(1032 days)
The NPTC is a facility designed to produce and deliver a proton beam of known energy, intensity and shape for treatment of a patient. It is indicated for use in the therapeutic application of a proton beam for the treatment of localized turnors or other diseases that are susceptible to treatment by radiation. The facility is designed so that it will: (1) create and direct (deliver) the proton beam appropriately to the patient treatment location: (2) produce a transverse and longitudinal dose distribution appropriate for the patient treatment; and (3) deliver the designated dose to the patient's treatment site.
The equipment installed in the NPTC is comprised of the following two main components: (1) the beam delivery equipment and (2) the beam production equipment. The primary responsibility of the beam delivery equipment is to direct the proton beam to the patient's treatment site within the patient treatment location and to ensure that the patient critical functions are properly and safely carried out. The beam production equipment is necessary to produce the proton beam and direct it to the appropriate treatment room. In addition to the main components, the equipment in the NPTC also includes: (1) a Therapy Safety System ("TSS"); and (2) a computer-based Therapy Control System ("TCS").
The provided text is a 510(k) summary for a medical device: the Northeast Proton Therapy Center (NPTC). This document is primarily focused on demonstrating substantial equivalence to predicate devices for regulatory approval, rather than a clinical study evaluating the performance of a diagnostic or predictive algorithm.
Therefore, many of the requested categories (like sample sizes for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance with metrics like sensitivity/specificity, and training set details) are not applicable or cannot be determined from this type of regulatory submission. This submission describes a treatment facility that produces and delivers a proton beam, not a diagnostic device that generates a "performance report" in the typical sense of AI/ML.
However, I can extract the relevant information that is present:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from Intended Use/Technological Characteristics) | Reported Device Performance (from "Performance Data" and "Substantial Equivalence Discussion") |
|---|---|
| Create and direct (deliver) the proton beam appropriately to the patient treatment location. | Performance testing conducted to demonstrate that the device meets its performance specifications. (Specific metrics not provided, but implicitly covers beam delivery). |
| Produce a transverse and longitudinal dose distribution appropriate for the patient treatment. | Performance testing conducted to demonstrate that the device meets its performance specifications. (Specific metrics not provided, but implicitly covers dose distribution). |
| Deliver the designated dose to the patient's treatment site. | Performance testing conducted to demonstrate that the device meets its performance specifications. (Specific metrics not provided, but implicitly covers dose delivery). |
| Beam range similar to predicate Loma Linda facility. | The beam range in the NPTC facility is similar to the Loma Linda facility. |
| Safety and control systems are equivalent to predicate devices (Loma Linda and HCL). | The safety and control systems for the NPTC, Loma Linda, and HCL facilities are equivalent. |
| Engineering principles underlying accelerators are the same as predicate devices. | Even though the NPTC and its predicate devices use different accelerators, the engineering principles underlying their design are the same. |
2. Sample size used for the test set and the data provenance:
- Not Applicable. This is not a study of a diagnostic algorithm or a device that uses a "test set" in the traditional sense of AI/ML evaluation. The "performance data" refers to engineering and operational tests of the physical facility and beam, not a dataset of patient cases.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. See point 2.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. See point 2.
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 proton therapy delivery system, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical facility and its equipment for radiation therapy, not a standalone algorithm. The "performance data" would refer to the facility's ability to produce and deliver the proton beam as specified.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the "performance data" mentioned, the ground truth would typically be engineering specifications, physical measurements, and industry standards for proton beam generation and delivery. For example, measurements of beam energy, intensity, shape, and dose distribution compared against design specifications.
8. The sample size for the training set:
- Not Applicable. This device is a physical therapy center; it does not utilize a "training set" in the context of machine learning. The design and construction were based on established physics and engineering principles.
9. How the ground truth for the training set was established:
- Not Applicable. See point 8.
§ 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.