(51 days)
MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.
The MHI-TM2000 Linear Accelerator System (hereinafter called "MHI-TM2000 (VER. 3.0)") has been developed based on MHI-TM2000 Linear Accelerator System previously cleared by FDA under K072047 (hereinafter called "MHI-TM2000 (K072047)").
MHI-TM2000 (VER. 3.0) introduces a new interface functionality for remotely controlling gimbaled motion (pan and tilt motion) of X-ray tube and MLC, based on position data received from radiation therapy positioning system "ExacTrac Vero", which is compatible 3rd party device manufactured by Brainlab AG. This functionality enables continuous alignment of treatment beam with moving target resulting in precise radiation treatment of moving targets.
The gimbal mechanism (pan and tilt) is one of the unique characteristics of MHI-TM2000 (K072047), which is called "X-ray-head-mounted gimbals".
The "X-ray-head-mounted gimbals" have been used to compensate for the residual mechanical deformation, mainly caused by gravity, but the MHI-TM2000 (VER. 3.0) utilizes this mechanism further for moving treatment-X-ray beam axis for continuously aligning it with moving target.
A new interface (communication board) for receiving position data is equipped to System Controller Panel of MHI-TM2000 (VER. 3.0).
The method of generating radiation and irradiation are the same as MHI-TM2000 Linear Accelerator System (K072047).
This 510(k) summary for the MHI-TM2000 Linear Accelerator System (K12245D) focuses on demonstrating substantial equivalence to a predicate device and does not describe acceptance criteria or a detailed study proving the device meets specific performance metrics in the way an AI/ML device submission would.
The document states:
- "The verification testing results from bench testing support the substantial equivalence of the MHI-TM2000 (Ver. 3.0) with the predicate devices."
- "The result also ensured conformance to system specifications, functional requirements, use cases, hazard mitigation, as well as compliance with applicable standards."
- "Accuracy of gimbaled (pan and tilt) motion of X-ray tube and MLC (treatment beam axis) to continuously align with moving target, has also been tested because this is the key function for the new functionality. The results also showed that MHI-TM2000 (Ver.3.0) meet the acceptance criteria."
However, it does not provide any specific acceptance criteria (e.g., numerical thresholds for accuracy, precision, or other performance metrics) nor does it provide a detailed study report with results that would allow for a table of acceptance criteria and reported device performance.
Therefore, most of the requested information cannot be extracted from the provided text.
Here's what can be stated based on the given document:
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in numerical terms (e.g., "accuracy within X mm"). The document only broadly states "meet the acceptance criteria" for the accuracy of gimbaled motion.
- Reported Device Performance: Not quantified. The document only broadly states "The results also showed that MHI-TM2000 (Ver.3.0) meet the acceptance criteria" for accuracy of gimbaled motion.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable/Not provided. The testing described is "bench testing" focusing on the physical performance of a linear accelerator system, not a study involving patient data or a "test set" in the context of an AI/ML device.
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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):
- Not applicable. This is not an AI/ML device requiring expert-established ground truth on medical images or diagnoses. The ground truth for bench testing would typically be engineering specifications and measurement standards.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable.
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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:
- Not applicable. This is a medical device (linear accelerator) for radiation therapy, not an AI/ML diagnostic or assistive device that would involve human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical linear accelerator system.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the "Accuracy of gimbaled (pan and tilt) motion" testing, the ground truth would be based on precise physical measurements against engineered specifications and calibration standards. No clinical ground truth (like pathology or expert consensus) is mentioned or relevant for this type of device's mechanical performance testing.
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The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set.
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How the ground truth for the training set was established:
- Not applicable.
§ 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.