(86 days)
The SonoScape S2 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 SonoScapeS2 Portable 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.
This document details the acceptance criteria for the SonoScape S2 Portable Digital Color Doppler Ultrasound System and the study supporting its compliance.
1. Table of Acceptance Criteria and Reported Device Performance
The device is evaluated against recognized medical device safety standards and acoustic output measurement standards to ensure substantial equivalence to its predicate device. The performance is documented through adherence to these standards rather than specific imaging metrics in this summary.
| Standard No. | Standard Title | Version | Device Performance |
|---|---|---|---|
| IEC 60601-1 | Medical Electrical Equipment - Part 1. General Requirements for Safety | 1988+A1:1991+A2:1995 | Conforms to applicable medical device safety standards in regards to thermal, mechanical, and electrical safety. |
| IEC 60601-1-2 | Medical Electrical Equipment, Part 1-2: General Requirements for Safety – Collateral Standard: Electromagnetic Compatibility – Requirements and Tests | 2007 | Conforms to applicable medical device safety standards in regards to electromagnetic compatibility. |
| IEC 60601-2-37 | Medical Electrical Equipment, Part 2-37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment | 2007 | Conforms to applicable medical device safety standards for ultrasonic medical diagnostic equipment. |
| NEMA UD 2 | Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Version 3 | 2004 (R 2009) | Acoustic output is measured and calculated per NEMA UID 2: 2004. |
| NEMA UD 3 | Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment | 2004 (R 2009) | Acoustic output is measured and calculated per NEMA UD3: 2004. |
| ISO 10993-5 | Biological evaluation of medical devices - Part 5: Tests for In Vitro cytotoxicity | 1999 | Conforms to applicable biocompatibility standards (in vitro cytotoxicity). |
| ISO 10993-10 | Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity | 2002 | Conforms to applicable biocompatibility standards (irritation and delayed-type hypersensitivity). |
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes non-clinical laboratory testing to verify the device's conformance to safety and performance standards. It does not mention a clinical test set involving human patient data the way AI/CAD devices typically do. Therefore, information regarding sample size, country of origin, or retrospective/prospective nature of a clinical test set is not applicable or provided in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
As there is no mention of a human-read clinical test set being used to assess the device's diagnostic performance (as it is a imaging system and not an AI/CAD system evaluated on diagnostic accuracy against human experts), this information is not applicable and not provided in the document.
4. Adjudication Method for the Test Set
Given that performance was assessed against engineering and safety standards rather than humanexpert interpretations of clinical images, an adjudication method for a test set is not applicable and not described.
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
This device is an ultrasound imaging system, not an AI or CAD (Computer-Aided Detection/Diagnosis) system. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study evaluating human reader improvement with or without AI assistance is not applicable to this submission and was not performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Again, this is an ultrasound imaging system, not an AI algorithm. A standalone performance evaluation in the context of an algorithm's diagnostic accuracy is not applicable here. The "standalone" performance for this device would be its ability to produce images and measurements according to its technical specifications, which was confirmed through laboratory testing against established standards.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The "ground truth" for this device's acceptance criteria is defined by recognized international and national standards for medical electrical equipment safety, electromagnetic compatibility, ultrasonic medical diagnostic equipment, acoustic output measurement, and biocompatibility. The device's conformance to these engineering and safety standards serves as its "ground truth."
8. The Sample Size for the Training Set
Since this is not an AI/Machine Learning device, the concept of a "training set" is not applicable. The device's functionality is based on established physics principles and engineering design, not on learning from a dataset.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for this type of medical device, this information is 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.