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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:

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.

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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 < 0.5mm," which is also the specification for the predicate device.

Therefore, many of the requested details cannot be extracted from the provided text.

Here's an attempt to fill the table and answer the questions based only on the available information, noting when information is missing:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not specified. The document refers to "bench tests" and "hardware and software verification and validation testing" but does not detail a specific test set of medical images or patient data.
• Data Provenance: Not specified, as no specific test set of patient data is described. The tests appear to be engineering and software validation rather than evaluation against a clinical dataset.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable/Not specified. The document describes engineering and software validation, not a study involving human experts to establish ground truth for clinical cases.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable/Not specified. There is no mention of human adjudication for a clinical test set.

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. The document explicitly states "Animal or clinical test: Not applicable for TaiChiC." This indicates no clinical study, including MRMC, was performed.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• The device described, TaiChiC Rotating Gamma System, is a hardware teletherapy device for radiation treatment, not an AI algorithm for diagnosis or image analysis. Therefore, a standalone algorithm performance study as typically understood for AI/CADe devices is not applicable here. The performance data focuses on system level compliance and accuracy.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable/Not specified. For the engineering and software tests described, the "ground truth" would be the specified technical requirements and expected device behavior rather than clinical ground truth (e.g., from pathology or expert consensus).

8. The sample size for the training set

• Not applicable/Not specified. This device is a radiation therapy system, not an AI/ML model that requires a training set in the conventional sense.

9. How the ground truth for the training set was established

• Not applicable/Not specified. As it's not an AI/ML model, the concept of a training set and its ground truth establishment doesn't apply.

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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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