(10 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.
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Fetal, Abdominal, Pediatric, Small Organ (specify), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Other (Ob/GYN), Other (Urology), Cardiac Adult, Cardiac Pediatric, Peripheral vessel.
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 1.0 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 subject of this submission is the addition of new probes to the legally marketed SonoScape S12.
New probes Add 3C-A, 4P-A and 10l2 probes.
Here's a breakdown of the acceptance criteria and study information for the SonoScape S12 Digital Color Doppler Ultrasound System, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary for the SonoScape S12 Digital Color Doppler Ultrasound System does not explicitly list specific numerical acceptance criteria (e.g., specific accuracy percentages, sensitivity/specificity thresholds) or detailed reported device performance in terms of these metrics.
Instead, the submission focuses on demonstrating substantial equivalence to a previously cleared predicate device (SonoScape S12 K142474) and compliance with relevant industry standards. The performance is assessed by confirming that the device meets its design specifications and conforms to applicable medical device standards, which implies satisfactory performance for its intended use.
Qualitative Acceptance Criteria (Implied by the 510(k) Summary):
| Acceptance Criteria Category | Reported Device Performance (as stated in the summary) |
|---|---|
| Intended Use | The SonoScape S12 system has the same intended uses as the legally marketed SonoScape S12 (K142474). |
| 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. (Pages 3, 23) | |
| Technical Characteristics | The basic and key technical features of the Subject Device S12 are the same as the legally marketed SonoScape S12 (K142474), including Design, Operation Controls, Display Modes, Operation Modes, Measurement Items, Cine Loop, Power Supply, Operating and Storage Condition and Screen Size. (Page 23) |
| Probe Performance | Performance and clinical application of new probes (3C-A, 4P-A, 1012) are stated to be the same or similar and meet clinical use compared to existing predicate probes (C344, 2P1, L741 respectively). (Page 24) |
| Safety and Effectiveness | The device complies with the same regulation and safety standards and has consistent acoustic output levels as the predicate device. "No new risk is raised." (Page 25) |
| Compliance with Standards | The S12 system has been designed and manufactured to meet the following standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-5, ISO10993-10, UD2, and UD3. (Page 25) |
| Design Specifications | Laboratory tests (including Phantom tests) were conducted to verify that the S12 system met all design specifications. (Page 25) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for a test set in the context of clinical performance evaluation. The submission relies on non-clinical tests (laboratory and phantom tests) to verify design specifications and compliance with standards.
The data provenance is implied to be from internal laboratory testing conducted by SonoScape Medical Corp. in China. The study is not a retrospective or prospective clinical study on patient data in the typical sense for demonstrating diagnostic accuracy or clinical effectiveness.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document as there was no clinical testing requiring expert review for ground truth establishment. The document refers to non-clinical laboratory and phantom tests.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided, as the submission did not involve clinical testing or human reader studies requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission explicitly states, "No clinical testing was required." (Page 25). Therefore, there is no effect size reported for human readers improving with or without AI assistance, as AI assistance is not mentioned or evaluated in this context.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This aspect is not applicable as the SonoScape S12 is a diagnostic ultrasound system and does not appear to feature AI algorithms requiring standalone performance evaluation in this 510(k) submission. The document primarily focuses on hardware and core imaging modalities.
7. The Type of Ground Truth Used
For the non-clinical tests (laboratory and phantom tests), the "ground truth" would have been established by:
- Known physical properties of phantoms: For acoustic output, imaging resolution, penetration, etc., phantoms with well-defined characteristics serve as the ground truth.
- Engineering specifications and standards: Compliance with IEC and ISO standards dictates the expected performance and limits.
- Comparison to predicate device's established performance: The primary method for demonstrating safety and effectiveness is substantial equivalence to the predicate device (K142474), implying that the predicate's performance serves as an established baseline.
8. The Sample Size for the Training Set
This information is not applicable as the submission does not describe an AI or machine learning model that would require a "training set." The device is a traditional ultrasound imaging system.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
§ 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.