(73 days)
The AV Expander Upgrade does not alter the intended use of the CT system to which it is attached, nor does it differ from the SR8000.
The Philips Tomoscan AV Expander Upgrade is an upgrade package to be installed on the existing Tomoscan SR 7000 (K924082). It is comprised of components and capabilities taken from the TOMOSCAN AVE CT system which has been cleared for commercial distribution by Premarket Notification submission K954255.
Identified components of the Expander Upgrade are the Rapidview Reconstructor, and an interface package; the included capabilities include a 7 mm slice thickness, and table speeds of 7 and 14 mm/sec.
This document describes the Philips TOMOSCAN AVE Upgrade, an upgrade package for the existing Tomoscan SR 7000 Computed Tomography (CT) X-ray System.
Based on the provided text, the Philips TOMOSCAN AVE Upgrade is a hardware/software upgrade that enhances the capabilities of an existing CT system. It's not a new standalone AI-powered diagnostic device, but rather a modification to an established medical imaging system. As such, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of an AI-driven diagnostic device as you've outlined in your input prompt (e.g., performance metrics, ground truth, expert consensus, MRMC studies) is not applicable to this submission.
Here's a breakdown of why the requested information cannot be provided from this document:
- AI/Machine Learning Component: There is no mention or indication of artificial intelligence, machine learning, or any algorithmic diagnostic component in the described upgrade. It focuses on hardware (Rapidview Reconstructor, Net Interface) and functional changes (faster reconstruction, new slice thickness, new table speeds).
- Diagnostic Performance Metrics: Because it's an upgrade to an existing CT scanner and not a new diagnostic algorithm, the document does not discuss diagnostic performance metrics like sensitivity, specificity, AUC, or other measures typically used for AI-driven devices.
- Clinical Study Design: The document does not describe a clinical study in the sense of evaluating diagnostic accuracy or effectiveness against ground truth. Instead, it refers to compliance with safety standards and the device's clearance based on previous submissions (K954255 for the TOMOSCAN AVE CT system).
Therefore, an answer to your request regarding acceptance criteria and a study proving performance for an AI device cannot be generated from this text because the product described is an upgrade to a conventional CT system, not an AI-powered diagnostic tool.
The document does provide:
- Classification Name: Computed Tomography X-ray System (Class II - 21 CFR 892.1750)
- Common/Usual Name: CT X-ray System
- Trade/Proprietary Name: Philips TOMOSCAN AVE Upgrade
- Performance Standards: 21 CFR Part 1020.33, IEC-601, and UL-187 (these are general safety and performance standards for CT systems)
- System Description: Details the components (Rapidview Reconstructor, Interface package) and capabilities (7 mm slice thickness, 7 and 14 mm/sec table speeds) that are part of the upgrade.
- Safety Information: States that CT is a mature technology, devices comply with the Radiation Control for Health and Safety Act, and Philips CT systems comply with national and international safety standards.
The statement "The resultant changes in specification do not affect clinical applications or effectiveness of the device" indicates that the upgrade is considered equivalent or an improvement without negatively impacting the established clinical utility of the base CT system. This is a common approach for upgrades and modifications in medical devices, where the focus is often on ensuring the modification doesn't introduce new hazards or diminish the existing performance, rather than conducting a full de novo clinical effectiveness study for the upgrade itself.
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JAN 1 0 1997
Philips Medical Systems
K9244318
Summary of Safety and Effectiveness
| CLASSIFICATION NAME: | Computed Tomography X-ray SystemClass II -21 CFR 892.1750 |
|---|---|
| COMMON/USUAL NAME: | CT X-ray System |
| TRADE/PROPRIETARY NAME: | Philips TOMOSCAN AVE Upgrade |
| ESTABLISHMENT No. | 1217116 |
| PERFORMANCE STANDARDS: | 21 CFR Part 1020.33, IEC-601, and UL-187. |
SYSTEM DESCRIPTION:
The Philips Tomoscan AV Expander Upgrade is an upgrade package to be installed on the existing Tomoscan SR 7000 (K924082). It is comprised of components and capabilities taken from the TOMOSCAN AVE CT system which has been cleared for commercial distribution by Premarket Notification submission K954255.
Identified components of the Expander Upgrade are the Rapidview Reconstructor, and an interface package; the included capabilities include a 7 mm slice thickness, and table speeds of 7 and 14 mm/sec. The AV Expander Upgrade does not alter the intended use of the CT system to which it is attached, nor does it differ from the SR8000. The resultant changes in specification do not affect clinical applications or effectiveness of the device. The X-ray tube and the different detectors will be the major difference between an upgraded SR 7000 and the Tomoscan AVE (SR 8000).
The AVE Upgrade is intended to address the primary operational differences between the Tomoscan SR 8000 and SR 7000:
Hardware/Software Content
-Rapidview Reconstructor -Interface package (Net Interface) Functional Changes - I sec reconstruction -7 mm slice thickness. -Table speeds of 7 and 14 mm/sec
SAFETY INFORMATION:
Computed Tomography is a mature technology with which the industry and users have many years of experience. These devices must comply with the appropriate sections of the Radiation Control for Health and Safety Act. . A Product Report will be submitted prior to first delivery. Additionally, Philips CT systems are designed to be in compliance with National and International safety standards.
Philips Medical Systems
North America Company
710 Bridgeport Avenue
Shelton, CT 06484-4708
Tel: (203) 926-7674
Fax: (203) 929-6099
N/A