(84 days)
The SonoScape S11 device 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, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology.
The SonoScape S11 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 all digital architecture with progressive dynamic receive focusing allows the system to maximize the utility of all imaging transducers to enhance the diagnostic utility and confidence provided by the system. The exam dependent default setting allows the user to have minimum adjustment for imaging the patient, while the in-depth soft-menu control allows the advanced user to set the system for different situations. The architecture allows cost-effective system integration to a variety of upgrade-able options and features. This SonoScape system is a general purpose, software controlled, diagnostic ultrasound system. Its basic function is to acquire ultrasound data and display the image in B-Mode (including Tissue Harmonic Image), M-Mode, TDI, Color-Flow Doppler, Pulsed Doppler and Power Doppler, or a combination of these modes, 4D.
The provided 510(k) summary is for a diagnostic ultrasound system, which is a hardware device. These types of submissions typically focus on demonstrating substantial equivalence to a predicate device based on technical specifications and adherence to recognized safety standards, rather than clinical performance metrics often associated with AI/ML-enabled devices.
Therefore, many of the requested criteria (acceptance criteria related to clinical performance, specific study types like MRMC, sample sizes for test/training sets, ground truth establishment, or expert qualifications) are not applicable or detailed in this document. The submission asserts substantial equivalence based on comparisons of design, function, and safety characteristics with a predicate device.
Here's a breakdown of what can be extracted and what is not provided based on the input:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria for device performance in terms of diagnostic accuracy, sensitivity, or specificity, as it's an ultrasound hardware device submission focused on substantial equivalence rather than a new clinical claim. Its "performance" is implicitly deemed acceptable if it meets the technical specifications and safety standards, and is substantially equivalent to the predicate.
The table below summarizes the comparison items where "SE" (Substantially Equivalent) is indicated, implying the proposed device meets the predicate's performance in those aspects.
| Comparison Item | Acceptance Criteria (Predicate) | Reported Device Performance (Proposed Device) | Remark |
|---|---|---|---|
| Classification Name | Ultrasonic Pulsed Doppler Imaging System, Ultrasonic Pulsed Echo Imaging System, Diagnostic Ultrasound Transducer | Ultrasonic Pulsed Doppler Imaging System, Ultrasonic Pulsed Echo Imaging System, Diagnostic Ultrasound Transducer | SE |
| Product Code | 90-IYN/90-IYO/90-ITX | 90-IYN/90-IYO/90-ITX | SE |
| Regulation Number | 892.1550/892.1560/892.1570 | 892.1550/892.1560/892.1570 | SE |
| Panel | Radiology | Radiology | SE |
| Class | II | II | SE |
| Intended Use | General-purpose ultrasonic imaging for Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Trans-rectal, Trans-vaginal, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology. | The same intended uses, with the addition of one more probe (C354) that does not introduce new intended uses, maintaining substantial equivalence. | SE |
| Probe Type & Connectors | L741, L742, L743 Linear Array; C344, C362 Curved Array; C611, 6V1, 6V3, EC9-5 Micro-curved Array; 2P1, 5P1 Phased Array. Multi-port connector connects 2 transducers. | Includes all predicate probes plus C354 (Curved Array, 2.0-5.0 MHz). Multi-port connector connects 3 transducers. | SE (Analysis 1, 2) |
| Acoustic Track | TRACK 3 | TRACK 3 | SE |
Design (Functions Comparison - Excerpt) | Based on embedded Linux OS, 64 channel full digital beam former, Autocorrelation for color/FFT for pulse/CW Doppler, supports Linear, Curve linear and Phase array probes from 2 to 15 MHz, Cine play back, Image file archive, Software upgrades with USB, Digital Scan Converter 800x600, TGC 8 slider, Depth Range 3 to 32 cm, Image sector size 32 lines to full B (256 lines), Image Sector position Steering. | Same as predicate. | SE |
| Operation Modes | B, M, PW, CW, CFM, DPI, TDI, Tissue Harmonic Image, 3D/4D Mode, Color M Mode. | B, M, PW, CW, CFM, DPI, TDI, Tissue Harmonic Image, 4D Mode, Color M Mode. (Note: 3D function is present in predicate but not explicitly listed for proposed device, addressed in SE Analysis 3). | SE (Analysis 3 specifies absence of 3D function but deems SE) |
| Display Modes | Dual B, Quad Display, B and M, B and Doppler, B + Color, Dual B (Flow), Triplex mode, Compound Imaging, Panoramic Imaging, Trapezoid Imaging. | Same as predicate. | SE |
| Measurement Items | Distance; area; circumference; calipers; volume, velocity, HR, PI, RI. Cardiac. OB/GYN, Urology, Vascular and small part package | Same as predicate. | SE |
| Cine Loop | Automatic/manual review. Review speed can be adjusted. | Automatic/manual review. Review speed can't be adjusted. | SE |
| Power Supply | Voltage: 110-240 VAC, Frequency: 50/60 Hz, Power Consumption: 2.7-1.2A | Voltage: 100-240 VAC, Frequency: 50/60 Hz, Power Consumption: 2.7-1.2A | SE (Analysis 4) |
| Operating Condition | Temperature: 10-40°C, Relative humidity: 30-85%, Air pressure: 700-1060hPa | Same as predicate. | SE |
| Storage Condition | Temperature: -20-55°C, Relative humidity: 20-90%, Air pressure: 700-1060hPa | Same as predicate. | SE |
| Screen Size | 15 inch Widescreen LCD monitor | Same as predicate. | SE |
| Acoustic Output | Track 3: MI,TIS,TIC,TIB, Derated ispta: 720Mw/cm² maximum, TIS/TIB/TIC: 6.0 Maximum, Mechanical Index: 1.9 Maximum, or Derated Isppa: 190W/cm² max | Same as predicate. | SE |
| Electrical Safety | IEC 60601-1 | Same as predicate. | SE |
| EMC | IEC 60601-1-2 | Same as predicate. | SE |
| Performance | IEC 60601-2-37 | Same as predicate. | SE |
| Biocompatibility | ISO 10993-5, ISO 10993-10 | Same as predicate. | SE |
| Level of Concern of Software | Moderate level of concern system | Same as predicate. | SE |
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 explicitly states "No clinical testing was required." Therefore, there is no information on sample size for a test set or data provenance related to clinical data. The testing mentioned in Section 7 refers to "Laboratory testing" to verify design specifications and compliance with safety standards, which is not a clinical test set.
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)
Not applicable, as no clinical testing or test set requiring ground truth was conducted for this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical testing or test set requiring adjudication was conducted for this submission.
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
Not applicable. This device is a diagnostic ultrasound system, not an AI-enabled device designed to assist human readers. No MRMC study was mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a hardware device; it does not perform as a standalone algorithm in the sense of AI/ML.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no clinical testing or test set requiring ground truth was conducted for this submission.
8. The sample size for the training set
Not applicable. This is a hardware device; there is no "training set" in the context of AI/ML algorithms.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this hardware device.
§ 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.