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Gelweave Vascular Prosthesis (with the exception of Valsalva variant) are indicated for the repair of damaged and diseased vessels of the thoracic and abdominal aorta in cases of aneurysm, dissection or occlusive disease. Branched configurations can also be used for debranching, i.e. reconstruction of the aortic vessels and associated Hybrid procedures. Hybrid procedures are defined as a treatment combination employing open surgical debranching with endovascular aortic repair.

Gelweave Valsalva Vascular Prosthesis are indicated for the repair or replacement of damaged and diseased thoracic aorta, such as aortic root replacement in cases of aneurysm or dissection.

Gelweave™ vascular prostheses are gelatin sealed woven polyester prostheses designed for vascular repair. The Gelweave™ polyester vascular prostheses family, which is this pre-market notification, is based on woven polyester textile technology.

The provided document describes the clearance of a medical device, the Gelweave™ Vascular Prostheses, based on substantial equivalence to a predicate device. It does not contain information about the acceptance criteria or a study that proves a device meets specific performance criteria in the context of AI/ML or diagnostic performance evaluation.

Therefore, I cannot extract the requested information (performance metrics, sample sizes, ground truth establishment methods, expert qualifications, adjudication methods, or MRMC study details) from the provided text.

The document states:

• "No clinical testing was necessary to demonstrate substantial equivalence."
• "Nonclinical testing, including bench testing, shelf-life, biocompatibility testing, chemical characterization and an animal performance study, have been conducted to demonstrate equivalency."

This indicates that the clearance was based on non-clinical data and equivalence to an existing device, rather than a study evaluating diagnostic or clinical performance against specific acceptance criteria relevant to AI/ML devices.

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Gelsoft™ Plus Vascular Prostheses are indicated exclusively for vascular repair of damaged and diseased vessels of the abdomen, i.e. replacement or bypass in aneurysmal and occlusive disease of abdominal arteries.

Gelsoft™ Plus vascular prostheses are gelatin sealed knitted polyester prosther repair. The Gelsoft™ Plus polyester vascular prosthesis family, which is the subject of this pre-market notification, is based on knitted polyester textile technology.

The provided text describes a 510(k) premarket notification for a medical device called Gelsoft™ Plus Vascular Prostheses. This submission is to demonstrate substantial equivalence to a legally marketed predicate device (K162803 Vascutek Gelsoft™ Plus Vascular Grafts).

The information provided does not include details about acceptance criteria, the specific study conducted, or device performance metrics as would typically be found in a study report. The document states:

"Nonclinical testing, including bench testing, shelf-life, biocompatibility testing, chemical characterization and an animal performance study, have been conducted to demonstrate equivalency. No clinical testing was necessary to demonstrate substantial equivalence."

This indicates that the assessment of substantial equivalence was based entirely on non-clinical data, and therefore, many of the requested categories in your prompt are not applicable to this type of submission.

Here's an analysis based on the information available in the provided text, addressing your points where possible:

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

The document does not provide a table of acceptance criteria or specific reported device performance metrics. Instead, it states that "nonclinical testing... have been conducted to demonstrate equivalency." This implies that the acceptance criteria would be that the new device's performance in these non-clinical tests is equivalent to, or within acceptable predefined limits compared to, the predicate device. However, these specific criteria and results are not detailed.

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

• Sample Size: Not specified for any of the non-clinical tests (bench, shelf-life, biocompatibility, chemical characterization, animal study).
• Data Provenance: Not specified. The applicant is Vascutek Ltd. in the United Kingdom, so the studies likely originated from there or a related testing facility. The studies are non-clinical, not human-patient based, so terms like "retrospective" or "prospective" are not applicable in the usual sense.

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

Not applicable. This was a non-clinical assessment, not requiring expert consensus on clinical findings. The "ground truth" would be established by standardized testing methods and measurements.

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

Not applicable. Adjudication methods like "2+1" are used in clinical studies where multiple human readers interpret data. This premarket notification is based on non-clinical tests.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a vascular prosthesis and not an AI-powered diagnostic or assistive tool.

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

Not applicable. This device is a vascular prosthesis, not a standalone algorithm.

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

The "ground truth" for the non-clinical tests would be based on:

• Established physical and chemical properties measured through bench testing.
• Standardized biocompatibility assessments (e.g., cytotoxicity, irritation).
• Observed effects in an animal model (for the animal performance study).
• Chemical characterization data.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable.

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Advanta VXT and Flixene vascular grafts are indicated for use in patients with peripheral vascular disease, where peripheral arteries must be repaired or replaced and open surgery is required. Indications for use also includes patients with end stage renal disease requiring arteriovenous vascular access for dialysis.

