(26 days)
The Cranial 4Pi Immobilization is a device used for immobilization of the patient's •cranial area •head and neck area in a CT- and linear accelerator environment.
The Cranial 4Pi Immobilization device is indicated for any medical condition in which the use of radiotherapy or radiosurgery may be appropriate for cranial and head & neck treatments.
The Cranial 4Pi Immobilization group of devices is used for fixation and repositioning of the patient's head and neck in a CT- and linear accelerator environment.
The SRS 4Pi CT Table Overlay (43430) is a medical device used for fixation and repositioning of the patient's head and neck in a CT- environment.
The mask sets Cranial 4Pi Stereotactic Mask (43450) / Cranial 4Pi Basic Mask (43451) / Cranial 4Pi Openface Mask (43452) are medical devices used for producing custom-made masks for patient fixation to the Overlay Board in a CT- and linear accelerator environment.
The device is portable. The system consists of two Overlays, three types of thermoplastic mask sets with the corresponding rear head support and a Target Pointer. The system fixates a patient mechanically to hold them still during CT scanning and again during Treatment. The Overlays (one for Linac room) are used to rigidly attach to multiple Table top/Couch Top types and to provide an interface to the Mask sets. The Target Pointer is used for performance of isocenter quality assurance procedures in a linear accelerator environment.
The provided text describes a medical device, Cranial 4Pi Immobilization, which is used for patient immobilization during radiotherapy and radiosurgery. The 510(k) submission primarily focuses on establishing substantial equivalence to a predicate device and details verification activities related to mechanical stability, usability, and biocompatibility.
However, the provided document does NOT contain information about any study that proves the device meets specific acceptance criteria related to its performance in terms of patient immobilization accuracy or any AI/imaging-related performance metrics. The text outlines the device's function (immobilization) and general safety/effectiveness verification, but it does not present a table of acceptance criteria with reported device performance outcomes for areas like:
- Accuracy of immobilization (e.g., maximum displacement allowed vs. measured displacement)
- Repeatability of patient positioning
- Performance compared to human readers (MRMC study)
- Standalone algorithm performance
- Details on test set or training set characteristics (sample size, provenance, ground truth establishment, expert adjudication).
The document is a regulatory submission for a physical immobilization device, not a software-driven AI diagnostic or therapeutic device. Therefore, questions 2 through 9 regarding study design, sample size, expert involvement, and AI performance are not applicable to the content provided.
Based on the provided text, I can only address the general nature of the "acceptance criteria" through the lens of safety and effectiveness for a physical device, and the "study" as the verification activities performed for regulatory clearance.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this type of physical immobilization device are largely focused on mechanical stability, usability, and biocompatibility, rather than diagnostic accuracy or AI performance metrics. The document lists "Key Performance Specifications/Characteristics" as "Immobilization of patient's head or head and neck." However, it doesn't quantify this performance.
Here's an interpretation based on the provided text, focusing on the types of verification activities performed, which imply the acceptance criteria were related to meeting harmonized standards and ensuring user safety and device function.
| Acceptance Criteria Category | Report Device Performance (Based on Verification Activities) |
|---|---|
| Mechanical Stability | Acceptance Criteria: Device withstands forces and operational stresses without failure, ensuring patient stability and safety. Meets applicable paragraphs of IEC 60601-1:2005 AMD 2012. |
| Reported Performance: "Mechanical stability tests (according to applicable paragraphs of IEC 60601-1:2005 AMD 2012)" were carried out. (Details of specific pass/fail results or quantitative data are not provided in this summary). | |
| Usability | Acceptance Criteria: Device is safe and effective for use by intended users, minimizing use errors. Meets EN 62366:2008. |
| Reported Performance: "Usability evaluations (according to EN 62366:2008)" were performed to ensure safe and effective user interaction (e.g., attachment of Overlay, patient immobilization with mask). (Specific findings or metrics of usability are not detailed). | |
| Biocompatibility | Acceptance Criteria: Materials used in patient contact are non-toxic and do not cause adverse biological reactions. Meets ISO 10993-1: 2010. |
| Reported Performance: "Biocompatibility testing acc. to ISO 10993-1: 2010" was conducted. (Specific results are not provided). | |
| Dosimetry (Radiation Interaction) | Acceptance Criteria: Device does not unduly attenuate or build up radiation dose, ensuring accurate treatment delivery. |
| Reported Performance: "Dosimetry testing (dose build-up, dose attenuation)" was performed. (Specific values or ranges are not provided). | |
| Compatibility/Interface | Acceptance Criteria: Device interfaces correctly and safely with other specified equipment (CT- and linear accelerator environment, couch tops). |
| Reported Performance: "Compatibility / interface testing" was performed. (Specific outcomes not detailed). | |
| General Safety & Effectiveness | Acceptance Criteria: No new issues of safety and effectiveness are presented compared to the predicate device. |
| Reported Performance: "The Subject Device do not present any new issues of safety and effectiveness when compared to the predicate device." This is a conclusion of the review, indicating these general criteria were met. |
The following points (2-9) are not applicable or cannot be answered based on the provided document, as it pertains to a physical immobilization device and not an AI/imaging diagnostic tool.
2. Sample size used for the test set and the data provenance: Not applicable. This document does not describe a clinical study with a patient image test set. The verification activities are related to device testing (e.g., mechanical, electrical, material).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" in the context of diagnostic imaging or AI performance is established or discussed.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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 not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable. No training set for an algorithm is mentioned.
9. How the ground truth for the training set was established: Not applicable.
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.