(173 days)
Intended as a medical diagnostic imaging system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from CT or MR imaging devices. It is also intended as preoperative software for simulating surgical treatment options. The True 3D Viewer is designed for use by health care professionals and is intended to assist the clinician who is responsible for making all final patient management decisions.
The True 3D Viewer system is comprised of a commercial off the shelf hardware platform and a proprietary software application that enables a health care professional (HCP) to visualize and interact with CT and MRI DICOM image data to assist in clinical decision making. The t3D-Viewer system hardware platform is comprised of an off the shelf stereoscopic display, an optical or electromagnetic motion tracking system and a computer system. The t3D-Viewer software application loads DICOM image data and presents a stereoscopic 3D rendered view of the DICOM image data. The t3D-Viewer software application enables HCPs to visualize and interact with image data and depictions of tissue and organs as if they were real physical objects.
The provided text is a 510(k) Summary for the EchoPixel True 3D Viewer device. It outlines the device's description, intended use, and the basis for its substantial equivalence to predicate devices. However, the document does not contain the detailed information required to describe acceptance criteria and the specifics of a study proving the device meets those criteria, especially regarding clinical performance with quantitative metrics like sensitivity, specificity, or reader performance improvement with AI assistance.
The document primarily focuses on:
- Regulatory Classification: Identifying the device as Class II, product code LLZ (Picture archiving and communications system, 21 CFR 892.2050).
- Substantial Equivalence: Comparing the EchoPixel True 3D Viewer to existing predicate devices (Surgical Theater Surgery Rehearsal Platform and Vital Images Vitrea 2) based on intended use and technological characteristics.
- Performance Data: This section broadly states that the device was validated according to the company's documented development and test procedures, including testing against applicable standards (IEC EN, ANSI 60601-1, IEC60601-1-2, NEMA PS 3.1 3.18 (DICOM), ISO 14971, and FDA Guidance on Software Contained in Medical Devices). It mentions "testing that fulfills the requirements" and "verification and validation was performed on qualified phantoms as well as in simulated use conditions."
Crucially, the document does not provide:
- A table of specific acceptance criteria (e.g., minimum sensitivity, specificity, or performance metrics).
- Reported device performance data against those criteria.
- Details about a clinical study involving human readers or a standalone AI performance evaluation.
- Information on sample size for test or training sets, data provenance, number/qualifications of experts, or ground truth establishment methods for clinical performance.
- Any mention of MRMC studies or an effect size for human reader improvement.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria using only the provided text, as the necessary details are not present.
What can be inferred from the document regarding "performance data," though it doesn't meet the detailed request:
The "Performance Data" section indicates that the validation was focused on technical and regulatory compliance standards rather than a clinical performance study with human readers or AI metrics. The "acceptance criteria" referred to here are likely related to:
- Safety and Essential Performance: Meeting standards like IEC 60601-1 (electrical safety) and IEC 60601-1-2 (electromagnetic compatibility).
- Risk Management: Compliance with ISO 14971.
- DICOM Conformance: Adherence to NEMA PS 3.1 3.18 (DICOM).
- Software Design Control: Meeting 21 CFR Part 820.30 requirements and FDA Guidance on Software.
- Rendering and Interaction Fidelity: The statement "verification and validation was performed on qualified phantoms as well as in simulated use conditions" suggests testing of the 3D rendering accuracy, interactive manipulation, and display of image data.
In summary, based on the provided text, the device's "performance" was evaluated for substantial equivalence through:
- Compliance with general medical device safety and quality system standards.
- Demonstration of its ability to process, review, and display multi-dimensional digital images, as stated in its intended use, likely via phantom studies and simulated use cases to confirm functionality and accuracy of rendering/interaction features.
The document does NOT describe:
- A table of acceptance criteria and reported device performance related to diagnostic accuracy, reader improvement, or AI standalone performance.
- Sample size for test set or data provenance for a clinical performance study.
- Number or qualifications of experts for ground truth establishment.
- Adjudication method for a test set.
- MRMC comparative effectiveness study or effect size.
- Standalone algorithm performance.
- Type of ground truth used for a clinical performance study.
- Sample size for a training set.
- How ground truth for training set was established.
§ 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).