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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 MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8/Nuda/Aquila/Malody Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in ophthalmic, fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal cephalic,adult cephalic,trans-rectal, trans-vaginal, musculo-skeletal(conventional), musculo-skeletal(superficial), thoracic/pleural, cardiac adult, cardiac pediatric, peripheral vessel and urology, intra-operative(abdominal, thoracic, and vascular) , Laparoscopic, trans-esoph(Cardiac) exams.

Modes of operation include: B, M, PWD, CWD, Color Doppler, Power Doppler, Combined mode(B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, iScape, TDI, color M, Smart 3D, 4D(Real-time 3D), Strain Elastography, Contrast imaging (Contrast agent for LVO), Contrast imaging (Contrast agent for Liver).

This device is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended to be used in a hospital or medical clinic.

The MX7, MX7T, Vaus7, Zeus, ME7, Anesus ME7, Anesus ME7T, MX7P, MX7W, MX8, MX8T, Vaus8, ME8, Nuda, Aquila, Malody Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound images in Modes of operation include: B, M, PWD, CWD, Color Doppler, Power Doppler, Combined mode (B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, iScape, TDI, color M, Smart 3D, 4D(Real-time 3D), Strain Elastography, Contrast imaging (Contrast agent for LVO), Contrast imaging (Contrast agent for Liver).

The MX7, MX7T, Vaus7, Zeus, ME7, Anesus ME7, Anesus ME7T, MX7P, MX7W, MX8, MX8T, Vaus8, ME8, Nuda, Aquila, Malody Diagnostic Ultrasound System can also measure anatomical structures and offer analysis packages to provide information based on which the competent health care professionals can make the diagnosis.

The provided FDA 510(k) Clearance Letter states that clinical studies were Not Applicable for the Mindray Diagnostic Ultrasound System (K251192) to support substantial equivalence. Therefore, there is no information in this document about acceptance criteria or a study proving the device meets specific performance criteria through clinical data.

The letter explicitly states:
"8. Clinical Studies
Not applicable. The subject of this submission, MX7, MX7T, Vaus7, Zeus, ME7, Anesus ME7, Anesus ME7T, MX7P, MX7W, MX8, MX8T, Vaus8, ME8, Nuda, Aquila, Malody Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence."

Instead, the submission relies on:

• Comparison with Predicate Devices: The document extensively details how the subject device is comparable and substantially equivalent to existing cleared predicate devices (e.g., MX7 (K241432), TEX20 (K241201), Resona I8W (K240115), TE Air (K240906), Consona N6 (K221300), QLAB (K190913)) in terms of intended use, imaging modes, features, functions, and technological characteristics.
• Non-clinical Tests: The device was evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness, and thermal, electrical, and mechanical safety, in compliance with various recognized standards (e.g., NEMA UD 2-2004, ANSI AAMI ES60601-1, IEC 60601-1-2, ISO 14971, ISO 10993-1).

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and a study proving device performance as they would apply to clinical efficacy/performance for a new AI/software component, because this information is not present in the provided 510(k) summary. The clearance is based on substantial equivalence to existing predicate ultrasound systems and non-clinical safety/performance testing.

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The ACUSON Sequoia and Sequoia Select ultrasound imaging systems are intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Fetal, Abdominal, Pediatric, Neonatal Cephalic, Small Parts, OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Cardiac, Transesophageal, Pelvic, Vascular, Adult Cephalic, Musculoskeletal and Peripheral Vascular applications.

The system supports the Ultrasonically-Derived Fat Fraction (UDFF) measurement tool to report an index that can be useful as an aid to a physician managing adult and pediatric patients with hepatic steatosis.

The system also provides the ability to measure anatomical structures for fetal, abdominal, pediatric, small organ, cardiac, transrectal, transvaginal, peripheral vessel, musculoskeletal and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

The ACUSON Origin and Origin ICE ultrasound imaging systems are intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Fetal, Abdominal, Pediatric, OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Cardiac, Transesophageal, Intracardiac, Vascular, Adult Cephalic, and Peripheral Vascular applications.

The catheter is intended for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.

The system also provides the ability to measure anatomical structures for fetal, abdominal, pediatric, cardiac, peripheral vessel, and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

The ACUSON Sequoia, Sequoia Select, Origin, and Origin ICE Diagnostic Ultrasound Systems (software version VC10) are multi-purpose, mobile, software-controlled, diagnostic ultrasound systems with an on-screen display of thermal and mechanical indices related to potential bio- effect mechanisms. The function of these ultrasound systems is to transmit, receive, process ultrasound echo data (distance and intensities information about body tissue) in various modes of operation and display it as ultrasound imaging, anatomical and quantitative measurements, calculations, analysis of the human body and fluid flow, etc. These ultrasound systems use a variety of transducers to provide imaging in all standard acquisition modes and also have comprehensive networking and DICOM capabilities.

The provided FDA 510(k) clearance letter and summary discuss the ACUSON Sequoia, Sequoia Select, Origin, and Origin ICE Diagnostic Ultrasound Systems. This document indicates a submission for software feature enhancements and workflow improvements, including an "AI Measure and AI Assist workflow efficiency feature" and "Liver Elastography optimization."

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

Acceptance Criteria and Reported Device Performance

The submission focuses on enhancements to existing cleared devices rather than a de novo AI device. Therefore, the "acceptance criteria" discussed are primarily related to the performance of the Liver Elastography optimization using phantom testing.

