(28 days)
The Sonosite LX ultrasound system is a general purpose ultrasound system intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or the human body. Specific clinical applications and exam types include:
Abdominal Adult Cephalic Neonatal Cephalic Cardiac Adult Cardiac Pediatric Fetal - OB/GYN Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Ophthalmic Pediatric Peripheral vessel Small Organ (breast, thyroid, testicles, prostate) Transesophageal (cardiac) Transrectal Transvaginal Needle Guidance
Modes of operation include: B Mode (M) (including simultaneous M-mode and anatomical M-Mode), PW Doppler (PWD) (including High Pulse Repetition Frequency (HPRF) and simultaneous PWD for certain exam types), Tissue Doppler Imaging (TDI), Continuous Wave Doppler (CWD), Color Power Doppler, Velocity Color Doppler, Color Variance, Tissue Harmonic Imaging (THI), Multi-beam imaging, Steep Needle Profiling, Trapezoid, and combined modes, including duplex and triplex imaging: B+M, B+PWD, B+C, (B+C)+PWD, (B+C)+CWD.
This device is indicated for Prescription Use Only.
The Sonosite LX system is intended to be used in medical practices, clinical environments, including Healthcare facilities, Hospitals, Clinics and clinical point-of-care for diagnosis of patients.
The system is used with a transducer attached and is powered either by battery or by AC electrical power. The clinician is positioned next to the patient and places the transducer onto the patient's body where needed to obtain the desired ultrasound image.
The Sonosite LX Ultrasound System is a full featured, general purpose, software controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data in 2D, M Mode, Pulsed Wave (PW) Doppler, Continuous Wave (CW) Doppler, Color Power Doppler (CPD), and color Doppler (Color) or in a combination of these modes. The Sonosite LX is designed as an integrated unit with its kiosk-style stand.
The system includes a variety of accessories including needle guide starter kits. The system includes USB host support for peripherals such as input devices, storage devices, and an Ethernet port. Input devices include wired and wireless devices. The system also includes an ECG-specific port to support the ECG feature. The non-diagnostic ECG module provides ECG tracing of the cardiac signal synchronized with the ultrasound image.
The provided text is a 510(k) summary for the FUJIFILM SonoSite LX Ultrasound System. It details the device's characteristics and compares it to predicate devices to establish substantial equivalence. However, it explicitly states that no clinical studies were required to support the determination of substantial equivalence for this device. Therefore, the device's acceptance criteria and studies proving it meets those criteria based on clinical performance metrics (like sensitivity, specificity, or reader improvement) are not detailed in this document.
The "acceptance criteria" discussed in the document are primarily related to technical and safety standards compliance rather than clinical performance based on a study.
Here's a breakdown of the requested information based on the provided text, with an emphasis on what is not available:
1. Table of Acceptance Criteria and Reported Device Performance
As no clinical study was conducted for performance claims, there is no direct table of acceptance criteria for clinical performance (e.g., sensitivity, specificity, accuracy) and corresponding reported device performance from such a study.
The provided document focuses on compliance with recognized medical device safety and performance standards. The "acceptance criteria" in this context are adherence to these standards, and the "reported device performance" is a statement of compliance.
| Acceptance Criteria (Standards Compliance) | Reported Device Performance |
|---|---|
| ISO 10993-1:2018 (Biological evaluation of medical devices) | All patient contact materials are biocompatible. Materials used have undergone identical biocompatibility testing to predicate devices. |
| IEC 60601-1 (General requirements for basic safety and essential performance) | Device conforms to applicable medical device safety standards. Compliance verified through independent evaluation. |
| IEC 60601-1-2 (Electromagnetic disturbances) | Device conforms to applicable medical device safety standards. Compliance verified through independent evaluation. |
| IEC 60601-1-6 (Usability) | Device conforms to applicable medical device safety standards. Compliance verified through independent evaluation. |
| IEC 60601-2-37 (Basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment) | Device conforms to applicable medical device safety standards. Compliance verified through independent evaluation. |
| IEC 62304 (Medical device software - Software life cycle processes) | Device conforms to applicable medical device safety standards. Compliance verified through independent evaluation. |
| ISO 14971 (Application of risk management to medical devices) | Assured quality by employing Design Phase Reviews, Risk Assessment. |
| IEC 62359 (Test methods for determining thermal and mechanical indices for diagnostic ultrasonic fields) | Acoustic output is less than FDA established limits. MI & TI values are always displayed, and a power management system ensures they never exceed derated FDA limits. |
| FDA Guidance: "Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" | Intended uses and other key features are consistent with traditional clinical practice and FDA guidance. |
| ISO 13485 and 21 CFR 820 (Quality system) | Device is manufactured using the same ISO 13485 and 21 CFR 820 quality system as predicates. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not available as no clinical studies were performed. The non-clinical tests involved evaluations against engineering standards and internal verification processes, not a dataset of patient cases.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not available as no clinical studies were performed requiring expert ground truth establishment for a test set.
4. Adjudication Method for the Test Set
This information is not available as no clinical studies were performed requiring an adjudication method for 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
No MRMC comparative effectiveness study was done. The document explicitly states: "The Sonosite LX Ultrasound System and transducers, subject of this submission, did not require clinical studies to support the determination of substantial equivalence." This device is a general-purpose ultrasound system, not an AI-powered diagnostic tool, so an MRMC study comparing human readers with and without AI assistance would not be applicable in this context.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No standalone algorithm performance study was done. This device is an ultrasound system, not a standalone algorithm, and no clinical studies were conducted for substantial equivalence.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
This information is not available as no clinical studies were performed requiring a type of ground truth. For the non-clinical tests, the "ground truth" was adherence to established engineering and safety standards.
8. The Sample Size for the Training Set
This information is not available as no clinical studies were performed. The device is an ultrasound system with software, but the document does not indicate it uses machine learning/AI models that would require a dedicated "training set" in the diagnostic performance sense. The software development follows IEC 62304 standards, which involve verification and validation but not necessarily clinical "training sets."
9. How the Ground Truth for the Training Set Was Established
This information is not available as no training set (in the context of clinical performance for an algorithm) was discussed or used in the provided documentation for establishing substantial equivalence.
§ 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.