(11 days)
eNTEGRA PE is designed to display, process, archive, and communicate data required and stored by Emission Tomography cameras and Nuclear Medicine/PET workstations. It is intended that use of the device be limited to review of studies, tagging images for detailed reading, determining whether the correct images were captured, and similar uses. The limited image size availble on eNTEGRA PE has not been fully demonstrated to be suitable for diagnostic use, and it is not intended to be used for direct diagnosis.
The eNTEGRA PE Diagnostic Imaging Personal Digital Assistant is a device intended to provide the same functionality as the eNTEGRA Workstation (cleared in 510(k) number K000395 as the "Einstein Processing And Review Workstation"). The eNTEGRA PE is different in that this functionality is implemented on a handheld personal computer or personal digital assistant (PDA). The eNTEGRA PE will extend the eNTEGRA P&R services to be utilized by the clinician while away from her office/desk.
This 510(k) submission describes the eNTEGRA PE, a personal digital assistant (PDA) intended to provide similar functionality to the existing eNTEGRA Workstation (K000395) for displaying, processing, archiving, and communicating data from Emission Tomography cameras and Nuclear Medicine/PET workstations.
The submission does not contain specific acceptance criteria with quantifiable metrics, nor does it present a detailed study with performance outcomes against such criteria for the eNTEGRA PE beyond a general statement. The submission is focused on demonstrating substantial equivalence to a predicate device.
Here's the information extracted and organized based on your request, with explicit notes about what is not present in the provided document:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Implicit Criteria for Substantial Equivalence to Predicate Device (K000395): | |
| Functionality (display, process, archive, communicate data for Emission Tomography cameras and Nuclear Medicine/PET workstations) | "Bench testing with representative sample images has concluded that the eNTEGRA PE system is fully functional and is operating as designed." |
| Safety and Effectiveness | "In the opinion of GE Medical Systems, the eNTEGRA PE system is substantially equivalent in terms of safety and effectiveness to the above mentioned legally marketed predicate device." |
| No specific quantitative performance metrics (e.g., accuracy, sensitivity, specificity, processing speed) are provided in this document. | No specific quantitative performance metrics are provided in this document. |
2. Sample Size and Data Provenance for Test Set
- Sample Size (Test Set): "representative sample images" are mentioned for bench testing, but the specific number or characteristics of these images are not provided.
- Data Provenance: Not specified in the document (e.g., country of origin, retrospective or prospective).
3. Number and Qualifications of Experts for Ground Truth (Test Set)
- Not applicable. The document describes bench testing for functionality rather than a clinical study requiring expert-established ground truth for diagnostic accuracy.
4. Adjudication Method for Test Set
- Not applicable. The document does not describe a process involving adjudication of results from a test set by multiple experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. A MRMC comparative effectiveness study was not performed as described in this document. The submission focuses on functional equivalence through bench testing.
6. Standalone (Algorithm Only) Performance Study
- Yes, implicitly. The "Bench testing with representative sample images" constitutes a standalone evaluation of the device's functionality. However, it's not a performance study in the sense of a diagnostic accuracy trial.
7. Type of Ground Truth Used (Test Set)
- The "ground truth" for the bench testing appears to be the expected/designed functionality of the eNTEGRA PE system. There is no mention of clinical ground truth (e.g., pathology, outcomes data, or expert consensus on patient diagnoses) for the test set.
8. Sample Size for Training Set
- Not applicable/not specified. This document describes a new device built upon existing technology and demonstrated through bench testing for functional equivalence. It does not mention machine learning or AI models requiring a training set in the contemporary sense.
9. How Ground Truth for Training Set Was Established
- Not applicable. As above, no training set for a machine learning model is mentioned.
§ 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).