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To provide treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy for lesions (e.g. arteriovenous malformations), tumors and conditions of the brain, base of skull (BOS), cervico-thoracic spine (CTS), head and neck.

The CyberKnife® System for Stereotactic Radiosurgery/Radiotherapy is a treatment planning, imaging, and treatment delivery system for image-guided stereotactic radiosurgery and precision radiotherapy. The treatment planning system provides 3-dimensional viewing of the patient anatomy with appropriate dose calculation of the target volume and surrounding tissue structures. The imaging system provides real-time, orthogonal x-ray images of the patient in the treatment position to verify treatment position and accuracy and provides information suitable for dynamically positioning and pointing a linear accelerator. The treatment delivery system consists of a linear accelerator which provides 6 MV x-rays. A six-access manipulator provides automated positioning and pointing of the linear accelerator. The treatment couch provides positioning of the patient.

The provided document is a 510(k) summary for the CyberKnife™ System, a medical device for stereotactic radiosurgery/radiotherapy. It focuses on the substantial equivalence to a predicate device and does not contain detailed information on acceptance criteria or a study proving that the device meets specific performance criteria.

Therefore, I cannot provide the requested information from the given text.

The document does not describe:

1. A table of acceptance criteria and the reported device performance: The "Feature Comparison Chart" compares technological characteristics between the CyberKnife and a predicate device (Varian Clinac 600SR), but these are not presented as acceptance criteria for a new device's performance validation. For example, "Mechanical Isocenter Accuracy" is listed as "≥ 0.05 cm RMS for all treatment nodes" for the CyberKnife, which could be an acceptance criterion, but the context does not explicitly state it as such for a validation study. There is no accompanying "reported device performance" against such a criterion in the document.
2. Sample size used for the test set and the data provenance: No information on any test set or data provenance is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No information on experts or ground truth establishment for a test set is provided.
4. Adjudication method for the test set: No information on an adjudication method is provided.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: No information on an MRMC study is provided.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The CyberKnife is a treatment delivery system, not an algorithm in the typical sense this question implies for AI/diagnostic devices. The document does not describe standalone performance testing for software components.
7. The type of ground truth used: No information on the type of ground truth for any study is provided.
8. The sample size for the training set: The document describes a medical device, not a machine learning model, so there is no concept of a "training set" in this context.
9. How the ground truth for the training set was established: Not applicable as there is no training set.

The document primarily focuses on establishing substantial equivalence in terms of technological characteristics and intended use compared to a predicate device, as required for 510(k) clearance by the FDA, rather than presenting a performance study with detailed acceptance criteria.

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The NOMOS TALON Positioning and Immobilization System is intended to provide an invasive means to repeatedly position and immobilize a patient during:

• a) diagnostic procedures in preparation for radiation therapy (RT) treatments of the head or head and neck, and
• b) during treatment procedures in the radiation therapy suite.

The NOMOS TALON Positioning and Immobilization System is intended to provide an invasive means to repeatedly position and immobilize a patient during diagnostic procedures in preparation for radiation therapy (RT) treatments of the head or head and neck, and during treatment procedures in the radiation therapy suite. Major components include the TALON Skull Mount, NOMOGrip, Target Box, CT Reference Pointer, Radiotherapy Table Adapter, and CT Head Support.

The provided text describes the NOMOS TALON Positioning and Immobilization System and its claim of substantial equivalence to predicate devices. However, it does not contain any information regarding specific acceptance criteria, a study proving the device meets those criteria, or details about sample sizes, ground truth establishment, or expert involvement for performance evaluation.

Therefore, I cannot populate the requested table and answer many of the questions based on the provided text.

Here's an assessment based on the available information:

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

2. Sample sized 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 mentioned in the document.
• Data Provenance: Not mentioned in the document. The document refers to predicate devices and their existing marketing status but gives no details about new testing data for the TALON system.

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 mentioned in the document.

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

• Not mentioned in the document.

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. This device is a physical positioning and immobilization system, not an AI or imaging interpretation tool. There is no mention of such a study.

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

• Not applicable. This device is a physical device, not an algorithm.

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

• Not mentioned in the document. The document relies on similarity comparisons to predicate devices rather than direct performance testing against a defined ground truth for the TALON system itself.

8. The sample size for the training set

• Not applicable. This device is a physical system, not a machine learning model that would have a "training set."

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

• Not applicable. See point 8.

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