Visions® PV.014P RX Digital IVUS Catheter:

The Visions® PV.014P RX Digital IVUS Catheter is designed for use in the evaluation of vascular morphology in blood vessels of the coronary and peripheral vasculature by providing a cross-sectional image of such vessels. This device is not currently indicated for use in the cerebral vessels.

The Visions® PV.014P RX Digital IVUS Catheter is designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures.

Visions® PV .018 Digital IVUS Catheter:

The Visions® PV .018 Digital IVUS Catheter is designed for use in the evaluation of vascular morphology in blood vessels of the coronary and peripheral vasculature by providing a cross-sectional image of such vessels. This device is not currently indicated for use in cerebral vessels.

The Visions® PV .018 Digital IVUS Catheter is designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures.

The Visions® PV .014P RX Digital IVUS Catheter and the Visions® PV .018 PV .018 Digital IVUS Catheter are being bundled into one submission per FDA Guidance for Industry: Bundling Multiple Devices or Multiple Indications in a Single Submission, June 2007 (FDA-2003-D-0376), as the two catheters share the same indications for use, FDA classification product codes, and technological characteristics, and part of the same product line of catheters.

Visions® PV .014P RX Digital IVUS Catheter

The Visions® PV .014P RX Digital IVUS Catheter incorporates a cylindrical ultrasound transducer array located near the distal tip of the catheter. The array radiates acoustic energy into the surrounding tissue and detects the subsequent ultrasonic echoes. The information from the echoes is used to generate real-time images of the coronary or peripheral vessels.

The Visions® PV .014P RX Digital IVUS Catheter utilizes an internal lumen that allows the catheters to track over a 0.018" (0.46 mm) guide wire. The guide wire exits from the guide wire lumen approximately 31 cm proximal to the catheter tip. The PV .018 catheters are introduced either percutaneously or via surgical cut down into the vascular system.

The Visions® PV .014P RX Digital IVUS Catheter may only be used with Volcano imaging systems, such as the Volcano s5™, Volcano s5i™, Volcano CORE Mobile, and Volcano CORE imaging systems. The catheter will not operate if connected to any other imaging system.

Visions® PV .018 Digital IVUS Catheter

The Visions® PV .018 Digital IVUS Catheter incorporates a cylindrical ultrasound transducer array located near the distal tip of the catheter. The array radiates acoustic energy into the surrounding tissue and detects the subsequent ultrasonic echoes. The information from the echoes is used to generate real-time images of the coronary or peripheral vessels.

The Visions® PV .018 Digital IVUS Catheter utilizes an internal lumen that allows the catheters to track over a 0.018" (0.46 mm) guide wire. The guide wire exits from the guide wire lumen approximately 31 cm proximal to the catheter tip. The PV .018 catheters are introduced either percutaneously or via surgical cut down into the vascular system.

The Visions® PV .018 Digital IVUS Catheter may only be used with Volcano imaging systems, such as the Volcano s5™, Volcano s5i™, Volcano CORE Mobile, and Volcano CORE imaging systems. The catheter will not operate if connected to any other imaging system.

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The XC11 ICE Box Ultrasound System is intended for intra-cardiac and intra-luminal ultrasound imaging when operated with the XC11 ICE Catheter and XC11 ICE System Handle.

The XC11 ICE Catheter is intended for intra-cardiac 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 XC11 ICE Catheter is for use with Yorlabs XC11 ICE System Handle only.

The XC11 ICE System, USA is a fully integrated imaging platform designed for wireless communications and a compact footprint. It provides precise, real-time visualization of intracardiac anatomy and devices positioned within the heart.

The System is comprised of two main components:

XC11 ICE Catheter (2D), USA
A 9F, single-use, sterile device capable of real-time 2D side-view imaging for intracardiac and intraluminal ultrasound in adult and pediatric patients. The catheter features easy steering maneuverability via deflection and rotation, along with on-handle imaging controls for enhanced usability.

XC11 ICE Box Ultrasound System, USA
This unit houses the image data acquisition and computer modules for image display and includes a connector for interfacing with the XC11 ICE System Handle. The XC11 ICE Tablet with a touchscreen interface, enables technicians to control the system software efficiently.

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EPIQ:

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:

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 special 510(k) Pre-Market Notification is to introduce EPIQ and Affiniti Series Diagnostic Ultrasound Systems with Custom Electromagnetic Interference (EMI) filter. The proposed EPIQ Series Diagnostic Ultrasound System and Affiniti Series Diagnostic Ultrasound Systems with new Custom EMI filter spare part, will reduce the electrical interferences induced by the external environments and feed the clean electrical signals to the ultrasound device, equivalent to predicate device, K250177.

