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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

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

This document describes a premarket notification for a modification to an existing device (adding a wireless hand-pendant). It is not a study involving patient data or a "test set" in the traditional sense of diagnostic or treatment efficacy. The testing described is primarily non-clinical performance testing of the device's components and system.

Therefore, there is no "sample size" of patients or data provenance in terms of country of origin or retrospective/prospective data for a clinical study. The tests were performed on the device and its sub-systems.

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

Not applicable. This is not a study requiring expert-established ground truth for a test set of medical cases. The "ground truth" for the non-clinical tests would be the established engineering specifications, recognized standards (e.g., electrical safety, EMC), and functional requirements of the device.

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

Not applicable. There was no test set of medical cases requiring adjudication.

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 proton therapy system for radiation treatment, not an AI-assisted diagnostic or interpretation tool for human readers. No MRMC study was conducted.

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

Not applicable. This device is a medical device for delivering radiation therapy, not a standalone algorithm.

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

For the non-clinical tests, the "ground truth" was based on:

• Recognized standards: For electrical safety and electromagnetic compatibility.
• Design requirements/specifications: For hardware performance, software functionality, latency, operating distance, and FCC radio frequency testing.
• Intended use and principles of operation: The fundamental basis for comparing the modified device to the predicate.

8. The sample size for the training set:

Not applicable. This is not a machine learning or AI-based device that requires a training set.

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

Not applicable. As there is no training set, there is no ground truth established for one.

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The 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 of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.

The device corresponds to the previously cleared IBA proton therapy system (K101508) with the addition of a compact Gantry Beam line designed to produce and deliver a proton beam from various directions in a range of 220° for the treatment of patients.

The provided text describes a 510(k) premarket notification for a modification to the IBA Proton Therapy System - Proteus 235, specifically the introduction of a Compact Gantry Beam Line (CGBL). This document is primarily focused on demonstrating substantial equivalence to a predicate device rather than a comprehensive study report with detailed acceptance criteria and performance data from clinical trials.

Therefore, many of the requested sections about specific study methodologies, sample sizes, expert qualifications, and comparative effectiveness (MRMC) cannot be fully addressed from the provided text. The document focuses on comparing technological characteristics and functionality to establish equivalence.

Here's an attempt to extract the information based on the provided text, with significant limitations due to the nature of the document:

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

The document presents a comparison of the modified device (Compact Gantry Beam Line) against the predicate device (360° Gantry Beam Line) for various characteristics. In the context of a 510(k), the "acceptance criteria" are implied by the predicate device's performance, meaning the new device must meet or be substantially equivalent to these values.

Study that proves the device meets the acceptance criteria:

The document states that the "Risk management approach that has been applied for the development of the Compact Gantry Beam Line is described in MID 38870. As described in this document, Risk Analyzes have been performed to identify possible risks associated with the Compact Gantry Beam Line and define appropriate risk mitigations. The main mitigation principles are already applied in the existing beam lines 360°."

It also asserts that "the modified product does not induce changes nor any new limitations for clinical use (and therefore all existing clinical evidence remains valid)."

And concludes: "The new Compact Gantry fulfills the same primary functions as the 360° Gantry... It allows reaching the same clinical performances."

This suggests that the "study" proving the device meets the criteria is primarily an engineering and risk analysis comparison against an existing, cleared device, demonstrating that the changes do not negatively impact performance or safety in the context of its intended use. There is no mention of a
new clinical study with patient data for this 510(k) submission.

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 does not describe a clinical test set with patient data for this 510(k) submission. The comparison is based on technical specifications and engineering assessments.

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. The document does not describe a test set requiring expert-established ground truth. The technical specifications are objectively measurable.

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

Not applicable. There is no test set in the clinical sense mentioned in the document.

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 or imaging diagnostic aid that would involve human readers. The document details a physical component modification to an existing therapeutic device.

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

Not applicable. This is not an algorithm-based device.

