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510(k) Data Aggregation
(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.
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(29 days)
The Sonosite PX Ultrasound System is a general purpose ultrasound system intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging of the human body. Specific clinical applications and exam types include: Abdominal Adult cephalic Cardiac Adult Cardiac Pediatric Fetal - OB/GYN Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Ophthalmic Pediatric Peripheral Vessel Small Organ (breast, thyroid, testicles, prostate) Transvaginal Needle Guidance This device is indicated for Prescription Use Only. The Sonosite PX Ultrasound 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 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 fluid 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-rectal Trans-vaginal Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Cardiac Adult Cardiac Pediatric Peripheral Vessel
The SonoSite iViz Ultrasound System is a general purpose ultrasound system and non-continuous platform intended for use in clinical care by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or fluid flow analysis. Specific clinical applications and exam types include: Fetal - OB/GYN Abdominal Pediatric Small Organ (breast, thyroid, testicles, prostate) Musculo-skel. (Convent.) Musculo-skel. (Superfic.) Cardiac Adult Cardiac Pediatric Peripheral vessel Ophthalmic
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 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 Edge II Ultrasound System is a general purpose ultrasound system intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging 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-rectal Trans-vaginal Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Cardiac Adult Cardiac Pediatric Trans-esophageal (cardiac) Peripheral Vessel
The SonoSite Maxx Ultrasound System is a general purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications include: Ophthalmic, Fetal - OB/GYN, Abdominal, Intraoperative (abdominal organs and vascular), Intra-operative (Neuro.), Pediatric, Small Organ (breast, thyroid, testicle, prostate), Neonatal Cephalic, Adult Cephalic, Trans-Rectal, Trans-Vaginal, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Cardiac Pediatic, Trans-esophageal (cardiac), Peripheral Vessel.
The Sonosite Diagnostic Ultrasound Systems are full featured, general purpose, software controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. They are intended to be used for general purpose ultrasound examination, cardiac imaging, fetal imaging and OB/GYN applications, vascular imaging and trans-rectal applications and fluid flow analysis among others. Some Sonosite Ultrasound Systems (Sonosite PX) also have needle guidance capabilities. They are intended to be used by qualified physicians and trained professionals in various patient care settings including hospitals, clinics, and point-of-care settings. Software modes/applications, scanning protocols, and pre-installed settings or functionality to create dedicated settings for imaging of specific anatomy are available with the subject Sonosite Ultrasound Systems and may vary among the different model configurations. The Sonosite Ultrasound Systems work on either battery or AC power. Some Sonosite Diagnostic Ultrasound Systems support Bluetooth and wireless connectivity for image transfer and over-the-air (OTA) software updates. The diagnostic ultrasound systems are manufactured with hardware components which consist of: 1) a primary console (e.g., workstation, tablet with touchscreen) with built-in software components, features, and various clinical applications, and 2) a range of compatible ultrasound transducers. A suite of compatible transducers are offered with the Sonosic Ultrasound Systems. These include linear array, curved array, phased array, intra-cavitary, static probes and trans-esophageal transducers. Linear array transducers (prefixed with the letter L) produce a rectangular field of view with uniform beam density throughout and are useful for imaging shallow structures and small parts. Curved array transducers (prefixed with the letter C) allow for a wider field of vith decreased line density at depth and reduced lateral resolution. They are the ideal probe for lung ultrasound imaging. Phased array transducers (prefixed with the letter P) are small faced transducers allowing for imaging in small spaces. They are able to change the focus of the ultrasound beam. It is the optimal transducer recommended for cardiac imaging. Trans-esophageal transducers (prefixed with the letters TE) are commonly used for evaluation of cardiac and aortic structures. Intra-cavitary transducers (prefixed with the letters IC) are used for trans-rectal ultrasounds. Some models may have additional previously-cleared accessories, or components which are manufactured by other manufacturers.
The provided document is a 510(k) Summary for multiple FUJIFILM Sonosite Diagnostic Ultrasound Systems. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices. The document explicitly states: "Relevant performance data does not apply to this submission. Design control measures described within the submission support a decision of substantial equivalence."
Therefore, the document does not include a study or acceptance criteria related to a new device or algorithm performance evaluation. Instead, it relies on the predicate devices' established safety and effectiveness. The modifications mentioned are primarily "Additional user labeling ... for patients with coronavirus disease 2019 (COVID-19)" based on existing methods or society guidelines, not a new AI-powered diagnostic feature.
Given this, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, ground truth, experts, or MRMC studies, as these types of studies were explicitly stated as not applicable to this submission.
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