(96 days)
The Diagnostic Ultrasound System Xario 200 Model TUS-X200 and TUS-X200S 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, intraoperative (abdominal), pediatric, small organs, trans-rectal, neonatal cephalic, adult cephalic, cardiac (both adult and pediatric), peripheral vascular, transesophageal, and musculoskeletal (both conventional and superficial).
The Xario 200 Model TUS-X200 and TUS-X200S 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 7.5 MHz.
The provided text describes the 510(k) summary for the Toshiba Medical Systems Xario 200 Diagnostic Ultrasound System. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.
The information provided does not include acceptance criteria or a study proving the device meets specific performance criteria in the way one might expect for an AI/ML-driven device with quantifiable clinical endpoints (e.g., sensitivity, specificity for disease detection). Instead, the substantial equivalence relies on demonstrating that the new device (Xario 200) has the same intended use and similar technological characteristics as a previously cleared device (Aplio 500/400/300).
Therefore, I cannot populate all sections of your request as they are typically applied to AI/ML device performance studies with concrete statistical metrics for diagnostic accuracy. However, I can extract information related to the device submission and testing.
Here's a breakdown of the available information based on your request:
1. Table of acceptance criteria and the reported device performance
There are no specific acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, AUC) or reported numerical performance metrics in the provided document. The "performance" assessment is based on demonstrating similar functionality and safety compared to a predicate device.
The document states: "The Xario 200 Model TUS-X200 and TUS-X200S, SW Version 1.0, functions in a manner similar to and is intended for the same use as the predicate device."
Acceptance Criteria (Implied for Substantial Equivalence): The Xario 200 system must function in a manner similar to and be intended for the same use as the predicate device (Aplio 500/400/300). It must also meet applicable safety standards.
Reported Device Performance: Not quantified in terms of clinical accuracy metrics, but described qualitatively as "functions in a manner similar to" the predicate device and being a "compact diagnostic ultrasound system by implementing latest technologies."
2. Sample size used for the test set and the data provenance
Not applicable for a substantial equivalence submission of an ultrasound system not primarily based on AI/ML diagnostic performance testing using a specific test set of cases. The testing mentioned appears to be related to safety and functional verification. The document states "Risk Analysis, Verification/Validation testing conducted through bench testing which are included in this submission demonstrates that the requirements for the features have been met."
There is no mention of a clinical test set with patient data for evaluating diagnostic accuracy.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The document does not describe a test set or ground truth established by experts for diagnostic performance evaluation.
4. Adjudication method for the test set
Not applicable. No test set for diagnostic performance evaluation is detailed in the provided information.
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
No. This document does not pertain to an AI-driven device with or without human assistance. It is a traditional diagnostic ultrasound system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable for a device performance study of this nature. The "ground truth" here is compliance with safety and functional standards, and equivalence to a predicate device.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. (See #8)
§ 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.