(11 days)
The MEVATRON MX Linear Accelerator is intended to deliver megavoltage x-ray treatment for therapeutic application in the treatment of cancer. The depth of penetration emulating from the MEVATRON MX ideally suits itself for treating deep-seated tumors while providing a skin sparing effect.
The MEVATRON MX is a single energy, high dose medical linear accelerator. The MEVATRON MX includes dual dose rate, asymmetric jaws, and either Virtual Wedge™ or standard cross-plane wedges.
The provided text describes a 510(k) premarket notification for the MEVATRON MX Linear Accelerator (K982513). This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics for a novel AI or diagnostic device.
Therefore, many of the requested categories for AI/diagnostic device studies are not applicable to this submission.
Here's a breakdown based on the information available:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device: The MEVATRON MX should demonstrate substantial equivalence to the MEVATRON M Class (K882729) in terms of intended use, technological characteristics, and performance characteristics. | The submission explicitly states: "The intended use of the MEVATRON MX is the same as the 6 MV MEVATRON M Class and has not changed as a result of this modification." and "The MEVATRON MX linear accelerator does not have significant changes in materials, energy source or performance characteristics compared to the predicate devices. The intended use and the performance characteristics are the same as the predicate device and therefore we believe it is substantially equivalent to it." |
| Intended Use: To deliver x-ray radiation for therapeutic treatment of cancer. | The intended use is clearly stated as: "to deliver x-ray radiation for therapeutic treatment of cancer." and "The MEVATRON MX Linear Accelerator is intended to deliver megavoltage x-ray treatment for therapeutic application in the treatment of cancer." |
| Performance Standards: No applicable FDA performance standards. | No applicable performance standards have been established by FDA under section 514 of the Food, Drug and Cosmetic ACT. |
It's important to note that for a 510(k) submission like this, the "acceptance criteria" are primarily centered around demonstrating substantial equivalence to a legally marketed predicate device. There aren't explicit quantitative performance metrics in the same way one would find for a diagnostic or AI device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a submission for a linear accelerator, not a diagnostic or AI device that relies on a test set of data for performance evaluation in the traditional sense. The equivalence is based on engineering design, performance characteristics (such as radiation output and beam properties), and intended use, not on analyzing patient data.
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)
Not applicable. Ground truth for a test set is not relevant for this device's substantial equivalence determination.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set requiring adjudication in this context.
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
Not applicable. This is not an AI device, and no MRMC study was performed or needed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device for radiation therapy, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" in this context is the performance and safety established for the predicate device, against which the new device is compared in terms of its technical specifications and intended functionality.
8. The sample size for the training set
Not applicable. This device does not involve a training set as it is not an AI or machine learning product.
9. How the ground truth for the training set was established
Not applicable. No training set is involved.
§ 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.