(64 days)
IMSure is indicated for use as a quality assurance tool to verify IMRT treatment plans developed on any radiation therapy treatment planning system with the appropriate transfer format. IMSure will also perform primary monitor unit calculations from measured physics data for plans of known geometry.
IMSure is a software program designed to provide a second, independent verification of IMRT plans created on primary radiation therapy treatment planning systems. After independently calculating the imported plan and fluence maps, IMSure compares results with the imported plan and maps, and calculates the differences. This second check provides an effective QA tool for verification of the original IMRT treatment plan. IMSure also may be used to compute primary monitor unit calculations for single and multiple beams with open, blocked, and wedged fields.
The provided 510(k) notification for the IMSure device (K031975) does not contain explicit acceptance criteria or detailed study results demonstrating performance against such criteria.
The document primarily focuses on establishing substantial equivalence to a predicate device (RadCalc V4.0, K010464) by comparing technological characteristics and intended use. While it states that "The New Device has the same intended use and safety characteristics as the predicate device," it does not present a performance study with acceptance criteria.
Therefore, most of the requested information cannot be extracted from this document. However, I can still provide what little is available:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in the document.
- Reported Device Performance: Not reported in terms of specific metrics against acceptance criteria. The document claims "IMSure compares results with the imported plan and maps, and calculates the differences. This second check provides an effective QA tool for verification of the original IMRT treatment plan," but no quantitative performance data is given.
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 provided in the document. No formal test set or study data is presented.
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 provided as no formal test set and ground truth establishment process are described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- This information is not provided as no formal test set and adjudication process are described.
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
- This information is not provided. The device is a software program for IMRT plan verification and monitor unit calculation, not an AI-assisted diagnostic tool that would typically involve human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- The document implies a standalone performance comparison by stating "IMSure compares results with the imported plan and maps, and calculates the differences." However, no specific standalone performance metrics or studies are detailed. The comparison is against the primary radiation therapy treatment planning system, but the agreement or difference thresholds are not quantified.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- This information is not explicitly stated as no formal ground truth for a performance study is described. For a QA tool verifying IMRT plans, the "ground truth" would implicitly be the correct physical dose distribution and monitor units as determined by established physics principles and measurements, which the device aims to verify.
8. The sample size for the training set
- This information is not provided. The document describes the algorithms used (Single Source model, Three Source model, Clarkson scatter algorithm, Khan (classical)), which are based on established physics models rather than machine learning algorithms that typically require a "training set" in the conventional sense.
9. How the ground truth for the training set was established
- Not applicable in the context of this device, as it employs physics-based algorithms rather than machine learning requiring a training set with established ground truth. The algorithms are based on "measured physical data" and "measured and modeled" scatter tables, implying established physical properties and calibrations as their basis.
§ 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.