(70 days)
The TOMOSCAN CS 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 are 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 the display, storage and analysis of digital diagnostic CT images. The TOMOSCAN CS is intended for use by a physician in the diagnosis and planning phases of patient conditions and treatment.
The TOMOSCAN CS is a whole body scanner based on slipring technology. With the TOMOSCAN CS, 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 AVP1, TOMOSCAN EG, and Easy Vision Workstation. The TOMOSCAN CS 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. All scanning facilities and features of the TOMOSCAN CS are the same as with predicate devices TOMOSCAN AVP1 (previously named TOMOSCAN SR5000, ref: K944326) and TOMOSCAN EG (also named ANATOM 2000; ref: K964890). The viewing and image processing features of the predicate device EasyVision (ref: K920950) are integrated as part of the TOMOSCAN CS system.
The provided text describes a 510(K) summary for the Philips TOMOSCAN CS, a Computed Tomography (CT) X-ray system. However, the document does not contain explicit details about acceptance criteria, specific performance metrics, or a study design to prove the device meets these criteria as requested in the prompt.
The document primarily focuses on establishing substantial equivalence to previously cleared predicate devices (Philips TOMOSCAN AVP1, TOMOSCAN EG, and EasyVision Workstation) based on scanning capabilities and viewing/post-processing features. It also highlights compliance with relevant safety and regulatory standards.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or information regarding specific study details such as sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details from the provided text.
The document states:
- Safety Information: "The results of the hazard analysis, combined with the appropriate preventive measures taken indicate that the device is of minor level of concern as per the August 29, 1991 issue of the 'Reviewer's Guidance for Computer Controlled Medical Devices Undergoing 510(k) Review'."
- Regulatory Compliance: The device complies with "the Federal X-ray Performance standards 21CFR 1020.33," "the international standard IEC-601-1," "national safety standard UL-2601-1," and "the ACR/NEMA DICOM Version 3 digital imaging communication standard."
These are general statements of compliance and safety, not specific performance acceptance criteria for an AI or imaging algorithm, nor do they describe a study to demonstrate such performance. In a 510(k) for a CT system, often the "acceptance criteria" are implied by performance specifications (e.g., spatial resolution, contrast resolution, dose) that need to be met or shown to be equivalent to predicate devices, but these specific metrics and their associated testing protocols are not detailed in this summary.
§ 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.