(19 days)
The SonoSite SII Ultrasound System is a general purpose ultrasound system intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or thuid flow analysis of the human body. Specific clinical applications and exam types include:
Ophthalmic Fetal - OB/GYN Abdominal Pediatric Small Organ (breast, thyroid, testicle, prostate) Neonatal Cephalic Adult Cephalic Trans-vaginal Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Cardiac Adult Cardiac Pediatric Peripheral Vessel
The SonoSite SII Ultrasound System is a mountable style, full featured, general purpose, software controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. SII is a custom fabricated digital electronic design that readily lends itself to be configured for specific ultrasound imaging applications through different system feature selections. SII can operate on either battery or AC power.
This document is a 510(k) premarket notification for the SonoSite SII Ultrasound System. It aims to demonstrate substantial equivalence to previously cleared predicate devices, not to present a study proving the device meets specific acceptance criteria based on performance metrics like accuracy, sensitivity, or specificity for a particular medical condition.
Therefore, many of the requested elements for describing acceptance criteria and a study proving their fulfillment are not applicable or cannot be extracted from this type of regulatory submission. The document focuses on demonstrating safety and technological equivalence, not clinical performance for a diagnostic task.
Here's a breakdown based on the provided document:
1. A table of acceptance criteria and the reported device performance
- Not Applicable in the traditional sense. This document does not present clinical performance acceptance criteria (e.g., specific sensitivity or specificity thresholds) because it is a 510(k) submission for an ultrasound system, not a device interpreting ultrasound images to make a diagnosis. The "performance" discussed relates to technical specifications and compliance with safety standards rather than diagnostic accuracy.
- The closest "acceptance criteria" are compliance with various safety and performance standards (e.g., ISO, IEC, NEMA) and demonstrating similar technological characteristics and intended uses to predicate devices. The "reported device performance" is the conclusion that the device conforms to these standards and is technologically equivalent.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. The document explicitly states: "The SonoSite SII Ultrasound System and transducers, subject of this submission, did not require clinical studies to support the determination of substantial equivalence." Therefore, there is no clinical test set, sample size, or data provenance from such a study.
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 studies were performed, there was no test set requiring expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No clinical 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
- Not Applicable. This device is an ultrasound system itself, not an AI or CAD (Computer-Aided Detection/Diagnosis) software designed to assist human readers. Therefore, an MRMC study related to AI assistance is irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is an ultrasound imaging device, not an algorithm for standalone diagnostic performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable. No clinical ground truth was established as no clinical studies were conducted to assess diagnostic accuracy. The "ground truth" for this submission concerns compliance with engineering standards and performance specifications, demonstrated through non-clinical testing.
8. The sample size for the training set
- Not Applicable. This is not an AI/machine learning device that would require a training set for an algorithm.
9. How the ground truth for the training set was established
- Not Applicable. No training set for an algorithm.
Summary from the document regarding acceptance criteria and study:
The acceptance criteria for the SonoSite SII Ultrasound System, as described in this 510(k) submission, are primarily focused on safety, technological equivalence to predicate devices, and compliance with recognized industry standards.
The "study" or justification for meeting these criteria involved:
- Non-Clinical Tests: Evaluation of electrical, thermal, mechanical, and EMC safety. Cleaning/disinfection, biocompatibility, and acoustic output were also evaluated.
- Compliance with Standards: The device was designed to comply with a list of FDA-recognized standards, including:
- ISO 10993-1 (Biological evaluation of medical devices)
- IEC 60601-1 (General requirements for basic safety and essential performance of medical electrical equipment)
- IEC 60601-1-2 (Electromagnetic compatibility)
- IEC 60601-1-6 (Usability)
- IEC 60601-2-37 (Particular requirements for ultrasonic medical diagnostic and monitoring equipment)
- IEC 62304 (Medical device software - Software life cycle processes)
- IEC 62359 (Ultrasonics - Field characterization - Test methods)
- ISO 14971 (Application of risk management to medical devices)
- NEMA UD 2-2004 (Acoustic Output Measurement Standard)
- Quality Assurance Processes: Assurance of quality was established through Design Phase Reviews, Risk Assessment, Requirements Development, and Verification and Validation.
- Substantial Equivalence Argument: The document argues that the SII system shares the same intended uses and fundamental scientific technology as the predicate devices (SonoSite Edge II and SonoSite S Series Ultrasound Systems), with a detailed comparison table showing technological characteristics.
The report explicitly states, "The SonoSite SII Ultrasound System and transducers, subject of this submission, did not require clinical studies to support the determination of substantial equivalence." This means that the regulatory pathway for this device did not necessitate clinical performance data demonstrating diagnostic accuracy against a ground truth.
§ 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.