(74 days)
The OmniPro Incline is a QA beam measuring system intended to be used for the verification of dose distribution in radio therapy. The system is intended to measure proton, photon and electron beams.
The Omni-Pro-Incline software is a workspace tool managing both the measurements and the analysis of depth dose distributions of particles with a range up to 33 cm Water Equivalent Thickness (WET): The software is delivered with a dedicated system of multi layer of ionization chambers and with a decicated electrometer based on the Tera chip technology. Single Bragg peaks as well as modulated distributions can be measured and analyzed with high spatial and temporal resolution (in the order of 2mm WET) with typical sampling time down to 10ms. The data format will be directly compatible with the one of the IBA Dosimetry conventional formats and at least easily exchangeable. The system is suitable for both active and passive delivery
I am sorry, but the provided text content does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the study proving adherence to them for the OmniPro Incline device. The document primarily consists of a 510(k) summary and an FDA clearance letter, which focus on regulatory approval and substantial equivalence to a predicate device, rather than a detailed study report with specific performance metrics and study design elements.
However, I can extract the following information:
1. A table of acceptance criteria and the reported device performance
The provided text does not explicitly state acceptance criteria or reported device performance in a quantified manner. It describes the device's capabilities:
- "managing both the measurements and the analysis of depth dose distributions of particles with a range up to 33 cm Water Equivalent Thickness (WET)"
- "high spatial and temporal resolution (in the order of 2mm WET)"
- "typical sampling time down to 10ms"
Without specific numerical targets for accuracy, precision, or other performance metrics, a table of acceptance criteria and reported performance cannot be generated from the given text.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not available in the provided text. The document acts as a summary for regulatory submission, not a detailed scientific study report.
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 information is not available in the provided text. The device is a QA beam measuring system, implying its measurements would be compared against expected physical properties or reference standards, not necessarily human expert consensus on diagnostic images.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not available in the provided text.
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
Given the device's function as a "Radiation therapy dose calculation QA tool" and its purpose "for the verification of dose distribution in radio therapy," it is highly unlikely that an MRMC comparative effectiveness study involving human readers and AI assistance was conducted or would be relevant for this type of device. The OmniPro Incline is a measurement and analysis tool for physical dose distributions, not an AI diagnostic or decision-support system for human interpretation. Therefore, there is no information about such a study or effect size in the provided text.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The device is described as a "software" that "manag[es] both the measurements and the analysis." It is bundled with "a dedicated system of multi layer of ionization chambers and with a dedicated electrometer." This suggests the software operates in conjunction with hardware to make measurements. The document does not specify a "standalone" algorithm-only performance study in the context of typical AI device evaluations. Its function is to perform measurements and analysis, implying its "standalone" operation is its primary mode without human intervention in the data acquisition and initial analysis phases, but the specific wording of a "standalone study" akin to AI evaluation is not present.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for a device like OmniPro Incline, which measures and analyzes radiation dose distributions, would typically involve established physics principles, reference dosimetry standards (e.g., traceable to national labs), or highly accurate alternative measurement techniques. The text does not explicitly state the type of ground truth used but implies comparison to expected physical properties of radiation beams.
8. The sample size for the training set
This information is not available in the provided text. The device is described as software for measurement and analysis, not as a machine learning or AI model that typically undergoes "training."
9. How the ground truth for the training set was established
As the device is not described as a machine learning or AI model requiring a "training set" in the conventional sense, this information is not applicable and therefore not available in the provided text.
§ 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.