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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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