Atrium ePTFE vascular grafts are offered in a variety of designs; (including Advanta VXT and Flixene). They are made primarily of expanded polytetrafluoroethylene (ePTFE), and are available in a wide variety of configurations:

• . "Rings" (also referred to as "helix") for added radial support (made from a PTFE monofilament coil)
• . The Slider Graft Deployment System consisting of a pre-attached tip(s) with a clear flexible sheath (polyethylene)
• . Tapered end
• . Thin or standard wall thickness

The Advanta VXT graft is a 2-layer graft employing a single-layer ePTFE graft, which is then wrapped with an additional layer of ePTFE for increased support. The rings available on some Advanta VXT grafts are bonded to the exterior surface of the graft. By following the prescribed procedure, the rings can be removed incrementally as needed. The Flixene vascular graft is a 3layer graft comprised of ePTFE. This graft was designed with an additional layer of ePTFE. As a result of its design, ring support is not necessary. Implantable portion of graft is comprised of polytetrafluoroethylene (PTFE) with no more than 0.1% cobalt chromite blue-green Spinel ink on surface of the graft, which is used as a reference line. Additional materials in transient contact during placement of the graft include 303 stainless steel and polyethylene, which represents the graft deployment system and transfer sleeve.

The provided text is a 510(k) premarket notification for a medical device (vascular grafts) and does not contain information related to an A.I./algorithm-driven device or study. Therefore, I cannot extract the requested information regarding acceptance criteria and study data for an A.I. device from this text.

The document focuses on demonstrating substantial equivalence of the Advanta VXT and Flixene Vascular Grafts to previously cleared predicate devices, primarily through non-clinical bench testing. It explicitly states: "There were no clinical studies of the modified device." and "The Advanta VXT and Flixene Vascular Grafts are substantially equivalent to the predicate devices in the fundamental scientific technology of the device. The design verification and validation testing established that the Advanta VXT and Flixene Vascular Grafts are substantially equivalent to the predicate devices."

As such, I cannot provide:

1. A table of acceptance criteria and reported device performance for an AI/algorithm.
2. Sample sizes for a test set or data provenance for an AI/algorithm.
3. Number of experts or their qualifications for establishing ground truth for an AI/algorithm.
4. Adjudication methods for an AI/algorithm test set.
5. MRMC comparative effectiveness study results for AI assistance.
6. Standalone performance of an algorithm.
7. Type of ground truth for an AI/algorithm.
8. Sample size for a training set for an AI/algorithm.
9. How ground truth for a training set was established for an AI/algorithm.

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The GORE® PROPATEN® Vascular Graft is intended for use as a vascular prosthesis for replacement or bypass of diseased vessels in patients suffering from occlusive or aneurysmal diseases, in trauma patients requiring vascular replacement, for dialysis access, or for other vascular procedures.

The GORE® PROPATEN® Vascular Graft is a synthetic graft made of an expanded polytetrafluoroethylene (ePTFE) tube with a reinforcing film for radial strength. The luminal surface of the vascular graft is coated with the CBAS® Heparin Surface.

The provided document is a 510(k) premarket notification letter from the FDA for a vascular graft. It does not contain information about acceptance criteria or a study proving device performance against such criteria. The document only discusses substantial equivalence to a predicate device based on similar technology, manufacturing, coating, sterilization, and intended use, with a minor update to the end-of-shelf-life Heparin Surface Activity specification.

Therefore, I cannot extract the requested information regarding acceptance criteria, reported device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for a training set from this document.

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The exGraft and exGraft Carbon ePTFE Vascular Grafts are indicated for use as vascular prostheses.

exGraft and exGraft Carbon ePTFE Vascular Grafts are intended for use as vascular prostheses for replacement or bypass of diseased vessels in patients suffering occlusive or aneurysmal diseases, in trauma patients requiring vascular replacement, for dialysis access, or for other vascular procedures.

The exGraft and exGraft Carbon ePTFE Vascular Grafts are single use sterile vascular grafts constructed of expanded polytetrafluoroethylene (ePTFE) with a radiopaque ink applied to the surface. The exGraft Carbon ePTFE vascular grafts also contain a carbon coating impregnated into the inner surface of the graft wall.

The provided text is a 510(k) summary from the FDA for a medical device called "exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts." This document primarily focuses on demonstrating substantial equivalence to a predicate device based on manufacturing changes, and does not contain information about the acceptance criteria or a study proving that the device meets those criteria in the context of an Artificial Intelligence/Machine Learning (AI/ML) device.

The document lists performance data that was included in the submission, such as:

• Burst Strength
• Strength after Repeated Puncture
• Tensile Strength
• Suture Retention Strength
• Kink Radius
• Water Entry Pressure
• Microscopic Porosity
• Wall Thickness Eccentricity
• Wall Thickness

However, these are engineering performance data points for a physical vascular graft, not metrics relevant to an AI/ML device's performance (e.g., accuracy, sensitivity, specificity).