Study Details for Liver Elastography Optimization (SWE Performance Testing)

The primary study mentioned in the document for performance evaluation is related to the Liver Elastography optimization.

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

   • Test Set: Calibrated elasticity phantoms. The specific number of phantoms used is not stated beyond "calibrated elasticity phantoms."
   • Data Provenance: Not explicitly stated, but implies laboratory testing using commercially available or manufacturer-certified phantoms. Transducers listed were DAX, 5C1, 9C2, 4V1, and 10L4.

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

   • Ground Truth Establishment: The ground truth for the test set (phantom stiffness) was established by the phantom manufacturer, as they were "calibrated elasticity phantoms certified by the phantom manufacturer."
   • Number/Qualifications of Experts: The document does not specify the number or qualifications of experts involved in the phantom's certification process or in the actual testing of the Siemens device. The testing appears to be objective, relying on the calibrated properties of the phantoms.

3. Adjudication Method for the Test Set:

   • Adjudication Method: Not applicable. Phantom testing typically relies on quantitative measurements against known phantom properties, not human adjudication of results.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

   • MRMC Study: No, an MRMC comparative effectiveness study was not conducted according to this document. The submission focuses on technical enhancements and phantom validation for elastography, and system safety/effectiveness.

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

   • Standalone Performance: The "SWE Performance Testing" with phantoms could be considered a form of standalone performance assessment as it evaluates the device's measurement capabilities against a known standard. However, the AI Measure and AI Assist features are described as "workflow efficiency features" where measurements are "automatically launched" after classification, implying an interaction with a human user rather than a fully standalone diagnostic output. No specific standalone performance metrics for the AI Measure/Assist components are provided.

6. The Type of Ground Truth Used:

   • Ground Truth: For the elastography testing, the ground truth was the known stiffness values of the calibrated elasticity phantoms.

7. The Sample Size for the Training Set:

   • Training Set Sample Size: The document does not provide information about a training set size for the AI Measure and AI Assist features or the elastography optimization. This type of 510(k) submission typically focuses on validation and verification of changes to an already cleared product, rather than detailing the initial development or training data for AI algorithms.

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

   • Training Set Ground Truth: Not applicable, as information on a specific training set is not provided in this document.

Summary regarding AI components:

While the document mentions "AI Measure" and "AI Assist" as workflow efficiency features (e.g., launching relevant measurements after cardiac view classification), it does not provide detailed performance metrics, test set sizes, ground truth establishment, or clinical study information specifically for these AI components. The 510(k) emphasizes that these are "software feature enhancements and workflow improvements" that, along with other changes, do not raise new questions of safety and effectiveness, leading to substantial equivalence with the predicate device. The only detailed "performance testing" described is for the Liver Elastography optimization using phantoms. This suggests that the AI features themselves might have been validated through internal software verification and validation activities that are not detailed in this public summary, or their impact on diagnostic performance was considered incremental and not requiring specific clinical comparative studies for this particular submission.

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The DeepSight NeedleVue LC1 Ultrasound System is intended for use in Abdominal, Pediatric, Small Organ, Peripheral Vascular, Fetal, Urological, and Musculoskeletal Conventional and Superficial Imaging. This device is indicated for Prescription Use Only and by qualified healthcare professionals (HCPs). The DeepSight NeedleVue LC1 ultrasound system is intended to be used by qualified and trained physicians or sonographers with at least basic ultrasound knowledge. The operator must have read and understood the user manual. The DeepSight NeedleVue LC1 ultrasound system is intended to be used in medical practices and clinical environments including healthcare facilities, hospitals and clinics.

The DeepSight NeedleVue LC1 Ultrasound System is a general-purpose diagnostic ultrasound system that is mounted on a movable cart and has a mobile console that provides digital acquisition, processing, and display capabilities. The subject device has three major functional blocks that are consistent across ultrasound systems including the predicate:

• A front end, which includes a single curved (a.k.a. convex) array transducer and analog signal processing functions. This transducer transmits acoustic energy into the body and receives the resulting reflections, and performs the signal processing functions on them required to produce an ultrasound image (e.g., analog to digital conversion, noise filtering);
• A back end, which includes a user interface, memory, and export via USB. The user interfaces include a computer keyboard, standard ultrasound parameter controls, an LCD touch screen, acoustic output display and an LCD image display. The touch screen is divided into a display area and a user interaction area, and allows for patient data entry, transmit voltage adjustment, transducer/preset selection, depth and focus adjustment, annotation, freeze, image and clip capture, and measurements.
• Power systems which generate, regulate and supply the required voltages to the system parts.

The provided FDA 510(k) Clearance Letter for the DeepSight NeedleVue LC1 Ultrasound System does not contain acceptance criteria for device performance nor does it describe a study to prove the device meets such criteria.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (GE Healthcare Logiq E9 Ultrasound System) based on:

• Intended Use and Indications for Use: Showing similarities in target patient populations and anatomical regions.
• Technological Characteristics: Comparing functional blocks, power sources, beamforming, controls, and display.
• Performance Testing (Non-clinical): Verifying compliance with relevant FDA guidance documents and recognized international standards for software, electromagnetic compatibility, thermal/mechanical/electrical safety, acoustic output, acoustic power, and reprocessing.

Therefore, it is not possible to provide the requested information based on the input document.

