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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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ProBeam 360° Proton Therapy System provides protons for precision radiotherapy of lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

The ProBeam 360° Proton Therapy System v2.0 (Multiroom) is designed to deliver radiation treatment in accordance with the physician's prescribed treatment plan. Proton radiation therapy takes advantage of the Bragg peak characteristic of proton attenuation to minimize radiation of normal tissue outside the target volume. Varian markets two lines of proton therapy systems, the standard ProBeam Proton Therapy Systems and the smaller, newer ProBeam 360° Systems. The ProBeam 360° Proton Therapy System line of proton systems includes single-room (cleared in K221791) and multi-room configurations. The ProBeam 360° System Multiroom (subject device) introduces the multi-room, compact configuration and includes the following primary components: Cyclotron (226MeV), Beam Transport System (energy selection system and beam transport system), Two (2) to five (5) Treatment Rooms: Rotating Isocentric Gantry room with attached scanning nozzle; and a treatment table, One Treatment Control Room for each treatment room within the chosen configuration.

The provided FDA 510(k) summary for the ProBeam 360° Proton Therapy System v2.0 (Multiroom) does not include specific acceptance criteria and detailed study results in the manner requested.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (ProBeam 360° Proton Therapy System v1.0, K221791) and a reference device (ProBeam Proton Therapy System v2.0, K133191). The study described is a design verification and validation process, rather than a clinical trial or performance study with defined statistically-based acceptance criteria against a specific benchmark.

Here's a breakdown of what can and cannot be extracted from the provided text according to your request:

Acceptance Criteria and Device Performance Study for ProBeam 360° Proton Therapy System v2.0 (Multiroom)

The ProBeam 360° Proton Therapy System v2.0 (Multiroom) primarily underwent design verification and validation testing to demonstrate that it performs as intended and meets its essential performance, confirming its substantial equivalence to previously cleared devices. The document does not specify quantitative acceptance criteria for performance metrics (such as sensitivity, specificity, accuracy) typically associated with medical device studies, nor does it provide a table of measured device performance against such criteria. The "performance" described is in the context of functionality and safety.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a "sample size" in terms of patient data or clinical cases for a test set. The testing described is non-clinical design verification and validation testing of the system components and software. This typically involves engineering tests, simulations, and hardware/software testing rather than patient data. Therefore, details regarding country of origin or retrospective/prospective nature are not applicable to the described non-clinical testing.

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

This information is not provided in the document. As the described testing is non-clinical design verification and validation, the concept of "ground truth" as established by experts (e.g., clinicians) in the context of diagnostic accuracy or treatment efficacy is not directly relevant. The "ground truth" for these engineering tests would be the design specifications and expected functional behavior, which are internally verified by the manufacturer's engineers.

4. Adjudication Method for the Test Set

This information is not provided in the document. The adjudication method (e.g., 2+1, 3+1) is typically used in studies where human readers independently assess cases, and their discrepancies are resolved. This is not applicable to the non-clinical design verification and validation testing described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed, or at least not described in this 510(k) summary. The submission explicitly states: "No animal studies or clinical tests have been included in this submission." This type of study would involve human readers (possibly with and without AI assistance) evaluating clinical cases, which is not what was conducted for this submission.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

A standalone performance study of an algorithm in a clinical context (e.g., diagnostic accuracy for a specific disease) was not performed, or at least not described in this 510(k) summary. The device described is a proton therapy system, not typically a diagnostic AI algorithm. While software is a component, its performance testing is framed within system functionality and safety, not as an isolated algorithm performance study against clinical ground truth.

7. Type of Ground Truth Used

The ground truth for the non-clinical design verification and validation testing would be the engineering specifications, design requirements, and recognized industry standards (e.g., electrical safety, electromagnetic compatibility). These are validated through a series of tests to ensure the device performs according to its design and regulatory requirements. Clinical ground truth (e.g., pathology, outcomes data) was not used, as no clinical studies were submitted.

8. Sample Size for the Training Set

This information is not applicable/not provided. The document describes a medical device (proton therapy system), not an AI model that requires a "training set" of data in the typical machine learning sense. The software development follows a lifecycle process (IEC 62304) and involves verification and validation, but not training on a dataset of clinical cases.

