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The PPTS 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.

When the patient is in the seated position using the chair, the System is indicated for treatment of patients with localized tumors and other conditions susceptible to treatment by radiation in the head, neck and thorax.

The P-CURE Proton Therapy System (PPTS) is comprised of 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 patient (seated or on supine); provides independent means of patient registration using CT (3D) and X-ray (2D)

  • CT system (P-ARTIS CT)
  • Robotic arm and chair/couch (6 Degree of freedom Couch) (P-ARTIS PPS)
  • X-ray system (P-ARTIS XR)
  • Positioning Software (P-ART)

• 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 FDA 510(k) clearance letter for the P-Cure Proton Therapy System (PPTS) does not contain specific acceptance criteria or a detailed study description with performance metrics that would allow for a comprehensive table and answer to all the questions. This document is a clearance letter, which summarizes the outcome of a review, rather than providing the full technical details of the submission.

However, based on the information provided, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

The clearance letter does not list specific numerical acceptance criteria (e.g., minimum accuracy percentages, maximum error values) or direct quantitative performance results in a table format. It states that:

• "In all instances, the PTTS functioned as intended and met its specifications."
• "Testing demonstrated substantial equivalence in terms of performance and safety to the predicate."

To construct a table, we would need the actual specifications and the measured performance against those specifications, which are typically found in the full 510(k) submission, not the clearance letter.

Inferred Performance Claims (from "Performance Data" section):

2. Sample Size Used for the Test Set and Data Provenance

The document does not provide details on the "sample size" in terms of patient data or case numbers for the performance testing. The testing described is primarily technical and engineering verification and validation of the system's components and functions (mechanical, beam, safety, software integration, repeatability). It does not mention clinical studies with patient data.

• Sample Size for Test Set: Not specified for clinical cases. The testing appears to be system-level verification and validation, not patient-based clinical performance data.
• Data Provenance: Not applicable as no patient data (e.g., country of origin, retrospective/prospective) is referenced for the performance testing cited. The submitter, P-Cure, Ltd., is located in Israel, but this pertains to the company, not necessarily the origin of any clinical data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not mention any "ground truth" established by experts in the context of clinical performance, as it focuses on the technical verification and validation of the device's physical and software functions. Therefore, this question is not applicable based on the provided text.

4. Adjudication Method for the Test Set

As no expert review or clinical case evaluation is mentioned, there is no adjudication method described. This question is not applicable based on the provided text.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No MRMC study is mentioned. The clearance letter details technical and engineering performance testing, not studies comparing human reader performance with or without AI assistance. This question is not applicable based on the provided text.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device described is a physical medical device (Proton Therapy System), not an AI algorithm to be used standalone or with human-in-the-loop for diagnostic or prognostic purposes. While the system has software, its "performance" refers to the entire system's ability to produce and deliver a proton beam accurately and safely. This question is not applicable in the typical sense of AI standalone performance.

7. The Type of Ground Truth Used

The "ground truth" for the performance testing appears to be based on:

• Known engineering specifications and physical laws: For beam performance, mechanical movements, dose delivery accuracy, etc.
• Safety standards: Compliance with IEC and AAPM standards.
• Software requirements: Validation against specified software functions.

There is no mention of expert consensus, pathology, or outcomes data as "ground truth" for the reported performance testing.

8. The Sample Size for the Training Set

The concept of a "training set" is usually applicable to machine learning algorithms. While the system involves software, the document describes traditional software validation and verification for system control and safety functions, not the development of a machine learning model that would require a distinct training set. Therefore, this question is not applicable based on the provided text.

9. How the Ground Truth for the Training Set Was Established

As no "training set" (in the context of machine learning) is mentioned, the method for establishing its ground truth is also not applicable.

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