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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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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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The P-ARTIS CT scanner is a Computed Tomography X-Ray System intended to produce images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. The system may include signal analysis and display equipment, patient and equipment supports, components and accessories. The system is intended for scanning patients while seated.

The P-ARTIS CT scanner is an adaptation of the cleared Philips AcQSim-Multislice-CT scanner (K033357, aka Brilliance Big Bore 16 Slice CT scanner) for imaging patients in a seated position. This adaptation is designed by P-Cure in agreement with Philips Medical Systems (Cleveland), Inc. P-Cure has developed a patient Chair and a wall mounted Sliding Platform that is responsible for moving the Gantry up and down along the center axis of the Gantry opening while the patient is seated. The Gantry motion serves to position the scan plane at the start of the region to be scanned and to increment the position of the scan plane during the scan itself.

Being a modification of the cleared Philips AcQSim CT scanner, the principal mode of operation and the essential principles of operation are the same as those of the AcQSim CT scanner. A difference yet exists in the implementation of the scan plane incrementation: instead of moving the table with the lying patient In and Out of the scan plane, the P-ARTIS moves the Gantry scan plane Up and Down over the seated patient. The relative motion is however considered identical between the two systems.

The provided text describes the P-ARTIS CT scanner, a modified version of an existing CT system (Philips AcQSim-Multislice-CT scanner), adapted for scanning patients in a seated position. The document primarily focuses on establishing substantial equivalence to predicate devices, rather than detailed performance criteria or a standalone clinical study for a novel AI/device.

Therefore, much of the requested information regarding acceptance criteria, study design for AI/human-in-the-loop performance, and detailed ground truth establishment is not explicitly available in this document. The document describes a device modification rather than a new AI or diagnostic algorithm, and as such, the testing described is primarily focused on safety, performance comparability to the predicate, and functionality of the physical system.

However, based on the provided text, I can extract the following information:

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

The document does not provide a formal table of quantitative acceptance criteria with corresponding device performance metrics for diagnostic accuracy (e.g., sensitivity, specificity). Instead, it states:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• The document mentions "Bench testing, performed using phantoms." This implies physical phantoms were used for testing, not patient data in the traditional sense of a clinical trial.
• No specific sample size for a "test set" of patient data is mentioned, nor is there information about data provenance (country of origin, retrospective/prospective). This is consistent with a 510(k) for a device modification without a new clinical indication requiring patient data.

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/Not provided. Ground truth in this context would relate to the physical properties measured by phantoms during bench testing, not expert interpretation of clinical images.

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

• Not applicable/Not provided, as this was not a study evaluating human interpretation or diagnostic accuracy on clinical cases.

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

• No MRMC study was described. The device is a CT scanner, not an AI-assisted diagnostic tool as understood in the context of MRMC studies.

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

• The device being reviewed is a CT scanner system, not a standalone algorithm in the typical sense of AI or image processing software. Its performance verification involved bench testing with phantoms and demonstration of comparability to its predicate device.

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

• For the "Bench testing," the ground truth was based on the known physical properties and measurements from phantoms.

8. The sample size for the training set

• Not applicable/Not provided. This is a modified CT scanner, not an AI model requiring a training set of data.

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

• Not applicable/Not provided.

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The P-ART device is designed to achieve patient correct geometric positioning with respect to a treatment device based on the specification of one or more successive treatment field prescriptions.

Not Found

This is a 510(k) clearance letter for the P-ART device, not a study report. The document indicates that the device has been found substantially equivalent to a predicate device but does not contain the detailed clinical study information requested. Therefore, I cannot provide a response to your request for acceptance criteria and study details based on the provided text.

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