(16 days)
The Leksell GammaPlan 4C with MultiView is a computer-based dose planning system specifically designed for use with the Leksell Gamma Knife®. The Leksell GammaPlan 4C with MultiView is intended to be used for planning the dosimetry of treatments in stereotactic radiosurgey and stereotactic radio therapy. It processes the inputs from the healt care professionals such that the desired radiation dose is provided by the Leksell Gamma Knife® to a precisely defined target area within the cranium.
The Leksell GammaPlan 4C with MultiView adds support for frameless images by means of co-registration of image series. This simplifies stereotactic radiosurgery procedures as only one image series needs to be acquired with the Leksell stereotactic frame. Leksell GammaPlan 4C with MultiView also adds support for brain altas structures and visualization of color mapped PET images for use in preoperative planning.
The provided text describes a Special 510(k) submission for the "Leksell GammaPlan 4C with MultiView" device. This submission focuses on demonstrating substantial equivalence to a predicate device ("Leksell GammaPlan", K973441) and highlights new features like support for frameless images via co-registration and visualization of color-mapped PET images.
However, the document does not contain specific acceptance criteria or details of a study designed to prove the device meets such criteria. It primarily details the device description, intended use, and substantial equivalence claim, which is a regulatory pathway for devices that are similar to already legally marketed devices.
Therefore, I cannot provide the requested table or answer most of the questions because the information is not present in the provided text.
Here's an assessment based on the available information:
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Table of acceptance criteria and the reported device performance:
- N/A. The document does not specify acceptance criteria or report performance against such criteria. The submission is a "Special 510(k)" which usually relies on demonstrating substantial equivalence to a predicate device, often without a detailed performance study like a traditional 510(k) might require for novel features.
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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):
- N/A. No information on a test set or data provenance is provided.
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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):
- N/A. No information on experts or ground truth establishment for a test set is provided.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. No information on adjudication methods for a test set is 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:
- N/A. This device is a dose planning system, not an AI-assisted diagnostic tool for human readers. No MRMC study is mentioned.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The document implies the device is a "computer-based dose planning system" for "health care professionals," indicating human-in-the-loop operation. No standalone performance study details are provided.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- N/A. No information on the type of ground truth is provided.
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The sample size for the training set:
- N/A. This document describes a software update for a medical device; it does not detail a machine learning model that would typically have a "training set."
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How the ground truth for the training set was established:
- N/A. As above, no training set is described in the context of a machine learning model.
§ 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.