(151 days)
The system is a general-ourpose ultrasonic imstrument intended for use by a qualified physician for evaluation of Abdomen, Cardiac, Small Organ (Thyroid, parathyroid, parotid,submaxillary gland, testes and breast.), Peripheral Vascular, Transvaginal, Transrectal.Musculo-skeletal (Conventional and Superficial), Pediatric, Fetal, OB/Gyn and Urology.
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application: Fetal Imaging & Other, Cardiac, Peripheral Vessel
Specific: Fetal, Abdominal, Pediatric, Small Organ (Thyroid, parathyroid, parotid,submaxillary gland, testes and breast.), Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Urology, Ob/GYN, Cardiac Pediatric, Peripheral vessel
The SONO TOUCH Series ultrasound system is an integrated preprogrammed ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications.
The CHISON ultrasound system is configured as a portable model (SONO TOUCH Series). These systems are designed with the latest technology, using the same quality procedure as ultrasound systems, which have been available in the market for years.
This CHISON ultrasound system is a general purpose, software controlled, diagnostic ultrasound system. Its basic function is to acquire ultrasound echo data and display the image in B-Mode (including Tissue Harmonic Imaging), M-Mode, or a combination of these modes.
The provided document is a 510(k) Premarket Notification Summary for the Chison Medical Imaging Co., Ltd. SONO TOUCH Series (Portable) Diagnostic Ultrasound System. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria and performance metrics for the new device.
Therefore, the document does not contain the requested information regarding:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set or data provenance.
- Number of experts or their qualifications for establishing ground truth.
- Adjudication method for the test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
- Standalone (algorithm only) performance study.
- Type of ground truth used (beyond implying visual comparison to a predicate).
- Sample size for the training set.
- How ground truth for the training set was established.
The core of a 510(k) submission for this type of device is usually a claim of substantial equivalence to a legally marketed predicate device, rather than comprehensive clinical trial data for new performance claims. The document states:
"The SONO TOUCH Series Models is of comparable type and substantially equivalent to the A6 Portable Ultrasonic Diagnostic Systems transmit ultrasonic energy into patients, then perform post processing of received echoes to generate on-screen display of anatomic structures and fluid flow within the body, and have the same intended uses and basic operating modes as the predicate device. All systems allow for specialized measurements of structures and flow, and calculations."
And concludes:
"The SONO TOUCH Series Models is substantially equivalent in safety and effectiveness to the predicate systems. The systems are intended for diagnostic ultrasound imaging and fluid flow analysis. The systems have the same gray-scale. The systems have acoustic output levels below the applicable FDA limits. The systems are designed to applicable electrical and physical safety standards."
This indicates that the "study" demonstrating the device meets "acceptance criteria" likely refers to the technical comparison and compliance with established standards (NEMA UD 2, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 10993-1, and FDA acoustic output limits) to show it performs identically or comparably to the predicate device for its intended uses. No specific performance metrics or clinical study results are detailed in this summary.
In summary, the provided text describes the device's intended use and its substantial equivalence to a predicate device, but it does not include a detailed study with acceptance criteria, sample sizes, expert ground truth, or performance metrics in the way you've outlined for AI/ML device evaluations.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.