Here's why and what information is missing:

1. Acceptance Criteria and Reported Device Performance: The document lists various standards and guidance documents that the device's non-clinical performance testing complied with. However, it does not explicitly state specific acceptance criteria (e.g., image resolution in millimeters, signal-to-noise ratio in dB, penetration depth) for the DeepSight NeedleVue LC1 Ultrasound System and does not report quantitative data on how the device performed against any such criteria. It only states that the device was "found to have a safety and effectiveness profile that is similar to the predicate device."

2. Sample Size, Data Provenance, and Ground Truth for a Test Set (Clinical Study): The document explicitly states: "Clinical data was not required for this submission." This means there was no clinical study conducted to evaluate the device's performance in a real-world setting with patient data. Consequently, there is no information regarding:

   • Sample size used for a test set.
   • Data provenance (country, retrospective/prospective).
   • Number of experts or their qualifications.
   • Adjudication method.
   • Type of ground truth used.

3. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Since no clinical study was performed, an MRMC study comparing human readers with and without AI assistance was not conducted. The DeepSight NeedleVue LC1 is described as a general-purpose diagnostic ultrasound system, with no mention of AI features that would necessitate such a study.

4. Standalone Performance Study (Algorithm Only): The document describes the DeepSight NeedleVue LC1 as a general-purpose ultrasound system. While it mentions software testing, it does not describe an "algorithm only (standalone)" performance study in the context of diagnostic accuracy, as it's not an AI/CADe (Computer-Aided Detection) device in the sense that it provides an interpretation or analysis beyond standard imaging. The software testing mentioned relates to compliance with software life cycle processes, cybersecurity, and off-the-shelf software use.

5. Training Set Information: As no clinical study was reported and the device is a general-purpose ultrasound system (not an AI/ML-based diagnostic algorithm requiring a training set for diagnostic outcome prediction), there is no information about a training set, its sample size, or how its ground truth was established.

In summary, the provided document details a 510(k) clearance process based on substantial equivalence and compliance with non-clinical performance standards and guidance. It does not include information on clinical acceptance criteria or a study that specifically measures the device's performance against such criteria using patient data, as such a study was not required for this submission.

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The Venue, Venue Go, Venue Fit and Venue Sprint are general purpose diagnostic ultrasound systems for use by qualified and trained healthcare professionals or practitioners that are legally authorized or licensed by law in the country, state or other local municipality in which he or she practices, for ultrasound imaging, measurement, display and analysis of the human body and fluid. The users may or may not be working under supervision or authority of a physician. Users may also include medical students working under the supervision or authority of a physician during their education / training.

Venue, Venue Go and Venue Fit are intended to be used in a hospital or medical clinic. Venue, Venue Go and Venue Fit clinical applications include: abdominal (GYN and Urology), thoracic/pleural, ophthalmic, Fetal/OB, Small Organ (including breast, testes, thyroid), Vascular/Peripheral vascular, neonatal and adult cephalic, pediatric, musculoskeletal (conventional and superficial), cardiac (adults and pediatric), Transrectal, Transvaginal, Transesophageal, Intraoperative (vascular) and interventional guidance (includes tissue biopsy, fluid drainage, vascular and non-vascular access). Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse and Combined modes: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD, B/CWD, B/Color/CWD.

The Venue Sprint is intended to be used in a hospital, medical clinic, home environment and road/air ambulance. Venue Sprint clinical applications include: abdominal (GYN and Urology), thoracic/pleural, ophthalmic, Fetal/OB, Small Organ (including breast, testes, thyroid), Vascular/Peripheral vascular, neonatal and adult cephalic, pediatric, musculoskeletal (conventional and superficial), cardiac (adults and pediatric, 40 kg and above) and interventional guidance (includes free hand tissue biopsy, fluid drainage, vascular and non-vascular access). Modes of operation include: B, M, PW Doppler, Color Doppler and Harmonic Imaging.

Venue, Venue Go, Venue Fit and Venue Sprint are general-purpose diagnostic ultrasound systems intended for use by qualified and trained healthcare professionals to evaluate the body by ultrasound imaging and fluid flow analysis.

The systems utilize a variety of linear, convex, and phased array transducers which provide high imaging capability, supporting all standard acquisition modes.

The systems have a small footprint that easily fits into tight spaces and positioned to accommodate the sometimes-awkward work settings of the point of care user.

The Venue is a mobile system, the Venue Go and Venue Fit are compact, portable systems that can be hand carried using an integrated handle, placed on a horizontal surface, attached to a mobile cart or mounted on the wall. Venue, Venue Go and Venue Fit have a high-resolution color LCD monitor, with a simple, multi-touch user interface that makes the systems intuitive.

The Venue Sprint is used together with the Vscan Air probes and provides the user interface for control of the probes and the needed software functionality for analysis of the ultrasound images and saving/storage of the related images and videos.

The Venue, Venue Go, Venue Fit and Venue Sprint systems can be powered through an electrical wall outlet for long term use or from an internal battery for a short time with full functionality and scanning. A barcode reader and RFID scanner are available as additional input devices. The systems meet DICOM requirements to support users image storage and archiving needs and allows for output to printing devices.

The Venue, Venue Go and Venue Fit systems are capable of displaying the patient's ECG trace synchronized to the scanned image. This allows the user to view an image from a specific time of the ECG signal which is used as an input for gating during scanning. The ECG signal can be input directly from the patient or as an output from an ECG monitoring device. ECG information is not intended for monitoring or diagnosis. Compatible biopsy kits can be used for needle-guidance procedures.

