(31 days)
The Metrx Workstation is intended for users to segment and differentiate tissues and anatomical structures from two-dimensional imaging data, and to construct accurate, three-dimensional models from these segmented data. Metrx also provides the user with tools to better visualize and analyze the processed data. Metrx data may be outputted as the source data for Preview® Treatment Planning Software. The Metrx product is not intended to provide medical diagnosis or a recommended treatment approach.
The Metrx Workstation is a software product that is intended for users to segment and differentiate tissues and anatomical structures from two-dimensional imaging data, and to construct accurate, three-dimensional models from these segmented data. Metrx also provides the user with tools to better visualize and analyze the processed data. Metrx data may be outputted as the source data for Preview® Treatment Planning Software. The Metrx Workstation product is not intended to provide medical diagnosis or a recommended treatment approach.
The provided text is a summary of safety and effectiveness for the Metrx Workstation and a 510(k) clearance letter from the FDA. It does not contain a study that proves the device meets specific acceptance criteria in the manner of a performance study with quantitative results.
The document states: "A table comparing the Metrx Workstation to the predicate devices is attached. This comparison demonstrates the substantial equivalence of the Metrx Workstation to the predicate devices." This indicates that the regulatory clearance was based on demonstrating substantial equivalence to already legally marketed devices, rather than a performance study against specific acceptance criteria.
Therefore, many of the requested details cannot be extracted from this document because it describes a different type of regulatory submission. The information below reflects what can be inferred or directly stated from the provided text.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state acceptance criteria or device performance in a quantitative manner as would be typical for a clinical or performance study. Instead, it relies on demonstrating substantial equivalence to predicate devices based on shared technological characteristics and intended use.
| Feature/Characteristic | Acceptance Criteria (Inferred from Predicate Device Features) | Reported Device Performance (Metrx Workstation's Capabilities) |
|---|---|---|
| Primary Function | Ability to segment and differentiate tissues/anatomical structures from 2D imaging data, construct accurate 3D models from segmented data, and provide tools to visualize and analyze processed data, without providing medical diagnosis or treatment recommendations. | Intended for users to segment and differentiate tissues and anatomical structures from two-dimensional imaging data, and to construct accurate, three-dimensional models from these segmented data. Provides tools to better visualize and analyze the processed data. Metrx data may be outputted as source data for Preview® Treatment Planning Software. Not intended to provide medical diagnosis or a recommended treatment approach. |
| Compatibility | Able to read data in DICOM format. | Reads data in DICOM format (Yes). |
| Imaging Capabilities | Supports 2D and 3D imaging. | Supports 2D and 3D imaging. |
| Operating Platform | Capability for user-driven modeling on UNIX, with viewing software on DOS/Windows (based on predicate). | Modeling done by user on UNIX. Viewing software run on DOS/Windows. |
| Image Data Source | Retrieval over network via DICOM or via hard media. | Retrieval over network via DICOM or via hard media. |
| Viewing Format | Multiple interactive 2D & 3D views. | Multiple interactive 2D & 3D views. |
| Analysis Capabilities | Measurements performed on image on workstation. | Measurements performed on image on workstation. |
| Data Manipulation | Data modeling performed by end user. | Data modeling performed by end user. |
| Model Manipulation | Manipulation in multiple planes and orientation. | In multiple planes and orientation. |
2. Sample size used for the test set and the data provenance:
Not applicable. The document describes a 510(k) submission based on substantial equivalence to predicate devices, not a performance study with a test set. There is no information about data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth for a test set is not mentioned in the context of this 510(k) submission.
4. Adjudication method for the test set:
Not applicable. No test set or related adjudication method is described.
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:
No MRMC comparative effectiveness study is mentioned. This device is described as a workstation for image segmentation and 3D model construction, not an AI-assisted diagnostic tool that would typically undergo such a study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. The "Metrx Workstation" is a software product that provides tools for users to perform segmentation and model construction. It is inherently human-in-the-loop, as indicated by "Modeling done by user on UNIX" and "Data modeling performed by end user." Therefore, a standalone (algorithm only) performance study would not be relevant or described here.
7. The type of ground truth used:
Not applicable. The document does not describe the use of specific ground truth data for a performance evaluation in the context of a study. The basis for clearance is substantial equivalence.
8. The sample size for the training set:
Not applicable. The document describes a 510(k) submission based on substantial equivalence, not a machine learning model that would require a training set.
9. How the ground truth for the training set was established:
Not applicable. No training set 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).