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

This information is not applicable/not provided, for the same reason as in point 8. No "training set" in the context of machine learning was used or described.

In summary: The provided document is an FDA 510(k) summary for a hardware-based medical device (a proton therapy system) with associated software. The "study" it describes is the design verification and validation process to demonstrate the device's safety and effectiveness compared to existing, cleared devices, rather than a clinical performance study with specific quantitative acceptance criteria and clinical outcome measures.

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The ProBeam 360° Proton Therapy System provides protons for precision radiotherapy of lesions, turnors, and conditions anywhere in the body where radiation treatment is indicated.

The ProBeam 360° Proton Therapy System is a device that generates ionizing radiation (protons) in order to deliver radiation therapy in accordance with a predetermined treatment plan. The ProBeam 360° System version 1.0 is available in single-room, compact configuration and includes the following primary components: Cyclotron, Beam Transport System, Treatment Room with a rotating Gantry, Treatment Control Room.

The provided text is a 510(k) Premarket Notification summary for the Varian ProBeam 360° Proton Therapy System. It details the device, its intended use, comparison to a predicate device, and a summary of performance testing.

However, it does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria in the context of an AI/ML-driven medical device validation. The document explicitly states:

"No animal studies or clinical tests have been included in this pre-market submission."

This indicates that the submission relies on design verification and validation testing, conformance to standards, and comparison to a predicate device, rather than performance studies that would involve a test set, ground truth experts, MRMC studies, or standalone algorithm performance as typically found in AI/ML medical device submissions.

Therefore, I cannot extract the information required to answer your prompt points 1-9 from the provided text. The document describes a traditional medical device (a radiation therapy system), not an AI/ML device that requires validation of its diagnostic or predictive performance on a data set.

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The IBA Proton Therapy System (PTS) is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.

IBA Proton Therapy System - Proteus 235 (PTS) is a proton beam irradiation system. The device is designed to: (1) create and deliver the proton beam to the patient treatment location: (2) produce a transverse and longitudinal dose distribution appropriate for the patient's treatment; and (3) deliver the designated dose to the patient's treatment site.

The PTS has three primary components: (1) the beam management equipment, which includes a cyclotron, transport and delivery system to direct the proton beam to the patient's treatment location; (2) the position management equipment that allows bringing the patient and the proton beam in the adequate position for treatment and verifying the patient position; and (3) the treatment control system which controls the parameters of the proton beam treatment.

The scope of the current 510(k) premarket notification is to add a new version of the handpendant, which uses wireless and touch screen technologies to move equipment in the treatment room to the cleared IBA Proteus 235.

This document describes a 510(k) premarket notification for the "IBA Proton Therapy System - Proteus 235" with the addition of a wireless hand-pendant system. The submission aims to demonstrate substantial equivalence to a previously cleared device (K152224).

The acceptance criteria and device performance are as follows:

1. Table of Acceptance Criteria and Reported Device Performance

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The SC360 is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.

Using a beam of protons, the SC360 is designed to accurately and safely deliver a prescribed dose to a Treatment Volume in a patient with a solid tumor or other disease susceptible to radiation. The SC360 includes a method to; 1) accelerate protons to a fixed energy; 2) vary the proton beam energy to adjust its range in the patient; 3) transport the protons; 4) deliver the dose; 5) image the patient using Cone Beam CT (CBCT) or planar images; 6) position the patient relative to the proton beam delivery; and 7) record the details of the dose delivery.

The functions of each treatment room of the SC360 are performed by six independent systems that may be described as the Beam Production System (BPS), the Beam Modification System (BMS), the Dose Delivery System (DDS), the Positioning System (POS), the Independent Safety System (ISS), and the Treatment Room Control System (TRCS). The primary user interface is presented by the TRCS where treatment workflow and clinical Quality Assurance activities may be controlled. Servicing is accomplished through Service Interfaces for each independent system. Access to the service interfaces may be through the TRCS or the individual system control computer, all accessible only by qualified service engineers.

In the SC360, the cyclotron and fixed energy portion of the beamline make up the BPS and are independent of the BMS, which degrades the beam energy and finally transports the protons to the DDS through either a fixed beamline or 360-degree rotating gantry beamline. The ISS monitors all safety related signals and uses a high confidence method to control beam admission into a Treatment Room.

