(121 days)
The SonoScape S22 system is a general-purpose ultrasonic 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, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), Trans-esoph.(Cardiac), OB/Gyn and Urology.
This SonoScape S22 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 basic principle is that system transmits ultrasonic energy into patient body and implements post processing of received echoes to generate onscreen display of anatomic structures and fluid flow within the body.
This system is a Track 3 device that employs a wide array of probes that include linear array, convex array and phased array with a frequency range of 2.0 MHz to 15.0 MHz. This system consists of a mobile console with keyboard control panel, power supply module, color LCD monitor and optional probes.
This system is a mobile, 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, TDI, Color-Flow Doppler, Pulsed Wave Doppler, Continued Wave Doppler and Power Doppler, or the combination of these modes, Elastography, 3D/4D.
The SonoScape S22 Digital Color Doppler Ultrasound System is a diagnostic ultrasound system. Based on the provided FDA 510(k) summary (K142815), here's an analysis of its acceptance criteria and the study that supports it:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly present a table of acceptance criteria with numerical targets and corresponding device performance metrics for the S22 system in the typical sense of a novel algorithm or AI device. Instead, the "acceptance criteria" are implied by the conformity to established medical device standards and the demonstration of substantial equivalence to predicate devices, particularly regarding safety and effectiveness.
However, the document does mention "design specifications" and that the system "met all design specifications." For the specific feature of Elastography, it states that "Elastography performance met design specifications, including accuracy and repeatability of strain-ratio measurement and etc."
Based on the information, a hypothetical table reflecting the mentioned information would look like this:
| Acceptance Criteria Category | Specific Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Electrical Safety | Compliance with IEC 60601-1 | System found to be compliant with IEC 60601-1. |
| Mechanical Safety | Design specifications met | System met all design specifications. |
| Thermal Safety | Compliance with IEC 60601-2-37 | System found to be compliant with IEC 60601-2-37. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 | System found to be compliant with IEC 60601-1-2. |
| Biocompatibility | Compliance with ISO 10993-5, ISO 10993-10 | Probes found to be compliant with ISO 10993-5 and ISO 10993-10. |
| Acoustic Output | Compliance with UD2, UD3 and consistent with predicate devices | System found to be compliant with UD2 and UD3. Acoustic output levels are consistent with predicate devices, suggesting they are within safe and effective limits. |
| Elastography Performance | Met design specifications for accuracy and repeatability of strain-ratio measurement | Phantom test showed excellent performance for strain Elastography, meeting design specifications, including accuracy and repeatability of strain-ratio measurement. The function was found to be effective. (No specific numerical values provided in the summary, but stated as "met design specifications"). |
| Overall Safety & Effectiveness | Substantially equivalent to predicate devices (SonoScape S30 K132527, Philips EPIQ K132304) | System demonstrated substantial equivalence to predicate devices regarding safety and effectiveness, indicating it performs as intended and is as safe and effective as devices already on the market. |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "No clinical testing was required." Therefore, there is no test set of patient data of the type typically associated with outcome or diagnostic accuracy studies for this submission. The testing revolved around device standards and phantom studies.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Since no clinical testing involving patient data was required or performed, there were no experts used to establish ground truth for a test set in the context of diagnostic performance.
4. Adjudication Method for the Test Set
As there was no clinical test set requiring human interpretation, no adjudication method was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No MRMC comparative effectiveness study was done. The submission demonstrates substantial equivalence primarily through technical comparisons and compliance with established standards, not through studies showing human reader improvement with or without AI assistance.
6. If a Standalone Performance Study Was Done
While not a "standalone performance study" in the context of AI algorithm only without human-in-the-loop, the document describes laboratory tests and a phantom test for the S22 system's functions and performance.
- Laboratory tests: These were conducted to verify that the system met all design specifications and conformed to applicable medical device standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-5, ISO10993-10, UD2, and UD3). This essentially acts as a rigorous standalone check against engineering and safety criteria.
- Phantom Test for Elastography: A specific phantom test was performed "to verify that the strain Elastography function was effective and Elastography performance met design specifications, including accuracy and repeatability of strain-ratio measurement and etc." This is a standalone evaluation of the Elastography feature's technical performance using a controlled phantom.
7. The Type of Ground Truth Used
- For regulatory compliance and safety/performance standards (electrical, mechanical, thermal, EMC, biocompatibility, acoustic output), the "ground truth" is defined by the specifications within the cited international and national standards (e.g., IEC, ISO, UD2/UD3). The device's output and performance are measured against these established quantitative and qualitative criteria.
- For the Elastography phantom test, the "ground truth" would be the known physical properties of the phantom material and the expected strain-ratio measurements, as defined by the phantom's design and engineering specifications.
8. The Sample Size for the Training Set
The S22 Digital Color Doppler Ultrasound System is described as an "integrated preprogrammed color ultrasound imaging system" and a "software controlled" system. While it uses complex algorithms for image processing and display (B-Mode, M-Mode, Color-Flow Doppler, etc., and features like Elastography), the document does not indicate that this specific device underwent a machine learning or AI training process that would require a "training set" of data to develop its core functionality. These systems typically rely on pre-programmed algorithms based on physics and signal processing, often optimized through extensive engineering rather than data-driven machine learning. Therefore, a "training set" of the kind used for AI development is not mentioned and likely not applicable to how this device's algorithms were developed or validated for this 510(k) submission.
9. How the Ground Truth for the Training Set Was Established
As no "training set" in the context of machine learning/AI development is indicated, the concept of establishing ground truth for such a set is not applicable to this 510(k) summary. The "ground truth" for the device's development and validation would instead stem from fundamental physics, engineering principles, and the specifications of the standards it adheres to.
§ 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.