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The Varian Head Frame System is for use with a computed tomography scanner to perform imaging for treatment planning and a charged particle accelerator to perform immobilization of the treatment target for stereotactic radiosurgery or radiotherapy treatments on cranial lesions, tumors and conditions where radiation treatment is indicated.

The Head Frame provides rigid immobilization of a patient's skull by attaching a rigid halo (head frame) to the patient through four invasive contact points (called screws or pins) which penetrate the patient's skin and contact the bone of the skull. The head frame is secured to either the CT table or the treatment table via a bracket which is included in the system. This ensures the patient cannot easily move during imaging or treatment. This level of immobilization is generally used for stereotactic radiosurgery.

This document is a 510(k) premarket notification for the "Varian Head Frame" system. It describes the device, its intended use, and a comparison to a predicate device, but it does not contain the detailed information requested regarding acceptance criteria and a study proving the device meets those criteria, specifically concerning performance metrics like accuracy, sensitivity, or specificity.

The document discusses:

• Device Name: Varian Head Frame
• Intended Use: For immobilization during stereotactic radiosurgery or radiotherapy treatments on cranial lesions.
• Predicate Device: Optical Guidance Platform (K071360)
• Technological Characteristics: Compares features like patient fixation (four pins), materials, sterilization methods, rigid fixation mechanisms, anatomy/head/neck fixation, couch mount degrees of freedom, and positioning/localization features.
• Summary of Performance Testing: States that "Results of verification and validation testing showed conformance to applicable performance requirements specifications and assured hazard safeguards functioned properly." It also mentions biocompatibility and cleaning validation tests were met.
• Standards Conformance: Lists several ANSI/AAMI/ISO and IEC standards related to biocompatibility and medical electrical equipment.

However, the document lacks specific quantitative acceptance criteria for device performance (e.g., maximum displacement, accuracy of targeting) and details of a study proving these criteria are met. It only broadly states that "verification and validation testing showed conformance to applicable performance requirements specifications."

Therefore, I cannot populate the table or answer most of the questions as the required information is not present in the provided text.

Here's an overview of what could be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information:

• Specific quantitative acceptance criteria (e.g., for immobilization accuracy, stability).
• Quantified reported device performance values against these criteria.

2. Sample size used for the test set and the data provenance

Missing Information: The document does not specify any test set sample size or data provenance (country of origin, retrospective/prospective) for performance evaluation. It mentions "verification and validation testing" but not the specifics of such testing in terms of patient data or sample size.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Missing Information: Not applicable, as there is no mention of a test set with ground truth established by experts. The device is a physical immobilization system, not one that generates diagnostic interpretations requiring expert consensus.

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

Missing Information: Not applicable, as there is no mention of a test set and associated adjudication process.

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

Missing Information: Not applicable. This device is an immobilization system and does not involve AI or human readers for diagnostic interpretation.

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

Missing Information: Not applicable. This device is an immobilization system, not an algorithm.

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

Missing Information: Not explicitly stated or applicable in the context of device performance metrics for an immobilization system. Ground truth would likely be against physical measurements (e.g., displacement measurements) rather than a diagnostic 'truth'.

8. The sample size for the training set

Missing Information: No training set is mentioned as this is a physical device, not an AI/algorithm-based system requiring training data.

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

Missing Information: Not applicable.

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