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

Not applicable for a clinical ground truth. The "ground truth" in this context refers to the established technical and functional performance of the predicate device (360° Gantry Beam Line) against which the modified Compact Gantry Beam Line is compared through engineering analysis and risk assessment.

8. The sample size for the training set

Not applicable. This device does not use machine learning, therefore, there is no training set mentioned or implied.

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

Not applicable. As there is no training set for machine learning.

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I2C is used with a charged particle or photon radiation therapy system for localization of the patient position with respect to the therapy equipment and to provide correction feedback to the radiation therapy device.

For clinical use, l2C must be integrated into a radiation therapy system. I2C will interact with components of the radiation therapy center. I2C supports the acquisition of 2D, 2D stereoscopic and 3D images using 2D detectors. I2C will be used by the clinical therapist to verify by imaging that the treatment target position received from the treatment control applicative laver is 'valid', i.e. that it brings the center of the treatment target volume at the isocenter of the therapy equipment with required accuracy. If it is not, InC will propose a correction shift - or correction vector - that will be exported to the radiation therapy system.

Here's a summary of the acceptance criteria and study information for the I2C device:

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 distinct "test set" sample size in the traditional sense. Instead, it describes various verification and validation activities:

• Simulated Clinical Environment: The X-Ray imaging equipment was installed on a test bench with a phantom to represent different configuration setups and simulate gantry rotation.
• Communication Testing: A second test environment was used to verify communication with different third-party software configurations (Elekta Mosaiq, Varian Aria).
• Additional Performance Tests: Conducted on a stand-alone system using:
  • Appropriate datasets collected from simulated treatments.
  • Radiographs of phantoms acquired in IBA treatment centers.
  • Anonymized patient data provided by IBA treatment centers.
• User Evaluation: Intermediate releases were distributed to a group of "a-users" (reference users in proton therapy) to assess usability.

The data provenance for the additional performance tests includes:

• Simulated treatments.
• Phantom data acquired in IBA treatment centers.
• Anonymized patient data (from IBA treatment centers).
  The document does not explicitly state the country of origin for the patient data, but "IBA treatment centers" suggests it likely comes from facilities where IBA technology is used. The data appears to be retrospective in nature for these tests, as it mentions "anonymised patient data provided by IBA treatment centers."

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

The document does not specify the number or qualifications of experts used to establish ground truth for the test set. The validation primarily relies on performance metrics derived from physical phantoms, simulated scenarios, and anonymized patient data.

4. Adjudication Method for the Test Set

No specific adjudication method (e.g., 2+1, 3+1) is mentioned for the test set. The evaluation seems to be based on direct measurement of performance metrics against predefined technological specifications and comparison to predicate devices, rather than a consensus-based expert review for individual cases.

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

No, an MRMC comparative effectiveness study is not mentioned. The document focuses on the technical performance of the device itself and its equivalence to predicate devices, not on the improvement of human reader performance with or without AI assistance.

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

Yes, standalone performance tests were done. The document states: "Third, additional performance tests were done on a stand-alone system with appropriate datasets collected from simulated treatments and radiographs of phantom acquired in IBA treatment centres, and from anonymised patient data provided by IBA treatment centers."

7. The Type of Ground Truth Used

The ground truth used for these non-clinical tests appears to be primarily:

• Physical measurements/known values from phantoms: For accuracy, resolution, contrast, and uniformity tests.
• Simulated treatment parameters: For evaluating the device's ability to process and generate correction vectors in controlled scenarios.
• Anonymized patient data: Used as input for the standalone system, likely comparing its output (e.g., calculated shifts) against expected or clinically established values, though the exact method of ground truth for patient data isn't detailed.

8. The Sample Size for the Training Set

The document does not specify a separate "training set" or its sample size. The focus is on the verification and validation of the developed system, suggesting that the algorithm's training (if any involving machine learning) was either done prior to these V&V activities or is not detailed in this summary.

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

As no training set is explicitly mentioned or detailed, the method for establishing its ground truth is not provided in this document.