Ultrasound systems are very sensitive in nature. These electrical interference couplings result in Image distortions or artifacts in Images, using this Custom EMI filter will reduce such artifact effects appearing on Ultrasound systems.

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The DUO Microcatheter is intended for the selective placement of devices and/or fluids, such as contrast media, into the peripheral, coronary, and neuro vasculature during diagnostic and/or therapeutic procedures.

The DUO Microcatheter is a disposable, single use, sterile device. The DUO Microcatheter is a single-lumen, variable stiffness catheter with radiopaque marker(s) on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating on the distal 80 cm to reduce friction during use. The radiopaque shaft and distal marker(s) facilitate fluoroscopic visualization. Device dimensions and configuration are shown on the product label. A steam shaping mandrel and a peel away introducer are provided with each microcatheter.

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The pREBOA-PRO Catheter is intended for temporary partial or complete occlusion of large vessels and blood pressure monitoring including patients requiring emergency control of hemorrhage.

The pREBOA-PRO™ Catheter is a large vessel occlusion catheter with a dedicated lumen for pressure monitoring. The device consists of a semi-compliant balloon, in-line pressure relief valve (safety valve), atraumatic distal tip (P-tip™), dual lumen catheter shaft and a hub with extension lines to provide access to each lumen.

The pREBOA-PRO™ Catheter is designed with flow channels to enable precise, smooth control of inflation and deflation of the balloon. Instructions for how to titrate the balloon for partial occlusion, if so desired by the clinician, are included in the Instructions for Use.

The device has an effective length of 72 cm and is compatible with 7 Fr introducer sheaths as shown in the compatibility section of the IFU. The catheter has a unibody design and is intended to be placed and advanced without a guidewire. In addition, the catheter is compatible with guidewires up to 0.025" that may be used to facilitate subsequent vascular procedures after a REBOA procedure. An orange peel-away sheath is preloaded on the catheter shaft covering the balloon to ease insertion of the catheter's P-tip™ into an introducer sheath hemostasis valve. A catheter shaft provides appropriate stiffness with a distal tip (P-tip™) designed for atraumatic advancement of the catheter in a blood vessel. Pad printed marks on both sides of the outer catheter shaft indicate distance to the center of the balloon as well as average insertion depth ranges to the center of aortic Zones 1 and 3 to facilitate proper placement. Radiopaque platinum iridium marker bands are located at the functional ends of the balloon to facilitate and visualize accurate balloon placement when used with imaging. The proximal end of the catheter has a hub and extension lines. The arterial line lumen is used to monitor blood pressure above the balloon. Below the balloon core aortic pressure monitoring is possible through the side arm of the sheath. The balloon lumen is used to inflate and deflate the balloon as needed. An in-line safety valve is connected to the balloon lumen stopcock and is designed to help prevent over-inflation of the balloon. The stopcocks provide control to each of the catheter's two lumens. The orange peel-away sheath can be separated from the catheter shaft after insertion if needed. The device is a single-use, sterile device.

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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

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

• Initial Cohort: 60 subjects
• Evaluable Study Sample (Test Set): 46 subjects (after 10 samples were non-reportable)
• Data Provenance: Retrospective data study, utilizing previously acquired exams (including contrast and non-contrast clips) with TTE transducers.
  • Country of Origin: The sample included data from two sites: one outside the USA and one in the USA.
    • 7 patient exams collected from the first site (outside USA).
    • Remaning 39 patient exams from the second site (USA).

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

• Ground Truth (Primary): The ground truth for the primary endpoint (Biplane EF - Manually Selected (Ground Truth)) was generated by one sonographer (reviewer) who manually selected contrast clips from subject exams. These clips were then automatically processed within the Contrast EF application, with the automated EF results serving as this ground truth. This ground truth was created as part of the K243235 submission.
• Ground Truth (Supporting): For the comparison against "Manual Tracing (Ground Truth)," three sonographers manually measured the previously selected clips (by the single sonographer) following a physician's review. This clinical ground truth was also created as part of the K243235 submission.
• Qualifications of Experts: The document specifies "sonographer" for those involved in manual clip selection and measurements, and "physicians review" for the support ground truth. Specific details on years of experience or board certification are not provided within this document.

4. Adjudication Method for the Test Set

The document does not explicitly state an adjudication method (e.g., 2+1, 3+1).

