(83 days)
The SonoScape S20 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 aduit), OB/Gyn and Urology.
The SonoScape S20 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, 3D/4D.
The SonoScape S20 Digital Color Doppler Ultrasound System is a general-purpose ultrasonic imaging system. It was found to be substantially equivalent to the predicate device, SonoScape S8 Diagnostic Ultrasound System and Transducers (K092922), by the FDA. The performance of the S20 system was verified through laboratory testing against applicable medical device safety standards.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standards Met) | Reported Device Performance |
|---|---|
| Safety and Electrical Performance: IEC 60601-1 (General Requirements for Safety) | Conforms to IEC 60601-1 (1988, Amendments 1991-11, 1995) |
| Electromagnetic Compatibility (EMC): IEC 60601-1-2 | Conforms to IEC 60601-1-2 (Second Edition, 2001, 2007) |
| Particular Requirements for Diagnostic Ultrasound Equipment: IEC 60601-2-37 | Conforms to IEC 60601-2-37 (2004, 2005 Amendment 2, 2007) |
| Acoustic Output Measurement: NEMA UD 2-2004 | Acoustic output measured and calculated according to NEMA UD 2-2004. |
| Real-time Display of Acoustic Output Indices: NEMA UD 3:2004 | Conforms to NEMA UD3:2004 (Standards for Real-time Display of Thermal and Mechanical Acoustic Output Indices). |
| Biocompatibility (In Vitro Cytotoxicity): ISO 10993-5 | Conforms to ISO 10993-5:1999 (Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity). |
| Biocompatibility (Irritation and Delayed Hypersensitivity): ISO 10993-10 | Conforms to ISO 10993-10:2002 (Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity). |
| Substantial Equivalence to Predicate Device (SonoScape S8 - K092922) regarding Safety and Effectiveness for the stated Indications for Use. | Laboratory testing verified that the S20 system met all design specifications and was substantially equivalent to the currently marketed Predicate Device. This includes safety (thermal, mechanical, electrical) and biocompatibility, as well as the ability to produce high detail resolution for clinical diagnostic imaging across its stated indications. |
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 describes laboratory testing to verify the device's adherence to design specifications and safety standards. There is no mention of a clinical "test set" in the context of patient data, nor is there information about data provenance (country of origin, retrospective/prospective). The assessment appears to be based on engineering and regulatory compliance testing rather than clinical study data involving patient samples.
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)
This information is not provided in the document. As noted above, the testing described is primarily technical and regulatory compliance-based, not a clinical study involving expert interpretation of images for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. The reported testing does not involve clinical adjudication of a test set.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not performed, nor is it applicable to this device. The SonoScape S20 is a diagnostic ultrasound system and transducers, a device that produces images, not an AI-assisted diagnostic tool. Therefore, the concept of human readers improving with AI assistance does not apply in this context.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This concept is not applicable to this device. The SonoScape S20 is a diagnostic ultrasound imaging system, an instrument that acquires and displays images for human interpretation, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not describe the establishment of a "ground truth" in a clinical sense. The "ground truth" here refers to the various safety and performance standards (e.g., IEC, NEMA, ISO) that the device was tested against in laboratory settings. Its performance was measured against the requirements of these standards.
8. The sample size for the training set
This information is not applicable as the device is not an AI/machine learning algorithm requiring a "training set."
9. How the ground truth for the training set was established
This information is not applicable as the device is not an AI/machine learning algorithm.
§ 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.