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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 LX 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:

• Abdominal
• Adult Cephalic
• Neonatal Cephalic
• Cardiac Adult
• Cardiac Pediatric
• Dermatological
• 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 Mode), PW Doppler (PWD) (including Pulsed Wave Tissue Doppler), Continuous Wave Doppler (CWD), Color Power Doppler (including Velocity Color Doppler), Tissue Harmonic Imaging (THI), Tissue Doppler 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 LX 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 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 FDA 510(k) clearance letter for the Sonosite LX Ultrasound System (K251830) describes a general-purpose ultrasound system. As such, the clearance does not detail specific acceptance criteria for diagnostic performance metrics (e.g., sensitivity, specificity, accuracy) that would typically be associated with AI-powered diagnostic devices. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through technical characteristics and compliance with general safety and performance standards.

However, based on the information provided, we can infer some "acceptance criteria" related to the device's technical specifications and safety, and how the study addresses them.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a general-purpose ultrasound system and not an AI/diagnostic algorithm, the acceptance criteria are not in the form of diagnostic performance metrics. Instead, they are related to equivalence with predicate devices, safety, and general performance standards.

Regarding specific AI-related questions (2-9), this clearance letter does not pertain to an AI/ML device for diagnostic interpretation. It's for a general-purpose ultrasound system. Therefore, most of these questions are not applicable to the information provided.

However, I will address them to indicate their non-applicability or provide any remotely relevant information.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable. This submission is for a general-purpose ultrasound system, not an AI/ML algorithm requiring a specific test set for diagnostic performance. The evaluation was primarily based on engineering testing (electrical, thermal, mechanical, EMC safety, biocompatibility, acoustic output, standards compliance) and comparison to predicate devices, rather than a dataset of patient cases.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. No ground truth (in the context of diagnostic accuracy) was established for a test set in this submission, as it's not an AI/ML diagnostic algorithm.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. No test set requiring expert adjudication for diagnostic ground truth.

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

• Not Applicable. This is not an AI-assisted diagnostic device, so no MRMC study comparing human readers with and without AI assistance was performed or reported.

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

• Not Applicable. This is a hardware device (ultrasound system), not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not Applicable. The "ground truth" here relates to engineering specifications and safety standards, such as:
  • Biocompatibility confirmed by ISO 10993-1 standards (chemical testing, etc.)
  • Acoustic output confirmed by IEC 62359 standards.
  • Electrical safety confirmed by IEC 60601-1 standards.
  • Functional "ground truth" confirmed by successful testing in a clinical environment, meaning it operates as intended for imaging and fluid flow analysis.

8. The sample size for the training set

• Not Applicable. This clearance is not for an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

• Not Applicable. No training set for an AI/ML device.

In summary, the FDA 510(k) clearance for the Sonosite LX Ultrasound System is focused on demonstrating substantial equivalence to pre-existing, legally marketed predicate ultrasound systems and compliance with international safety and performance standards. The "study" proving it meets acceptance criteria primarily involves comprehensive engineering validation and verification testing (electrical, thermal, mechanical, EMC, acoustic output, biocompatibility, cleaning/disinfection) and documented adherence to a robust Quality System, rather than a clinical study evaluating diagnostic accuracy with a patient dataset or the performance of an AI algorithm.

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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.

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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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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The Vevo MD Imaging System is a general purpose imaging 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:

Abdominal
Dermatological
Musculoskeletal (conventional)
Musculoskeletal (superficial)
Neonatal Cephalic
Ophthalmic
Pediatric
Peripheral vessel
Small Organ (breast, thyroid, testicles, prostate)

The Vevo MD Imaging System is a high frequency general purpose, software controlled, diagnostic imaging system used to acquire ad display high-resolution, real-time ultrasound data in 2D, Color Doppler, Power Doppler, PW Doppler and M-Mode. The Vevo MD Imaging System is comprised of transducers responsible for ultrasound signal generation and recording, and a main unit that controls the transducers, processes the acoustic data, and processes and displays images.