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« The Proton Therapy System - Proteus 235 is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized turnors and other conditions susceptible to treatment by radiation. »

The PTS is a medical device designed to produce and deliver a proton beam for treatment of a patient. It is intended for use in the therapeutic application of a proton beam for the treatment of localized tumours or other diseases that are susceptible to treatment by radiation. The PTS is comprised of beam production equipment which generates the beam used by the beam delivery systems. The technological aspects of a patient treatment consist of protons generated by the beam production equipment, directed to the patient's treatment site by the beam delivery system. The patient is put into the correct position relative to the beam by a positioning system. The PTS has two primary components: (1) the beam delivery equipment, which directs the proton beam to the patient's treatment site within the patient treatment location and ensures the patient critical functions are properly and safely accomplished; and (2).the beam production equipment. which includes a cyclotron and delivery system to produce the proton beam and deliver it to the patient treatment locations. In addition to these primary components, the PTS includes a Therapy Safety System to protect against unsafe conditions, having both automatic and manual controls to shut down the PTS in the event problems occur; and a computer-based Therapy Control System which controls the parameters of the proton beam.

The provided text describes a 510(k) submission for the IBA Proton Therapy System - Proteus 235, specifically for an interface to an external medical device called the universal beam triggering interface (UBTI). This submission does not contain the information requested regarding acceptance criteria and a study proving those criteria are met for a medical device.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed performance study results against specific acceptance criteria. It only states that "The adequate performance and safety test results have been provided to the FDA in the submission. The conclusions drawn from those tests demonstrate that the device is as safe, as effective, and performs as well as the already legally marketed device."

Therefore, I cannot populate the table or answer the specific questions based on the provided text.

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The Proton Therapy System - Proteus 235 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 treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localised to the head and neck.

The PTS is a device designed to produce and deliver a proton beam for treatment of a patient. It is intended for use in the therapeutic application of a proton beam for the treatment of localized tumours or other diseases that are susceptible to treatment by radiation. 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 two primary components: (1) the beam delivery equipment, which directs the proton beam to the patient's treatment site within the patient treatment location and ensures the patient critical functions are properly and safely accomplished; and (2) the beam production equipment., which includes a cyclotron and delivery system to produce the proton beam and deliver it to the patient treatment locations. In addition to these primary components, the PTS includes a Therapy Safety System to protect against unsafe conditions. having both automatic and manual controls to shut down the PTS in the event problems occur; and a computer-based Therapy Control System which controls the parameters of the proton beam. The scope of this 510(k) submission comprehends a fixed beam treatment room customised for small beams that can accommodate sitted treatment.

This document (K100766) is a 510(k) summary for a medical device called the "IBA Proton Therapy System - Proteus 235." It is a proton therapy system used for treating localized tumors and other conditions susceptible to radiation treatment. The submission describes modifications to an existing proton therapy system.

The provided text does not contain any information about acceptance criteria or a study proving the device meets those criteria, nor does it contain any of the other requested details such as sample sizes, expert qualifications, adjudication methods, or MRMC studies.

This document is a regulatory submission focused on demonstrating substantial equivalence to a predicate device (IBA proton therapy system K983024) under 21 CFR 892.5050. It describes the device's intended use, technological characteristics, and a series of modifications made to the original system over time (e.g., PPVS, SIS and US, IOIS, Pencil Beam Scanning, Robotic PPS, Proteus RTT, and Inclined Beam Line).

The FDA's letter (Exhibit 3) confirms that the device has been reviewed and determined to be substantially equivalent to legally marketed predicate devices. This indicates that the device meets the regulatory requirements for market clearance based on its similarity to previously cleared devices, rather than through a novel performance study against specific acceptance criteria.

Therefore, I cannot populate the requested table or answer the specific questions based on the provided text. The document's purpose is to establish regulatory equivalence, not to present a clinical validation study with detailed performance metrics.

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The Proton Therapy System - Proteus 235 is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible tc treatment by radiation.

