(29 days)
The TOMOSCAN AV-NT is a whole body Computed Tomography (CT) system which is a diagnostic X-ray system intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission of data from the same axial plane taken at different angles. It includes signal analysis and display equipment, patient and equipment supports, component parts and accessories which used in combination with signal and image processing software to facilitate the relative localization of anatomy with gray-scale representation of density relative to water utilizing Houndsfield indices with or without contrast mediums. It is used for display , storage and analysis of digital diagnostic CT images. The TOMOSCAN A V-NT is intended for use by a physician in the diagnosis phases and planning phases of patient conditions and treatment.
The Tomoscan AV-NT is a whole body scanner based on slipring technology. With the Tomoscan AV-NT, Philips introduces a new product to its Tomoscan product family which is based on and includes the technological features of existing computed tomography systems and support systems, i.e. Philips Tomoscan AV-E1, Tomoscan CS, and EasyVision Workstation. The Tomoscan AV-NT is comprised of two main parts: The operator console (back-end part) to enable scanning and advanced image processing. It . is comprised of a data acquisition part and a post-processing part with separate monitors and keyboards for each part. The gantry and patient table (front-end part). The gantry and table movements are controlled ● via the control panels on either side of the gantry. Patient positioning laser lights are mounted both externally on the gantry as an aid to patient positioning and at the scan plane.
This document describes the Philips Tomoscan AV-NT as a Computed Tomography (CT) X-ray system. The submission mainly establishes substantial equivalence to predicate devices and discusses safety information, rather than providing a detailed study proving performance against specific acceptance criteria.
Therefore, many of the requested sections about a performance study cannot be answered from the provided text.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly list quantitative acceptance criteria in a dedicated table, nor does it present device performance data from a specific study against such criteria. The submission focuses on establishing substantial equivalence to predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
No specific test set or associated sample size is mentioned in the document. The submission is based on comparison to predicate devices, not on a new clinical performance study with a test set.
3. Number of Experts Used to Establish Ground Truth for the Test Set and their Qualifications
Since no specific test set is described, there's no information about experts used to establish ground truth.
4. Adjudication Method for the Test Set
No adjudication method is mentioned as there's no described test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study is mentioned. The submission is not focused on evaluating human reader improvement with AI assistance, as it pertains to a CT system, not an AI-driven image analysis tool.
6. Standalone (Algorithm Only) Performance Study
No standalone performance study is mentioned. The device is a CT system, and the submission focuses on its equivalence to other CT systems.
7. Type of Ground Truth Used
No specific type of ground truth is mentioned in relation to proving device performance. The "ground truth" implicitly relies on the established safety and effectiveness of the predicate devices.
8. Sample Size for the Training Set
As the document describes a CT scanner and establishes substantial equivalence, rather than an AI/machine learning algorithm, there is no mention of a "training set" or its size.
9. How the Ground Truth for the Training Set Was Established
Since no training set is discussed, there is no information on how its ground truth was established.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.