(107 days)
The SonoScape S12 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), OB/Gyn and Urology.
This SonoScape S12 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.
This document describes the safety and performance evaluations for the SonoScape S12 Digital Color Doppler Ultrasound System (K142474) and its transducers, in comparison to predicate devices, to establish substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the SonoScape S12 Digital Color Doppler Ultrasound System are primarily demonstrated through conformance to established international and national standards, and by showing substantial equivalence to predicate devices for its intended uses and technological characteristics. The document doesn't present a specific table of numerical performance acceptance criteria and reported performance values in a typical AI/software context. Instead, it relies on a comparison of technical specifications and functionalities with predicate devices.
However, based on the provided text, we can infer some "acceptance criteria" through comparison to predicate devices and adherence to standards. Since direct numerical performance metrics are not given, the "Reported Device Performance" for equivalence is qualitative, stating "Same" or "Substantially Equivalent (SE) with detailed analysis".
Here's a summarized view of the comparisons:
| Acceptance Criteria (Inferred from Predicate Device Features & Standards) | Reported Device Performance (SonoScape S12 vs. Predicate) | Basis for Equivalence/Conclusion |
|---|---|---|
| Design Characteristics: | ||
| Embedded Linux operating system | Same as SonoScape S8 Exp | Direct match |
| Autocorrelation for color processing, FFT for pulse and CW Doppler | Same as SonoScape S8 Exp | Direct match |
| Support for Linear, Curved, & Phased array probes (2-15 MHz) | Same as SonoScape S8 Exp | Direct match |
| Cine play back capability | Same as SonoScape S8 Exp | Direct match |
| Image file archive | Same as SonoScape S8 Exp | Direct match |
| Software upgrade with USB flash drive | Same as SonoScape S8 Exp | Direct match |
| Digital Scan Converter (800x600) | Same as SonoScape S8 Exp | Direct match |
| Full keyboard panel, TGC 8 slider | Same as SonoScape S8 Exp | Direct match |
| Operation Controls: | ||
| Depth Range (3-24.8 cm) | Same as SonoScape S8 Exp | Direct match |
| B Dynamic range (20-280 dB) | Same as SonoScape S8 Exp | Direct match |
| Gray Scale Control (7 optional) | Same as SonoScape S8 Exp | Direct match |
| Focal Number (adjustable, max 12) | Same as SonoScape S8 Exp | Direct match |
| B persistence (0-95%) | Same as SonoScape S8 Exp | Direct match |
| PW sweeping speed (2,4,6,8 sec) | Same as SonoScape S8 Exp | Direct match |
| PW Wall filter setting (35-750) | Same as SonoScape S8 Exp | Direct match |
| PW sample volume (0.7-21mm) | Same as SonoScape S8 Exp | Direct match |
| PW angle correction (0-72 degree) | Same as SonoScape S8 Exp | Direct match |
| Spectrum baseline (adjustable) | Same as SonoScape S8 Exp | Direct match |
| Color ROI setting (trackball & set key) | Same as SonoScape S8 Exp | Direct match |
| Color Wall Filter settings (35-750) | Same as SonoScape S8 Exp | Direct match |
| Zoom adjustable | Same as SonoScape S8 Exp | Direct match |
| Freeze control (Toggling freeze key) | Same as SonoScape S8 Exp | Direct match |
| Cine control (play/stop, loop speed, frame by frame) | Same as SonoScape S8 Exp | Direct match |
| Operation Modes & Functions: | ||
| B, M, PW, CW, CFM, DPI, TDI, Tissue Harmonic Image, Color M Mode, PIH, Compound Imaging, 3D/4D Mode, Panoramic Imaging, Trapezoid Imaging | Same as SonoScape S8 Exp | Substantially Equivalent (SE Analysis 1 for Elastography) |
| Elastography Technique (Strain Elastography) | Same as Philips EPIQ | Substantially Equivalent (SE Analysis 1) |
| Elastography Clinical Applications (adjunct for hard/soft tissue, tumor discovery) | Same as Philips EPIQ | Substantially Equivalent (SE Analysis 1) |
| Elastography Functions (elasticity image generation, distance/area measurement, strain ratio calc) | Similar to Philips EPIQ | Substantially Equivalent (SE Analysis 1) |
| Display Modes: | ||
| Single, Dual, Quad for B,CFM,DPI,TDI, 4D; Dual Live for B+CFM, B+DPI, B+TDI; various split screens for B/M, CFM/M, TDI/M, Steer M, PW, CW | Same as SonoScape S8 Exp | Direct match |
