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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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Verification Console is designed to assist the operator of a proton radiation therapy device. Verification Console retrieves treatment plans from an oncology information system (OIS) and sends plans to the treatment device's treatment control system (TCS). Verification Console then performs verification of treatment plan parameters against TCS delivery parameters for accuracy prior to beam authorization, and sends the treatment history for recording to the OIS.

Verification Console is designed to perform an interface role to connect to proton therapy control systems. The general function of the Verification Console is to allow treatment plans and images to be retrieved from the Varian Oncology Information System and sent to the device's treatment control system (TCS), planned treatment plan parameters to be verified against the TCS delivery parameters for accuracy, and treatment history to be recorded in the Varian Oncology Information System for use and display throughout ARIA and Eclipse. ARIA and Eclipse are separately cleared devices from Varian Medical System.

The provided text describes a "Verification Console" device, but it lacks detailed information about acceptance criteria, a specific study proving device performance against those criteria, or most of the other requested elements for summarizing a device study. The document is primarily a 510(k) summary for regulatory approval, focusing on substantial equivalence to a predicate device rather than presenting a performance study with detailed metrics.

Based on the available information:

1. Table of acceptance criteria and reported device performance: This information is not provided in the document. The document states "Results of verification and validation testing showed conformance to applicable requirements specifications and assured hazard safeguards functioned properly," but it doesn't list the specific requirements, their acceptance criteria, or quantitative performance results.

2. Sample size used for the test set and the data provenance: Not specified. The document mentions "verification and validation testing" in a general sense but does not detail a test set, its size, or its provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or specified. Given the device's function (interfacing between systems and verifying parameters), "ground truth" in the traditional sense of medical image interpretation by experts is not directly relevant. There's no mention of experts establishing a ground truth for any test set.

4. Adjudication method: Not applicable or specified.

5. Multi-reader multi-case (MRMC) comparative effectiveness study: No, an MRMC study was not done. The device is not an AI/CAD device for diagnostic interpretation; therefore, an MRMC study to assess human reader improvement with AI assistance is not relevant to this device's function.

6. Standalone performance study (algorithm only without human-in-the-loop performance): The document doesn't detail a standalone performance study with specific metrics. The device's function (verification of treatment plan parameters against delivery parameters) is inherently a "human-in-the-loop" assistance tool, not a standalone diagnostic algorithm. The summary broadly states that the "functionality of both devices is equivalent in safety and effectiveness," referring to the predicate device.

7. Type of ground truth used: Not explicitly stated or applicable in the traditional sense. For a device that verifies treatment plan parameters against delivery parameters, the "ground truth" would likely be the actual, correct delivery parameters and system states, which are intrinsically digital and rule-based, rather than subjective expert interpretations or pathology. The document doesn't elaborate on how this "ground truth" was established for testing.

8. Sample size for the training set: Not applicable or specified. The device is not described as an AI/machine learning model that undergoes a training phase.

9. How the ground truth for the training set was established: Not applicable, as there is no mention of a training set for an AI/ML model.

Summary of what is available regarding verification and validation:

The document states: "Results of verification and validation testing showed conformance to applicable requirements specifications and assured hazard safeguards functioned properly."

This general statement indicates that Varian Medical Systems, Inc. performed internal testing to ensure the "Verification Console" met its design requirements and safety standards. However, the specific protocols, metrics, sample sizes, and detailed outcomes of these tests are not provided in this 510(k) summary. The summary's focus is on establishing substantial equivalence to the predicate "Varian Treatment" device, primarily through comparing their intended use and technological characteristics (e.g., supporting proton vs. photon delivery, interface type).

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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 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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