(23 days)
AccuSketch Cardiac Quantitative Analysis System w/ Advanced Analysis Components is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. AccuSketch is intended to provide and document an objective quantification of coronary artery stenosis and measurement and quantification of left ventricular function. Also provided is the ability to digitize and store video images and the ability to interactively annotate and report current and post procedural patient cardiac status.
The AccuSketch Cardiac Quantitative Analysis System w/ Advanced Analysis Components is a PC based software system comprised of 4 individual programs used to view, capture/print, analyze and annotate images from cardiac catheterization procedures. AccuSketch is offered as a complete turn-key system or can be ported into other GE cardiac image devices for image analysis. The AccuSketch is a Personal Computer (PC) based software system designed to be permanently installed in a hospital in or near the cardiac catheterization laboratory. AccuSketch is comprised of four individual programs responsible for a specific function. Their purpose is to view, capture/print, analyze and annotate images from cardiac catheterization procedures. The CardioTree is an editable coronary tree tool used to electronically annotate and document the anatomy of the patient's vessels.
The provided text describes a 510(k) submission for the "AccuSketch Cardiac Quantitative Analysis System w/ Advanced Analysis Components." This submission demonstrates substantial equivalence to predicate devices rather than proving specific performance against acceptance criteria in a standalone study. Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes, expert involvement, and ground truth establishment from a dedicated performance study is not explicitly available within this document.
However, I can extract information related to the device description, intended use, and the general approach to demonstrating effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance:
As this is a 510(k) submission focused on substantial equivalence, explicit "acceptance criteria" with numerical targets and reported performance values from a dedicated performance study are not detailed in the provided text. The document states that the device "employs the same functional scientific technology as its predicate devices" and "is as safe, as effective, and performs as well as the predicate devices," implying a comparison to the established performance of those predicates rather than a new set of independent criteria.
| Acceptance Criteria (Implied through Substantial Equivalence to Predicate) | Reported Device Performance (Implied) |
|---|---|
| Same functional scientific technology as predicate devices. | The device employs the same functional scientific technology as its predicate devices. |
| As safe as predicate devices. | The device is as safe as the predicate devices. |
| As effective as predicate devices. | The device is as effective as the predicate devices. |
| Performs as well as predicate devices. | The device performs as well as the predicate devices. |
| Complies with voluntary standards. | The device complies with voluntary standards as detailed in Section 9 of the submission. |
2. Sample Size Used for the Test Set and Data Provenance:
Not explicitly mentioned. The document focuses on demonstrating equivalence to predicate devices and describes internal testing phases (unit, integration, final acceptance, performance, safety, environmental testing) but does not provide details on specific clinical test sets, their sizes, or data provenance (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
Not explicitly mentioned. Given the nature of a 510(k) addressing substantial equivalence, a formal ground truth establishment by external experts for a test set is not detailed. The device is intended to "aid the Cardiologist or trained technician," suggesting clinical professionals are the intended users who would interpret outputs.
4. Adjudication Method for the Test Set:
Not explicitly mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not explicitly mentioned. The provided text does not describe an MRMC study or any quantitative effect size of human readers improving with AI vs. without AI assistance.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance):
Not explicitly mentioned. The document refers to "requirements reviews," "design reviews," and various forms of testing (unit, integration, final acceptance, performance, safety, environmental), which are internal development and quality assurance measures. These are not typically standalone clinical performance studies. The device's stated intended use is to "aid the Cardiologist or trained technician," suggesting a human-in-the-loop design.
7. Type of Ground Truth Used:
Not explicitly mentioned for a formal performance study. The device's function involves "objective quantification of a patient's Left Ventricular function" and "objective quantification of coronary artery stenosis." For these types of measurements in the clinical context, the "ground truth" would typically be established by expert interpretation/consensus or potentially by comparison to other established quantitative methods. However, the document doesn't detail how this was specifically handled for a ground truth in a clinical study.
8. Sample Size for the Training Set:
Not applicable or not mentioned. The document describes a traditional software system for analysis rather than a machine learning/AI model that undergoes a "training" phase with a specific dataset. The "advanced analysis components" refer to software features, not a continuously learning algorithm.
9. How the Ground Truth for the Training Set Was Established:
Not applicable (as it's not described as an AI/ML training set).
Summary of available information from the document:
- Device: AccuSketch Cardiac Quantitative Analysis System w/ Advanced Analysis Components.
- Intended Use: Aid cardiologists or trained technicians in providing and documenting objective quantification of Left Ventricular function and coronary artery stenosis, digitize/store video images, and annotate/report cardiac status.
- Demonstration of Effectiveness: By demonstrating substantial equivalence to predicate devices (CardioTrace K912829; MUSE Cardiovascular Information System with Accusketch K992937). The device employs the same functional scientific technology and is claimed to be as safe, effective, and perform as well as the predicates.
- Quality Assurance Measures (Internal Testing): Risk Analysis, Requirements Reviews, Design Reviews, Unit-level testing (Module verification), Integration testing (System verification), Final acceptance testing (Validation), Performance testing, Safety testing, Environmental testing. These are internal development and verification processes, not a formal clinical performance study demonstrating acceptance criteria.
§ 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).