In each Treatment Room, prior to patient setup and treatment, information from a treatment plan is downloaded to the SC360. Next, the patient is immobilized on a robotic couch and moved to a treatment position as specified in the treatment plan. Volumetric (or orthogonal planar) x-ray images are acquired using a couch-mounted CBCT imaging ring. These images are used to determine the current location/orientation of the Treatment Volume by comparing and aligning with reference images and regions of interest provided in the treatment plan. The couch position/orientation is adjusted to bring the treatment isocenter to beam isocenter (in the prescribed orientation). The proton beam is delivered to the Treatment Volume in accordance with the treatment plan. During irradiation, the DDS controls and monitors the dose delivered to each spot, the spot location, and the total dose delivered. Results are recorded and stored in a format compatible with an Oncology Information System (OIS).

I'm sorry, but the provided text does not contain the specific information required to describe the acceptance criteria and the study that proves the device meets those criteria in the format you requested, including a table, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, ground truth type, and training set details.

The document is a 510(k) summary for the ProNova SC360 Proton Therapy System. It discusses substantial equivalence to a predicate device, device description, technological characteristics, and a summary of non-clinical performance testing.

Here's what I can extract related to performance testing, but it does not meet the detailed requirements of your request:

Acceptance Criteria and Device Performance (based on general statements in the document):

Missing Information:

• Specific quantitative acceptance criteria: The document only mentions categories of requirements, not the actual numerical or qualitative criteria.
• Sample sizes used for the test set: Not mentioned.
• Data provenance: Not mentioned.
• Number of experts and their qualifications: Not applicable, as this was non-clinical performance testing of the system itself, not diagnostic image interpretation.
• Adjudication method: Not applicable.
• MRMC comparative effectiveness study details: The document explicitly states "No clinical testing was performed or required."
• Standalone (algorithm only) performance: Not applicable, as this is a physical medical device (proton therapy system), not a software algorithm for interpretation.
• Type of ground truth used: Not explicitly stated beyond "design specifications" and "Essential Performance and Safety Requirements" for the physical system. It would likely involve engineering standards and measurements.
• Sample size for the training set: Not applicable, as it's a physical device, not an AI model.
• How the ground truth for the training set was established: Not applicable.

In summary, the provided document is focused on demonstrating substantial equivalence of a physical proton therapy system through non-clinical performance testing against internal design specifications and general safety/performance requirements, rather than clinical efficacy through studies involving human readers or AI algorithms with detailed statistical endpoints.

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The Sumitomo Proton Therapy System is a medical device designed to produce and deliver a proton beam for treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.

The Sumitomo Proton Therapy System (PTS) is a large-scale medical electrical system that consists of an integrated system of medical electrical equipment and non-medical electrical components to provide proton beam radiation therapy. The Sumitomo PTS consists of a 230 MeV Cyclotron, an Energy Selection System, a Beam Transport System, and a Gantry Treatment System. The new Sumitomo PTS is a modification of the Sumitomo PTS cleared for marketing under K130426 in November 2013. The purpose of the current 510(k) premarket notification is to add the pencil beam scanning functionality to the cleared Sumitomo PTS. The pencil beam scanning function allows for precise treatment of complex cancers, such as tumors located near critical structures and tumors with special shapes, including multi-site targets, without the need for beam shaping devices such as collimators or compensators. The pencil beam scanning function also produces a radiation field directly from the beam scan path layer by layer, which shortens the treatment duration.

The Sumitomo Proton Therapy System with pencil beam scanning addresses the treatment of localized tumors and other conditions susceptible to radiation.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

   The document does not explicitly state "acceptance criteria" in a quantitative manner with pass/fail metrics. Instead, it describes general design specifications and performance requirements that the device met. It provides a side-by-side comparison of the new device with predicate devices, highlighting technological characteristics.