This document, K190476, details the 510(k) premarket notification for the FUJIFILM SonoSite Vevo MD Imaging System.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific acceptance criteria and performance metrics from device testing. The document states that the device was evaluated for safety and effectiveness against its predicate. The "acceptance criteria" for a 510(k) typically involve demonstrating that the new device is as safe and effective as a legally marketed predicate device.

The study presented does not specify quantitative acceptance criteria (e.g., specific accuracy, sensitivity, specificity thresholds) or report numerical device performance against such metrics. Instead, it relies on demonstrating equivalence through:

• Intended Use Alignment: Both the new device and the primary predicate (FUJIFILM SonoSite Vevo MD Imaging System K160674) share the same intended use.
• Technological Characteristics Comparison: The document provides a table comparing features, modes of operation, acoustic output, DICOM capabilities, and channels with the predicate devices. The new device and primary predicate are highly similar, particularly for "Track 3" devices.
• Compliance with Voluntary Standards: The device is designed to comply with several recognized standards related to biological evaluation, electrical safety, electromagnetic disturbances, ultrasonic medical diagnostic equipment, field characterization, software life cycle, and risk management. This compliance forms a key part of demonstrating safety.

Summary of "Acceptance Criteria" (Implicit) and Reported Performance:

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states: "The Vevo MD Imaging System and transducers, subject of this submission, did not require clinical studies to support the determination of substantial equivalence." This means there was no clinical "test set" in the traditional sense of patient data used to evaluate performance metrics like sensitivity or specificity. The evaluation was primarily non-clinical, comparing technical specifications and adherence to standards against a predicate device. Therefore, no information on sample size or data provenance for a clinical test set is provided.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

As no clinical study was conducted for performance evaluation in this 510(k) submission, there was no "ground truth" to be established by experts for a test set of patient data.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set for performance evaluation was used.

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

Not applicable. This device is an imaging system, not an AI-based diagnostic aid that would involve human readers improving with AI assistance. Clinical studies were not performed for this submission.

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. Clinical studies were not performed for this submission.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable, as no clinical study for performance evaluation was conducted where ground truth would be established. The "ground truth" for this submission revolves around the technical specifications and safety profile of the device aligning with regulated standards and the predicate device.

8. The sample size for the training set

Not applicable. As this 510(k) is for an ultrasound imaging system and not for an AI/ML-driven device or an algorithm requiring a training set, no information about a training set size is provided.

9. How the ground truth for the training set was established

Not applicable, as there was no training set.

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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 SII Ultrasound System is a mountable style, full featured, general purpose, software controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. SII is a custom fabricated digital electronic design that readily lends itself to be configured for specific ultrasound imaging applications through different system feature selections. SII can operate on either battery or AC power.

This is an FDA 510(k) premarket notification for the FUJIFILM SonoSite, Inc. SonoSite SII Ultrasound System. The document focuses on establishing substantial equivalence to previously cleared predicate devices, rather than presenting a standalone study with specific acceptance criteria and performance metrics for a novel AI device.

Therefore, the information you're requesting regarding acceptance criteria, study details, sample sizes, expert qualifications, and comparison with human readers is not directly available in this type of regulatory submission for a standard ultrasound system. This document is a clearance for a medical device that does not appear to involve AI/ML components for diagnostic interpretation that would necessitate such detailed performance studies.

However, I can extract information relevant to the device's characteristics and how its substantial equivalence was determined based on what is provided:

1. A table of acceptance criteria and the reported device performance

The document doesn't present a table of specific acceptance criteria in numerical performance metrics typically seen with AI devices (e.g., sensitivity, specificity, AUC). Instead, substantial equivalence is claimed based on similar technological characteristics, intended uses, and compliance with recognized safety and performance standards to the predicate devices.

