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510(k) Data Aggregation
(247 days)
The IBA Proton Therapy System (PTS) is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.
IBA Proton Therapy System - Proteus 235 (PTS) is a proton beam irradiation system. The device is designed to: (1) create and deliver the proton beam to the patient treatment location: (2) produce a transverse and longitudinal dose distribution appropriate for the patient's treatment; and (3) deliver the designated dose to the patient's treatment site.
The PTS has three primary components: (1) the beam management equipment, which includes a cyclotron, transport and delivery system to direct the proton beam to the patient's treatment location; (2) the position management equipment that allows bringing the patient and the proton beam in the adequate position for treatment and verifying the patient position; and (3) the treatment control system which controls the parameters of the proton beam treatment.
The scope of the current 510(k) premarket notification is to add a new version of the handpendant, which uses wireless and touch screen technologies to move equipment in the treatment room to the cleared IBA Proteus 235.
This document describes a 510(k) premarket notification for the "IBA Proton Therapy System - Proteus 235" with the addition of a wireless hand-pendant system. The submission aims to demonstrate substantial equivalence to a previously cleared device (K152224).
The acceptance criteria and device performance are as follows:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Predicate device: Proteus 235 with wired hand-pendant - K152224) | Reported Device Performance (Proteus 235 with wireless hand-pendant) |
|---|---|---|
| Functional Equivalence | Deliver a proton beam for treating localized tumors and other conditions (Same) | Deliver a proton beam for treating localized tumors and other conditions (Same) |
| Principles of Operation | Create, deliver proton beam; produce dose distribution; deliver designated dose (Same) | Create, deliver proton beam; produce dose distribution; deliver designated dose (Same) |
| Energy Source to Patient | Proton beam (Same) | Proton beam (Same) |
| Clinical Performance | (Not explicitly detailed, but stated as "same") | (Not explicitly detailed, but stated as "same") |
| Hand-pendant weight | < 700 g | < 250 g |
| Hand-pendant volume | < 3500 cm³ | < 400 cm³ |
| Hand-pendant communication link | Wired communication link | Wireless communication link (complies with wireless coexistence, latency, operating distance, FCC regulations) |
| User interface | Passive display screen, Buttons for movement and selection | Touch screen (Human factor validation conducted for usability) |
| Electrical safety | Compliant with recognized standards | Compliant with recognized standards |
| Electromagnetic compatibility | Compliant with recognized standards | Compliant with recognized standards |
| Software performance | Performs as intended | Performs as intended (Software tests verified) |
| Hardware performance | Performs as intended | Performs as intended (Hardware verification and reliability testing ensured) |
2. Sample size used for the test set and the data provenance:
This document describes a premarket notification for a modification to an existing device (adding a wireless hand-pendant). It is not a study involving patient data or a "test set" in the traditional sense of diagnostic or treatment efficacy. The testing described is primarily non-clinical performance testing of the device's components and system.
Therefore, there is no "sample size" of patients or data provenance in terms of country of origin or retrospective/prospective data for a clinical study. The tests were performed on the device and its sub-systems.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is not a study requiring expert-established ground truth for a test set of medical cases. The "ground truth" for the non-clinical tests would be the established engineering specifications, recognized standards (e.g., electrical safety, EMC), and functional requirements of the device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. There was no test set of medical cases requiring adjudication.
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 proton therapy system for radiation treatment, not an AI-assisted diagnostic or interpretation tool for human readers. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This device is a medical device for delivering radiation therapy, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the non-clinical tests, the "ground truth" was based on:
- Recognized standards: For electrical safety and electromagnetic compatibility.
- Design requirements/specifications: For hardware performance, software functionality, latency, operating distance, and FCC radio frequency testing.
- Intended use and principles of operation: The fundamental basis for comparing the modified device to the predicate.
8. The sample size for the training set:
Not applicable. This is not a machine learning or AI-based device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. As there is no training set, there is no ground truth established for one.
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