(108 days)
The SonoScape E5 Exp/E5/E5 Pro/E3 Exp/E3/E3 Pro/E2 Exp/E2/E2 Pro/E1 Exp/E1/E1 Pro Digital Color Doppler Ultrasound System is a general-purpose ultrasonic instrument intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Transrectal, Trans-vaginal, Peripheral Vascular, Cerebral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (pediatric and adult), OB/Gyn and Urology.
This SonoScape E5 Exp/E5/E5 Pro/E3 Exp/E3/ E3 Pro/E2 Exp/E2/E2 Pro/E1 Exp /E1/E1 Pro 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 E5 Exp/E5/E5 Pro/E3 Exp/E3/ E3 Pro/E2 Exp/E2/E2 Pro/ E1 Exp/E1/E1 Pro 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.
The provided text does not contain information about acceptance criteria for a device's performance, nor does it describe a study to prove the device meets such criteria.
Instead, the document is a 510(k) premarket notification for a medical device (SonoScape E5 Series Digital Color Doppler Ultrasound System). The purpose of this notification is to demonstrate substantial equivalence to a legally marketed predicate device (SonoScape X5 Digital Color Doppler Ultrasound System K160258), rather than to establish or meet specific acceptance criteria through a performance study.
Here's a breakdown of why the requested information is not present and what the document does describe:
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Acceptance Criteria and Reported Device Performance: This information is not explicitly stated. The document focuses on showing that the new device's intended use and technical characteristics are either the same as or comparable to the predicate device, implying that the performance is therefore acceptable by virtue of being similar to an already cleared device.
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Study That Proves Device Meets Acceptance Criteria: The document explicitly states: "No clinical testing was required." The "Non-Clinical Tests" section mentions various evaluations (electrical, mechanical, thermal, electromagnetic compatibility, biocompatibility, and acoustic output) to verify the system met design specifications and conformed to applicable medical device standards. These are conformity assessments against engineering and safety standards, not a performance study against specific clinical acceptance criteria for diagnostic accuracy.
Therefore, many of the specific points requested cannot be answered from this document:
- Table of Acceptance Criteria and Reported Device Performance: Not provided. The document outlines general intended uses and comparability to a predicate.
- Sample size for the test set and data provenance: No clinical test set or data provenance mentioned as clinical testing was not required. Non-clinical tests were performed, but details on sample sizes for these tests are not provided.
- Number of experts used to establish ground truth and qualifications: Not applicable, as no clinical performance study involving ground truth assessment is described.
- Adjudication method: Not applicable.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not conducted or mentioned. The document is about demonstrating substantial equivalence, not comparative effectiveness.
- Standalone (algorithm only) performance: Not applicable, as this is a medical imaging system, not an AI algorithm.
- Type of ground truth used: Not applicable, as no clinical performance study is described.
- Sample size for the training set: Not applicable, as no AI model training is disclosed.
- How ground truth for the training set was established: Not applicable.
In summary, this document is a regulatory submission focused on demonstrating substantial equivalence to a predicate device, and it explicitly states that clinical testing (which would typically involve performance studies against acceptance criteria) was not required for this submission. The "study" mentioned is the battery of non-clinical tests to ensure the device meets design specifications and relevant safety standards.
§ 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.