Here's a summary of the characteristics of the SonoSite SII Ultrasound System as reported in the submission, compared to its predicates (K162045 SonoSite SII Ultrasound System and K162045 SonoSite Edge II Ultrasound System):

Acceptance Criteria for Substantial Equivalence (General, inferred from 510(k) process):

• Identical Intended Use: The device must have the same intended use as a legally marketed predicate device.
• Similar Technological Characteristics: The device must have similar technological characteristics to the predicate, or if there are differences, these differences must not raise new questions of safety or effectiveness.
• Equivalent Safety and Effectiveness: The device must be as safe and effective as the predicate device. This is often demonstrated through adherence to recognized standards for electrical, thermal, mechanical, EMC safety, cleaning/disinfection, biocompatibility, and acoustic output.
• Compliance with Standards: Conformance to relevant national and international medical device safety and performance standards (e.g., ISO, IEC, NEMA UD).

Reported Performance (Relevant to ultrasound system functionality, not AI-specific):

The performance of the device is assessed against the established standards and its predicate's performance. The submission states: "The SonoSite SII Ultrasound System and predicates meet FDA requirements for Track 3 devices, share indications for use, have biosafety equivalence, and conform to applicable electromedical device safety standards."
New "N" indications for specific transducers (found in Tables 1.3-1 to 1.3-14) for Pulsed Wave Doppler (PWD), and in some cases, Color Doppler modes show the scope of the device's capabilities are being expanded or specifically detailed for certain transducers.

2. Sample size used for the test set and the data provenance:

The document explicitly states: "The SonoSite SII Ultrasound System, subject of this submission, did not require clinical studies to support the determination of substantial equivalence."
Therefore, there is no test set sample size or data provenance related to clinical performance metrics for this device as it is not an AI/ML device requiring such validation for regulatory clearance. The assessment is based on technical, safety, and performance characteristic comparison.

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

Not applicable, as no clinical study or test set with ground truth established by experts was conducted or required for this 510(k) submission.

4. Adjudication method for the test set:

Not applicable, as no clinical study or test set requiring adjudication was conducted or required for this 510(k) submission.

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:

Not applicable, as this device is a general-purpose ultrasound system and does not appear to incorporate AI assistance for diagnostic interpretation. Hence, no MRMC study or AI assistance effect size is mentioned.

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

Not applicable, as this is a medical imaging device as opposed to an AI algorithm.

7. The type of ground truth used:

Not applicable, as no clinical study requiring ground truth for clinical decision or diagnostic performance was conducted. The "ground truth" in this context refers to compliance with performance and safety standards, and equivalence to predicate devices, rather than diagnostic accuracy.

8. The sample size for the training set:

Not applicable, as this is a traditional ultrasound system and not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established:
Not applicable, for the same reason as above.

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The SonoSite iViz Ultrasound System is a general purpose ultrasound system and non-continuous patient monitoring 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 iViz Ultrasound System is a highly featured, general purpose, software controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. iViz is a custom fabricated digital electronic handheld tablet that is highly portable, battery-operated, and consists of an active transducer that connects to and is controlled by the tablet. iViz supports Bluetooth and wireless network connectivity for image transfer and over-the-air (OTA) software updates.

The provided document is a 510(k) premarket notification for the FUJIFILM SonoSite iViz Ultrasound System. The purpose of this document is to demonstrate that the iViz Ultrasound System is substantially equivalent to legally marketed predicate devices.

Here's an analysis of the acceptance criteria and the study information as requested:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state acceptance criteria in terms of specific performance metrics (e.g., accuracy, sensitivity, specificity, image quality scores) for the device's diagnostic capabilities. Instead, the "acceptance criteria" are implied through the comparisons to predicate devices and adherence to recognized standards.

