(28 days)
The FUJIFILM SonoSite X-Porte 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 and exam types include:
Ophthalmic
Fetal - OB/GYN
Abdominal
Intra-operative (Abdominal organs and vascular)
Pediatric
Small Organ (breast, thyroid, testicles, prostate)
Neonatal Cephalic
Adult Cephalic
Trans-vaginal
Musculo-skel. (Convent.)
Musculo-skel. (Superfic.)
Cardiac Adult
Cardiac Pediatric
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 readliy 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.
This report is a 510(k) Premarket Notification for the FUJIFILM SonoSite X-Porte Ultrasound System. It is a submission to the FDA to demonstrate substantial equivalence to a previously cleared device, not a study to prove a device meets specific performance criteria in the way a clinical trial would for a novel device or AI.
Therefore, the document does not contain acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy) for an AI or diagnostic algorithm, nor does it describe a study that explicitly proves the device meets such criteria. Instead, it demonstrates substantial equivalence to predicate devices for its intended uses.
Based on the provided text, here's an analysis of the requested information, understanding that this is a medical device clearance document based on substantial equivalence, not a clinical performance study of an AI device:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) for an ultrasound system, not an AI diagnostic algorithm, there are no specific diagnostic acceptance criteria (like sensitivity, specificity, or AUC) and corresponding reported performance metrics in the document. The "acceptance criteria" for a 510(k) submission revolve around demonstrating that the new device is as safe and effective as a legally marketed predicate device.
The tables within the document detail the intended uses and modes of operation for the X-Porte Ultrasound System and its various transducers, comparing them to predicate devices (K133134 and K133454). The "performance" demonstrated is that the device functions according to its intended use and complies with relevant safety and performance standards.
| Acceptance Criteria (Implied by 510(k) process) | Reported Device Performance (as demonstrated for 510(k)) |
|---|---|
| Safety and Effectiveness Equivalence: New device is as safe and effective as identified predicate devices for claimed indications for use. | The FUJIFILM SonoSite X-Porte Ultrasound System has "Intended uses and other key features are consistent with traditional clinical practice and FDA guidance." |
| "The X-Porte device and predicates conform to applicable electromedical device safety standards with compliance verified through independent evaluation." | |
| Many intended clinical applications and modes of operation are described as "P" (previously cleared) or "N" (new indications for this specific transducer/system, which implies they have been deemed equivalent or safe and effective based on the provided technical information and comparison to predicates). | |
| The document explicitly states: "FUJIFILM SonoSite, Inc. believes that the X-Porte Ultrasound System is substantially equivalent with regard to safety and effectiveness to the predicate devices." | |
| Compliance with Voluntary Standards: Device adheres to recognized national and international safety, performance, EMC, and biocompatibility standards. | Non-Clinical Tests: Evaluated for electrical, thermal, mechanical, EMC safety, cleaning/disinfection, biocompatibility, and acoustic output. Found to conform to applicable mandatory medical device safety standards. |
| Voluntary Standards Met: AAMI/ANSI/ISO 10993-1, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62359, ISO 14971, NEMA UD 2-2004, NEMA PS 3.15. | |
| Quality Assurance: Established by Design Phase Reviews, Risk Assessment, Requirement, System and Software Verification, Hardware Verification, Safety Compliance Verification, Clinical Validation. All patient contact materials are biocompatible. | |
| Acoustic Output Limits: Meets specified limits for acoustic intensity and indices. | Acoustic Output Display & FDA Limits: ISTPA.3 ≤ 720 (mW/cm^2), TI ≤ 4.0, MI ≤ 1.9 (These are the limits the device must meet, and are listed as features of the system). |
| Technological Characteristics Equivalence: Shares fundamental technology, transducer types, frequency range, and modes of operation with predicates. | A detailed comparison table ({16}) shows that the X-Porte Ultrasound System generally uses the same transducer types, frequency, acoustic output limits, and modes of operation as its predicate devices (K133134 and K133454), with some minor differences or additions that were deemed equivalent. |
2. Sample Size Used for the Test Set and the Data Provenance
The document explicitly states: "The SonoSite X-Porte Ultrasound System and transducers, subject of this submission, did not require clinical studies to support the determination of substantial equivalence."
Therefore, there is no test set of patient data (images, etc.) described with a sample size or provenance (country of origin, retrospective/prospective). The assessment was based on non-clinical engineering tests and comparison to previously cleared devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Since no clinical studies or test sets with patient data were required, no experts were used to establish ground truth from such a test set. The evaluation relies on established engineering and regulatory standards and a determination of equivalence to predicate devices.
4. Adjudication Method for the Test Set
Not applicable, as no test set requiring ground truth adjudication was used.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done, as explicitly stated that clinical studies were not required. This submission is for an ultrasound hardware system, not an AI medical device that interprets images.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to an ultrasound system, not a standalone algorithm. Performance was assessed through engineering characteristics and compliance with standards. So, no standalone algorithm performance study was done in the context of AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Given that clinical studies were not required, there was no ground truth derived from expert consensus, pathology, or outcomes data in the context of diagnostic performance. The "ground truth" in this submission relates to the verification of the device's technical specifications and safety standards (e.g., acoustic output measurements, electrical safety tests, biocompatibility tests). These are considered facts established through physical measurement and standardized test procedures, not through expert interpretation of clinical data in the way an AI diagnostic device would.
8. The Sample Size for the Training Set
Not applicable, as this is a traditional ultrasound system and not an AI device that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable, as this is a traditional ultrasound system and not an AI device that requires a training set.
In summary: This document is a 510(k) premarket notification for an ultrasound system, not an AI diagnostic software. The "acceptance criteria" are regulatory (demonstrating substantial equivalence to predicate devices and adherence to safety standards) rather than performance metrics for an AI algorithm. Clinical studies and associated concepts like test sets, ground truth derivation, and reader studies were not part of this clearance process.
§ 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.