• For the primary ground truth, it appears one sonographer made the manual selection, which then fed into an automated process.
• For the supporting ground truth ("Manual Tracing"), three sonographers performed measurements following a physician's review. It is not clear if these three sonographer measurements were averaged, or if disagreements were arbitrated by the physician or another expert.

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

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was explicitly mentioned in the provided text, nor was an effect size of human readers improving with AI vs. without AI assistance. The study focused on the agreement between the device's automated selection and manually established ground truth, rather than human reader performance.

6. Standalone (Algorithm Only) Performance

Yes, a standalone performance of the algorithm (SVS v2 Contrast) was performed. The study evaluates the algorithm's ability to automatically select appropriate clips and its subsequent impact on Biplane EF calculation. The comparison is made between the "Biplane EF - SVS Selected (Automated)" and the "Biplane EF - Manually Selected (Ground Truth)," where the latter represents a ground truth derived with manual input for clip selection but still using an automated EF calculation. Additionally, a comparison was made against "Biplane EF – by Manual Tracing (Ground Truth)," which reflects a more direct human-traced ground truth reference.

7. Type of Ground Truth Used

The ground truth used was primarily a hybrid approach:

• Expert consensus/manual selection combined with automated processing: For the primary ground truth, a single sonographer manually selected clips, which were then processed by the Contrast EF application to yield the ground truth EF.
• Expert manual tracing (with physician review): For the supporting analysis, three sonographers performed manual tracings/measurements following a physician's review.

This suggests a "clinical ground truth" established by human experts, sometimes in conjunction with other software tools. It is not pathology or direct outcomes data.

8. Sample Size for the Training Set

The document does not specify the sample size for the training set. It mentions "To ensure data separation between development and testing data, the data set to which each exam belongs was identified," indicating that there were distinct training and test sets, but the training set size is not provided.

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

The document does not provide details on how the ground truth for the training set was established. It only refers to the test set's ground truth and mentions that the algorithm is based on a Deep Learning AI inference engine, implying the use of a training set.

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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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DualView Catheter is intended for the intravascular imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures.

The DualView Catheter is a catheter consisting of two assemblies: the catheter sheath and the imaging core (consisting of lens and transducer). During imaging, the imaging core rotates inside the catheter sheath to obtain a 360°image of the surface layer of the vessel wall by irradiating with near-infrared light and ultrasound. By pulling back the imaging core inside the catheter sheath, an image in the long axis direction can be obtained.

This is a rapid exchange (RX) design (short monorail) catheter, which is used with a 0.014" (0.36 mm) guidewire. The catheter is 2.6 Fr (0.86 mm) in the imaging window section and 3.0 Fr (1.01 mm) in the shaft section with an effective length of 137 cm. The catheter has a 100 cm hydrophilic coating starting from the distal end, which becomes highly lubricious when wet. The catheter has a telescoping section, and the telescoping length is 155 mm. When connected to the OPUSWAVE, the imaging core can be pulled back 150 mm in the catheter sheath. There are two radiopaque markers. The distal radiopaque marker is located 7 mm from the distal end of the catheter sheath, and the sensor radiopaque marker is located where the near-infrared light and ultrasound are emitted. Those markers allow a user to confirm the positional relationship between the distal end of the catheter and the sensor position (imaging point). There are two depth markers, one at 90 cm and the other at 100 cm from the distal end of the catheter sheath, which serves as a guide for insertion.

The transducer has an IPX7 ingress rating in accordance with IEC 60529.

The catheter is stored in the holder tube and is secured to the catheter holder. The catheter comes with the Motor Drive Unit (MDU) Cover and accessories. The MDU Cover consists of an adapter and a plastic cover sheet to maintain the sterility of the catheter and clean field. The catheter accessories consist of a connection tube with a three-way stopcock, a priming syringe, and a reservoir syringe for priming the catheter lumen with heparinized saline solution.

The provided FDA 510(k) Clearance Letter concerns the DualView Catheter, a diagnostic intravascular catheter. This document is a Summary of a Traditional 510(k) submission, which primarily focuses on demonstrating substantial equivalence to existing predicate devices based on non-clinical performance testing.

Therefore, the submission does not include a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, standalone algorithm performance, or extensive details on ground truth establishment involving human expert consensus for a clinical test set as would be typical for an AI/ML-based device. The clearance is based on direct device performance and safety, primarily through bench testing and animal studies, not a human reader study.

Here's an analysis of the provided information, specifically addressing the questions as much as possible given the nature of this particular 510(k) (a medical device clearance, not an AI/ML algorithm clearance):

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

Since this is a non-clinical device clearance, the "acceptance criteria" are the successful completion of the listed performance and safety tests, demonstrating the device meets its design specifications and is suitable for its intended use. The "reported device performance" is that it successfully met these criteria.