The PTS is a medical device designed to produce and deliver a proton beam for treatment of a patient. It is intended for use in the therapeutic application of a proton beam for the treatment of localized tumours or other diseases that are susceptible to treatment by radiation. The device is comprised of beam production equipment which generates the beam used by the beam delivery systems. The technological aspects of a patient treatment consist of protons generated by the beam production equipment, directed to the patient's treatment site by the beam delivery system. The patient is put into the correct position relative to the beam by a positioning 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 two primary components: (1) the beam delivery equipment, which directs the proton beam to the patient's treatment site within the patient treatment location and ensures the patient critical functions are properly and safely accomplished; and (2) the beam production equipment, which includes a cyclotron and delivery system to produce the proton beam and deliver it to the patient treatment locations. In addition to these primary components, the PTS includes a Therapy Safety System to protect against unsafe conditions, having both automatic and manual controls to shut down the PTS in the event problems occur; and a computer-based Therapy Control System which controls the parameters of the proton beam.

The provided text is a 510(k) summary for the IBA Proton Therapy System-Proteus 235, specifically for an inclined beam line modification. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, this document does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in clinical validation studies for AI/ML devices.

The document is a regulatory submission for a modification to a medical device, focusing on demonstrating substantial equivalence to a previously cleared device. It does not present a performance study with acceptance criteria in the way a diagnostic or AI algorithm would.

Therefore, I cannot populate the requested table and answer the study-related questions based on the provided text. The document primarily discusses:

• Classification Name: Medical charged-particle radiation therapy systems. (21 C.F.R. §892.5050)
• Predicate Device: IBA proton therapy system (K983024)
• Intended Use/Indications for Use: To produce and deliver a proton beam for the treatment of localized tumors or other diseases susceptible to treatment by radiation.
• Description of Device Modifications: Addition of an inclined beam line, which is a simplified gantry accommodating two beam orientations (30° and 90°).
• Technological Characteristics: Creating and delivering the proton beam, producing appropriate dose distribution, and delivering the designated dose.
• Components: Beam delivery equipment, beam production equipment, Therapy Safety System, and Therapy Control System.
• Previously Added Features (from prior 510(k)s): PPVS (K053641), SIS and US (K060695), IOIS (K061913), Pencil Beam Scanning (K082416), Robotic PPS (K083058), Proteus RTT and patient gantry access upgrade (K091629).

This type of submission focuses on technical specifications and comparison to a predicate, rather than a clinical performance study with defined acceptance criteria and statistical analysis.

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The Proton Therapy System - Proteus 235 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.

IBA PROTON THERAPY SYSTEM - PROTEUS 235 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 provided document is an FDA 510(k) clearance letter for the "IBA Proton Therapy System - Proteus 235." This letter confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed.

However, this document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, or ground truth establishment. It is a regulatory approval document, not a detailed technical report of the device's validation.

To answer your request, a detailed performance study report (often submitted as part of the 510(k) application but not part of this public clearance letter) would be required. The information you are seeking is typically found in the clinical or technical validation sections of the 510(k) submission, which are not included in this FDA correspondence.

Therefore, I cannot extract the requested information from the provided text.

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The 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 has two primary components: (1) the beam delivery equipment, which directs the proton beam to the patient's treatment site within the patient treatment location and ensures the patient critical functions are properly and safely accomplished; and (2) the beam production equipment, which includes a cyclotron and delivery system to produce the proton beam and deliver it to the patient treatment locations. In addition to these primary components, the PTS includes a Therapy Safety System to protect against unsafe conditions, having both automatic and manual controls to shut down the PTS in the event problems occur; and a computer-based Therapy Control System which controls the parameters of the proton beam.

The provided text is a 510(k) summary for the IBA Proton Therapy System (PTS). It details the device's intended use, modifications, and substantial equivalence to predicate devices, but does not contain any information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
5. Multi-reader, multi-case (MRMC) comparative effectiveness study results or effect size
6. Standalone performance study results
7. Type of ground truth used
8. Sample size for the training set
9. How the ground truth for the training set was established

This document is a regulatory submission focused on demonstrating substantial equivalence, not a performance study report.

