(30 days)
The Diaqnostic Ultrasound System Xario 200 Model TUS-X200 and Xario 200 Model TUS-X200S are indicated for the visualization of structures, and dynamic processes with the human body using ultrasound and to provide image information for diaqnosis in the following clinical applications: fetal, abdominal, intra-operative(abdominal), laparoscopic, pediatric, small orqans, neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional), musculo-skeletal (superficial), cardiac adult, cardiac pediatric, trans-esoph(cardiac) and peripheral vessel.
The Xario200 Model TUS-X200 and Model 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 12 MHz.
Here's the information regarding the acceptance criteria and the study that proves the device meets the acceptance criteria, extracted from the provided text:
Device Name: Xario 200 TUS-X200, V3.0 and Xario 200 TUS-X200S, V3.0 (Diagnostic Ultrasound System)
K Number: K143027
Date of Document: November 20, 2014
1. A table of acceptance criteria and the reported device performance
The provided text does not contain a specific table of quantitative acceptance criteria or detailed reported device performance metrics in numerical form (e.g., sensitivity, specificity, accuracy, or specific measurements like image resolution or signal-to-noise ratios). Instead, the performance is described qualitatively in relation to a new feature.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device improves needle visualization during biopsy procedures. | "A study was conducted to compare an existing imaging mode with the needle enhancement feature and confirmed that the subject device improves needle visualization." |
| Compliance with existing regulations and standards. | "The device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820 and ISO 13485 Standards. This device is in conformance with the applicable parts of the IEC60601-1 (2005), IEC 60601-1-2:2007, IEC 60601-2-37 (2007), IEC 62304 (2006), AIUM RTD2-2004 Output Display and ISO 10993-1 standards." |
| Effective and safe for its intended use post-modifications. | "Based upon bench testing, successful completion of software validation, application of risk management and design controls, it is concluded that this device is safe and effective for its intended use." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample size used for the test set or the data provenance (country of origin, retrospective/prospective). It mentions "A study was conducted to compare an existing imaging mode with the needle enhancement feature," which implies a test phase, but details are not provided.
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)
This information is not provided in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
The document mentions "A study was conducted to compare an existing imaging mode with the needle enhancement feature and confirmed that the subject device improves needle visualization." This suggests a comparative study, but it is not explicitly described as an MRMC study comparing human readers with and without AI assistance (the device itself is an ultrasound system, not explicitly an AI-assisted diagnostic tool in the sense of image interpretation). Therefore, an effect size of human reader improvement with/without AI assistance cannot be determined from this text. The focus appears to be on the device's inherent capability to improve needle visualization.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This document describes a diagnostic ultrasound system and a feature within it ("BEAM which improves needle visualization"). It is not describing a standalone algorithm but rather a device's inherent imaging capability. Therefore, the concept of "standalone performance" for an algorithm without human-in-the-loop does not directly apply in the context presented.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not explicitly state the type of ground truth used for the study that confirmed improved needle visualization. It only states the study "confirmed that the subject device improves needle visualization," implying a subjective or objective assessment of the visualization quality.
8. The sample size for the training set
This information is not applicable as the document does not describe an AI or machine learning model that would typically have a "training set." The device described is an ultrasound system with a new imaging feature.
9. How the ground truth for the training set was established
This information is not applicable as the document does not describe an AI or machine learning model.
§ 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.