(27 days)
The SonoSite X-Porte Ultrasound System is a general purpose ultrasound system intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging of thid flow analysis of the human body. Specific clinical applications and exam types include:
Ophthalmic Fetal – OB/GYN Abdominal Pediatric Small Organ (breast, thyroid, testicles, prostate) Neonatal Cephalic Adult Cephalic Trans-vaginal Musculo-skel. (Convent.) Musculo-skel. (Superfic.) Cardiac Adult Cardiac Pediatric Trans-esophageal (card.) Peripheral Vessel
The SonoSite X-Porte Ultrasound System is a highly mobile, full featured, general purpostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. X-Porte is a custom fabricated digital electronic design that readily lends itself to be configured for specific ultrasound imaging applications through different system feature selections. The system interface can be customized for the user and controlled using a backlit touchscreen much like what is used in consumer tablet products. X-Porte can be operated in two different configurations, standbased with AC power or battery, and desktop-based with AC power only. In desktop configuration the ultrasound engine can be removed from the stand and used by itself with a single transducer and external monitor.
The provided documentation is a 510(k) Premarket Notification for the FUJIFILM SonoSite, Inc. SonoSite X-Porte Ultrasound System. This document focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than establishing performance criteria through novel clinical studies. Therefore, much of the requested information regarding algorithm performance, sample sizes for test/training sets, expert qualifications, and MRMC studies is not present.
However, based on the provided text, we can extract details regarding the general acceptance criteria (primarily safety and compliance with standards) and the "study" (non-clinical tests and comparisons to predicates) used to demonstrate adherence to these criteria.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily conformance to various medical device safety and performance standards. The "reported device performance" is implicitly that the device meets these standards, enabling a substantial equivalence determination.
| Acceptance Criteria (Standards Adherence) | Reported Device Performance |
|---|---|
| Product Safety Certification: | Conforms to specified standards |
| AAMI/ANSI ES60601-1:2005 (R2012) | |
| IEC 60601-2-37: 2007 | |
| CAN/CSA C22.2 No. 601.1 | |
| JIS T 0601-1, JIS T 1507 | |
| CEI/IEC 61157 | |
| ANSI/AAMI EC53 | |
| NEMA UD2-2004 | |
| IEC 62359:2010 | |
| Biocompatibility ISO 10993-1:2009/(R)2013 | All patient contact materials are biocompatible (implicit) |
| Risk Management ISO 14971: 2007 | Employed in product development (implicit) |
| Electrical, thermal, mechanical safety evaluation | Evaluated (implicit) |
| Acoustic Output Measurement Standard (NEMA UD 2-2004) | Conforms, specific maximum outputs provided |
| EMC Compliance: | Conforms to specified standards |
| IEC 60601-1-2:2007 | |
| CISPR 11 | |
| IEC 61000-4 pt 2-5 | |
| DIOCOM Compliance: | Conforms to specified standard |
| NEMA PS3.15:2011 | |
| Airborne Equipment Standards: | Conforms to specified standard |
| RTCA/DO160D (section 21) | |
| Indications for Use: (e.g., Ophthalmic, Fetal, Abdominal, etc., across various modes for the system and for each transducer type) | Device is intended for these specific clinical applications and exam types |
| Technological Characteristics: (e.g., Transducer Types, Frequency, Maximum Outputs, Modes of Operation, PW/CW Doppler features, ECG, DICOM, Channels, Patient Contact Materials, System Characteristics) | The new device has comparable technological characteristics to predicate devices |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not applicable in the context of this 510(k) submission. The submission relies on non-clinical testing and comparison to predicates, not a clinical test set for AI performance.
- Data Provenance: Not applicable for performance evaluation in the usual sense. The "data" here refers to measurements and tests conducted to ensure compliance with standards, and these are typically internal engineering tests. The document states "Clinical Validation" was part of product development, but no details are provided about this "validation" with respect to a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. "Ground truth" in the clinical performance sense (e.g., expert consensus on diagnoses) is not described or required for this type of 510(k) submission focused on substantial equivalence of an ultrasound system, not an algorithmic diagnostic device. The "truth" is established by adherence to engineering and safety standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. There is no mention of an adjudication method as no clinical test set for diagnostic accuracy is 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
Not applicable. This is a submission for an ultrasound imaging system, not an AI-assisted diagnostic algorithm. There is no MRMC study mentioned or required for this type of device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithmic diagnostic device, but rather a general-purpose ultrasound system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" or basis for the acceptance of this device primarily stems from:
- Engineering and safety standards compliance (e.g., IEC 60601-1, NEMA UD2-2004 for acoustic output).
- Biocompatibility testing for patient contact materials.
- Risk assessment outcomes.
- Comparison of technological characteristics and intended uses to previously cleared predicate devices (K152209, K133454, K162045).
8. The sample size for the training set
Not applicable. This document describes an ultrasound hardware system, not an AI/algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as no training set for an algorithm is described.
§ 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.