Therefore, it is not possible to provide the requested information about acceptance criteria and a study proving an AI/ML device meets them, because this medical device is a physical vascular graft, not an AI/ML device. The request asks for details like "sample size used for the test set," "number of experts used to establish the ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," and "type of ground truth," all of which are concepts applicable to AI/ML device validation, not to a physical vascular graft.

The 510(k) summary clearly states:

"The exGraft and exGraft Carbon ePTFE Vascular Grafts are single use sterile vascular grafts constructed of expanded polytetrafluoroethylene (ePTFE) with a radiopaque ink applied to the surface. The exGraft Carbon ePTFE vascular grafts also contain a carbon coating impregnated into the inner surface of the graft wall."

This describes a physical product, not a software device that would have AI/ML components requiring the type of performance study details requested.

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GORE® PROPATEN® Vascular Graft is intended for use as vascular prostheses for replacement or bypass of diseased vessels in patients suffering occlusive or aneurysmal diseases, in trauma patients requiring vascular replacement, for dialysis access, or for other vascular procedures.

The GORE® PROPATEN® Vascular Graft is a synthetic graft made of an expanded polytetrafluoroethylene (ePTFE) tube with a reinforcing film for radial strength. The luminal surface of the vascular graft is coated with the CBAS® Heparin Surface.

The provided text describes a 510(k) premarket notification for the GORE® PROPATEN® Vascular Graft. This type of FDA submission is for medical devices and does not involve an AI/ML algorithm. Therefore, the device does not have acceptance criteria, a study proving it meets acceptance criteria, or any of the other AI/ML-specific information requested (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth types, training set size, or how training set ground truth was established).

The document details the device, its intended use, predicate devices, and a summary of performance testing conducted to demonstrate substantial equivalence to the predicate device. These tests are physical and material property tests related to the vascular graft's design and manufacturing, not AI/ML performance.

Therefore, I cannot provide the requested information as it is not applicable to the provided document.

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The GORE® ACUSEAL Vascular Graft is intended for use as a vascular prosthesis in patients requiring vascular access.

The GORE® ACUSEAL Vascular Graft is a synthetic graft made of an expanded polytetrafluoroethylene (ePTFE) tube with a reinforcing film for radial strength. The luminal surface of the vascular graft is coated with the CBAS® Heparin Surface.

The provided document is a 510(k) clearance letter from the FDA for a medical device called the GORE® ACUSEAL Vascular Graft. This type of document establishes substantial equivalence to a predicate device and does not contain the detailed study information typically found in a clinical trial report or an academic paper describing device performance against explicit acceptance criteria.

Specifically, the document states:

• "One in vitro study was conducted to demonstrate substantial equivalence to the predicate device."
• "The GORE® ACUSEAL Vascular Graft is substantially equivalent to the predicate device. The change to the end-of-shelf-life Heparin Surface Activity specification does not raise new types of safety or effectiveness questions, and the testing provided in this application supports a determination of substantial equivalence."

Therefore, the document does not provide the information requested regarding acceptance criteria and the detailed study that proves the device meets them because it's a 510(k) clearance based on substantial equivalence, not a performance study against predefined criteria.

The 510(k) process focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than proving performance against specific quantitative acceptance criteria or conducting extensive clinical trials, especially for Class II devices like this vascular graft.

As a result, I cannot fill in the requested table and details about the study because that information is not present in the provided FDA clearance letter.

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GORE® ACUSEAL Vascular Graft is intended for use as a vascular prosthesis in patients requiring vascular access.

GORE® ACUSEAL Vascular Graft is intended for use as a vascular prosthesis in patients requiring vascular access. The GORE® ACUSEAL Vascular Graft is a multi-layer vascular graft with a low bleed layer between the inner and outer layers of ePTFE (expanded polytetrafluoroethylene). The luminal surface of the inner graft component is coated with the CBAS® Heparin Surface.

This document is a 510(k) Summary for the GORE® ACUSEAL Vascular Graft. It describes a medical device and its regulatory review, not an AI/ML powered device. Therefore, the request to describe acceptance criteria and associated studies for an AI/ML powered device cannot be fulfilled.

The document states that the GORE® ACUSEAL Vascular Graft has the same clinical use, indications for use, fundamental technology, materials, sterilization, and intended use as its predicate device (K130215, GORE® ACUSEAL Vascular Graft). The only differences are an additional packaging configuration and additional device configurations with different diameters.

The performance testing summarized relates to the physical and material properties of the vascular graft itself, not to the performance of an AI/ML algorithm.