   Characteristic	Acceptance Criteria (Implied by meeting design specs)	Reported Device Performance (as stated in the document)
   General Performance	Met all performance requirement specifications for hardware, software, and safety.	"The Sumitomo PTS with pencil beam scanning met the requirements of all design specifications."
   Safety	Safe and effective operation.	"The addition of the pencil beam scanning function raises no new issues of safety or effectiveness." and "The new device raises no new issues of safety and effectiveness."
   Usability	Users can safely and effectively perform activities involved in pencil beam scanning.	"The results confirmed that users can safely and effectively perform the activities involved in pencil beam scanning." and "The usability evaluation confirmed that users can safely and effectively use the new Sumitomo PTS for pencil beam scanning."
   Dose Rate (Wobbling Mode)	> 2 Gy/min (110 to 230 MeV); > 0.5 Gy/min for 10 cm x 10 cm x 4 cm (SOBP) at 70 MeV.	"> 2 Gy/min (110 to 230 MeV); > 0.5 Gy/min for 10 cm x 10 cm x 4 cm (SOBP) at 70 MeV" (This matches the predicate, indicating it meets or exceeds the previous performance).
   Dose Rate (Pencil Beam)	> 2Gy/min/liter (>150 MeV); > 2Gy/min/(10cmx10cmx4cm) (110MeV); > 0.5 Gy/min/(10cmx10cmx4cm) (Max depth 5cm with snout degrader).	"> 2Gy/min/liter (>150 MeV); > 2Gy/min/(10cmx10cmx4cm) (110MeV); > 0.5 Gy/min/(10cmx10cmx4cm) (Max depth 5cm with snout degrader)" (This is the specific performance for the new feature).

2. Sample Size used for the test set and the data provenance:

   • Test Set Sample Size: The document does not specify a quantitative "test set sample size" in terms of number of patients or cases. The testing involved "a series of factory and on-site safety and performance studies" and a "usability assessment." These appear to be engineering and system validation tests rather than clinical patient data analysis.
   • Data Provenance: The testing was "performed at the unit level, subsystem level at the factory and on-site, and system level on-site." This indicates engineering and system testing data, not clinical patient data from a specific country or whether it was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   Since no clinical testing was conducted or described, there is no information about experts establishing ground truth for a clinical test set. The usability assessment involved "study participants," but their qualifications or number are not specified beyond them being "users" capable of simulating clinical treatment scenarios. For the engineering tests, "ground truth" would be established by design specifications and measurement standards.

4. Adjudication method for the test set:

   Not applicable. No clinical test set with adjudicated ground truth is described.

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 device is a radiation therapy system, not an AI-assisted diagnostic or interpretation tool that would involve human readers. No MRMC study was conducted.

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

   The "pencil beam scanning functionality" is an integral part of the proton therapy system. Its performance was assessed as part of the overall system validation, rather than as a standalone algorithm in the typical sense of AI/image analysis. The device itself (the therapy system) operates "stand-alone" in delivering the therapy based on a treatment plan, but its development involved human design and engineering. The document focuses on the system's performance and safety, not on an algorithm's standalone diagnostic accuracy.

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

   For the non-clinical performance testing, the "ground truth" would be defined by engineering design specifications, internationally recognized standards for radiation therapy equipment, and validated measurement techniques for beam characteristics (e.g., dose rate, energy, depth of penetration, beam stability). For the usability assessment, the "ground truth" was likely defined by predetermined safe and effective operational procedures. No clinical ground truth (e.g., pathology, outcomes data) was used or mentioned, as no clinical testing was performed for this 510(k).

8. The sample size for the training set:

   Not applicable. The document describes a medical device (proton therapy system), not a machine learning or AI model that requires a training set of data.

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

   Not applicable. There was no training set for a machine learning model.

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The Proton Therapy System - Proteus 235 (brand names: Proteus ONE) is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.

The Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2) is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The system includes a proton accelerator (either an isochronous cyclotron (C230) or a Superconducting Synchro-Cyclotron (S2C2)) for beam production, which can be shared between several treatment rooms or directed to a single room. The system can be equipped with different types of treatment rooms, such as fixed beam or gantry rooms, connected to the beam line. The change introduced in this filing is the option of a new IBA Compact Beam Production System (CBPS) based on a Superconducting Synchro-Cyclotron (S2C2).

The provided text contains information about a 510(k) premarket notification for a Proton Therapy System, specifically focusing on the introduction of a new Compact Beam Production System (CBPS) feature. However, it does not include the type of study typically associated with device performance against acceptance criteria for diagnostic or AI-based devices (e.g., studies involving human readers, ground truth establishment through expert consensus, or performance metrics like sensitivity/specificity).