The primary method to demonstrate acceptance is through substantial equivalence to existing, legally marketed predicate devices by showing comparable:

• Intended Use
• Indications for Use
• Technological Characteristics
• Safety and Effectiveness (via non-clinical testing)

Below is a table summarizing the general "acceptance criteria" (implicitly by comparison to predicates and standards) and the device's reported performance (by asserting compliance and equivalence).

Study Proving Acceptance Criteria:

The document states: "The iViz Ultrasound System and transducers, subject of this submission, did not require clinical studies to support the determination of substantial equivalence."

Instead, the determination of substantial equivalence is based on non-clinical tests and a comparison of technological characteristics and intended uses with identified predicate devices.

2. Sample Size Used for the Test Set and Data Provenance:

No clinical test set was used, as no clinical studies were deemed necessary. The acceptance was based on non-clinical testing and comparison to predicates.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Not applicable, as no clinical test set requiring expert ground truth was utilized.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set requiring adjudication was utilized.

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:

Not applicable. This device is a diagnostic ultrasound system, not an AI-assisted diagnostic tool for interpretation by human readers. The document makes no mention of AI assistance.

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

Not applicable. The device is a diagnostic ultrasound system, operated by a qualified physician or healthcare professional. It is not a standalone algorithm.

7. The Type of Ground Truth Used:

For the non-clinical tests (e.g., electrical, thermal, EMC, acoustic output), the "ground truth" would be the specifications and requirements defined by the referenced industry standards (e.g., IEC 60601 series, ISO 10993, NEMA UD 2-2004). The device's performance against these standards served as the "ground truth" for non-clinical acceptance.

8. The Sample Size for the Training Set:

Not applicable. The document does not describe the development of an AI model or algorithm that would require a "training set."

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there was no mention of a training set for an AI model.

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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 thid flow analysis 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 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 readily 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.

The provided documentation is a 510(k) Premarket Notification for the FUJIFILM SonoSite, Inc. SonoSite X-Porte Ultrasound System. This document focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than establishing performance criteria through novel clinical studies. Therefore, much of the requested information regarding algorithm performance, sample sizes for test/training sets, expert qualifications, and MRMC studies is not present.

However, based on the provided text, we can extract details regarding the general acceptance criteria (primarily safety and compliance with standards) and the "study" (non-clinical tests and comparisons to predicates) used to demonstrate adherence to these criteria.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily conformance to various medical device safety and performance standards. The "reported device performance" is implicitly that the device meets these standards, enabling a substantial equivalence determination.

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: Not applicable in the context of this 510(k) submission. The submission relies on non-clinical testing and comparison to predicates, not a clinical test set for AI performance.
• Data Provenance: Not applicable for performance evaluation in the usual sense. The "data" here refers to measurements and tests conducted to ensure compliance with standards, and these are typically internal engineering tests. The document states "Clinical Validation" was part of product development, but no details are provided about this "validation" with respect to a test set.

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

Not applicable. "Ground truth" in the clinical performance sense (e.g., expert consensus on diagnoses) is not described or required for this type of 510(k) submission focused on substantial equivalence of an ultrasound system, not an algorithmic diagnostic device. The "truth" is established by adherence to engineering and safety standards.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. There is no mention of an adjudication method as no clinical test set for diagnostic accuracy is described.

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

Not applicable. This is a submission for an ultrasound imaging system, not an AI-assisted diagnostic algorithm. There is no MRMC study mentioned or required for this type of device.

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

Not applicable. This is not an algorithmic diagnostic device, but rather a general-purpose ultrasound system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" or basis for the acceptance of this device primarily stems from:

• Engineering and safety standards compliance (e.g., IEC 60601-1, NEMA UD2-2004 for acoustic output).
• Biocompatibility testing for patient contact materials.
• Risk assessment outcomes.
• Comparison of technological characteristics and intended uses to previously cleared predicate devices (K152209, K133454, K162045).

8. The sample size for the training set

Not applicable. This document describes an ultrasound hardware system, not an AI/algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable, as no training set for an algorithm is described.

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