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The Sonosite LX and Sonosite PX ultrasound systems are general purpose ultrasound systems 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:

• 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 (B), M-Mode (M) (including simultaneous M-mode and anatomical M-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+CWD, B+C, (B+C)+PWD, (B+C)+CWD.

This device is indicated for Prescription Use Only.

The Sonosite LX and Sonosite PX ultrasound systems are intended to be used in medical practices, clinical environments, including Healthcare facilities, Hospitals, Clinics, and clinical point-of-care for diagnosis of patients.

The systems are used with a transducers attached and they are 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 and Sonosite PX Ultrasound Systems are full featured, general purpose, software controlled diagnostic ultrasound systems 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 systems include a variety of accessories including needle guide starter kits. The systems include USB host support for peripherals such as input devices, storage devices and Ethernet port. Input devices include wired and wireless devices. The systems also include 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 document details the 510(k) clearance for the Sonosite LX and Sonosite PX Ultrasound Systems, specifically focusing on the addition of the PIV Assist AI feature. Here's a breakdown of the acceptance criteria and the study proving the device meets them:

Acceptance Criteria and Reported Device Performance

The document presents performance metrics for the PIV Assist AI algorithm, which serve as the acceptance criteria for its functionality. Specifically, the metrics cover "Vessel Precision," "Vessel Recall," "Vein Classification Accuracy," and "Artery Classification Accuracy" for two different transducers (L19-5 and L12-3). Additionally, average depth and diameter errors are reported.

Here's a table summarizing the reported device performance against implicitly defined acceptance criteria (as these are the results presented to demonstrate performance). No explicit "desired" or "threshold" values are given for acceptance criteria; rather, the reported performance is the demonstration of meeting the criteria.

Note: While specific acceptance thresholds are not explicitly stated, the reported high percentages and low error margins demonstrate the device's acceptable performance for its intended use.

Study Details for PIV Assist AI Algorithm Performance Testing

Here's a breakdown of the study details as provided in the document:

1. Sample Size used for the test set and the data provenance:

   • Sample Size: 584 ultrasound clips from 292 subjects.
   • Data Provenance: The data was collected prospectively from 3 hospitals within the United States. The document explicitly states that the validation dataset was collected at a "much later timeframe" and at "different sites from the training and tuning data" to ensure independence.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The document states that "certified Clinical Sonographers" independently labeled the data.
   • For adjudication, an "Interventional Radiologist" evaluated the labeled data.
   • Specific numbers of sonographers or the interventional radiologist are not provided. Their general qualifications (certified Clinical Sonographers, Interventional Radiologist) are mentioned, but specific experience (e.g., "10 years of experience") is not detailed.

3. Adjudication method for the test set:

   • An adjudication process took place "in cases where there was disagreement between the images."
   • The adjudication was performed by an "Interventional Radiologist" who evaluated the labeled data to establish the final ground truth. This suggests a form of expert consensus with a tie-breaker, though specific methods like "2+1" or "3+1" are not explicitly stated. It implies a process where disagreements among sonographers were resolved by a higher-level expert.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • No, an MRMC comparative effectiveness study was not done. The document focuses solely on the "AI algorithm performance testing" in a standalone manner, evaluating its accuracy against ground truth. There is no mention of comparing human reader performance with and without AI assistance, nor any effect size.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

   • Yes, a standalone study was done. The "Summary of PIV Assist AI Algorithm Performance Testing" section details metrics like precision, recall, and classification accuracy, which are inherent to the algorithm's performance when processing and interpreting ultrasound data. There's no indication of human interaction during the measurement of these performance metrics.

6. The type of ground truth used:

   • The ground truth was established through expert consensus and adjudication of ultrasound clips and frames. "Certified Clinical Sonographers" independently labeled the data, and an "Interventional Radiologist" adjudicated disagreements to establish the "final ground truth."

7. The sample size for the training set:

   • The document states that the validation dataset was collected independently from the "training and tuning data," but it does not provide the sample size of the training set.

8. How the ground truth for the training set was established:

   • The document mentions "training and tuning data" but does not explicitly detail how the ground truth for the training set was established. It can be inferred that a similar process of expert labeling, potentially with adjudication, was used given the rigorous approach for the validation set, but this is not explicitly stated.

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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, Transesophageal (cardiac), Transrectal, Needle Guidance. Modes of operation include: B Mode (B), M-Mode (M) (including simultaneous M-mode and anatomical M-Mode), PW Doppler Mode (B), M-Mode (M) (Including simultaneo (PWD) (including Pulsed Wave Tissue Doppler), Continuous Wave Doppler (including Velocity Color Dopler), Tissue Harmonic Imaging (THI), Tissue Dopler Imaging (TDI), and Combined modes, including Triplex imaging: B+M, B+PWD, B+CWD, B+C, (B+C)+PWD, (B+C)+CWD. 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 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 and anatomical 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. including Triplex imaging. The system includes a variety of accessories including optional needle guide starter kits. 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 does not contain information about acceptance criteria for a medical device or a study proving its performance against these criteria. Instead, it is a 510(k) summary for the FUJIFILM Sonosite PX Ultrasound System, establishing its substantial equivalence to previously cleared predicate devices.

The document focuses on:

• Indications for Use: Listing the clinical applications and exam types for which the ultrasound system is intended.
• Technological Characteristics: Comparing the subject device (Sonosite PX Ultrasound System) with its predicate devices (Sonosite PX Ultrasound System K200964 and SonoSite Edge II Ultrasound System K162045) in terms of features like intended use, indications for use (subsets of predicates), transducer types and frequencies, acoustic output, modes of operation, DICOM support, and safety certifications.
• Non-Clinical Tests: Stating that the device underwent evaluations for electrical, thermal, mechanical, and EMC safety, as well as cleaning/disinfection, biocompatibility, and acoustic output, conforming to applicable medical device safety standards. It also mentions compliance with specific ISO and IEC standards.
• Clinical Tests: Explicitly stating that clinical studies were not required to support the determination of substantial equivalence.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving performance against them, as it is not present in the given text.

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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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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.

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.

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