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510(k) Data Aggregation
(86 days)
The AIDA V1.8 Diagnostic Ultrasound System GM-72P00A is intended for Peripheral Vessel application. The system provides ultrasound imaging information such as the visualization of anatomical structures, characteristics and dynamic processes within the human body using ultrasound to aid diagnosis. The AIDA V1.8 Diagnostic Ultrasound System GM-72P00A also provides an automated intima-media thickness measurement of peripheral vessels such as the common carotid in the BIMT-mode of operation for heart rate range of 20-150 beats per minute. This system is contraindicated for fetal use.
The AIDA V1.8 Diagnostic Ultrasound System GM-72P00A is a portable ultrasound system optimized to perform a non-invasive examination of the peripheral vessels. The system provides ultrasound imaging information such as the visualization of anatomical structures, characteristics and dynamic processes within the human body using ultrasound to aid diagnosis. This system also provides an automated measurement of the intima-media thickness (IMT) of peripheral arteries such as the common carotids and allows the user to search for arterial plaques using realtime Brightness, Color Doppler and Pulse Doppler imaging modes. The touchscreen keyboard allows the user to input various parameters relating to traditional cardiovascular risk factors. A built in calculator provides risk scores commonly used in a variety of geographical locations (Framingham Risk Score, PROCAM Health Check Score, Reynolds Risk Score, Risk score based on the SCORE Project). This information is supplemented with an IMT measurement of the artery to generate a comprehensive report of cardiovascular risk assessment.
Here's an analysis of the provided text, focusing on the acceptance criteria and study information for the AIDA V1.8 Diagnostic Ultrasound System GM-72P00A:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text focuses on regulatory clearance for an ultrasound system, not the detailed performance characteristics of its automated IMT measurement feature. Therefore, explicit "acceptance criteria" and "reported device performance" in the terms of a quantitative study (e.g., accuracy, precision) are not directly stated in this document.
However, we can infer some criteria from the context:
| Acceptance Criteria (Inferred) | Reported Device Performance (Inferred/Stated) |
|---|---|
| Primary Indication: Provide ultrasound imaging and automated IMT measurement for peripheral vessels. | The device is intended for "Peripheral Vessel application," provides "ultrasound imaging information such as the visualization of anatomical structures, characteristics and dynamic process within the human body using ultrasound to aid diagnosis," and "provides an automated intima-media thickness measurement of peripheral vessels such as the common carotid in the BIMT-mode of operation." This is a statement of functionality and intended use, implying it does perform these actions. |
| Heart Rate Range: Operate within a specified heart rate range for IMT measurement. | The automated IMT measurement operates for "heart rate range of 20-150 beats per minute." |
| Safety and Effectiveness: Substantial equivalence to predicate devices for intended use. | The FDA's substantial equivalence determination (K122009) indicates that the device is considered as safe and effective as the predicate devices (K113612 - AIDA V1.5 Diagnostic Ultrasound System GM-72P00A, and K093171 - Viamo SSA-640A). This is the primary "acceptance criterion" for regulatory clearance based on substantial equivalence. |
| Compliance with Standards: Adherence to relevant medical device and electrical safety standards. | The system is designed to comply with UL 60601-1: 2003; IEC 60601-1-1: 2000; IEC 60601-1-2: 2nd Edition (2001), Amendment 1 (2004); IEC 60601-2-37: 2001, Amendment 1 (2004), Amendment 2 (2005); IEC 62304: Ed. 1.0 (2006); ISO 10993-1:2009; ISO 10993-5:2009; ISO 10993-10:2010; NEMA UD 2-2004 (R2009); NEMA UD 3-2004 (R2009). This implicitly means passing tests related to these standards. |
| Specific Clinical Applications: Support specified clinical applications and modes of operation (e.g., Peripheral Vessel, B-mode, Pulse Doppler, Color Doppler, Combined BIMT). | The "Indications for Use Statement" and the "Intended Use" tables (Pages 6 and 7) list "Peripheral Vessel" as the application with operational modes B (P, existing), PWD (N, new), Color Doppler (P, existing), and Combined Mode Note 1 (BIMT, BD, BCD). This implies that these functionalities have been demonstrated or are considered to be equivalent to predicate devices. |
Important Note: This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It typically does not include detailed performance data from clinical trials or validation studies for the device's diagnostic accuracy or specific metrics beyond what's required to prove equivalence (e.g., comparison of technical features or a limited performance comparison if there are significant changes from the predicate).
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not contain any information regarding a specific "test set" sample size or data provenance (e.g., country of origin, retrospective/prospective) for validating the IMT measurement accuracy. The 510(k) process for this type of device often relies on demonstrating substantial equivalence through technical comparisons and sometimes limited comparative performance data, but detailed clinical validation study results with specific sample sizes are rarely included in the publicly available 510(k) summaries.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There is no mention of experts being used to establish ground truth for a test set in the provided document. This type of information would typically be found in detailed performance studies, which are not outlined here.
4. Adjudication Method for the Test Set
Since there is no test set or ground truth establishment described, there is also no information about an adjudication method.
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
This document describes a diagnostic ultrasound system with an automated IMT measurement feature, which is a type of image analysis tool. However, it does not describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. Such studies are more common for AI systems that assist or augment human interpretation of medical images (e.g., CAD systems for radiology). The automated IMT measurement is presented as a standalone functional feature. Therefore, there is no information on the effect size of human reader improvement with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device "provides an automated intima-media thickness measurement of peripheral vessels." This statement inherently implies a standalone algorithm performance for the IMT measurement. However, the document does not provide the results of such a standalone performance study (e.g., accuracy, precision relative to a gold standard). It merely states the functionality exists and is part of a system determined substantially equivalent to predicate devices.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The document does not specify the type of ground truth used for validating the automated IMT measurement. If a performance study were detailed, ground truth for IMT is typically established through manual measurements by highly trained sonographers or experts, or occasionally compared against other established, highly accurate measurement techniques.
8. The Sample Size for the Training Set
There is no information regarding a training set sample size provided in this 510(k) summary. This document describes an ultrasound system, and while it has an "automated" IMT feature, it doesn't characterize this feature as a machine learning/AI model that would require a distinct "training set" in the modern sense. Even if it uses algorithms that were developed using data, the specifics of that development data are not disclosed here.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned or described, there is no information on how its ground truth was established.
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