(199 days)
The intended use of Blue Phantom PT is to move detectors in one dimension within a water tank. It transfers indicated ionization beams (proton beams) at a certain position into electrical signals.
The Blue Phantom PT system consists of a water tank with a one-dimensional servo including a common control unit (CCU PT) with integrated two-channel electrometer. An ionisation chamber (e.g. Stingray) is placed inside the Blue Phantom PT with a holder and is used as detector for measurements.
The Blue Phantom PT is intended to be used in the magnetic environment of a proton therapy treatment unit and its technology has been designed to meet those requirements.
On the horizontal Y-rail, detector holders for various detectors can be mounted on a sliding shoe. The detector can be positioned in the Y-direction for measuring horizontal beams.
The provided text is a 510(k) summary for the Blue Phantom PT device and discusses its substantial equivalence to a predicate device (WP 1D). It outlines performance testing but does not contain detailed acceptance criteria and performance data in the structured format requested. However, it does provide some device characteristics that can be interpreted as performance metrics.
Here's an attempt to extract and organize the information based on the provided text, recognizing that some requested details are not explicitly present:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" but rather lists "Device Characteristics" for both the predicate and the new device. We can infer that the Blue Phantom PT aiming to at least match or improve upon the predicate's characteristics constitutes a form of meeting "acceptance criteria."
| Characteristic | Acceptance Criteria (Inferred from Predicate WP 1D) | Reported Device Performance (Blue Phantom PT) |
|---|---|---|
| Position resolution | 0.1 mm | 0.1 mm |
| Position accuracy | ± 0.4 mm | ± 0.05 mm |
| Reproducibility | ± 0.1 mm | ± 0.03 mm |
| Maximum scan range | 25 cm | 38 cm max. |
| Positioning speed | 25 mm/s | Max. 25 mm/s |
| Scanning speed (continuous measurement) | Not applicable, not part of application scope (WP 1D) | max. 20 mm/s (Blue Phantom PT) |
| Electrometer | Separate device | Embedded in control unit CCU |
| Sensortype | Magneto-restrictive | Inductive |
| Radiation Type | Ionizing radiation (photon, electron), excluding proton | Proton beams |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "BP PT was successfully tested to demonstrate safety and effectiveness and substantial equivalence to the predicate device. It was subject to the following tests: System test, Clinical environment test, Usability test, Unit test (Mechanics), Firmware test, Non-clinical test against the following standards."
- Test Set Sample Size: Not specified.
- Data Provenance: The document implies internal testing ("Internal testing") and testing by "external test house" for some standards. There is no information on country of origin or whether the data was retrospective or prospective in the context of device performance data, as this is a physical measurement device, not an AI/software device processing patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable (N/A) as the device is a physical measurement tool, not an AI or diagnostic device that relies on expert ground truth for interpretation of medical data. The ground truth would be physical standards or direct measurements.
4. Adjudication Method for the Test Set
N/A. This concept is typically relevant for studies involving human interpretation or subjective assessments, not for objective physical measurements of device characteristics. The "ground truth" for the performance metrics would be derived from calibrated measurement instruments, not human 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
N/A. The Blue Phantom PT is a physical device for radiation dosimetry, not an AI-assisted diagnostic tool. Therefore, an MRMC study is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
N/A. This refers to AI algorithm performance. The device is a hardware system with embedded firmware. Its performance is inherent to its design and operation.
7. The Type of Ground Truth Used
The ground truth for the performance metrics (e.g., position accuracy, reproducibility) would be established through physical standards, highly accurate calibration systems, and traceable measurement techniques. The document mentions testing against "standards" (e.g., IEC, ISO), which implies adherence to methods and limits defined by these standards.
8. The Sample Size for the Training Set
N/A. This is a physical device, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
N/A. (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.