(51 days)
The Emprint™ Procedure Planning Application is a stand-alone software product that allows physicians to visualize and compare CT imaging data. The display, annotation, and volume rendering of medical images aids intervention planning for video-assisted thoracoscopic surgery (VATS) and ablation procedures using the Emprint Ablation System. The software is not intended for diagnosis.
The Emprint™ Procedure Planning Application is a stand-alone software product that is intended to be used to view and compare CT image sets. The system is composed of image review and planning software and a Windows-based computer. The system includes tools that provide 3-D rendering of the image sets, pre-procedure planning of interventional thermal ablation procedures, and post-procedure review of interventional thermal ablation procedures. The Emprint™ Procedure Planning Application does not prescribe therapy and is not intended for the diagnosis or treatment of any disease. It does not control or alter the functions or parameters of any medical device and has no direct patient contact.
The provided text is a 510(k) Summary for the Emprint™ Procedure Planning Application. This document describes the device's intended use and technological characteristics but does not contain the detailed performance study results, acceptance criteria, or sample sizes typically found in a full validation study report.
Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes, expert qualifications, and ground truth establishment cannot be extracted from this document.
Here's what can be gathered:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Stated Goal) | Reported Device Performance |
|---|---|
| Evaluate all functions performed by the software as configured on the computer workstation. | The system was tested and passed all criteria established by the design specifications and verification/validation test plans. |
Missing Information: Specific quantitative acceptance criteria (e.g., accuracy, precision targets for measurements, rendering display fidelity) are not provided. The document only states that the system "passed all criteria." No reported metrics (e.g., specific accuracy values, error rates) are given.
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not mentioned.
- Data Provenance: Not mentioned. (e.g., country of origin, retrospective/prospective)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not mentioned.
- Qualifications of Experts: Not mentioned.
- Role of Experts: It's unclear if "experts" were formally used to establish ground truth or if it was based on engineering design specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication Method: Not mentioned.
5. 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:
- MRMC Study: Not mentioned. The device is described as a "procedure planning application" that "aids in the intervention planning." It's a visualization and measurement tool, not primarily an AI-driven diagnostic aid that would typically undergo MRMC studies to compare human reader performance with and without AI. It explicitly states, "The software is not intended for diagnosis."
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: The document states, "The Emprint™ Procedure Planning Application was tested in accordance with a test plan to evaluate all functions performed by the software as configured on the computer workstation." This implies standalone testing of the software's functionality, though specific quantitative results are not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: Not explicitly stated. Given the description of testing "all functions performed by the software as configured," the ground truth likely refers to the expected output according to the software's design specifications for measurement accuracy, rendering fidelity, and data import/display. It's not based on external medical ground truth like pathology or outcomes.
8. The sample size for the training set:
- Sample Size for Training Set: Not applicable/not mentioned. This device is described as software for viewing, rendering, and planning, not a machine learning model that would have a "training set" in the traditional sense. It processes DICOM data from CT scanners.
9. How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable/not mentioned, as it's not described as a device that uses a training set in the machine learning context.
§ 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).