Detailed Study Information (Where Applicable for this Device Type):

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

   • Test Set (Non-Clinical): The document refers to various non-clinical tests (e.g., performance testing, software V&V, electrical safety, biocompatibility, sterilization). The "sample size" for these tests would correspond to the number of catheters or test articles subjected to each specific test. This specific number is not provided in the summary but is assumed to be sufficient for each test type according to relevant standards.
   • Animal Study: A "swine model" was used for both safety and performance animal studies. The specific number of animals is not provided in this summary.
   • Data Provenance: The document does not explicitly state the country of origin for the data (e.g., test labs, animal facilities). This is a traditional 510(k) submission, and the manufacturer is Terumo Corporation (Japan), with manufacturing in Japan. Animal studies were likely prospective.

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

   • Not Applicable in the context of this 510(k). This clearance is for a medical device (catheter), not an AI/ML algorithm that requires human expert consensus for image interpretation ground truth. The "ground truth" for this device's performance is established by direct physical measurements, engineering validations, and physiological outcomes in animal models against predefined specifications and safety standards.

3. Adjudication method for the test set:

   • Not Applicable. Since there's no human interpretation component needing adjudication for ground truth establishment. Test outcomes are determined by objective measurements against acceptance criteria.

4. 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, an MRMC study was NOT done. The document explicitly states: "This 510(k) does not include data from clinical tests." MRMC studies are typically used to assess the impact of AI algorithms on human reader performance, which is not relevant for this device's non-clinical clearance pathway.

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

   • No, not in the sense of an AI algorithm. This device does not appear to involve an AI algorithm whose performance would be assessed in a standalone manner for image interpretation or diagnosis. It is a diagnostic imaging catheter that generates images for human interpretation.

6. The type of ground truth used:

   • Engineering Specifications, Physical Measurements, and Physiological Outcomes (Animal Model):
     • For non-clinical performance tests (e.g., tensile strength, dimensions, imaging quality, etc.), the ground truth is the device's adherence to pre-defined engineering specifications and measurable performance characteristics.
     • For biocompatibility and sterilization, the ground truth is established by adherence to relevant ISO standards and successful completion of validated tests.
     • For animal studies, the "ground truth" relates to the physiological effects observed (e.g., absence of tissue injury, thrombus formation) and the successful performance of the device in a living system as intended by design, compared to predicate devices.

7. The sample size for the training set:

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

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

   • Not Applicable. As no training set for an AI/ML algorithm is involved.

Summary:

The DualView Catheter received 510(k) clearance based on demonstrating substantial equivalence to predicate devices primarily through rigorous non-clinical performance testing and animal studies. This type of submission relies on showing that the new device meets established safety and performance standards equivalent to existing legally marketed devices, rather than a clinical study evaluating an AI algorithm's interpretive accuracy and its impact on human readers. Therefore, many of the questions pertinent to AI/ML device clearances (e.g., human expert ground truth, MRMC studies) are not applicable to this traditional medical device submission.

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Intended Use / Indications for Use

EPIQ:

The intended use of Philips EPIQ 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, Intra-cardiac Echo, Intra-luminal, Intraoperative (Vascular), Intraoperative (Cardiac), 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 Philips EPIQ 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:

The intended use of the 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 judgment and best clinical procedure.

The purpose of this Special 510(k) Pre-Market Notification is to expand the Smart View Select (SVS) software application onto the Affiniti Series Diagnostic Ultrasound Systems and to modify the Smart View Select software application onto both the EPIQ Series Diagnostic Ultrasound Systems.

Smart View Select is an automated software feature that assists the user in selection of images for analysis with the existing Philips AutoStrain LV or 2D Auto LV application in Adult Echo Transthoracic (TTE) examination. 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 interface engine; the selection is a non-AI algorithm that considers the view classification and image depth to select the optimal set of images.

No hardware changes to the EPIQ or Affiniti systems are required when using SVS, and existing, cleared Philips TTE transducers are used with these software applications.

The SVS v2 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 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 and SWM software features are associated with the cardiac adult indication.

The provided document details the 510(k) clearance for Philips Ultrasound's EPIQ and Affiniti Series Diagnostic Ultrasound Systems with the Smart View Select (SVS) v2 software. The SVS feature is an automated software that assists users in selecting images for Left Ventricle (LV) analysis using existing Philips AutoStrain LV or 2D Auto LV applications in Adult Echo Transthoracic (TTE) examinations. It classifies acquired images by view using a Deep Learning AI interface and then uses a non-AI algorithm to select an optimal set of images.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The study aimed to demonstrate agreement between LV analysis outputs (Ejection Fraction - EF, and Global Longitudinal Strain - GLS) derived from manually selected clips (ground truth) and automatically selected clips by the SVS software.

