical device like a linear accelerator in the context of its regulatory clearance based on substantial equivalence. This question typically applies to AI/ML software.

9. How the ground truth for the training set was established
This information is not provided and is not applicable for the type of device and regulatory submission described.

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