(118 days)
StorM-Base 2.0 is intended to be used by physicians and other qualified medical personnel for the documentation, communication, display, printing and storage of medical diagnostic data in the field of Lithotripsy. When installed with a Storm-Touch system, it is also an image archiving system based on the DICOM standard capable of capturing and annotating lithotripsy procedures for documentation purposes. Images imported and distributed by StorM-Base 2.0 are for viewing and reference purposes only and are not intended for primary diagnosis.
The Strorz StorM-Base 2.0 is a Windows XP based software application that stores patient data, examination results including the number, type and location of stones, treatment images and data. The application may be installed on a standalone PC or on the StroM-Touch MODULITH Lithotripter (K070579). When installed on the StroM-Touch MODULITH Lithotripter, the system can acquire the images and treatment data directly from the lithotripter via an import function and be networked to the Storz Controller Buss.
The Karl Storz Endoscopy StorM-Base 2.0 is a software application intended for documentation, communication, display, printing, and storage of medical diagnostic data in lithotripsy. It is explicitly stated that "Images imported and distributed by StorM-Base 2.0 are for viewing and reference purposes only and are not intended for primary diagnosis."
Given this intended use, the submission primarily focuses on software verification and validation, compliance with standards (DICOM), and comparison to a predicate device regarding similar technical characteristics and safety. There are no clinical performance acceptance criteria or studies involving human readers or ground truth for diagnostic accuracy, as the device is not intended for primary diagnosis.
Therefore, I cannot provide a table of acceptance criteria and reported device performance related to diagnostic accuracy, nor can I answer questions about sample sizes for test sets, expert-established ground truth, adjudication methods, MRMC studies, or standalone performance. The document only addresses the software's functional and safety aspects.
Here's a summary of the information available based on the provided text, primarily focusing on the software's development and validation:
1. Table of Acceptance Criteria and Reported Device Performance (Operational and Safety Focus):
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with software verification and validation methods | Developed in compliance with software verification and validation methods. |
| Implementation of appropriate risk control measures | Appropriate risk control measures identified and implemented through a risk management process meeting ISO 14971. |
| Proper implementation of requirements | Verification and validation testing performed to ensure requirements are properly implemented. |
| Compliance with DICOM standard | Verified to be in compliance with the DICOM standard. |
| System functionality (storage, display, printing, etc.) | Technical characteristics similar to predicate (Windows-based, stores patient info, complies with HL7/DICOM, archives data, imports/distributes images). |
| No manipulation of original PACS or HIS data | Does not manipulate original PACS or HIS data. |
| Images not for diagnostic use | Stored images are not intended for diagnostic use. |
Since the device is not intended for primary diagnosis, the following points address what is NOT applicable or available in the provided text:
- Sample size used for the test set and the data provenance: Not applicable as no clinical diagnostic performance study was conducted or reported. The "test set" would refer to software validation tests, not clinical data sets for diagnostic accuracy.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there is no ground truth for diagnostic accuracy established for this device's intended use.
- Adjudication method for the test set: Not applicable.
- 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: Not applicable. The device is not an AI for diagnostic assistance.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable for diagnostic performance. The device is a data management system.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for diagnostic accuracy. Ground truth for software validation would be based on functional requirements.
- The sample size for the training set: Not applicable as this is not a machine learning or AI device requiring a "training set" in the context of diagnostic data.
- How the ground truth for the training set was established: Not applicable.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).