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CHROMA PRINT PREMIUM REGULAR AND FAST SET:
Indications:
Chroma Print Premium is indicated for total or partial impressions of dentate or edentulous mouths in the fabrication of complete and partial removable dentures, orthodontic study models, and impressions for the manufacture of single and multiple restorations, crowns, and fixed bridges.

HYDRO PRINT PREMIUM REGULAR AND FAST SET
Indications:
Hydro Print Premium is indicated for total or partial impressions of dentate or edentulous mouths in the fabrication of complete and partial removable dentures, orthodontic study models, and impressions for the manufacture of single and multiple restorations, crowns, and fixed bridges.

PERFIL PRO
Indications:
Perfil Pro is indicated for total or partial impressions of dentate and edentulous mouths in the fabrication of complete and partial removable dentures, orthodontic study models, and impressions for the manufacture of single and multiple restorations, crowns, and fixed bridges.

PERFIL PRO CHROMA
Indications:
Perfil Pro Chroma is indicated for total or partial impressions of dentate and edentulous mouths in the fabrication of complete and partial removable dentures, orthodontic study models, and impressions for the manufacture of single and multiple restorations, crowns, and fixed bridges.

PERFIL PRO +
Indications:
Perfil Pro+ is indicated for total or partial impressions of dentate and edentulous mouths in the fabrication of complete and partial removable dentures, orthodontic study models, and impressions for the manufacture of single and multiple restorations, crowns, and fixed bridges.

Device Description – Principle of Operation
The Vigodent Alginate Impression Materials are irreversible hydrocolloid powders intended to be mixed with water to form a paste that sets by gelation. The material is placed in a standard dental impression tray and introduced into the patient's oral cavity to capture the anatomical details of teeth and soft tissues. Once set, the impression is removed from the mouth and poured with dental gypsum to obtain a working model.

Conditions of Use
The products are used in dental clinics and laboratories for total or partial impressions in the fabrication of study models, provisional prostheses, orthodontic appliances, and other preliminary dental applications. The device directly contacts the oral cavity tissues for a short duration (minutes) and does not remain in the body.

Interaction with Patient and Other Devices
The alginate material only interacts with oral tissues during impression taking and does not require any surgical procedure. The material interfaces with standard dental trays and dental gypsum products, with which it is compatible. No electronic components, implants, or additional medical devices are involved.

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The AiORTA - Plan tool is an image analysis software tool for volumetric assessment. It provides volumetric visualization and measurements based on 3D reconstruction computed from cardiovascular CTA scans. The software device is intended to provide adjunct information to a licensed healthcare practitioner (HCP) in addition to clinical data and other inputs, as a measurement tool used in assessment of aortic aneurysm, pre-operative evaluation, planning and sizing for cardiovascular intervention and surgery, and for post-operative evaluation in patients 22 years old and older.

The device is not intended to provide stand-alone diagnosis or suggest an immediate course of action in treatment or patient management.

AiORTA - Plan is a cloud-based software tool used to make and review geometric measurements of cardiovascular structures, specifically abdominal aortic aneurysms. The software uses CT scan data as input to make measurements from 2D and 3D mesh based images. Software outputs are intended to be used as a measurement tool used in assessment of aortic aneurysm, pre-operative evaluation, planning and sizing for cardiovascular intervention and surgery, and for post-operative evaluation.

The AiORTA - Plan software consists of two components, the Analysis Pipeline and Web Application.

The Analysis Pipeline is the data processing engine that produces measurements of the abdominal aorta based on the input DICOM images. It consists of multiple modules that are operated by a trained Analyst to preprocess the DICOM images, compute geometric parameters (e.g., centerlines, diameters, lengths, volumes), and upload the results to the Web App for clinician review. The Analyst plays a role in ensuring the quality of the outputs. However, the end user (licensed healthcare practitioner) is ultimately responsible for the accuracy of the segmentations, the resulting measurements, and any clinical decisions based on these outputs.

The workflow of the Analysis Pipeline can be described in the following steps:

• Input: the Analysis Pipeline receives a CTA scan as input.
• Segmentation: an AI-powered auto-masking algorithm performs segmentation of the aortic lumen, wall, and key anatomical landmarks, including the superior mesenteric, celiac, and renal arteries. A trained Analyst performs quality control of the segmentations, making any necessary revisions to ensure accurate outputs.
• 3D conversion: the segmentations are converted into 3D mesh representations.
• Measurement computation: from the 3D representations, the aortic centerline and geometric measurements, such as diameters, lengths, and volumes, are computed.
• Follow-up study analysis: for patients with multiple studies, the system can detect and display changes in aortic geometry between studies.
• Report generation: a report is generated containing key measurements and a 3D Anatomy Map providing multiple views of the abdominal aorta and its landmarks.
• Web application integration: the outputs, including the segmented CT masks, 3D visualizations, and reports, are uploaded to the Web App for interactive review and analysis.