The provided document, a 510(k) Clearance Letter and Submission Summary, primarily focuses on the substantial equivalence of the GE Healthcare Venue series of diagnostic ultrasound systems to previously cleared predicate devices. It specifically details the "Auto Bladder Volume (ABV)" feature as an AI-powered component and provides a summary of its testing.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance (for Auto Bladder Volume - ABV)

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

• Test Set (Verification Dataset) Sample Size: 1874 images from 101 individuals.
• Data Provenance:
  • Country of Origin: USA and Israel.
  • Retrospective or Prospective: Not explicitly stated as either retrospective or prospective. However, the description of "data collected from several different Console variants" for training and verification suggests pre-existing data, which often leans towards a retrospective collection.

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

• Number of Experts: Not explicitly stated. The document refers to "annotators" who performed manual annotation.
• Qualifications of Experts: Not explicitly stated. The annotators are described as performing "manual annotation," implying they are skilled in this task, but specific qualifications (e.g., radiologists, sonographers, years of experience) are not provided.

4. Adjudication Method for the Test Set

• Adjudication Method: Not explicitly stated. The document mentions "annotators performed manual annotation," but does not detail if multiple annotators were used for each case or any specific adjudication process (e.g., 2+1, 3+1 consensus).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was an MRMC study done? No. The document states: "The subjects of this premarket submission, Venue, Venue Go, Venue Fit and Venue Sprint, did not require clinical studies to support substantial equivalence." The testing described for ABV is a standalone algorithm performance validation against established ground truth, not a comparative human-AI study.
• Effect Size of Human Readers Improvement: Not applicable, as no MRMC study was performed.

6. Standalone (Algorithm Only) Performance Study

• Was a standalone study done? Yes. The "AI Summary of Testing" section describes a study for the Auto Bladder Volume (ABV) feature, which assesses the algorithm's "automatic caliper placement success rate" against manually established ground truth. This is a standalone performance evaluation of the algorithm.

7. Type of Ground Truth Used (for ABV Test Set)

• Ground Truth Type: Expert consensus/manual annotation. The document states: "Ground truth annotations of the verification dataset were obtained as follows: In all Training/Validation and Verification datasets, annotators performed manual annotation on images converted from DICOM files." They identified "landmarks, which represent the bladder edges," corresponding to standard measurement locations.

8. Sample Size for the Training Set (for ABV)

• Training Set Sample Size: Total dataset included 8,392 images from 496 individuals. Of these, 1,874 were used for the verification dataset, and "the rest" were used for training/validation. This implies the training/validation set would be 8392 - 1874 = 6518 images from the remaining individuals not included in the verification set.

9. How the Ground Truth for the Training Set Was Established (for ABV)

• Ground Truth Establishment: Similar to the verification dataset, "annotators performed manual annotation on images converted from DICOM files" for both Training/Validation and Verification datasets. They chose "4-6 images that represent different bladder volume status" for each individual and annotated "4 different landmarks" per view (transverse and longitudinal) representing bladder edges.

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EPIQ Series Diagnostic Ultrasound System: The intended use of EPIQ Ultrasound Diagnostic System is diagnostic ultrasound imaging and fluid flow analysis of the human body, with the following indications for use: Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), intra-luminal, intra-cardiac echo, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Ophthalmic, Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal, Lung.
Modes of operation include: B Mode, M Mode, PW Doppler, CW Doppler, Color Doppler, Color M Mode, Power Doppler, and Harmonic Imaging.
The clinical environments where EPIQ Series Diagnostic ultrasound Systems can be used include clinics, hospitals, and clinical point-of-care for diagnosis of patients.
When integrated with Philips EchoNavigator, the systems can assist the interventionalist and surgeon with image guidance during treatment of cardiovascular disease in which the procedure uses both live X-ray and live echo guidance.
The systems are intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the product user information. Systems are to be operated only by appropriately trained healthcare professionals for the purposes for which they were designed. However, nothing stated in the user information reduces your responsibility for sound clinical judgement and best clinical procedure.

Affiniti Series Diagnostic Ultrasound Systems: The intended use of Affiniti Series Diagnostic Ultrasound Systems is diagnostic ultrasound imaging and fluid flow analysis of the human body, with the following indications for use: Abdominal, Cardiac Adult, Cardiac Other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal, Lung.
Modes of operation include: B Mode, M Mode, PW Doppler, CW Doppler, Color Doppler, Color M Mode, Power Doppler, and Harmonic Imaging.
The clinical environments where the Affiniti diagnostic ultrasound systems can be used include clinics, hospitals, and clinical point-of-care for diagnosis of patients. The systems are intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the product user information. Systems are to be operated only by appropriately trained healthcare professionals for the purposes for which they were designed. However, nothing stated in the user information reduces your responsibility for sound clinical judgement and best clinical procedure.

