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The P-Cure Proton Therapy System is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other condition susceptible to treatment by radiation in the head, neck and thorax.

The P-CURE system is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other condition susceptible to treatment by radiation in the head, neck and thorax.

The P-CURE proton beam therapy system comprises four main subsystems that function in tandem to generate the desired dose level and distribution at the target site:
Beam production system (Synchrotron based accelerator)

• Injector produces and delivers protons to the synchrotron
• Synchrotron ring accelerates the proton beam in circular orbit (within the ring) to the desired energy level
• Extraction system extracts the beam from the ring to the beam delivery subsystem
  Beam delivery system for a single fixed beam treatment room. Steers and monitors the extracted proton pencil beam from the synchrotron to the desired treatment location (Nozzle).
  Patient Positioning System (P-ARTIS). Mechanically orients the seated patient; provides independent means of patient registration using CT (3D) and X-ray (2D)
• CT system (P-ARTIS CT)
• Robotic arm and chair (6 Degree of freedom Couch) (P-ARTIS PPS)
• X-ray system (P-ARTIS XR)
• Positioning Software (P-ARTIS SW)
  Control and Safety Systems
• Control Subsystem (TSM). Synchronizes the various subsystem actions and connects with hospital oncology information systems and PACS.
• Safety Subsystem. Includes hardware and software means to ensure safe system operation for patient and personnel. It includes subsystem interlocks, treatment beam parameters monitoring, and others.

The provided text describes a 510(k) premarket notification for the P-Cure Proton Beam Therapy System, demonstrating its substantial equivalence to a predicate device (ProTom Radiance 330). However, it does not contain the specific information required to answer your request regarding acceptance criteria and a detailed study proving the device meets those criteria for an AI/CADe device.

The document primarily focuses on:

• Legal/Regulatory Status: FDA clearance (K221996), device classification, and general controls.
• Device Description: Components of the P-Cure system (synchrotron, beam delivery, patient positioning, control/safety).
• Comparison to Predicate: Highlighting similarities in core technology (proton beam, synchrotron, energy range, pencil beam scanning) and differences (fixed beam vs. gantry, seated vs. supine patient position).
• Performance Data (General): A high-level list of tests performed (mechanical, beam performance, safety interface, simulation/validation, repeatability/reproducibility) and a general statement that the device "functioned as intended and met its specifications."

Therefore, I cannot provide the requested information for the following reasons:

• No Acceptance Criteria Table or Reported Performance: The document states "In all instances, the P-Cure System functioned as intended and met its specifications" but does not provide a table with specific acceptance criteria (e.g., precision, accuracy, sensitivity, specificity values) or the numerical results of performance for each criterion.
• No Information on AI/CADe Study: The P-Cure device is a Proton Beam Therapy System, not an AI/CADe (Computer-Assisted Detection/Diagnosis) device for image analysis. The performance data mentioned (mechanical, beam, safety, positioning) are related to the physical operation and output of the radiation therapy system itself, not to the performance of an AI algorithm in detecting or diagnosing conditions from medical images.
• No Test Set Details: Since it's not an AI/CADe study, there's no mention of sample size for a test set, data provenance, ground truth establishment methods (expert consensus, pathology), adjudication, or MRMC studies.
• No Training Set Details: Similarly, for a physical device, there isn't a training set in the context of an AI model.

If the request was based on a misunderstanding of the document's content and aimed at describing the performance validation of a complex medical device (like the proton therapy system) in a general sense, the document provides the following limited details:

• General Performance Testing Categories: Mechanical, beam performance, safety interface, simulation/validation, and repeatability/reproducibility testing.
• Applicable Standards: IEC 60601-1, IEC 600601-1-2, EN 606601-2-44, IEC 60601-1-3, IEC 60601-1-8, IEC 60601-2-54, IEC 60601-1-64, IEC 60601-2-68, IEC 62667, and AAPM TG-224. These standards are typically related to general medical electrical equipment safety, electromagnetic compatibility, radiation therapy equipment, and specific performance measurements for such devices.
• Overall Conclusion: "In all instances, the P-Cure System functioned as intended and met its specifications. Testing demonstrated substantial equivalence in terms of performance and safety to the predicate."

In summary, the provided document is a 510(k) clearance letter for a proton beam therapy system, not a study report for an AI/CADe device. Therefore, it does not contain the specific information required for your detailed questions about AI model acceptance criteria and validation.

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