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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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