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510(k) Data Aggregation
(56 days)
EchoPixel, Inc.
The True 3D Viewer Software is intended for processing, review, analysis, communication and media interchange of digital images acquired from CT, MRI, XA and Ultrasound sources. It is also intended as software which provides visual information to be used by the health care professional for analysis of surgical options, and the intraoperative display of the mentioned images. The True 3D Viewer software 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.
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The provided text is a 510(k) premarket notification letter from the FDA for a device called "True 3D Viewer Software." It outlines the device's intended use and regulatory classification but does not contain any information regarding acceptance criteria, study details, performance metrics, sample sizes, ground truth establishment, or expert qualifications.
Therefore, I cannot provide the requested information based on the input text. The text does not describe a study that proves the device meets specific acceptance criteria.
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(44 days)
EchoPixel Inc.
The True 3D Viewer Software is intended for processing, review, analysis, communication and media interchange of digital images acquired from CT, MRI, XA and Ultrasound sources. It is also intended as software which provides visual information to be used by the health care professional for analysis of surgical options, and the intraoperative display of the mentioned images. The True 3D Viewer software 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.
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I apologize, but the provided text focuses on an FDA 510(k) clearance letter for the "True 3D Viewer Software" and its stated "Indications for Use." It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input. The document is primarily a regulatory communication confirming clearance.
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(43 days)
EchoPixel Inc.
The True 3D Viewer Software is intended for processing, review, analysis, communication and media interchange of digital images acquired from CT, MRI and Ultrasound sources. It is also intended as software for pre-operative analysis of surgical options. The True 3D Viewer Software is designed for use only with performance tested hardware specified in the user documentation. The device is intended to be used by health care professionals, who are responsible for making all final patient management decisions.
The True 3D Viewer Software is a software application that enables a Health Care Professional (HCP) to visualize and interact with DICOM image data, from CT, MRI and Ultrasound imaging modalities, to assist in clinical decision making.
The application loads DICOM image data and presents a stereoscopic 3D rendered view of the DICOM image data. The True 3D Viewer Software application enables HCPs to visualize and interact with image data and depictions of tissue and organs in an open 3D space as if they were real physical objects. The objects that the software will display are 2D MPR images, 3D volumes, 3D surfaces, labels, and measurements. The system is intended for use in the clinic or hospital settings. Information on performance tested hardware that is provided by the user is described in product labeling.
The provided text is a 510(k) summary for the EchoPixel True 3D Viewer Software and does not contain detailed information about specific acceptance criteria, device performance metrics, or the study methodologies typically found in the clinical study report itself. The document primarily focuses on establishing substantial equivalence to a predicate device.
Therefore, many of the requested details about acceptance criteria, reported performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment are not explicitly available in this document.
However, based on the information provided, here's what can be inferred and what is explicitly stated:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table of precise quantitative acceptance criteria or reported device performance metrics in terms of clinical accuracy or statistical targets. Instead, it makes a general statement about meeting design requirements and user needs.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Functional & Performance Specifications (Implicit – all design requirements and user needs met) | "Every specification of the True 3D Viewer Software device has been validated according to the company's documented development and test procedures." |
| "Results of performance testing demonstrated that the device met the design requirements and as well as the user needs." | |
| Compliance with Standards | Complies with: |
- PS 3.1 3.20 (2016), Digital Imaging and Communications in Medicine (DICOM) Set PS 3.1
- ISO 14971 - Standard for the Application of Risk Management to Medical Devices
- IEC/TR 80002-1:2009 - Medical device software -- Part 1: Guidance on the application of ISO 14971 to medical device software
- IEC 62304- Medical Device Software-Software Lifecycle Processes
- 21 CFR Part 820.30 (Design Control process)
- FDA "Guidance on Software Contained in Medical Devices" |
| Safety and Efficacy (Indirect) | "Based on the performance data provided in the submission these differences [from predicate] do not introduce new issues related to safety and efficacy." |
2. Sample size used for the test set and the data provenance
Not explicitly stated in the document. The document mentions "performance data provided in the submission" and "performance testing" but does not specify the sample size of cases, images, or subjects used for testing, nor their provenance (e.g., country of origin, retrospective/prospective nature).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not explicitly stated in the document. The document mentions the device is intended for use by "health care professionals" who make "final patient management decisions" and that human intervention is involved in image interpretation. However, it does not specify if experts were used to establish ground truth for a test set, their number, or their qualifications.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not explicitly stated in the document. Without information on how ground truth was established, the adjudication method cannot be determined.
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 indication of an MRMC study related to AI assistance. The device is described as "imaging software" for visualization and interaction with DICOM data, not as an AI-assisted diagnostic tool. The document focuses on its functionality as a viewer and processing tool, and its substantial equivalence to a predicate viewer. Therefore, an MRMC comparative effectiveness study for AI assistance would not be applicable in this context, and no effect size is mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
No indication of a standalone algorithm performance study. The device is "intended to be used by health care professionals, who are responsible for making all final patient management decisions." This implies human-in-the-loop use. The 510(k) summary does not present performance data for a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not explicitly stated in the document. Given the device's function as a 3D viewer and processing software for existing DICOM images, the "ground truth" for its performance testing would likely refer to the accuracy of its rendering, measurements, and manipulation features compared to expected outputs or calculations from the original DICOM data. It's not a diagnostic device that would typically establish ground truth against pathology or outcomes data in the traditional sense, but rather a tool to accurately display and interact with existing diagnostic information.
8. The sample size for the training set
Not applicable/Not stated. This device is described as imaging software for visualization and interaction, not a machine learning or AI algorithm that typically requires a "training set" in the context of diagnostic interpretation. Therefore, a sample size for a training set is not provided.
9. How the ground truth for the training set was established
Not applicable/Not stated. As the device does not appear to be an AI/ML diagnostic algorithm requiring a training set, the establishment of ground truth for such a set is not discussed.
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