The purpose of this 510(k) Pre-market Notification is to introduce the SVS v2 Contrast software application with the EPIQ and Affiniti Series Diagnostic Ultrasound Systems as part of the VM13.0 program.
SVS v2 Contrast is an automated software feature that assists in the selection of images for analysis with the new Philips license options 2D Auto EF Advanced (Adv) developed by DiA Imaging Analysis (K243235), now part of Philips Ultrasound LLC, and existing Philips license options AutoStrain LV; or 2D Auto LV (both K240850) license application in Adult Echo Transthoracic (TTE) examinations.
As described in 510(k) K240850, this feature automatically classifies each acquired image by view and selects an appropriate set of images for Left ventricle (LV) analysis. The classification is based on a Deep Learning AI inference engine; the selection is a non-AI algorithm that considers the view classification and image depth to select the optimal set of images. The difference in SVS v2 Contrast from the predicate SVS v1 (K240850) is that the algorithm is revised to include the selection of optimal images for analysis when contrast is used in routine TTE exams.
Users can launch existing 2D Auto EF; 2D Auto EF Adv; AutoStrain LV; or 2D Auto LV with the set of images that have been automatically selected without the need to review the acquired images and manually select the views. Users may select 2D Auto EF Adv, to process the selected views by SVS v2 Contrast. SVS v2 Contrast prioritizes the contrast image pair; however, if an appropriate pair of contrast images is not found, then Auto EF Adv may select non-contrast images. The manual approach to select views is still available and the user can override automatically selected images from SVS v2 Contrast.
No hardware changes to the EPIQ or Affiniti Series Diagnostic Ultrasound Systems are required when using SVS v2 Contrast, and existing, cleared Philips TTE transducers.
The SVS v2 Contrast feature is supported by all EPIQ models running software version 13.0 or higher including EPIQ CVx/CVxi, EPIQ Elite Advanced, EPIQ Elite, EPIQ 7, EPIQ 5. The SVS v2 Contrast feature is supported by the Affiniti models running software version VM13.0 or higher, including Affiniti CVx, Affiniti 70, Affiniti 50, and Affiniti 30. The SVS v2 Contrast feature is associated with the cardiac adult indication.

Acceptance Criteria and Study Details for SVS v2 Contrast Software

This document outlines the acceptance criteria and details of the study conducted to demonstrate that the Philips Ultrasound systems (EPIQ and Affiniti Series Diagnostic Ultrasound System) with the SVS v2 Contrast software application meet the established performance benchmarks.

1. Table of Acceptance Criteria and Reported Device Performance

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TINGS FINDERS 2 Color Doppler Diagnostic Ultrasound System is intended for intracardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult patients.

Modes of operation include: B,M, Color Doppler,PW Doppler, CW Doppler,Power Doppler; Combined modes: B/M,B/Color,B/M/Color, B/PWD, B/CWD, B/Color/PWD, B/Color/CWD, B/Power.

The device is intended for use in Professional healthcare facility environment including echo lab, other hospital settings, operating room, Cath lab and EP lab.

The intended users of the Device is to be used exclusively by physicians who are appropriately trained personnel in a fully equipped electrophysiology or catheterization room or under their direct supervision.

The proposed TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System is a Track 3 diagnostic device designed for imaging intracardiac anatomical structures and blood flow dynamics in adult patients. It comprises two primary components: the ultrasound console and the TINGSN Sonic Eyes 10 Eco Disposable Intracardiac Echocardiography Catheter. The console features a 17.3-inch touch-enabled LCD screen, a control panel, and interfaces for connectivity, powered by a rechargeable battery or AC adapter, with optional peripherals including a cart and foot switch. The catheter, a sterile, single-use device with a 95 cm insertable length and 10Fr diameter, is equipped with a 64-element phased array transducer at its tip for high-resolution imaging. It connects to the console via the Finders 2 Sonic Eyes Connector, featuring a locking mechanism to ensure secure attachment during procedures. The system supports multiple imaging modes—B-Mode, M-Mode, Pulsed Wave (PW) Doppler, Continuous Wave (CW) Doppler, Color Doppler, Power Doppler, and combined modes —along with advanced functionalities, displayed with real-time thermal (TI) and mechanical (MI) indices.

The provided text is a 510(k) Clearance Letter and 510(k) Summary for the TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System. This document describes the device, its intended use, and a comparison to predicate devices to establish substantial equivalence.

Crucially, the document explicitly states under "8. CLINICAL DATA": "No clinical data was included in this submission."

Therefore, based on the provided text, a study that proves the device meets acceptance criteria through clinical data (either standalone or MRMC comparative effectiveness) was not performed, or at least, not included in this submission. The entire submission relies on non-clinical testing and comparison to predicate devices to establish substantial equivalence.

As the request specifically asks for information about a "study that proves the device meets the acceptance criteria" and mentions clinical outcomes, it is impossible to provide the requested details from the given text.

However, I can extract the information related to the non-clinical tests that were performed to verify the device met design specifications and was substantially equivalent, which serve as the basis for clearance in lieu of clinical data.

Here's an interpretation based on the non-clinical data presented:

Device Acceptance Criteria and Performance (Based on Non-Clinical Data)

The TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System established its substantial equivalence (SE) based primarily on non-clinical testing and comparison to predicate devices, as no clinical data was included in the submission. The acceptance criteria and "performance" are therefore framed in terms of compliance with relevant standards and demonstration of functional equivalence.

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)

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

• Sample Size: Not explicitly stated for specific non-clinical tests. General statements indicate "non-clinical tests were conducted."
• Data Provenance: The tests were conducted internally by Jiangsu Tingsn Technology Co., Ltd. The document refers to "non-clinical tests (integration and functional) were conducted on the TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System during product development."

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

• Not applicable for non-clinical testing. The "ground truth" for non-clinical tests typically refers to engineering specifications, regulatory standards, and established physical principles, not expert interpretations of clinical data.