Therefore, since the input document does not pertain to an AI/ML powered device, I cannot provide the requested information regarding AI/ML acceptance criteria, study details, ground truth establishment, or sample sizes for AI/ML models.

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The HeRO Graft is indicated for end stage renal disease patients on hemodialysis who have exhausted all other access options. These catheter-dependent patients are readily identified using the KDOQI guidelines as patients who:
• Have become catheter-dependent or who are approaching catheter-dependency (i.e., have exhausted all other access options, such as arteriovenous fistulas and grafts).
• Are not candidates for upper extremity fistulas or grafts due to poor venous outflow as determined by a history of previous access failures or venography.
• Are failing fistulas or grafts due to poor venous outflow as determined by access failure or venography (e.g. fistula/graft salvage).
• Have poor remaining venous access sites for creation of a fistula or graft as determined by ultrasound or venography.
• Have a compromised central venous system or central venous stenosis (CVS) as determined by a history of previous access failures, symptomatic CVS (i.e., via arm, neck, or face swelling) or venography.
• Are receiving inadequate dialysis clearance (i.e., low Kt/V) via catheters. KDOQI guidelines recommend a minimum Kt/V of 1.4.

The HeRO Graft is a non-autogenous (i.e., synthetic) vascular graft prosthesis which provides arterial venous access with continuous outflow into the central venous system. The HeRO Graft is composed of the following components: (1) Venous Outflow Component (VOC) with delivery stylet, (2) Arterial Graft Component (AGC) or HeRO Adapter with Support Seal (used in conjunction with commercial vascular grafts), and (3) Accessory Component Kit (ACK). The VOC consists of a radiopaque silicone base tube, a nitinol braid (imparts kink and crush resistance), a distal radiopaque marker band, and an outer silicone elastomer encapsulation layer. During surgery, the VOC is cut to length for the patient anatomy and then advanced over the barbs of the AGC Connector or HeRO Adapter. The AGC is a conventional ePTFE vascular graft with a guideline and beading near the custom titanium alloy connector to provide kink resistance. As an alternative to the AGC, the titanium alloy HeRO Adapter with Support Seal allow the clinician to choose one of the commercially available 6mm ID vascular grafts qualified for use with the HeRO Graft. The HeRO Graft Accessory Component Kit is intended to aid in the implantation of the HeRO Graft and contains instruments including, introducers, dilators, hemostasis valve with stopcock, disposable clamp, and hemostasis plug.
The HeRO Graft is a fully subcutaneous surgical implant single-use device provided sterile via ethylene oxide for long-term (>30 day) use.

The document provided does not contain information related to an AI/ML powered device, so there is no data to extract for device performance, ground truth, or expert review. The device described, the HeRO Graft, is a vascular graft prosthesis, which is a physical implant used in hemodialysis patients.

Therefore, I cannot fulfill the request to describe the acceptance criteria and study proving device meets acceptance criteria for an AI/ML powered device, as the provided text pertains to a traditional medical device.

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The exGraft and exGraft Carbon ePTFE Vascular Grafts are indicated for use as vascular prostheses. exGraft and exGraft Carbon ePTFE Vascular Grafts are intended for use as vascular prostheses for replacement or bypass of diseased vessels in patients suffering occlusive or aneurysmal diseases, in trauma patients requiring vascular replacement, for dialysis access, or for other vascular procedures.

The exGraft and exGraft Carbon ePTFE Vascular Grafts are single use sterile vascular grafts constructed of expanded polytetrafluoroethylene (ePTFE) with a radiopaque ink applied to the surface. The exGraft Carbon ePTFE vascular grafts also contain a carbon coating impregnated into the inner surface of the graft wall.

I am sorry, but the provided text from the FDA 510(k) notification for the exGraft and exGraft Carbon ePTFE Vascular Grafts does not contain the information necessary to describe acceptance criteria or a study proving the device meets those criteria, specifically concerning performance data related to AI/algorithm performance.

The document is a 510(k) clearance letter and summary for a vascular graft, which is a physical medical device, not a software or AI-based device. Therefore, it does not involve AI performance metrics, expert adjudication for ground truth, MRMC studies, or training/test sets as would be relevant for an AI/ML device.

The "Performance Data" section (VII) in the 510(k) Summary explicitly states: "The proposed exGraft and exGraft Carbon ePTFE Vascular Grafts utilize the same performance data as the exGraft and exGraft Carbon ePTFE Vascular Grafts cleared under K202471. Additional nonclinical data related to packaging, shelf life and sterilization was provided to support substantial equivalence." This indicates that the performance data refers to the physical characteristics and safety/efficacy of the vascular graft itself, not an AI algorithm.

Therefore, I cannot provide the requested information based on the given input.

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