The Web Application (Web App) is the front end and user facing component of the system. It is a cloud-based user interface offered to the qualified clinician to first upload de-identified cardiovascular CTA scans in DICOM format, along with relevant demographic and medical information about the patient and current study. The uploaded data is processed asynchronously by the Analysis Pipeline. Once processing is complete, the Web App then enables clinicians to interactively review and analyze the resulting outputs.

Main features of the Web App include:

• Segmentation review and correction: Clinicians can review the resulting segmentations from the Analysis Pipeline segmentations by viewing the CT slices alongside the segmentation masks. Segmentations can be revised using tools such as a brush or pixel eraser, with adjustable brush size, to select or remove pixels as needed. When clinicians revise segmentations, they can request asynchronous re-analysis by the Analysis Pipeline, which generates updated measurements and a 3D Anatomy Map of the aorta based on the revised segmentations.
• 3D visualization: The aorta and key anatomical landmarks can be examined in full rotational views using the 3D Anatomy Map.
• Measurement tools: Clinicians can perform measurements directly on the 3D Anatomy Map of the abdominal aorta and have access to a variety of measurement tools, including:
  • Centerline distance, which measures the distance (in mm) between two user-selected planes along the aortic centerline.
  • Diameter range, which measures the minimum and maximum diameters (in mm) within the region of interest between two user-selected planes along the aortic centerline.
  • Local diameter, which measures the diameter (in mm) at the user-selected plane along the aortic centerline.
  • Volume, which measures the volume (in mL) between two user-selected planes along the aortic centerline.
  • Calipers, which allow additional linear measurements (in mm) at user-selected points.
• Screenshots: Clinicians can capture images of the 3D visualizations of the aorta or the segmentations displayed on the CT slices.
• Longitudinal analysis: For patients with multiple studies, the Web App allows side-by-side review of studies. Clinicians have access to the same measurement and visualization tools available in single-study review, enabling comparison between studies.
• Reporting: Clinicians can generate and download reports containing either the default key measurements computed by the Analysis Pipeline or custom measurements and screenshots captured during review.

Here's a breakdown of the acceptance criteria and the study details for the AiORTA - Plan device, based on the provided FDA 510(k) clearance letter:

Acceptance Criteria and Reported Device Performance

Explanation for Lengths and Diameters that did not meet initial criteria:
For the following measurements which did not meet the initial acceptance criteria:

• Length: renal to left iliac bifurcation (7.0mm vs ≤ 6.0mm)
• Length: renal to right iliac bifurcation (6.6mm vs ≤ 6.0mm)
• Diameter: wall right iliac (2.5mm vs ≤ 2.3mm)

A Mean Pairwise Absolute Difference (MPAD) comparison was performed. The device-expert MPAD was smaller than the expert-expert MPAD in all three cases, indicating that the device's measurements were more consistent with experts than the experts were with each other.

Study Details for Device Performance Evaluation:

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

   • Auto-segmentation masks and Landmark Identification: The document does not explicitly state the sample size for this specific test, but it mentions using "clinical data, including aortic aneurysm cases from both US and Canadian clinical centers."
   • Diameters and Lengths: The document does not explicitly state the sample size for this specific test, but it mentions using "clinical data, including aortic aneurysm cases from both US and Canadian clinical centers."
   • Volumes: 40 CT scans. The data provenance is "clinical data, including aortic aneurysm cases from both US and Canadian clinical centers." The studies were retrospective, as they involved existing clinical data.

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

   • Auto-segmentation masks and Landmark Identification: 3 US-based board-certified Radiologists.
   • Diameters and Lengths: 3 US-based board-certified Radiologists.
   • Volumes: The ground truth for volumes was established using a reference device (Simpleware ScanIP Medical), not directly by human experts, although the input segmentations for both the device and the reference device were analyst-revised.

3. Adjudication method for the test set:

   • Auto-segmentation masks and Landmark Identification: Ground truth was "annotations approved by 3 US-based board-certified Radiologists." This implies consensus or a primary reader with adjudication, but the exact method (e.g., 2+1, 3+1) is not specified.
   • Diameters and Lengths: Ground truth was "annotations from 3 US-based board-certified Radiologists." Similar to above, the specific consensus method is not detailed.
   • Volumes: Ground truth was established by a reference device, Simpleware ScanIP Medical.

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 MRMC comparative effectiveness study was explicitly mentioned in the provided text. The testing focused on the standalone performance of the AI-powered components and the consistency of the device's measurements with expert annotations, not on human reader improvement with AI assistance.

