(28 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 Healthicare facilities, Hospitals, Clinics and clinical point-of-care for diagnosis of patients.
The Sonosite PX 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 (including Simultaneous M-Mode), Pulsed Wave (PW) Doppler (including Pulsed Wave Tissue Doppler), Continuous Wave (CW) Doppler, Color Power Doppler (including Velocity Color Doppler), Tissue Harmonic Imaging or in a combination of these modes. The Sonosite PX Ultrasound System also includes needle guidance capability. The system is capable of working with two different types of needle guide brackets available, including 1) Fixed-angle, in-plane brackets where a pair of guidelines are generated that represent the path of the needle and 2) Transverse-angle, out-of-plane brackets (adjustable depths) where the quidelines appear down the center of the imaqe. Each Sonosite PX transducer has an appropriate needle quide bracket kit to support needle quidance with the system.
The provided text is a 510(k) Pre-Market Notification for the FUJIFILM SonoSite PX Ultrasound System. It focuses on demonstrating substantial equivalence to existing predicate devices (SonoSite Edge II Ultrasound System and SonoSite X-Porte Ultrasound System) rather than presenting a study to prove acceptance criteria for a new AI/algorithm-based diagnostic device.
Therefore, many of the requested details about acceptance criteria, device performance metrics, sample sizes, ground truth establishment, and comparative effectiveness studies are not applicable as they are specific to studies evaluating the performance of diagnostic algorithms.
However, I can extract and summarize the information that is present:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a table of acceptance criteria with specific performance metrics (e.g., sensitivity, specificity, AUC) for an AI or algorithmic function. Instead, it demonstrates substantial equivalence to predicate devices based on technological characteristics and compliance with safety standards.
The "reported device performance" in this context refers to the device's ability to perform various ultrasound imaging modes across different clinical applications, which is considered equivalent to the predicate devices.
| Feature / Criterion | Sonosite PX Ultrasound System (This submission) | Predicate Devices (SonoSite Edge II & X-Porte) |
|---|---|---|
| Intended Use | Diagnostic ultrasound imaging or fluid flow analysis of the human body | Diagnostic ultrasound imaging or fluid flow analysis of the human body |
| Indications for Use (Clinical Applications) | 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. | Similar clinical applications (Abdominal, Adult Cephalic, Cardiac Adult, Cardiac Pediatric, Fetal - OB/GYN, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Ophthalmic, Pediatric, Small Organ, Trans-vaginal, Peripheral vessel, Neonatal Cephalic, Trans-Rectal (Edge II), Trans-esophageal (Cardiac) (Edge II & X-Porte), Needle Guidance). Some minor differences exist (e.g., PX has "Adult Cephalic" but not "Neonatal Cephalic" explicitly listed in its primary indication table, though it is general purpose). |
| Modes of Operation | B-mode Grayscale Imaging, Tissue Harmonic Imaging, M-mode, Simultaneous M-Mode, Color Power Doppler, Zoom, Combination Modes, Pulsed Wave (PW) Doppler, Continuous Wave (CW) Doppler, Speckle reduction algorithm, SonoMB/MBe Image Compounding, CW Doppler, Velocity Color Doppler, Tissue Doppler Imaging (TDI). | Similar modes, including B-mode, M-mode, PW Doppler, CW Doppler, Color Power Doppler, Tissue Harmonic Imaging, SonoHD2 Noise Reduction (instead of speckle reduction algorithm, though similar function), SonoMB/MBe Image Compounding, Velocity Color Doppler, Tissue Doppler Imaging (TDI). |
| Transducer Frequency Range | 1.0-19.0 MHz | 1.0-15.0 MHz |
| Acoustic Output (Worst Case) | I_spta.3: 607 mW/cm^2 (L12-3); TI Value: 4.87 (P5-1); MI: 1.72 (L12-3); I_pa.3 @MI Max: 793 mW/cm^2 (L15-4). | I_spta.3: 598.9 (HFL50x) [Edge II], 629.3 (P21xp) [X-Porte]; TI Value: 4.98 (rP19x) [Edge II], 4.0 (P21xp) [X-Porte]; MI: 1.7 (rP19x) [Edge II], 1.7 (P21xp) [X-Porte]; I_pa.3 @MI Max: 776 (L38xi) [Edge II], 678 (L38xp) [X-Porte]. |
| Product Safety Certification | Complies with AAMI/ANSI ES60601-1, IEC 60601-2-37, CAN/CSA-C22.2 No. 60601-1, JSA JIS T 0601-1, IEC 61157, NEMA UD 2-2004, IEC 62359. | Complies with similar and relevant versions of safety standards (e.g., AAMI/ANSI ES60601-1, IEC 60601-2-37, NEMA UD2-2004, IEC 62359). |
| EMC Compliance | Complies with IEC 60601-1-2:2014, CISPR 11:2015+AMD1:2016+AMD2:2019, IEC 61000-4 series. | Complies with AAMI / ANSI / IEC 60601-1-2:2007 (R)2012 CISPR 11, IEC 61000-4 pt 2-5 (X-Porte). |
| Number of Transmit/Receive Channels | 128 digital channels (Transmit), 128 digital channels (Receive) | 128 digital channels (Transmit) [Edge II & X-Porte]; 64 digital channels (Receive) [Edge II & X-Porte], with X-Porte also noting "128 digital channels using Synthetic Aperture". |
| Biocompatibility | All patient contact materials are biocompatible (Silicone Rubber, Polysulfone, PolyVinylChloride (PVC), Silicone RTV Adhesive, Silicone). | Patient contact materials listed for transducers and needle guides, similar materials used (e.g., ABS, Polysulfone, Polyurethane, Silicone Rubber, PVC). |
2. Sample size used for the test set and data provenance:
- Not Applicable. The document explicitly states: "The Sonosite PX Ultrasound System and transducers, subject of this submission, did not require clinical studies to support the determination of substantial equivalence." Non-clinical tests were conducted for safety and technological characteristics, not for clinical performance evaluation comparable to an AI algorithm's test set.
3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:
- Not Applicable. No clinical test set requiring expert ground truth was conducted for this submission. The device is a general-purpose ultrasound system, and its functionality relies on the interpretation of images by qualified healthcare professionals.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. No clinical test set requiring adjudication was performed.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs. without AI assistance:
- Not Applicable. This is a submission for a general-purpose ultrasound imaging system, not an AI-assisted diagnostic algorithm. Therefore, no MRMC study comparing human readers with and without AI assistance was conducted or mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This device is an imaging system, not a standalone algorithm. Its intended use is for qualified physicians and healthcare professionals to perform evaluations using the ultrasound images.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. As no clinical studies were performed to establish performance metrics for a diagnostic algorithm, no specific ground truth type was established for that purpose. The "ground truth" for demonstrating substantial equivalence was conformity to recognized safety standards and verification of technological functionality against predicate devices.
8. The sample size for the training set:
- Not Applicable. This device is an ultrasound system. While it includes "software controlled" elements and features like "Speckle reduction algorithm" and "SonoMB/MBe Image Compounding," these are traditional image processing techniques inherent to ultrasound technology, not machine learning algorithms that would require a distinct "training set" in the modern AI sense.
9. How the ground truth for the training set was established:
- Not Applicable. See point 8.
§ 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.