(114 days)
The diagnostic ultrasound system (U50) is applicable for adults, pregnant women, pediatric patients' ultrasound evaluation in hospitals and clinics. It is intended for use in abdominal, obstetrics, gynecology, pediatric, small parts, urology, peripheral vascular, musculoskeletal (conventional and superficial), transvaginal and cardiac clinical applications, by or on the order of a physician or similarly qualified health care professional.
The U50 is a portable Diagnostic Ultrasound System, which applies advanced technologies such as Phased Inversion Harmonic Compound Imaging (eHCI), Multi-Beam-Forming (mBeam), Speckle Resistance Imaging (eSRI), and Spatial Compounding Imaging, etc. Various image parameter adjustments, 12.1 inch LCD and diverse probes are configured to provide clear and stable images. Its function is to acquire and display Ultrasound images in B-mode, M-mode, PW-mode, Color-mode, PDI/DPDI mode. This system provides a series of probes that include linear array, convex array, micro-convex array with a frequency range of approximately 2.5 MHz to 11 MHz.
This document is a 510(k) summary for the Edan Instruments, Inc. U50 Diagnostic Ultrasound System. It details the device's intended use and compares it to predicate devices to establish substantial equivalence.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not specify quantitative acceptance criteria (e.g., specific accuracy, sensitivity, or specificity thresholds). Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices. The "reported device performance" is implicitly that the device performs equivalently to the listed predicate devices in terms of its intended use, design, performance effectiveness, and safety.
Since the document doesn't provide specific numerical performance metrics, a table summarizing them as requested cannot be created. The "performance" is implicitly deemed acceptable because it meets the standards of the predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Clinical testing is not required." This indicates that no clinical test set was used for this submission. The evaluation was based on non-clinical testing and comparison to existing predicate devices. Consequently, there is no data provenance (e.g., country of origin, retrospective/prospective) for a clinical test set.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Since no clinical testing was performed and thus no clinical test set was used, no experts were used to establish ground truth for a test set. The determination of substantial equivalence relies on non-clinical data and regulatory comparison.
4. Adjudication Method for the Test Set
As no clinical test set was used, there was no adjudication method for a test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No MRMC comparative effectiveness study was done. The submission explicitly states "Clinical testing is not required."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is a diagnostic ultrasound system, which inherently involves a human operator to acquire and interpret images. It is not an AI algorithm that functions in a standalone manner without human-in-the-loop performance. Therefore, no standalone algorithm-only performance study was conducted or is applicable in this context. The "performance effectiveness" is evaluated in the context of the complete system, including human operation.
7. The Type of Ground Truth Used
Given that clinical testing was not required for this 510(k) submission, there was no clinical ground truth established or used in the way typically seen in AI/CAD device submissions (e.g., pathology, expert consensus, outcomes data). The "ground truth" for the device's acceptable performance is its compliance with recognized safety standards and its demonstrated substantial equivalence to predicate ultrasound devices through non-clinical testing.
8. The Sample Size for the Training Set
This document does not describe the development of an AI algorithm or a training set for machine learning. The device is a traditional diagnostic ultrasound system. Therefore, there is no training set sample size described in this submission.
9. How the Ground Truth for the Training Set Was Established
Since no training set for an AI algorithm is mentioned, there is no information on how ground truth for a training set was established.
Summary of the Study:
The study proving the device meets acceptance criteria is a 510(k) Pre-market Notification submission, not a clinical trial. The acceptance criteria are based on demonstrating substantial equivalence to predicate devices. This is achieved through:
- Non-clinical testing: This includes electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), acoustic output testing (per FDA guidelines), and biocompatibility (ISO 10993-1, -5, -10). The document does not provide specific results or acceptance values for these tests, only that they were conducted according to the standards.
- Comparison to predicate devices: The submission asserts that the U50 Diagnostic Ultrasound System has the "same intended use, similar product design, same performance effectiveness, performance safety and the same needle-guide bracket material, property, and sterilization methods as the predicate devices." The differences are stated to "not affect the basic design principle, usage, effectiveness and safety of the subject device."
The FDA's letter (K123249) confirms that the device was deemed "substantially equivalent" to legally marketed predicate devices, thereby meeting the regulatory acceptance criteria for market clearance. This clearance specifically applies to the U50 system and a list of associated transducers for a wide range of clinical applications in B-mode, M-mode, PW-mode, Color-mode, and PDI/DPDI mode, including biopsy guidance and harmonic imaging.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.