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510(k) Data Aggregation
(367 days)
PROTON BEAM THERAPY SYSTEM (PBTS)
The Optivus Technology, Inc.'s Proton Beam Therapy System (PBTS) is an integrated facility designed to administer proton radiation treatments to patients through delivery of a predetermined radiation dose to a predetermined treatment target volume in a manner that protects people from unnecessary exposure to radiation and other hazards.
The Optivus Proton Beam Therapy System (PBTS) is an integrated facility designed to deliver radiation treatment. Optivus' proposed facility is essentially the same as the facility that is currently operating at LLUMC. Both facilities consists of three major functional blocks; the accelerator, the beam transport system, and the treatment rooms. This complete, turnkey system consists of seven major subsystems:
- 70 - 250 MeV proton synchrotron;
- beam transport system;
- . one or more fixed beam delivery systems;
- . one or more isocentric gantries;
- patient positioning system;
- integrated facility control system; and .
- integrated facility safety system.
This document describes a 510(k) premarket notification for the Optivus Proton Beam Therapy System (PBTS). The submission seeks to demonstrate substantial equivalence to a predicate device, the Loma Linda University Medical Center (LLUMC) PBTS, which was already cleared for marketing.
Here's an analysis of the provided information concerning acceptance criteria and supporting studies:
1. Acceptance Criteria and Reported Device Performance
The report does not define explicit quantitative "acceptance criteria" through specific performance metrics like sensitivity, specificity, accuracy, or other benchmark values. Instead, the basis for approval is establishing substantial equivalence to a predicate device. This means the Optivus PBTS must demonstrate that it is as safe and effective as the LLUMC PBTS.
The "reported device performance" is presented through a comparison matrix, highlighting the technological characteristics of the Optivus PBTS and showing them to be the "Same as LLUMC PBTS" or having comparable specifications.
| Characteristic | LLUMC PBTS (Predicate Device) | Optivus PBTS (Proposed Device) | Acceptance Criteria (Implied) | Reported Performance |
|---|---|---|---|---|
| Accelerator | Synchrotron, approx. 20 ft. diameter | Same as LLUMC PBTS | Functionally and structurally equivalent to predicate accelerator. | Synchrotron, approx. 20 ft. diameter (Same as LLUMC PBTS) |
| Particle | Protons | Same as LLUMC PBTS | Uses protons for therapy. | Protons (Same as LLUMC PBTS) |
| Energy | Continuously variable from 70-250 MeV, corresponding to a water depth of 3 cm to 38 cm. | Same as LLUMC PBTS | Capable of delivering doses within the same energy range. | 70-250 MeV, 3 cm to 38 cm water depth (Same as LLUMC PBTS) |
| Total Cycle Time | 2 seconds nominal | 1.5-10.0 seconds (2.2 sec nominal) | Comparable cycle time. Nominal time is close to predicate. | 2.2 sec nominal (within range, close to predicate's nominal) |
| Spill Time | 1 second | 0.1-9.0 seconds (0.5 sec nominal) | Comparable spill time. | 0.5 sec nominal (within range, comparable to predicate's nominal) |
| Cycle Completion Time | 0.5 seconds | 0.1-9.0 second (1 sec nominal) | Comparable cycle completion time. | 1 sec nominal (within range, comparable to predicate's nominal) |
| Beam Intensity | > 1.5x10^11 protons per pulse | A variable beam intensity in ten steps over range (1x10^9 to 3x10^10 protons per pulse). | Sufficient beam intensity for therapeutic use. | Variable, 1x10^9 to 3x10^10 protons per pulse (Different but acceptable range) |
| Proton Source | 40 keV duoplasmatron | 40 keV duoplasmatron (nominal) | Same type of proton source. | 40 keV duoplasmatron (nominal) (Same type) |
| Injector Type | Radio Frequency Quadrupole | Same as LLUMC PBTS | Same type of injector. | Radio Frequency Quadrupole (Same as LLUMC PBTS) |
| Injection Energy | 1.7 MeV | 2 MeV (nominal) | Comparable injection energy. | 2 MeV (nominal) (Close to predicate) |
| Treatment Facilities | 3 treatment rooms with isocentric gantries, one treatment room with fixed horizontal beam, and a fixed-beam dedicated to calibration and non-patient use. | At least one isocentric gantry treatment room and one fixed-beam treatment room. | Provide sufficient treatment capabilities; configuration may vary but core functionality is maintained. | At least one isocentric gantry and one fixed-beam (subset of predicate's configuration) |
2. Sample size used for the test set and the data provenance:
- Sample Size: This 510(k) submission does not describe a test set or clinical study involving patient data. The "study" is a comparison of two device specifications.
- Data Provenance: Not applicable, as no external data set (patient or otherwise) is mentioned for performance evaluation beyond the device specifications themselves.
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):
- This question is not applicable. The "ground truth" here is the established and accepted specifications and performance of the predicate device (LLUMC PBTS). There's no mention of external experts being used to establish a "ground truth" for a test set for the Optivus PBTS. The FDA review process implicitly relies on the agency's experts to evaluate the technical comparison.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This question is not applicable. There is no "test set" in the context of a clinical study that would require an adjudication method. The comparison is based on documented specifications of the two devices.
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:
- This question is not applicable. The device is a proton beam therapy system, not an imaging analysis AI or diagnostic aid that would involve human readers or AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This question is not applicable. The device is a physical radiation therapy system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" in this context is the established and regulatory-cleared specifications and performance characteristics of the predicate device (LLUMC PBTS), which has been legally marketed. The submission's core argument is that the proposed device shares the same fundamental technological characteristics and principles of operation as this already-cleared device.
8. The sample size for the training set:
- This question is not applicable. There is no "training set" as this is not a machine learning or AI-based device requiring training data. The device is hardware.
9. How the ground truth for the training set was established:
- This question is not applicable. As there is no training set, there isn't a method for establishing its ground truth.
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