(228 days)
INTDose is a software product intended to support the radiation therapy treatment planning process by providing independent dose verification through Monte Carlo simulation. INTDose is not a treatment planning system or a radiation delivery device and should only be used by trained radiation oncology personnel as a quality assurance tool.
INTDose is a software product used within a radiation therapy clinic for quality assurance and treatment plan verification. It allows clinicians to perform a second check of a radiotherapy dose generated by a treatment planning system by simulating the transport of ionizing radiation in patients using an independent Monte Carlo algorithm. INTDose is implemented such that one or more clients may communicate calculation requests to a central dose calculation server.
While INTDose operates in the field of radiation therapy, it is neither a treatment planning system nor radiation delivery device. INTDose never comes into contact with patients and cannot control treatment delivery devices or any other medical devices. It is an analysis tool to be used only by trained radiation oncology personnel for quality assurance purposes.
This FDA 510(k) clearance letter and summary describe a software product called INTDose, intended for independent dose verification in radiation therapy treatment planning. However, the provided document does not contain the specific details required to fully address your request regarding acceptance criteria and the study that proves the device meets those criteria.
Here's a breakdown of what can and cannot be answered based on the provided text:
Information NOT available in the provided text:
- A table of acceptance criteria and the reported device performance: The document states that performance was "evaluated and verified" and "established that the device meets its design requirements," but it does not provide specific quantitative acceptance criteria (e.g., dose accuracy within X%) or the results against those criteria.
- Sample sized used for the test set and the data provenance: There is no mention of the size of the test set used for verification and validation, nor the origin (country, retrospective/prospective) of the data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned.
- 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: The device is described as "independent dose verification through Monte Carlo simulation," a quality assurance tool, and an "analysis tool," but it does not specify an AI component that would typically be evaluated with MRMC studies comparing human readers with and without AI assistance. It's a "secondary check QA software." Therefore, it's highly unlikely an MRMC study in this context would involve human readers in the typical sense of interpreting images for diagnosis.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: While the nature of the device (a dose calculation software) implies independent performance, the study details of this standalone performance (what metrics were used, against what ground truth, sample size, etc.) are not provided.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The document refers to "independent Monte Carlo algorithm" and "second check of a radiotherapy dose generated by a treatment planning system," implying the "ground truth" or reference for comparison would be another established dose calculation method or physical measurement, but the exact nature or method of ground truth establishment is not detailed.
- The sample size for the training set: As a Monte Carlo simulation software, it's not explicitly stated that there's a "training set" in the machine learning sense. If there are underlying models that are trained, this information is not provided.
- How the ground truth for the training set was established: See above.
What is mentioned in the document:
- Device Type: INTDose is "software product intended to support the radiation therapy treatment planning process by providing independent dose verification through Monte Carlo simulation." It's a "Secondary Check QA Software."
- Purpose: Quality assurance tool to perform a "second check of a radiotherapy dose generated by a treatment planning system."
- Technology: Uses an "independent Monte Carlo algorithm" to simulate the transport of ionizing radiation.
- Performance Evaluation (General): "The safety and performance of INTDose has been evaluated and verified in accordance with software specifications and applicable performance standards through software verification and validation testing."
- Conclusion: "Non-clinical verification and validation test results, including simulation performance and software usability, established that the device meets its design requirements and intended use, that it is as safe and as effective as the predicate device, and that no new issues of safety and effectiveness were raised."
- Compatibility Testing: Successfully completed with specific treatment delivery machines (Accuray TomoTherapy HDA, Varian TrueBeam, Varian Clinac (21EX-Platinum), Varian Clinac (iX), Varian Halcyon). This indicates a form of performance testing, possibly verifying dose agreement or data transfer capabilities.
- Risk Management: "Potential hazards were controlled by a risk management plan including risk analysis, risk mitigation, verification and validation."
In summary, while the document confirms that performance testing was conducted for the INTDose device and asserts that it met design requirements and proved substantially equivalent to its predicate, it lacks the detailed quantitative data, sample sizes, ground truth establishment methods, and expert adjudication information typically found in a comprehensive study report. This level of detail is usually found in the full 510(k) submission, not the public summary or clearance letter.
§ 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.