(79 days)
Indiana University Cyclotron Facility's Proton Therapy System is a medical device intended to deliver proton radiation treatment to patients with solid tumors or other diseases susceptible to radiation.
IUCF's PTS is a charged particle radiation therapy system. The PTS contains three major systems: the Cyclotron System (CYS), JUSTIS, and the Treatment Systems (TS). The TS is divided into seven subsystems to carry out the proton treatment process: the Treatment Room Control System (TRCS); the Kicker Enable System (KES); the Beam Delivery System (BDS); the Dose Delivery System (DDS); the Patient Positioning System (PPS); the MPRI Radiation Interlock System (MIRS); and the Emergency Stop System (ESS). These subsystems work together to generate the desired dose level and distribution at the target site. Treatment System 2 (TS2) of the PTS, the subject of this 510(k) notice, employs a rotating gantry, which allows the proton radiation beam to be delivered to the target site from any direction in a plane. The gantry includes the gantry structure; retractable gantry floor; Digital Radiography panel positioning systems; gantry safety mechanisms; and gantry rotation controls. Computer control of the gantry is provided by the PPS.
The provided text describes the Indiana University Cyclotron Facility's Proton Therapy System (IUCF PTS) as a medical device intended to deliver proton radiation treatment. However, it does not include a table of acceptance criteria or a detailed study proving the device meets specific performance criteria.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices (Loma Linda Medical Center Proton Beam Therapy System (K872369) and Ion Beam Applications, SA's, Proton Therapy Systems (K983024, K060695)).
Here's a breakdown of what is recoverable from the text, and what is not:
1. A table of acceptance criteria and the reported device performance:
- Not provided. The text states: "Extensive performance testing conducted at the system and subsystem (hardware and software) levels, and electromagnetic compatibility, electromagnetic interference ("EMC/EMI") and electrical safety demonstrated that the system and subsystems met or exceeded design specifications, clinical performance requirements and EMC/EMI and electrical safety applicable standards."
- This indicates that internal design specifications and clinical performance requirements existed and were met, but the specific criteria and results are not detailed in this 510(k) summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not provided. The document does not describe a clinical study with a "test set" in the context of patient data or outcomes. The "performance testing" mentioned refers to engineering and system-level validation.
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 / Not provided. Since there's no clinical "test set" with ground truth established by experts, this information is not present.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Not provided. (See point 3)
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. This is a system for delivering radiation therapy, not an imaging or diagnostic AI device. Therefore, an MRMC study and AI assistance effect size are not relevant or discussed. The device is for treatment delivery, not interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable / Not provided. The device is a treatment system, not a standalone algorithm. Its performance is demonstrated through its ability to deliver the intended proton radiation, which involves hardware and software working together. The "Performance Data" section indicates system-level testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable / Not provided for clinical ground truth. The "ground truth" for this device would be its adherence to engineering specifications and its ability to accurately deliver a specified dose of proton radiation. The document states it "met or exceeded design specifications" and "functioned as intended."
8. The sample size for the training set:
- Not applicable / Not provided. This is a proton therapy system, not a machine learning model that requires a distinct "training set" of data in the typical AI sense.
9. How the ground truth for the training set was established:
- Not applicable / Not provided. (See point 8)
Summary of Device Acceptance Information Present in the Document:
The acceptance of the IUCF PTS is based on demonstrating substantial equivalence to existing legally marketed predicate devices rather than proving performance against specific quantitative acceptance criteria in a detailed clinical study.
Acceptance Criteria and Reported Device Performance (as inferred from the text):
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Design Specifications | "met or exceeded design specifications" |
| Clinical Performance Requirements | "met or exceeded clinical performance requirements" |
| EMC/EMI and Electrical Safety Standards | "met or exceeded EMC/EMI and electrical safety applicable standards" |
| Intended Functionality | "In all instances, the IUCF PTS functioned as intended." |
| Safety and Effectiveness (relative to predicates) | "The IUCF PTS is as safe and effective as the Loma Linda Medical Center Proton Beam Therapy System (K872369) and Ion Beam Applications, SA's, Proton Therapy Systems (K983024, K060695)." |
| Technological Characteristics | "The IUCF PTS has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices." |
| New Questions of Safety or Effectiveness | "The minor technological differences... raise no new questions of safety or effectiveness." |
Study Information:
- Type of Study: Not a typical clinical study with patient cohorts, but rather a technical performance testing and substantial equivalence argument.
- Test Set Sample Size: Not applicable as no patient-specific test set is described. Performance testing was conducted at "system and subsystem levels."
- Data Provenance: Not applicable for a clinical test set. The testing was likely conducted in a controlled engineering environment.
- Ground Truth Establishment for Test Set: Not applicable in the clinical sense. Ground truth was adherence to engineering design specifications and regulatory standards.
- Adjudication Method: Not applicable.
- MRMC Study: No.
- Standalone Performance Study: Performance testing was done at system/subsystem levels, which represents the device's standalone capability in delivering radiation according to design.
- Type of Ground Truth: Adherence to engineering "design specifications," "clinical performance requirements," and "EMC/EMI and electrical safety applicable standards."
- Training Set Sample Size: Not applicable.
- Ground Truth for Training Set: Not applicable.
In essence, the document serves as a regulatory filing (510(k) summary) to demonstrate that the device is "substantially equivalent" to already approved devices, rather than a detailed report of a new clinical trial or performance validation against explicit, public acceptance criteria.
§ 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.