Instead, the document details the technical specifications and comparative performance of a radiation therapy system, which is evaluated based on physical beam characteristics and operational parameters rather than diagnostic accuracy.

Therefore, many of the requested items (e.g., sample size for test set, expert qualifications, MRMC study, standalone performance for diagnostic tasks, training set details) are not applicable or not present in the provided text for this type of medical device.

Here's an attempt to answer the applicable questions based on the provided text, while noting the limitations:

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

The document provides a table comparing key clinical beam performance characteristics. While not explicitly termed "acceptance criteria" in the context of diagnostic performance, these are the parameters against which the new CBPS feature is evaluated for equivalency to the predicate device.

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

This information is not provided in the text. The evaluation is based on "testing performed at the system and sub-system level" rather than patient or diagnostic data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable as the device is a radiation therapy system, not a diagnostic device requiring expert interpretation of images or patient data for ground truth. The 'ground truth' for this type of device would involve physical measurements and technical specifications.

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

This is not applicable for the reasons stated above.

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

A multi-reader multi-case (MRMC) comparative effectiveness study is not applicable as this is a radiation therapy system, not an AI-assisted diagnostic device. The study is comparing the technical performance of a new component (CBPS) to an existing one.

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

This is not applicable in the context of an AI algorithm, as this device is a physical system. The "standalone performance" is implicitly the performance of the system as described in the table, without human interaction in its beam delivery characteristics.

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

The "ground truth" for this device's performance would be established through physical measurements and engineering specifications (e.g., beam range, field size, spot size, irradiation time) using phantoms or measurement equipment, rather than expert consensus on diagnostic images or pathology. The text states "Testing has been performed at the system and sub-system level."

8. The sample size for the training set

This is not applicable as this is not an AI/machine learning device that would require a "training set" in the conventional sense.

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

This is not applicable.

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The McLaren 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 conditions susceptible to treatment by radiation.

The McLaren Proton Therapy System consists primarily of Beam Delivery and Beam Production systems. These systems are comprised of various components and/or accessories designed to produce and deliver a proton beam appropriate for patient treatment. The system components include:

• Beam Production System. This system produces the proton beam and directs it to the appropriate treatment room and is comprised of the following subsystems:
  • Synchrotron subsystem. The accelerator unit is the source of the proton beam and is composed of the injector (which generates the proton beam) and the synchrotron (which accumulates, accelerates, and extracts the proton beam).
  • Beam Transport subsystem. This subsystem guides the proton beam extracted from the synchrotron to the treatment room.
• Beam Delivery System. This system controls the irradiation dose and shapes the proton beam supplied through the beam transportation system into the configuration required for patient treatment, and directs the beam appropriately. It is comprised of the following subsystems:
  • Scan/Dose subsystem
  • Gantry subsystem
  • Patient Positioning subsystem.
  • Treatment Delivery Control subsystem

The provided text does not contain detailed information about specific acceptance criteria and a study proving a device meets these criteria in the typical format where performance metrics are reported against defined thresholds.

Instead, the document is a 510(k) summary for the McLaren Proton Therapy System, stating its substantial equivalence to a predicate device (ProTom Radiance 330™ Proton Beam Therapy System, K134052). In this regulatory context, proving substantial equivalence means demonstrating that the new device is as safe and effective as a legally marketed predicate device.

Here's an attempt to extract and infer the requested information based on the provided text, acknowledging that much of it is not explicitly stated in the detail typically found for AI/imaging device performance studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table with specific quantitative acceptance criteria or detailed performance metrics. It generally states that the device "met its specifications for its intended use."

• Creation and direction of the proton beam appropriately to the patient treatment location
• Production of a transverse and longitudinal distribution appropriate for the patient treatment
• Delivery of the designated dose to the patient's treatment site.
  "All testing demonstrated that the system met its specifications for its intended use." |
  | Usability: Users can interact with the system effectively and safely. | "A usability evaluation was conducted to confirm that users can interact with the system user interface to perform treatment with the device system."
  "All testing demonstrated that the system met its specifications for its intended use." |
  | Substantial Equivalence to Predicate Device: Shares identical intended use, indications, principles of operation, and technological characteristics. | "Except for the device name, the McLaren Proton Therapy System has the identical intended use, indications, principles of operation, and technological characteristics as the ProTom Radiance 330™ Proton Beam Therapy System (K134052)."
  "The McLaren Proton Therapy System is identical to the ProTom Radiance 330™ Proton Beam Therapy System and there are no new questions of safety or effectiveness." |

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

The document does not specify a "test set" in the context of patient data or image datasets, as would be common for AI/imaging devices. The testing described is primarily for the physical and functional aspects of the proton therapy system itself. Therefore, sample sizes for medical data are not applicable here.

