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Cranial 4Pi is intended for patient immobilization in radiotherapy and radiosurgery procedures.

Cranial 4Pi is indicated for any medical condition in which the use of radiotherapy or radiosurgery may be appropriate for cranial and head & neck treatments.

Cranial 4Pi is an assembly of the following medical device/ accessory groups:

• CRANIAL 4PI OVERLAYS (CRANIAL 4PI CT OVERLAY, CRANIAL 4PI TREATMENT OVERLAY)
• CRANIAL 4PI HEADRESTS (CRANIAL 4PI HEADREST STANDARD, CRANIAL 4PI HEADREST LOW-NECK, CRANIAL 4PI HEADREST PLATFORM)
• CRANIAL 4PI HEADREST INLAYS (CRANIAL 4PI HEADREST INLAY STANDARD, CRANIAL 4PI HEADREST INLAY OPEN FACE, CRANIAL 4PI HEADREST INLAY H&N, CRANIAL 4PI HEAD SUPPORT STANDARD, CRANIAL 4PI HEAD SUPPORT WIDE)
• CRANIAL 4PI MASKS (CRANIAL 4PI BASIC MASK, CRANIAL 4PI OPEN FACE MASK, CRANIAL 4PI EXTENDED MASK, CRANIAL 4PI STEREOTACTIC MASK, CRANIAL 4PI STEREOTACTIC MASK 3.2MM)
• CRANIAL 4PI WEDGES AND SPACERS (CRANIAL 4PI WEDGE 5 DEG., CRANIAL 4PI WEDGE 10 DEG., CRANIAL 4PI SPACER 20MM, CRANIAL 4PI INDEXING PLATE)

The Cranial 4Pi Overlays are medical devices used for fixation of the patient in a CT- resp. linear accelerator - environment.

The Cranial 4Pi Headrests and the Cranial 4Pi Headrest Inlays are accessories to the Cranial 4Pi Overlays to allow an indication specific positioning of the patient's head and neck. The Cranial 4Pi Wedges and Spacers are accessories to the Cranial 4Pi Headrest Platform to adapt the inclination of the head support to the patients necks.

The Cranial 4Pi Masks are accessories to the Cranial 4Pi Overlays used for producing individual custom-made masks for patient immobilization to the Cranial 4Pi Overlay.

The provided text is a 510(k) Clearance Letter and 510(k) Summary for a medical device called "Cranial 4Pi Immobilization." This document focuses on demonstrating substantial equivalence to a predicate device, as required for FDA 510(k) clearance.

However, the provided text does not contain the detailed information typically found in a clinical study report or a pre-market approval (PMA) submission regarding acceptance criteria, study methodologies, or specific performance metrics with numerical results (like sensitivity, specificity, or AUC) that would be used to "prove the device meets acceptance criteria" for an AI/ML-driven device. The document primarily describes the device's components, indications for use, and a comparison to a predicate device to establish substantial equivalence.

The "Performance Data" section primarily addresses biocompatibility, mechanical verification, dosimetry, compatibility with another system, and mask stability. It does not describe a study to prove AI model performance against clinical acceptance criteria. The "Usability Evaluation" section describes a formative usability study, which is different from a performance study demonstrating clinical effectiveness or accuracy.

Therefore, many of the requested elements (especially those related to AI/ML model performance, ground truth establishment, expert adjudication, MRMC studies, or standalone algorithm performance) cannot be extracted from the provided text. The Cranial 4Pi Immobilization device appears to be a physical immobilization system, not an AI/ML diagnostic or prognostic tool.

Given the nature of the document (510(k) for an immobilization device), the concept of "acceptance criteria for an AI model" and "study that proves the device meets the acceptance criteria" in the traditional sense of an AI/ML clinical study does not apply here.

I will answer the questions based on the closest relevant information available in the provided text, and explicitly state where the information is not available or not applicable to the type of device described.

Preamble: Nature of the Device and Submission

The Cranial 4Pi Immobilization device is a physical medical device designed for patient immobilization during radiotherapy and radiosurgery. The 510(k) premarket notification for this device seeks to demonstrate substantial equivalence to an existing predicate device (K202050 - Cranial 4Pi Immobilization). This type of submission typically focuses on comparable intended use, technological characteristics, and safety/performance aspects relevant to the physical device's function (e.g., biocompatibility, mechanical stability, dosimetry interaction).

The provided documentation does not describe an AI/ML-driven component that would require acceptance criteria related to AI model performance (e.g., accuracy, sensitivity, specificity, AUC) or a study to prove such performance. Therefore, many of the questions asking about AI-specific validation (like ground truth, expert adjudication, MRMC studies, training/test sets for AI) are not applicable to this type of device and submission.

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

Based on the provided document, specific numerical "acceptance criteria" and "reported device performance" in the context of an AI/ML model are not available and not applicable. The document focuses on demonstrating substantial equivalence of a physical immobilization device.

However, the "Performance Data" section lists several tests and their outcomes, which serve as evidence that the device performs as intended for its physical function. These are not acceptance criteria for an AI model.

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 applicable/not stated in the context of an AI/ML test set. The usability evaluation involved "seven participants" in "three different clinics." For biocompatibility, animal studies were performed (guinea pigs for sensitization, rabbits for irritation; specific number of animals not stated but implied to be sufficient for ISO standards).
• Data Provenance: Not applicable for an AI/ML test set. The usability evaluation involved "three different clinics" but the country of origin is not specified.

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. This device is a physical immobilization system, not an AI/ML diagnostic or prognostic tool that requires expert-established ground truth on medical images.

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

• Not applicable. This information is relevant to validating AI/ML diagnostic performance against ground truth, which is not described for this device.

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 is an AI/ML-specific study design. The device is a physical immobilization system, not an AI assistance tool for human readers.

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

• Not applicable. This is an AI/ML-specific validation. There is no AI algorithm component described for this physical device.

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

• Not applicable. No ground truth for diagnostic or prognostic purposes is established for this physical device. The "performance data" relies on standards compliance (e.g., ISO, IEC), physical measurements, and usability feedback.

8. The sample size for the training set

• Not applicable. There is no AI model described that would require a training set.

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

• Not applicable. There is no AI model described.

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