(98 days)
MIRS ™ is used to create treatment plans for patients for whom radiation therapy has been prescribed. The system will calculate and display three dimensional radiation dose distributions within the patient for a given treatment plan set up. MIRS can be used for different treatment modalities of radiation therapy, such as conventional therapy, Conformal Radiation Therapy, Intensity Modulated Radiation Therapy, and Radiosurgery with Conic Collimators.
MIRS ™ is used to create treatment plans for patients for whom external beam radiation therapy has been prescribed. MIRS is used to create three dimensional radiation dose distributions within the patient for a given treatment plan set up. MIRS (Module Integrated Radiotherapy System) is a modular patient treatment planning system for different treatment modalities of radiation therapy, from three dimensional radiotherapy to Conformal Radiation Therapy, Intensity Modulated Radiation Therapy and Conventional radiotherapy with Conic Collimators. MIRS supports any stereotactic frame. MIRS has automatic multimodality image registration, with and without fiducials. Besides 3D RMI and CT images studies with any orientation (axial, coronal or sagital), MIRS supports registration of functional RMI, PET and angiography.
The provided 510(k) summary for the MIRS™ (Module Integrated Radiotherapy System) device does not contain specific acceptance criteria or an explicit study describing formal performance testing against such criteria. The document claims substantial equivalence to predicate devices based on "Technological Characteristics Comparison" and "Performance Data" sections, but these sections only state that items were found to be substantially equivalent without detailing the actual comparisons or performance metrics.
Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes, ground truth establishment, expert involvement, adjudication methods, and MRMC studies cannot be extracted from the provided text.
Based on the available information:
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Table of Acceptance Criteria and Reported Device Performance: This information is not provided in the document. The document states, "All of the items contained in the tables of section 10 have been found to be substantially equivalent," but does not present these tables or their content.
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Sample sized used for the test set and the data provenance: This information is not provided.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided.
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Adjudication method: This information is not provided.
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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 described is a treatment planning system, not an AI-assisted diagnostic tool that would typically involve human readers for interpretation.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The document does not describe specific standalone performance studies. Its claims are centered around substantial equivalence to predicate devices, implying that its performance is comparable, but details of such a comparison are absent.
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The type of ground truth used: This information is not provided.
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The sample size for the training set: This information is not provided.
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How the ground truth for the training set was established: This information is not provided.
Summary of what is available:
- Device Name: MIRS™ Module Integrated Radiotherapy System
- Intended Use: To create treatment plans for patients for whom radiation therapy has been prescribed, calculating and displaying three-dimensional radiation dose distributions. It supports various modalities (conventional, conformal, IMRT, radiosurgery).
- Comparison Method: Substantial equivalence claimed against multiple predicate devices based on technological characteristics and performance data, but specific details of the comparison are not given in the provided text.
- Submission Type: Traditional Premarket Notification (510(K)).
- Submission Date: December 8th, 2008
- Clearance Date: May 4, 2009
§ 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.