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

The Proteus 235 system with Pencil Beam Scanning (PPBS) is an external beam irradiation system which provides a therapeutic proton beam for clinical treatment. It is designed to deliver a proton beam to the designated patient treatment site with the assigned dose distribution. The equipment required to perform this work is comprised of the main components. The Beam Delivery System (BDS) has the primary responsibility to ensure that the prescribed beam parameters are properly delivered. The Beam Supply System (BSS) generates the proton beam. The pencil beam scanning is defined as the act of moving a charged particle beam or changing one or more of the properties of that beam (e.g. Intensity (e.g. # protons/second), size (e.g. 1 sigma), position etc.). The goal of this beam delivery is to deliver the appropriate proton fluence according to a prescription. The prescription provides a map of the fluence that is necessary to deliver at each location. The beam is moved to each location on the target and the appropriate fluence is deposited at each location.

This document, K082416, is a 510(k) summary for the IBA Proton Therapy System - Proteus 235. It describes modifications to an existing device, focusing on the addition of a Pencil Beam Scanning (PBS) capability.

However, the provided text does not contain acceptance criteria, device performance results, details of a study to prove acceptance criteria, sample sizes, data provenance, information on expert ground truth establishment, adjudication methods, MRMC studies, standalone performance data, or training set details.

The document primarily focuses on establishing substantial equivalence to predicate devices (Loma Linda University Proton Beam Therapy device and a pre-1976 Harvard University Cyclotron) based on intended use, technological characteristics, and functions. It describes how the Proteus 235, with its new PBS functionality, is similar to these predicate devices.

The FDA's 510(k) clearance letter (pages 3-5) confirms the substantial equivalence determination but does not delve into detailed performance studies or acceptance criteria, as that is typically contained in the full 510(k) submission, not the summary document provided.

Therefore, I cannot provide the requested table and study information based on the given input. The 510(k) summary is a high-level overview, and detailed performance data and acceptance criteria are usually part of the comprehensive submission package that is not publicly available in this format.

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The 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 has two primary components: (1) the beam delivery equipment, which directs the proton beam to the patient treatment location and ensures the patient critical functions are properly and safely accomplished; and (2) the beam production equipment, which includes a cyclotron and delivery system to produce the proton beam and deliver it to the patient treatment locations. In addition to these primary components, the PTS includes a Therapy Safety System to protect against unsafe conditions, having both automatic and manual controls to shut down the PTS in the event problems occur; and a computer-based Therapy Control System which controls the parameters of the proton beam. The modification in this submission is the addition of an automatic network-based interface from an Oncology Information System (OIS) to the PTS for the input of patient information, which information initially is entered into the OIS by means of a Graphical User Interface. After the patient treatment is completed, the treatment data is transferred from the PTS to the OIS through the automatic network-based interface.

This document is a 510(k) summary for the Ion Beam Applications S.A. Proton Therapy System (PTS). It is a regulatory submission to the FDA, not a study report. Therefore, it does not contain the information required to answer your request in detail.

Specifically, the document does not describe or contain:

• Acceptance criteria and reported device performance in a table format.
• Details about a specific study proving the device meets acceptance criteria.
• Sample sizes for test sets or training sets.
• Data provenance (country of origin, retrospective/prospective).
• Number of experts or their qualifications for establishing ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness study results or effect sizes.
• Standalone (algorithm-only) performance results.
• Type of ground truth used (pathology, expert consensus, outcomes data).
• How ground truth for a training set was established.

This document focuses on establishing substantial equivalence to previously cleared predicate devices (Loma Linda University Medical Center Proton Beam Therapy device K872369 and Harvard University Cyclotron Laboratory Proton Beam Therapy device) based on intended use, principles of operation, and technological characteristics. It describes the device and its modifications (an automatic network-based interface from an Oncology Information System to the PTS), but not a performance study as you've requested.

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