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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 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 nonmedical 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.

This 510(k) summary (K130426) describes the Sumitomo Proton Therapy System (PTS) and its substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria in the context of diagnostic performance or AI model validation. The document focuses on establishing equivalence through technological characteristics and non-clinical performance testing.

Therefore, many of the requested categories related to clinical study design, AI performance metrics, ground truth establishment, and expert involvement are not applicable to this submission.

Here's an analysis based on the provided text, structured to address the requested information where applicable:

Acceptance Criteria and Device Performance

Since this is a submission for a proton therapy system and not a diagnostic AI device, the "acceptance criteria" discussed are primarily related to meeting design specifications and demonstrating performance and safety comparable to predicate devices. The document does not provide specific quantitative acceptance criteria for parameters like sensitivity or specificity.

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

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

• Not Applicable. This submission is for a proton therapy system, not a diagnostic AI device that would utilize a "test set" in the context of data analysis. The "testing" referred to is engineering and system performance testing.
• The document mentions "A series of factory and on-site safety and performance studies were completed to assess the performance of the Sumitomo PTS." This refers to hardware and system-level validation, not data-driven testing with a specific "test set" like in AI.

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

• Not Applicable. There is no "test set" or "ground truth" in the context of diagnostic interpretation for this type of device submission. The validation involves engineering specifications and performance against those specifications.

4. Adjudication method for the test set:

• Not Applicable. As there is no "test set" in the context of diagnostic AI, no adjudication method was used.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No. An MRMC study was not done. This device is a treatment system, not an AI diagnostic tool designed to assist human readers.

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

• Not Applicable. This is a physical medical device (proton therapy system), not an algorithm. While it presumably has internal algorithms for beam control, the submission does not discuss them in the context of "standalone performance" as an AI device.

7. The type of ground truth used:

• Engineering Specifications and Physical Measurements: For the system performance testing, the "ground truth" would be established by the design specifications of the device and validated through physical measurements and engineering tests. For example, verifying the energy of the proton beam, accuracy of beam delivery, and safety interlocks.
• "The design outputs of the system and its components have met design specifications in a complete and verifiable manner."

8. The sample size for the training set:

• Not Applicable. This submission does not involve an AI model or a "training set."

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

• Not Applicable. There is no training set for an AI model in this submission.

Summary of Non-Clinical and Clinical Testing

• Non-Clinical Testing: "A series of factory and on-site safety and performance studies were completed to assess the performance of the Sumitomo PTS." These tests ensured the system met design and safety requirements.
• Clinical Testing: "No clinical testing was conducted or required in support of this premarket clearance notification." The clearance was based on substantial equivalence to predicate devices and validated non-clinical performance and safety.

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