(134 days)
fulAccess is a standalone software product that provides basic image processing and communication functionality for use in radiology, oncology, and other clinical specialties. With fulAccess the user can review images from different modalities including CT, MR, and PET, perform basic functions including zoom, pan, measure, sample pixel intensity, and make annotations. Users may also create and save a set of files that include a copy of the data being viewed, any annotations, and an instance of the viewer executable. These files can be stored locally or on portable media (e.g. CD and DVD).
fulAccess is a stand-alone software package that assists users in the display, analysis, comparison and communication of medical imaging data from various sources. It allows the display, analysis, annotation, and communication of medical images. The intended users of fulAccess are trained medical professionals including physicians, nurses, physicists and other medical technologists. fulAccess is not intended for use in mammography.
fulAccess is a standalone software product that provides basic image processing and communication functionality for use in radiology, oncology, and other clinical specialties. With fulAccess the user can review images from different modalities including CT, MR, and PET, perform basic functions including zoom, pan, measure, sample pixel intensity, and make annotations. Users may also create and save a set of files that include a copy of the data being viewed, any annotations, and an instance of the viewer executable. These files can be stored locally or on portable media (e.g. CD and DVD).
fulAccess is a Windows application and will be used on recommended hardware that is provided by the company or the end user.
The provided text describes the regulatory clearance of "fulAccess," a medical imaging software. However, it does not contain information about specific acceptance criteria, a detailed study proving device performance against those criteria, or the methodology (like sample sizes, expert qualifications, or ground truth establishment) typically associated with such studies.
The document focuses on:
- Device Description: What fulAccess is and what it does (image processing, viewing, annotation, communication for CT, MR, PET data).
- Intended Use: For trained medical professionals in various specialties, not for mammography.
- Predicate Devices: Comparison to K071964 (MIM 4.1) and K081076 (Velocity AI) to establish substantial equivalence.
- Verification and Validation: A general statement about internal testing.
Here's a breakdown of what is and is not in the provided text:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated. The document mentions "functional specifications and performance requirements" but doesn't elaborate on specific metrics or thresholds.
- Reported Device Performance: No quantitative performance metrics (e.g., accuracy, sensitivity, specificity, processing speed) are provided. The document generally states that "All verification tests were passed and no anomalies remained."
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not specified. The validation testing used "a variety of data types and combinations" but no numbers are given.
- Data Provenance: Not specified. It's unclear if the data was retrospective or prospective, or its country of origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Experts: "Validation testing was performed by a board certified clinician." Only one such clinician is mentioned for validation.
- Qualifications: "board certified clinician." No specific specialty (e.g., radiologist, oncologist) or years of experience are detailed.
4. Adjudication method for the test set
- Adjudication Method: Not applicable or not described, as only one clinician is mentioned for validation. There is no mention of consensus or multi-reader review for ground truth.
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: No. This document describes a software for viewing and basic manipulation, not an AI-powered diagnostic aid that would typically undergo an MRMC study to compare reader performance with and without AI.
- Effect Size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: The described "validation testing" by a single clinician could be considered a form of standalone testing in the sense that the software was evaluated on its own without comparing it to other tools or a specific human-in-the-loop scenario. However, it's not "algorithm only" in the sense of an AI model's performance on its own. The device is software for user interaction.
7. The type of ground truth used
- Ground Truth Type: For validation, the "board certified clinician" judged the data types as "representative of the types of data the device will encounter in clinical use." This implies a clinical expert's judgment of the data's suitability and the device's functionality, rather than a specific "ground truth" derived from pathology, outcomes, or a detailed consensus on findings.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This device is described as "Medical Imaging Software" for processing and communication, not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Training Set Ground Truth: Not applicable, as there's no mention of a training set for an AI/ML model.
In summary: The provided 510(k) summary for fulAccess focuses on establishing substantial equivalence to predicate devices based on intended use, features, and general claims of software verification and validation. It does not present the type of detailed performance study data, acceptance criteria, or ground truth methodology that would be expected for an AI-powered diagnostic device or a quantitative performance claim. The "study" mentioned is internal verification and validation testing, not a formal clinical efficacy study with specific endpoints and statistical measures.
§ 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).