(43 days)
The Diagnostic Ultrasound System Xario200G Model CUS-X200G and Xario100G Model CUS-X100G are indicated for the visualization of structures, and dynamic processes with the human body using ultrasound and to provide image information for diagnosis in the following clinical applications: fetal, abdominal, intra-operative(abdominal), laparoscopic, pediatric, small organs, neonalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional), musculo-skeletal(superficial), cardiac pediatric, trans-esoph(cardiac) and peripheral vessel.
The Xario200G Model CUS-X200G and Xario100G Model CUS-X100G are mobile diagnostic ultrasound systems. These systems are Track 3 devices that employ a wide array of probes including flat linear array, convex linear array, and sector array with frequency ranges between approximately 2 MHz to 12 MHz.
This FDA 510(k) summary document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a standalone study for the device's performance in a clinical context (e.g., diagnostic accuracy metrics like sensitivity, specificity, AUC).
Instead, the document highlights that the new device, Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System, functions similarly and is intended for the same use as its predicate (Xario 200 Diagnostic Ultrasound System V6.0, K172276).
Therefore, specific acceptance criteria related to diagnostic performance (like those for AI/ML devices) and a study proving the device meets those criteria in terms of clinical accuracy are not present in this document. The "testing" mentioned refers to engineering and software validation tests.
Here's a breakdown of the information that can be extracted and what is not available in the provided text:
1. A table of acceptance criteria and the reported device performance
- Not Available directly in terms of clinical performance metrics. The document states "Risk Analysis, Verification/Validation testing conducted which are included in this submission demonstrates that the requirements for the features have been met." This implies internal engineering and functional acceptance criteria were met, but specific quantitative clinical performance metrics (e.g., sensitivity, specificity, accuracy) deemed as acceptance criteria are not provided. The comparison table (page 32) focuses on technical specifications to demonstrate equivalence, not performance against specific clinical acceptance thresholds.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not Available for clinical performance testing. The document explicitly states: "No clinical studies were required to demonstrate safety and efficacy of the Xario200G/Xario100G systems." This indicates that there was no test set of patient data used for clinical performance evaluation as part of this submission. The testing revolved around non-clinical aspects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not Applicable. Since no clinical studies or test sets with patient data were conducted for clinical performance, there was no need for experts to establish ground truth for such a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. As no clinical performance study was conducted.
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
- Not Applicable. This device is a diagnostic ultrasound system, not an AI-assisted device for interpretation. Furthermore, no clinical studies were performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a hardware/software system, not an algorithm in the sense of a standalone AI model. No clinical performance testing (standalone or otherwise) was reported as being done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable for clinical performance. For the non-clinical testing conducted, the ground truth would be established by engineering specifications, regulatory standards, and internal quality control measures.
8. The sample size for the training set
- Not Applicable. No AI/ML model training data is discussed for this device.
9. How the ground truth for the training set was established
- Not Applicable. No AI/ML model training data is discussed for this device.
Summary from the document:
This 510(k) submission for the Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System is based on demonstrating substantial equivalence to a previously cleared predicate device (Xario 200 Diagnostic Ultrasound System V6.0, K172276). The "testing" mentioned in the document refers to Risk Analysis, Verification/Validation testing, and adherence to applicable standards (e.g., IEC60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62304, AIUM RTD2-2004 Output Display and ISO 10993-1). The document explicitly states: "No clinical studies were required to demonstrate safety and efficacy of the Xario200G/Xario100G systems." Therefore, information regarding clinical acceptance criteria, sample sizes for clinical test sets, ground truth establishment by experts, adjudication methods, or comparative effectiveness studies is not provided in this document.
§ 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.