• Test Set Sample Size: Not applicable in the context of device performance testing described. The "test set" here refers to the actual device and its components undergoing engineering verification and validation.
• Data Provenance: Not applicable. The "data" comes from the performance measurements of the physical device during engineering tests.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided. "Ground truth" in this context would likely refer to engineering specifications or established physics principles against which the proton beam performance is measured. The experts involved would be engineers, physicists, and medical physicists, but their numbers and specific qualifications are not detailed.

4. Adjudication Method for the Test Set

Not specified or applicable in the sense of expert consensus for a medical diagnosis or interpretation. Adjudication would refer to the process of determining if the device met its engineering specifications, which is typically done through measurement and comparison to predefined thresholds by testing personnel.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not performed or mentioned. This type of study is specifically designed for evaluating the impact of AI on human reader performance, typically in diagnostic imaging, which is not the primary function of a proton therapy system.

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

This concept is not directly applicable to a proton therapy system in the way it is for an AI algorithm. The McLaren Proton Therapy System is a physical medical device. Its "standalone" performance refers to its ability to produce and deliver a proton beam according to specifications, which was indeed tested. The "Performance Data" section describes this: "Each individual subsystem... was verified and validated, and full system verification and validation was also performed."

7. The Type of Ground Truth Used

The ground truth used for validating the McLaren Proton Therapy System is based on:

• Engineering Specifications: Pre-defined design requirements for parameters like beam energy, dose delivery accuracy, beam uniformity, and patient positioning precision.
• Physical Laws and Standards: Compliance with established principles of physics for radiation therapy and relevant international standards (e.g., IEC 60601-1, IEC 60601-1-2 for electrical safety and EMC).
• Functional Requirements: The ability to achieve the intended clinical function of producing and delivering a proton beam for cancer treatment.

8. The Sample Size for the Training Set

Not applicable. This device is a physical system, not an AI algorithm trained on a dataset.

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

Not applicable, as there is no "training set" for this physical device. The device's design and operation are based on established scientific and engineering principles, not machine learning from a training dataset.

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The ProTom Radiance 330 is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.

The Radiance 330 consists primarily of Beam Delivery and Beam Production systems. These systems are comprised of various components and/or accessories designed to produce and deliver a proton beam appropriate for patient treatment. The system components include:

• Beam Production System. This system produces the proton beam and directs it to the appropriate treatment room and is comprised of the following subsystems:
  • Synchrotron subsystem. The accelerator unit is the source of the proton beam and is composed of the injector (which generates the proton beam) and the synchrotron (which accumulates, accelerates, and extracts the proton beam).
  • Beam Transport subsystem. This subsystem guides the proton beam extracted from the synchrotron to the treatment room.
• Beam Delivery System. This system controls the irradiation dose and shapes the proton beam supplied through the beam transportation system into the configuration required for patient treatment, and directs the beam appropriately. It is comprised of the following subsystems:
  • Scan/Dose subsystem
  • Gantry subsystem
  • Patient Positioning subsystem.
  • Treatment Delivery Control subsystem

The provided text describes the ProTom Radiance 330™ Proton Beam Therapy System, but it is not an AI diagnostic device. It is a medical device for delivering proton beam radiation therapy. As such, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of diagnostic performance (e.g., sensitivity, specificity, AUC) is not applicable here.

Instead, the performance data presented focuses on the functional aspects of the device in delivering radiation therapy rather than a diagnostic performance study.

Here's a breakdown of the information that is available, reframed to fit the device's purpose:

1. Table of System Specifications and Demonstrated Performance (Conceptual - Based on text)

The document states, "All testing demonstrated that the system met its specifications for its intended use." However, it does not provide a specific table of numerical acceptance criteria or reported performance values (e.g., beam uniformity, dose accuracy to a specific tolerance). It describes the types of performance evaluated.

