(45 days)
The PIPSpro QA Software System displays, enhances and analyses portal images, and is used in conjunction with commercially available electronic portal imaging detectors (EPIDs). PIPSpro provides numerous measurement tools, image processing routines, statistical analysis and capabilities that are not available in the standard software provided by the EPID suppliers. These include the processing of simulator and portal verification images, analyzing patient registration errors, measuring of image quality from an EPID during installation tests, providing a platform for quality assurance programs in radiation therapy, and tools for writing and editing notes attached to images for easy communication. In this capacity, it can only import images and information.
PIPSpro QA Software System (Portal Imaging Processing System, professional version) is a stand-alone software program for use on PC computers running under Microsoft Windows 9x/Me/2000/NT/XP. The PC is not supplied with PIPSpro, and must be provided by the user. PIPSpro is supplied on a CD together with a software security key ("dongal" or hard lock) which is inserted into a parallel or USB port on the computer to allow the software to work. PIPSpro does not use, control, or operate any hardware, it is purely a stand-alone software program.
AQUA is also a stand-alone software program, consisting of a small part of the PIPSpro system. AQUA includes only those routines required for the analysis of images acquired with the QC-3 phantom, and used for quality control of electronic portal imaging devices
The PIPSpro OA Software System, which displays, enhances and analyses portal images, and is used in conjunction with commercially available electronic portal imaging detectors (EPIDs). PIPSpro provides numerous measurement tools, image processing routines, statistical analysis and capabilities that are not available in the standard software provided by the EPID suppliers. These include the processing of simulator and portal verification images, analyzing patient registration errors, measuring of image quality from an EPID during installation tests, providing a platform for quality assurance programs in radiation therapy, and tools for writing and editing notes attached to images for easy communication. In this capacity, it can only import images and information.
The provided document is a 510(k) Summary of Safety and Effectiveness Information for the Standard Imaging PIPSpro QA Software System. It describes the software's functionality and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a specific study proving the device meets those criteria with quantitative values.
The document states: "The Standard Imaging PIPSpro QA Software System has met its predetermined design specifications, risk analysis and validation objectives." It also mentions "nearly 10 years of evolving development and use" and lists validation activities such as "Algorithm and image transfer," "Results presentation and graphing," "Beta testing," "Interface, compatibility, use and misuse," and "Bug, Modification and/or Addition change testing." However, these are general statements about development and validation processes, not a detailed account of specific performance metrics or a study.
Therefore, I cannot provide the requested information from this document.
Summary of missing information:
- Table of acceptance criteria and reported device performance: Not provided. The document states validation objectives were met, but does not list specific criteria or performance metrics.
- Sample size used for the test set and data provenance: Not provided.
- Number of experts used to establish ground truth for the test set and qualifications: Not provided.
- Adjudication method for the test set: Not provided.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned.
- Standalone (algorithm only) performance study: Not detailed, although the software is described as "standalone."
- Type of ground truth used: Not specified.
- Sample size for the training set: Not provided.
- How the ground truth for the training set was established: Not provided.
§ 892.1940 Radiologic quality assurance instrument.
(a)
Identification. A radiologic quality assurance instrument is a device intended for medical purposes to measure a physical characteristic associated with another radiologic device.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 892.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.