4. Adjudication Method for the Test Set

• Not applicable for non-clinical testing. Adjudication methods like 2+1 or 3+1 are used for human expert review of clinical cases to establish ground truth or compare diagnostic performance, which was not part of this submission.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC study was done. The submission explicitly states: "No clinical data was included in this submission." MRMC studies inherently involve human readers evaluating clinical cases.

6. Standalone (i.e., algorithm only without human-in-the-loop performance)

• Not applicable as an AI/algorithm-only device. The TINGSN FINDERS 2 is a diagnostic ultrasound system that produces images for human interpretation, not an AI algorithm performing diagnosis independently. The software features listed are for image optimization, measurements, and display, assisting the human user, not replacing them in a "standalone" diagnostic role.

7. The Type of Ground Truth Used

• For non-clinical testing: The "ground truth" was established by performance specifications, engineering requirements, and compliance with the international and national standards listed (e.g., IEC, ISO, NEMA, ASTM, FDA guidance). This includes electrical safety, mechanical robustness, image quality parameters (resolution, penetration, consistency), acoustic output levels, and software functionality validation against design requirements.

8. The Sample Size for the Training Set

• Not applicable. This device is a traditional ultrasound system, not an AI/ML product that undergoes "training."

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

• Not applicable. See point 8.

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V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System:

The diagnostic ultrasound system and probes are designed to obtain ultrasound images and analyze body fluids. The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Intra-operative, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Thoracic, Trans-esophageal (Cardiac) and Peripheral vessel. It is intended for use by, or by the order of, and under the supervision of, an appropriately trained healthcare professional who is qualified for direct use of medical devices. It can be used in hospitals, private practices, clinics and similar care environment for clinical diagnosis of patients. Modes of Operation: 2D mode, Color Doppler mode, Power Doppler (PD) mode, M mode, Pulsed Wave (PW) Doppler mode, Continuous Wave (CW) Doppler mode, Tissue Doppler Imaging (TDI) mode, Tissue Doppler Wave (TDW) mode, ElastoScan Mode, Combined modes, Multi-Image mode(Dual, Quad), 3D/4D mode.

V5 Diagnostic Ultrasound System; cV5 Diagnostic Ultrasound System; V4 Diagnostic Ultrasound System; cV4 Diagnostic Ultrasound System:

The diagnostic ultrasound system and probes are designed to obtain ultrasound images and analyze body fluids. The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Intra-operative, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Thoracic, Trans-esophageal (Cardiac), Peripheral vessel and Dermatology. It is intended for use by, or by the order of, and under the supervision of, an appropriately trained healthcare professional who is qualified for direct use of medical devices. It can be used in hospitals, private practices, clinics and similar care environment for clinical diagnosis of patients. Modes of Operation: 2D mode, Color Doppler mode, Power Doppler (PD) mode, M mode, Pulsed Wave (PW) Doppler mode, Continuous Wave (CW) Doppler mode, Tissue Doppler Imaging (TDI) mode, Tissue Doppler Wave (TDW) mode, ElastoScan Mode, Combined modes, Multi-Image mode(Dual, Quad), 3D/4D mode, MV-Flow Mode.

■ V8/cV8, V7/cV7, V6/cV6
The V8/cV8, V7/cV7, V6/cV6 Diagnostic Ultrasound Systems are general purpose, mobile, software controlled, diagnostic ultrasound systems. Its function is to acquire ultrasound data and to display the data as 2D mode, Color Doppler mode, Power Doppler (PD) mode, M mode, Pulsed Wave (PW) Doppler mode, Continuous Wave (CW) Doppler mode, Tissue Doppler Imaging (TDI) mode, Tissue Doppler Wave (TDW) mode, ElastoScan Mode, Combined modes, Multi-Image mode(Dual, Quad), 3D/4D mode. The V8/cV8, V7/cV7, V6/cV6 also give the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The V8/cV8, V7/cV7, V6/cV6 have real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.

■ V5/cV5, V4/cV4
The V5/cV5, V4/cV4 Diagnostic Ultrasound Systems are general purpose, mobile, software controlled, diagnostic ultrasound systems. Its function is to acquire ultrasound data and to display the data as B-mode, M-mode, Pulsed wave (PW) Doppler, Continuous wave (CW) Doppler, Color Doppler, Tissue Doppler Imaging (TDI), Tissue Doppler Wave (TDW), Power Amplitude Doppler, Pulse Inversion Harmonic Imaging (S-Harmonic), Directional Power Doppler (S-Flow), Color M-Mode, 3D Imaging Mode, 4D Imaging Mode, Elastoscan+ Mode, Tissue Harmonic Imaging, MV-Flow Mode or as a combination of these modes. The V5/cV5, V4/cV4 diagnostic ultrasound systems also give the operator the ability to measure anatomical structures and offer analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The V5/cV5, V4/cV4 diagnostic ultrasound systems have a real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.

The provided FDA 510(k) clearance letter describes the Samsung Medison Ultrasound Systems (V8/cV8, V7/cV7, V6/cV6, V5/cV5, V4/cV4) and their AI-powered features: BiometryAssist, ViewAssist, HeartAssist (fetus), and EzNerveMeasure of NerveTrack.

Below is a breakdown of the acceptance criteria and study details for each AI feature, based on the provided text.