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

   • Yes, a standalone performance evaluation of the auto-masking algorithm (prior to analyst correction) was performed for auto-segmentation masks and landmark identification. The results demonstrated the performance of the auto-masking algorithm "independently of human intervention."
   • However, for diameters and lengths, the measurements were "based on segmentations that underwent Analyst review and correction, ensuring that the verification reflects real-world use conditions." This suggests a semi-automatic, human-in-the-loop performance evaluation for these specific metrics.

6. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

   • Expert Consensus: Used for auto-segmentation masks, landmark identification, diameters, and lengths. The consensus involved 3 US-based board-certified Radiologists.
   • Reference Device: Used for volumes, comparing against results from Simpleware ScanIP Medical.

7. The sample size for the training set:

   • The document does not explicitly state the sample size for the training set. It mentions "critical algorithms were verified by comparing their outputs to ground truth data to ensure accuracy and reliability. Algorithms were first verified using synthetic data...Subsequent verification was performed using clinical data, including aortic aneurysm cases from both US and Canadian clinical centers." This refers to verification data, not necessarily the training data size.

8. 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 describes the ground truth for the verification/test sets. It can be inferred that similar expert review or other validated methods would have been used for training data, but this is not explicitly stated.

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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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Disposable Vinyl Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

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The Vesalio Peripheral Catheter is intended for use in the peripheral arterial vasculature for:

• the removal of fresh, soft emboli and thrombi
• infusion of diagnostic agents, such as contrast media

The Vesalio Peripheral System consists of 1) Peripheral Catheter, 2) Peel away Introducer Sheath and 3) an Aspiration Tubing Set.

The Peripheral Catheter is a single-lumen, coil-reinforced, flexible, variable stiffness composite catheter that facilitates the removal of thrombus from the peripheral arterial vasculature when connected to a compatible aspiration pump and the Aspiration Tubing Set.

The catheter is a hollow cylindrical tube constructed using a combination of medical-grade polymers with metal reinforcement, a lubricous inner liner made from PTFE and the outer jacket consisting of thermoplastics made of polyurethane, polyether block amide, and nylon 12. The distal end of the catheter has a hydrophilic coating aimed to reduce friction and aid tracking through the vasculature. The catheter employs radiopaque characteristics for angiographic visualization.

On the proximal end, the catheter incorporates a flexible strain relief, which provides kink resistance, and a translucent, polycarbonate female luer hub to allow attachment of ancillary devices for navigation, infusion of fluids, and aspiration through the catheter.

A peel-away introducer sheath is provided in the package to facilitate the insertion of the Peripheral Catheter's distal tip into an appropriate vascular sheath.

The Aspiration Tubing Set is provided in a separate package and is made of common medical grade polymers. It comprises of a hollow cylindrical tube that is bonded to a standard male rotator fitting on one end. The male rotator allows the tubing to connect to an RHV or the female luer hub of the catheter. The other end of the tubing consists of a hose fitting to enable connection with a vacuum pump. A flow switch is connected in line to provide vacuum control. The Peripheral System is provided sterile, non-pyrogenic, and is intended for single use only.

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PerQseal Introducer: The PerQseal Introducers are intended to provide access and facilitate the insertion of diagnostic or endovascular devices into femoral vasculature.

PerQseal Elite Introducer: The PerQseal Elite Introducers are intended to provide access and facilitate the insertion of diagnostic or endovascular devices into femoral vasculature.

Each PerQseal Introducer ('S', 'L', Elite 14F, and Elite 18F) includes an Introducer Sheath with a Dilator positioned within the lumen. The Introducer Sheath comprises a simple sheath that provides access to the site, while the Dilator is a component which guides the Introducer Sheath to the access site and provides a blood signal that is used to ensure proper positioning of the Introducer Sheath.

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The Spiral Laminar Flow Vascular Arteriovenous Graft is intended for use as a subcutaneous arteriovenous conduit for vascular access during hemodialysis.

SLF™ Vascular Arteriovenous Grafts are straight tubes constructed of expanded polytetrafluoroethylene (ePTFE) with the unique spiral flow inducer and nonremovable external inducer indicator ring (palpable ring) formed from ChronoFlex™* AL-80A, a Biodurable Medical Grade polyurethane. The spiral flow inducer is a helical deformation in the wall of the graft. The inducer indicator ring is on the outer surface of the proximal end of the spiral flow inducer, indicating the beginning of the spiral inducer segment and the no cannulation area of the graft.

A Shaped Hood is provided to guide the surgeon when creating the distal anastomosis. Although not critical to the functioning of the device, the hood does provide for an effective attachment angle and alignment of the spiral flow inducer with the native vessel

All grafts are supplied sterile and will remain so for the stated shelf life unless the packaging is opened or damaged.

SLF™ Vascular Arteriovenous grafts are available in one size (Table 1).

Table 1: SLF Graft Dimensions

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