(272 days)
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:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Overall Performance | "The Sumitomo PTS system was found to meet all performance requirement specifications for hardware, and safety requirements for a proton therapy system." |
| Design Specifications | "The Sumitomo PTS met the requirements of all design specifications." |
| Safety | "Nonclinical safety and performance testing performed demonstrates that the proposed device met all test specifications and is suitable for its intended use." |
| Technological Equivalence | "Has the same of intended use, similar operating parameters and similar system features compared to the predicate systems." |
| Differences Impact | "Differences between these devices are limited to design modifications... These design modifications are minor and raise no new issues of safety or effectiveness." |
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.
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.