BiometryAssist

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

• Individual Patients: 52 (17 from South Korea, 35 from the US)
• Images: 320 static images
• Data Provenance: Mix of retrospective and prospective data collection from hospitals in South Korea and the United States.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: 3 (one obstetrician, two sonographers) + 1 senior obstetrician for supervision.
• Qualifications:
  • One obstetrician with over 20 years of experience in fetal cardiology.
  • Two sonographers, each with more than 10 years of experience.
  • One senior obstetrician with over 25 years of clinical experience (supervised and corrected annotations).

4. Adjudication Method for Test Set

• Expert reviewers manually performed view classification and measurements following the same protocol as used during actual device operation. The entire process was supervised by a senior obstetrician who reviewed and corrected all annotations to ensure consistency and accuracy. This implies an expert consensus-based adjudication, likely 3+1 or similar, though not explicitly stated as a formal (X+Y) method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Not explicitly mentioned. The study focuses on standalone algorithm performance against expert ground truth.

6. Standalone Performance (Algorithm Only)

• Yes, performance metrics (Dice-score, error rates) are reported for the algorithm's output compared to established ground truth.

7. Type of Ground Truth Used

• Expert Consensus: Ground truth was established by expert reviewers manually classifying views and performing measurements, supervised and corrected by a senior obstetrician. This closely reflects the clinical use environment.

8. Sample Size for Training Set

• Not specified. The document only states that data used for training, tuning, and validation were completely separated.

9. How Ground Truth for Training Set Was Established

• All images used for training and tuning were first classified into the correct ultrasound views by three participating experts. Following view classification, the corresponding anatomical structures were manually annotated for each image.

ViewAssist

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

• Individual Patients: 102 (42 from South Korea, 60 from the US)
• Images: 680 static images
• Data Provenance: Mix of retrospective and prospective data collection from hospitals in South Korea and the United States.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: 3 (one obstetrician, two sonographers) + 1 senior obstetrician for supervision.
• Qualifications:
  • One obstetrician with over 20 years of experience in fetal cardiology.
  • Two sonographers, each with more than 10 years of experience.
  • One senior obstetrician with over 25 years of clinical experience (supervised and corrected annotations).

4. Adjudication Method for Test Set

• Expert reviewers manually performed view classification and measurements following the same protocol as used during actual device operation. The entire process was supervised by a senior obstetrician who reviewed and corrected all annotations to ensure consistency and accuracy. This implies an expert consensus-based adjudication, likely 3+1 or similar.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Not explicitly mentioned. The study focuses on standalone algorithm performance against expert ground truth.

6. Standalone Performance (Algorithm Only)

• Yes, performance metrics (sensitivity, specificity, Dice-score) are reported for the algorithm's output compared to established ground truth.

7. Type of Ground Truth Used

• Expert Consensus: Ground truth was established by expert reviewers manually classifying views and performing measurements, supervised and corrected by a senior obstetrician. This closely reflects the clinical use environment.

8. Sample Size for Training Set

• Not specified. The document only states that data used for training, tuning, and validation were completely separated.

9. How Ground Truth for Training Set Was Established

• All images used for training and tuning were first classified into the correct ultrasound views by three participating experts. Following view classification, the corresponding anatomical structures were manually annotated for each image.

HeartAssist (fetus)

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

• Individual Patients: 70 (26 from South Korea, 44 from the US)
• Images: 280 static images
• Data Provenance: Mix of retrospective and prospective data collection from hospitals in South Korea and the United States.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: 3 (one obstetrician, two sonographers) + 1 senior obstetrician for supervision.
• Qualifications:
  • One obstetrician with over 20 years of experience in fetal cardiology.
  • Two sonographers, each with more than 10 years of experience.
  • One senior obstetrician with over 25 years of clinical experience (supervised and corrected annotations).

4. Adjudication Method for Test Set

• Expert reviewers manually performed view classification and measurements following the same protocol as used during actual device operation. The entire process was supervised by a senior obstetrician who reviewed and corrected all annotations to ensure consistency and accuracy. This implies an expert consensus-based adjudication, likely 3+1 or similar.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Not explicitly mentioned. The study focuses on standalone algorithm performance against expert ground truth.

6. Standalone Performance (Algorithm Only)

• Yes, performance metrics (sensitivity, specificity, Dice-score, error rates) are reported for the algorithm's output compared to established ground truth.

7. Type of Ground Truth Used

• Expert Consensus: Ground truth was established by expert reviewers manually classifying views and performing measurements, supervised and corrected by a senior obstetrician. This closely reflects the clinical use environment.

8. Sample Size for Training Set

• Not specified. The document only states that data used for training, tuning, and validation were completely separated.

9. How Ground Truth for Training Set Was Established

• All images used for training and tuning were first classified into the correct ultrasound views by three participating experts. Following view classification, the corresponding anatomical structures were manually annotated for each image.

EzNerveMeasure of NerveTrack

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

• Individual Patients: 20 (10 from South Korea, 10 from the US)
• Images: 200 static images (10 static images per patient from a 2D sequence)
• Data Provenance: Prospective data collected in clinical practice using Samsung ultrasound systems (RS80A and V8) from South Korea and the United States.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: 3 anesthesiologists + 1 senior anesthesiologist for resolution.
• Qualifications: All three anesthesiologists had over 10 years of experience. The senior anesthesiologist had over 10 years of extensive clinical experience in regional anesthesia and ultrasound-guided procedures.