| Measurement Items: | ||
| Various measurements for B, CFM, DPI, TDI (Area Ratio, Angle, Volume, etc.), M (Distance, Time, Slope, HR, etc.), PW/CW (Flow Velocity, Acceleration, Time, Trace, Auto Trace, HR, etc.) | Same as SonoScape S8 Exp | Direct match |
| Operating Conditions: | ||
| Temperature (10-40°C), Relative humidity (30-75%), Air pressure (700-1060 hPa) | Same as SonoScape S8 Exp | Direct match |
| Storage Conditions: | ||
| Temperature (-20-55°C), Relative humidity (20-90%), Air pressure (700-1060 hPa) | Same as SonoScape S8 Exp | Direct match |
| Power Supply: | ||
| Voltage (100-240V AC), Frequency (50/60 Hz), Power Consumption (2.7-1.1A) | Wider input voltage range, minor current difference compared to SonoScape S8 Exp (110-240 VAC, 2.7-1.2A) | Substantially Equivalent (SE Analysis 2), complies with IEC60601-1 |
| Screen Size: | ||
| 15 inch LCD monitor | Minor difference in screen size (vs. 15 inch Widescreen LCD monitor) compared to SonoScape S8 Exp | Substantially Equivalent (SE Analysis 3), complies with IEC60601-1 & IEC60601-1-2, meets clinical needs. |
| Compliance with Standards: | Meet IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-5, ISO10993-10, UD2, and UD3 | Verified through laboratory tests |
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 states, "Laboratory tests were conducted to verify that the S12 system met all design specifications... Phantom test was conducted 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."
However, the specific "sample size" for these laboratory and phantom tests (e.g., number of phantom measurements, specific dataset sizes) is not provided. The data provenance (country of origin, retrospective/prospective) is also not specified/mentioned for these tests.
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)
The document does not mention the use of experts to establish ground truth for testing. The evaluation appears to be based on technical specifications, direct comparison to predicate devices, and phantom testing, rather than human expert interpretation of images. The "phantom test" mentioned for Elastography implies a physical standard or controlled environment rather than expert-labeled cases.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Since the document does not describe the use of human experts or clinical data for a test set that would require ground truth adjudication, there is no adjudication method mentioned or applicable in the context presented.
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
There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study being done. The device is a diagnostic ultrasound system, and the submission focuses on establishing substantial equivalence based on technical characteristics and safety standards, not on AI-assisted diagnostic improvement.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The document describes a diagnostic ultrasound system and its transducers, which are hardware devices with embedded software for image acquisition and processing. It is not an AI-based standalone diagnostic algorithm. The phrase "algorithm only without human-in-the-loop performance" is not applicable in this submission. The system produces images for human interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the Elastography function (the only feature specifically mentioned with a "test"), the ground truth was established using phantom tests. This suggests a physical phantom with known properties (e.g., stiffness) was used as the reference, rather than expert consensus on clinical cases, pathology, or outcomes data. For other aspects of the ultrasound system, the "ground truth" seems to be adherence to engineering specifications and performance matching that of the predicate devices.
8. The sample size for the training set
The document is for a traditional diagnostic ultrasound system and does not mention machine learning or AI algorithms requiring a "training set." Therefore, no training set size is provided or applicable.
9. How the ground truth for the training set was established
As there is no mention of a training set (see point 8), the method for establishing its ground truth is also not applicable.
§ 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.