2. Sample Size and Data Provenance:

• Sample Size for Test Set: Not applicable in the context of a diagnostic dataset. The "testing" refers to verification and validation of the physical system's operation. No information on the number of "cases" or "patients" used for testing is provided, as the testing focuses on hardware performance, not diagnostic accuracy.
• Data Provenance: Not applicable. The testing is likely internal to the manufacturer (ProTom International Inc.) and conducted on the device itself, rather than using patient data from a specific country or being retrospective/prospective in a diagnostic sense.

3. Number of Experts and Qualifications for Ground Truth:

• Not applicable as this is not a diagnostic device requiring expert consensus for ground truth on images or patient outcomes in the same way. The ground truth for operational performance would be established by engineering specifications and metrology standards.

4. Adjudication Method for Test Set:

• Not applicable. This concept is typically related to diagnostic reviews where multiple human readers assess a case.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• Not applicable. This is a study design for evaluating the impact of AI on human reader performance in diagnostic tasks. The ProTom Radiance 330™ is a treatment delivery device, not an AI diagnostic tool.

6. Standalone Performance Study:

• Yes, a standalone performance was done for the device itself (as opposed to an algorithm). The document explicitly states: "Each individual subsystem of the Radiance 330™ was verified and validated, and full system verification and validation was also performed." This refers to the operational performance of the machine and its components.

7. Type of Ground Truth Used:

• The ground truth for the device's functional performance would be engineering specifications, physical measurements, and internationally recognized safety/performance standards (e.g., IEC 60601-1). For example, a "designated dose" would have a specified target value, and the device's output would be measured against that.

8. Sample Size for the Training Set:

• Not applicable. This device is not an AI algorithm that undergoes "training" on a dataset. The components are engineered and tested, not "trained."

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

• Not applicable for the same reason as point 8.

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ProBeam Proton Therapy System provides protons for precision radiotherapy of lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

ProBeam Proton therapy system, has been designed by Varian Medical Systems to deliver radiation treatment in accordance with a prescribed treatment plan. The system takes advantage of the characteristics of proton charged particle beam delivery. The major characteristic of proton radiation therapy utilizes the Bragg peak to prevent radiation of normal tissue outside the target volume. The system consists of 4 major components: 1) Cyclotron required to generate the proton beam (output 250MeV) 2) Beam line to transport beam from the cyclotron to the required treatment room 3) Treatment room where the patient is irradiated as per the prescribed treatment plan 4) Control room to select patient and activate treatment delivery

The provided text describes the "ProBeam Proton Therapy System" and its substantial equivalence to a predicate device, but it does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria in the way typically expected for an AI/ML medical device.

Instead, the document is a 510(k) summary for a medical device that delivers radiation therapy. The submission focuses on demonstrating substantial equivalence to a previously cleared device (K101294 ProBeam Proton Therapy System and K042720 Varian On-board Imager Device) by comparing technological characteristics.

Therefore, many of the requested sections about acceptance criteria, study details, ground truth, and expert involvement are not explicitly present in the provided text.

Based on the information available:

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

The document doesn't provide a table of acceptance criteria for specific performance metrics that would be applicable to an AI/ML device (e.g., sensitivity, specificity, accuracy). Instead, it compares the technological characteristics of the modified device to the predicate device. The "performance" in this context refers to the technological specifications and capabilities, not a clinical or analytical performance study.

Here's an adaptation of the table comparing the modified ProBeam to the predicate, highlighting the changes:

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

Not applicable. The document states "Testing has been performed at the system and sub-system level" but does not detail specific test sets, sample sizes, or data provenance in the context of analytical or clinical performance of an AI/ML algorithm. This is a proton therapy system, not an AI/ML software.

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. Ground truth for an AI/ML algorithm is not relevant for this device submission as described.

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.

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.

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

Not applicable.

Summary of Performance Testing mentioned in the document:
The document (Page 3) explicitly states: "Testing has been performed at the system and sub-system level and demonstrated ProBeam is substantially equivalent to the predicate device." This indicates engineering and functional testing to ensure the modified device meets its specifications and functions similarly to the predicate, rather than a clinical performance study using patient data and ground truth as would be relevant for an AI/ML device.

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