4. Adjudication Method for Test Set

• The ground truth (GT) for median nerve locations was initially drawn by one anesthesiologist performing the ultrasound scans, then verified by the other two anesthesiologists. Disagreements were resolved by a senior anesthesiologist. This is a consensus-based adjudication process, effectively a 3+1 method for resolving disagreements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Not explicitly mentioned. The study focuses on standalone algorithm performance against expert ground truth.

6. Standalone Performance (Algorithm Only)

• Yes, performance metrics (average error rate, confidence interval, standard deviation) are reported for the algorithm's output compared to established ground truth.

7. Type of Ground Truth Used

• Expert Consensus: Ground truth (median nerve locations, FR, CSA measurements) was established by three anesthesiologists, with disagreements resolved by a senior anesthesiologist. A clinical evaluation was also conducted by experienced doctors to assess clinical significance.

8. Sample Size for Training Set

• Not specified. The document only states that data used for training, tuning, and validation were completely separated.

9. How Ground Truth for Training Set Was Established

• Not explicitly detailed for the training set itself, but it implies a similar expert annotation process as described for validation, with clear separation between data sets.

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EchoPAC Software Only / EchoPAC Plug-in is intended for diagnostic review and analysis of ultrasound images, patient record management and reporting, for use by, or on the order of a licensed physician. EchoPAC Software Only / EchoPAC Plug-in allows post-processing of raw data images from GE ultrasound scanners and DICOM ultrasound images.

Ultrasound images are acquired via B (2D), M, Color M modes, Color, Power, Pulsed and CW Doppler modes, Coded Pulse, Harmonic, 3D, and Real time (RT) 3D Mode (4D).

Clinical applications include: Fetal/Obstetrics; Abdominal (including renal and GYN); Urology (including prostate); Pediatric; Small organs (breast, testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Transesophageal (TEE); Musculo-skeletal Conventional; Musculo-skeletal Superficial; Transrectal (TR); Transvaginal (TV); Intraoperative (vascular); Intra-Cardiac; Thoracic/Pleural and Intra-Luminal.

EchoPAC Software Only / EchoPAC Plug-in provides image processing, annotation, analysis, measurement, report generation, communication, storage and retrieval functionality to ultrasound images that are acquired via the GE Healthcare Vivid family of ultrasound systems, as well as DICOM images from other ultrasound systems. EchoPAC Software Only will be offered as SW only to be installed directly on customer PC hardware and EchoPAC Plug-in is intended to be hosted by a generalized PACS host workstation. EchoPAC Software Only / EchoPAC Plug-in is DICOM compliant, transferring images and data via LAN between systems, hard copy devices, file servers and other workstations.

The provided 510(k) clearance letter and summary discuss the EchoPAC Software Only / EchoPAC Plug-in, including a new "AI Cardiac Auto Doppler" feature. The acceptance criteria and the study proving the device meets these criteria are primarily detailed for this AI-driven feature.

Here's an organized breakdown of the information:

1. Acceptance Criteria and Reported Device Performance (AI Cardiac Auto Doppler)

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Vivid Pioneer is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified and trained physician or sonographer for ultrasound imaging, measurement, display and analysis of the human body and fluid.

Vivid Pioneer is intended for use in a hospital environment including echo lab, other hospital settings, operating room, Cath lab and EP lab or in private medical offices. The systems support the following clinical applications:

Fetal/Obstetrics, Abdominal (including renal, GYN), Pediatric, Small Organ (breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (adult and pediatric), Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Urology (including prostate), Transesophageal, Transvaginal, Transrectal, Intra-cardiac, Intra-luminal and Interventional Guidance (including Biopsy, Vascular Access), Thoracic/Pleural and Intraoperative (vascular).

Modes of operation include: 3D, Real time (RT) 3D Mode (4D), B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse and Combined modes: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

The proposed Vivid Pioneer is a general purpose, Track 3, diagnostic ultrasound system, which is primarily intended for cardiac imaging and analysis but also includes vascular and general radiology applications. It provides digital acquisition, processing, display and analysis capabilities. It consists of a mobile console with a height-adjustable control panel, color LCD touch panel, and a display monitor.

Vivid Pioneer includes a variety of electronic array transducers operating in linear, curved, sector/phased array, matrix array or dual array format, including dedicated CW transducers and real time 3D transducer. The proposed Vivid Pioneer can be used with the stated compatible OEM ICE transducers. The system includes capability to output data to other devices like printing devices.

The user-interface includes an operator control panel, a 23.8" High-Definition Ultrasound LCD type of display monitor (mounted on an arm for rotation and / or adjustment of height), a layout of pre-defined user controls (hard-keys) and a 15.6-inch multi-touch LCD panel with mode-and operation dependent soft-keys.

The operator panel also includes two loudspeakers for audio, shelves for convenient placement of papers or accessories, and 6 holders with cable management for the connected transducers.

The lower console is mounted on 4 rotational wheels with brakes, for ergonomic transport and safe parking. The lower console also includes all electronics for transmit and receive of ultrasound data, ultrasound signal processing, software computing, hardware for image storage, hard copy printing, and network access to the facility through both LAN and wireless (supported by use of a wireless LAN USB-adapter) connection.

This document describes the acceptance criteria and study proving the device meets the criteria for two AI features of the Vivid Pioneer Ultrasound System: AI Cardiac Auto Doppler and AI FlexiViews LAA.

1. Table of Acceptance Criteria and Reported Device Performance

AI Cardiac Auto Doppler

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