(28 days)
The SonoScape X3 Exp/X3/X3 Pro/X1 Digital Color Doppler Ultrasound System is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Trans-rectal, Trans-vaginal, Peripheral Vascular, Cerebral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (pediatric and adult), OB/Gyn and Urology.
This SonoScape X3 Exp/X3/X3 Pro/X1 Digital Color Doppler Ultrasound System is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications.
The X3 Exp/X3/X3 Pro/X1 Pro/X1 system utilizes the ultrasound echo characteristics, transmits ultrasonic energy into patient body, sweeps in a certain direction, processes the signals according to the delay time and the echo strength, and images the organs by using the electronic circuits and backend controller to process, then analyzes the distance and the status of organs; and at the same time, this system utilizes Doppler and autocorrelation technology to image the blood flow and add the color-coding information to the grayscale image of B mode, then displays the image in real time. The probes provided with this system are electrical-acoustical and acoustical-electrical transducers. The probes firstly convert the electric excitation signal to the acoustic signal and transmit the signal into the patient body, then converts the echo signals from the patient body to electric signal. The echo signal is processed and converted by DSC to image signal to output to the LCD display.
This system is a Track 3 device that employs a wide array of probes that include linear array, convex array and phased array.
This system consists of keyboard control panel, power supply module, color LCD monitor and optional probes.
This system is a portable, general purpose, software controlled, color diagnostic ultrasound system. Its basic function is to acquire ultrasound data and to display the image in B-Mode (including Tissue Harmonic Image), M-Mode, Color-Flow Doppler, Pulsed Wave Doppler, Continued Wave Doppler and Power Doppler, or the combination of these modes.
This document is a 510(k) Premarket Notification for the Sonoscape X3 Exp/X3/X3 Pro/X1 Digital Color Doppler Ultrasound System. It focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific performance acceptance criteria through a study with predefined metrics.
Therefore, most of the requested information regarding acceptance criteria, performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and comparative effectiveness studies cannot be extracted from this document.
The document states:
- "No clinical testing was required." This explicitly indicates that a clinical study designed to test performance against acceptance criteria was not part of this submission for substantial equivalence.
- The tests conducted were non-clinical, primarily focused on safety and essential performance in comparison to recognized standards and the predicate device.
However, I can provide the following based on the document:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria for device performance (e.g., sensitivity, specificity, accuracy) or report specific performance metrics for the device. Instead, it relies on demonstrating substantial equivalence to a predicate device by asserting that the subject device has the "same technical characteristics" and "complies with the same regulation and safety standards."
| Acceptance Criteria (Not explicitly stated as performance metrics, but implied from substantial equivalence) | Reported Device Performance |
|---|---|
| Same Intended Use as Predicate Device (SonoScape X5 K160258) | The Subject Device X3 Exp/X3/X3 Pro/X1 Pro/X1 has the same intended use as the predicate device. The intended use is "for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Trans-rectal, Trans-vaginal, Peripheral Vascular, Cerebral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (pediatric and adult), OB/Gyn and Urology." |
| Same Technical Characteristics as Predicate Device | The Subject Device X3 Exp/X3/X3 Pro/X1 Pro/X1 has the same technical characteristics, "including Design, Operation Controls, Operation Mode, Display Modes, Measurement Items, Power Supply, Screen Size, Cine Loop, Operating and Storage Condition." Minimal hardware optimizations (video conversion chip, IO docking station isolation) are noted but stated "will not affect the safety and effectiveness." |
| Same Probes as Predicate Device | The Subject device X3 Exp/X3/X3 Pro/X1 Pro/X1 has the same probes as the predicate device SonoScape X5 (K160258), including: 3C-A Curved Array, C613 Micro-curved Array, 3P-A Phased Array, 7P-B Phased Array, L741 Linear Array, 6V1 Micro-curved Array, EC9-5 Micro-curved Array, PWD2.0 TCD. |
| Compliance with Safety Standards | The system was evaluated for "electrical, mechanical, thermal and electromagnetic compatibility safety, biocompatibility and acoustic output" and designed/manufactured to meet standards including: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-5, ISO 10993-10, AIUM/NEMA UD 2:2004 (R2009), and AIUM/NEMA UD 3:2004 (R2009). The acoustic output levels are stated to be "consistent." |
| Substantial Equivalence | Based on the above comparisons, the device is concluded to be "substantially equivalent" to the predicate device in safety and effectiveness, implying it meets the same implicit performance levels as the predicate and raises no new safety or effectiveness concerns. This means its performance is assumed to be acceptable because it is similar to a device already cleared by the FDA, not quantified by new objective data or specific performance criteria. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The submission states "No clinical testing was required." The "phantom tests" mentioned under Non-Clinical Tests would involve phantoms, not human data.
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 applicable as no clinical test set with ground truth established by experts was used.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as no clinical test set with expert adjudication was used.
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 information is not applicable. The device is an ultrasound system, not an AI-assisted diagnostic tool, and no MRMC study was mentioned or performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is an ultrasound system, not an algorithm being evaluated in isolation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical "phantom tests," the ground truth would be based on the known, controlled properties of the phantoms used. No clinical ground truth (expert consensus, pathology, outcomes data) was used or required for this 510(k) submission.
8. The sample size for the training set
This information is not applicable. This is not an AI/ML device that requires a training set. The device's "development" would involve engineering design and validation against specifications, not machine learning training.
9. How the ground truth for the training set was established
This information is not applicable. As explained above, this is not an AI/ML device that requires a training set.
§ 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.