(51 days)
The Profiler 2 is a device that is designed for use as a radiation scanning system that is used to measure beam data in radiotherapy departments for dose modeling in the treatment planning computer.
Profiler 2 is only used by the radiation therapy professionals, and is not used with the patient. A standard commercial power converter converts the power from the wall outlet voltage (100 to 240 VAC) to 18 VDC. The converter is then connected to a power/data interface (PDI) and then supplies the 18 VDC power to the Profiler 2 through a single 8 pin DIN connector. A standard 9 pin serial connectors connects the PDI to a computer. The commercial power converter and PDI device are fully tested for safety. Therefore, Profiler 2 should not generate a shock hazard to the operator.
The provided text describes a medical device, Profiler 2, which is used to measure beam data in radiotherapy for dose modeling. However, the text does not contain any information regarding acceptance criteria, a study proving the device meets those criteria, or specific performance metrics and their supporting data provenance.
The document is primarily a 510(k) premarket notification approval letter from the FDA, confirming that the device is substantially equivalent to legally marketed predicate devices. It focuses on regulatory compliance, safety features, and the intended use of the device.
Therefore, I cannot fulfill your request for the following information based on the provided text:
- A table of acceptance criteria and the reported device performance: This information is not present.
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set, sample size, or data provenance is mentioned.
- 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): No information on ground truth establishment for a test set.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as no test set details are provided.
- 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. Profiler 2 is not an AI-based diagnostic tool for human readers; it's a measurement device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. Profiler 2 is a physical device measuring radiation, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable as no ground truth for a test set is discussed.
- The sample size for the training set: Not applicable as this is not an AI/machine learning device.
- How the ground truth for the training set was established: Not applicable.
The document confirms that "Sun Nuclear has deemed the devices safe and effective for their intended uses as long as they are used in accordance with all of the accompanying labeling and instructions," and "Sun Nuclear believes that responsible design and quality assurance practices were followed during the development and manufacture of Profiler 2 (Model 1174)." However, these are statements of belief and internal assessment, not a description of a study proving specific performance against 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.