2. Sample Size and Data Provenance

• Test Set Sample Size: The exact number of patients or cases in the test set is not explicitly stated as a single number. However, the demographic characteristics section indicates n=71 for various demographic variables like Sex, Age, Height, Weight, BMI, Race, LV systolic function, RWMA, Known CAD, Previous reported MI Location, and LV Hypertrophy, suggesting the test dataset comprised data from at least 71 unique patients.
• Data Provenance: The data was collected from a US-based medical center. The study was a retrospective data analysis.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Three (3) reviewers (clinical experts) participated in establishing the ground truth.
• Qualifications of Experts: They are referred to as "clinical experts." No further specific qualifications (e.g., years of experience, specific board certifications like radiologist/cardiologist) are provided in the document.

4. Adjudication Method for the Test Set

The adjudication method used to establish ground truth was consensus/averaging. For each output (GLS and EF), the average across the three reviewers was used as the ground truth.

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

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was described. The study focused on comparing the AI-selected clips' performance (GLS and EF) against the ground truth established by human experts using manually selected clips. There is no information provided regarding how much human readers improve with AI vs. without AI assistance. The study evaluates the AI's ability to select optimal clips, a step that precedes human analysis with AutoStrain LV.

6. Standalone Performance Study (Algorithm Only)

Yes, a standalone performance study was done. The performance of the SVS software was evaluated solely based on its ability to automatically select appropriate clips, and then the subsequent, un-edited evaluation of GLS and EF through AutoStrain LV using these SVS-selected clips was compared against the human-selected clips. This represents the algorithm's performance in its specific task (clip selection) without direct human intervention in the selection process.

7. Type of Ground Truth Used

The ground truth used was expert consensus. Specifically, it was the average of GLS and EF measurements obtained from clips manually selected and subsequently semi-automatically processed by three clinical experts using the AutoStrain LV software.

8. Sample Size for the Training Set

The document does not provide the sample size used for the training set of the deep learning AI model for image classification. It only states that "the neural network of the subject device was revised as described in attachment 002," implying updates to an existing model rather than a completely new one, but no training data details are given.

9. How Ground Truth for Training Set was Established

The document does not explicitly state how the ground truth for the training set was established. It mentions that the "classification is based on a Deep Learning AI interface engine," but details regarding the training data annotation and ground truth establishment are not provided within the excerpt.

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The Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters 8F, 8FG, 10F 10FG are indicated for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart. When used with compatible CARTO 3 EP Navigation Systems, the SOUNDSTAR eco Catheter provides location information.

The Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters 8F, 8FG, 10F, 10FG are licensed for single use only. Models differ in shaft diameter (8F or 10F) and ultrasound system compatibility (Siemens [8F and 10F] or GE [8FG and 10FG]). The catheter consists of a CARTO connector, SwiftLink (ultrasound) connector, handle and shaft. In the distal tip of each catheter's shaft are a 64-element ultrasound transducer providing 2D imaging and a 3D location sensor providing location information to the compatible CARTO 3 Electrophysiology (EP) Navigation System. The deflection and tension knobs on the handle are used to articulate the distal tip and control the image plane orientation with four-directional (anterior-posterior, left-right) deflection.

The provided FDA 510(k) clearance letter pertains to the Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters. This document outlines the regulatory review and approval process for a reprocessed medical device, asserting its substantial equivalence to original predicate devices.

However, the provided text does not contain any information regarding specific acceptance criteria for AI/ML performance, nor does it describe a study involving AI assistance or standalone AI performance evaluation. The "Non-clinical Testing Summary" focuses on the physical, electrical, and reprocessing aspects of the reprocessed catheter itself (e.g., functional performance, electrical safety, cleaning validation, biocompatibility, sterilization validation, packaging and shelf life). It explicitly states: "The current submission does not include consoles or any other system components as part of this respective submissions." The device subject to clearance is an ultrasound catheter, not an AI-powered diagnostic system.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria for AI/ML device performance based on the provided document. The document pertains to a physical medical device (an ultrasound catheter) and its reprocessing, not an AI/ML-driven diagnostic or assistive technology.

If you have a document describing an AI/ML device and its performance study, I would be happy to analyze it according to your requested criteria.

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