Search Results

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.

Ask a specific question about this device

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.

Ask a specific question about this device

Indicated for extra anatomical vascular repair, primarily for axillo-femoral bypass and femoro- popliteal reconstruction.

Gelsoft Plus ERS grafts are an externally reinforced (ERS), gelatin-sealed, knitted polyester grafts.

Vascutek's polyester vascular prosthesis family is based on a polyester textile technology. The starting point for all products is polyester yarn. This is fabricated into tubular form by knitting. This is referred to as the base fabric and exists in a variety of designs to meet particular end uses. Further processing is designed to retain the tubular form of the graft e.g. crimping and addition of an external polypropylene support. In Gelsoft Plus ERS, this external polypropylene support is to provide kink resistance and a smooth flow surface for extra-anatomical applications. The polypropylene support may be peeled where it extends to the ends of the prosthesis, in order to facilitate the fashioning of the anastomosis. Additional branches are also attached in a variety of configurations. The last process is impregnation with a bovine derived gelatin sealant. This process fills the gaps between threads of the polyester base graft and eliminates the need for pre-clotting of the graft prior to implant.

The provided text is a 510(k) summary for the Vascutek Gelsoft Plus ERS Vascular Graft. This document outlines the device's characteristics, intended use, and claims of substantial equivalence to a predicate device. However, it does not describe a study involving AI, human readers, or image analysis for detection or diagnostic purposes.

The section "The nonclinical testing performed, including physical bench, biocompatibility, chemical characterisation and an animal performance study, have demonstrated that the device is substantially equivalent to the predicate device" refers to engineering and animal studies to demonstrate the physical and biological properties of the vascular graft itself, not a performance study of a diagnostic AI system.

Therefore, the information required to answer the requested questions about acceptance criteria for an AI device performance, sample sizes, ground truth establishment, expert adjudication, or MRMC studies for AI is not present in the provided text.

Based on the provided text, the device is a vascular graft, not an AI-powered diagnostic device. The acceptance criteria and studies described relate to the physical and biological performance of the graft material, not an AI's diagnostic performance.

Ask a specific question about this device

Vascutek Cardiovascular Fabric is indicated for vascular repair whenever knitted polyester fabrics are normally indicated.

Due to its particularly high strength. Gelseal is especially suitable for thoracic use whereas the softer handle of the Gelsoft makes it ideal for peripheral use. The Thin Wall fabric is designed for endaterectorny, particularly of the carotid arteries.

The Vascutek Cardiovascular Fabric are a range of gelatin sealed, knitted, polyester patch fabrics. The range consists of three different patch fabrics which are manufactured using identical materials, processes and procedures but which, because of slight differences in the pattern of the base fabric, exhibit different physical characteristics. This range of products is provided in order to give the implanting surgeon a choice of several different fabrics from which they can chose the most suitable according to their own preferences and according to specific demands of any given surgical situation.

Two of the patches, Gelseal™ and Gelsoft™, are based on fabrics which are currently used in Vascutek's range of tubular vascular prostheses, which have received Premarket approval from the FDA. The only difference between the cardiovascular fabrics and the tubular grafts is that the patches are produced in flat, patch formats (i.e. square or rectangular) and have not been subjected to the crimping process which is used in the production of the tubular prostheses. With this single exception, the manufacturing facilities, equipment, processes and the quality control processes and procedures are identical to those used in the manufacture of the Gelseal™ and Gelsoft™ vascular prostheses.

The third type of patch, the Thin Wall Carotid Patch, is also manufactured using the identical materials, processes and procedures as the other cardiovascular patches but with a slightly modified knit pattern. This new structure has been developed in order to maintain the physical characteristics necessary for general cardiovascular patching but with a reduced wall thickness and characteristics which make it ideally suited to use for parching carotid arteries after endarterectomy procedures.

This is a 510(k) premarket notification for a medical device, not a study evaluating an AI algorithm. Therefore, the requested information about acceptance criteria, study design, expert involvement, and ground truth for an AI device is not available in the provided text.

The document describes the Vascutek Gelseal Patch, Vascutek Gelsoft Patch, and Vascutek Thin Wall Carotid Patch, which are cardiovascular fabric patches. The FDA has determined these devices are substantially equivalent to legally marketed predicate devices.

The "study" referenced in the document is a series of nonclinical tests performed to demonstrate that the device is safe and effective when compared to predicate devices. These tests included:

• Physical testing
• Biocompatibility testing
• Chemical characterization
• An animal performance study

The purpose of these tests was to show that the new devices, with a change in the gelatin supplier, perform as well as the previously approved devices.

Since this is not an AI device, the specific questions about acceptance criteria related to AI performance metrics (like sensitivity, specificity, or AUC), sample sizes for AI training/test sets, expert adjudication, or MRMC comparative effectiveness studies are not applicable and therefore cannot be answered from the provided text.

Ask a specific question about this device

Gelseal™ Vascular Prostheses: "Indicated for replacement or bypass of abdominal arteries afflicted with aneurysmal or occlusive disease."

Gelsoft™ Vascular Prostheses: "Indicated for abdominal and peripheral vascular repair, i.e. replacement or bypass in aneurysmal and occlusive disease of arteries."

Gelsoft™ Plus Vascular Prostheses: "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."

Gelseal. Gelsoft and Gelsoft Plus vascular prostheses are gelatin sealed knitted polyester prostheses, designed for vascular repair.

The Vascutek Gelseal, Gelsoft and Gelsoft Plus polyester vascular prosthesis family, which is the subject of this pre-market notification, is based on knitted polyester textile technology.

This is a medical device submission for a vascular graft. The document is a 510(k) summary and FDA clearance letter. It does not describe a study involving an algorithm or AI. Instead, it describes a device (vascular grafts) and its equivalence to predicate devices based on non-clinical testing.

Therefore, many of the requested categories related to algorithm performance, ground truth, expert review, and sample sizes for AI/algorithm studies are not applicable.

Here's the information that can be extracted, with notes on what is not applicable:

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

The document states: "The nonclinical testing performed, including physical and biocompatibility testing, chemical characterisation and an animal performance study, have demonstrated that the device is substantially equivalent the predicate devices."

However, specific acceptance criteria and reported numerical performance metrics for these nonclinical tests are not detailed within this document. The document primarily focuses on establishing substantial equivalence to predicate devices for regulatory clearance rather than presenting detailed test results.

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 in this document for the nonclinical tests.
• Data Provenance: Not specified, but the tests were performed by the manufacturer, Vascutek Ltd., which is based in Scotland, UK. The studies would have been prospective to generate the data for this submission.

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 device is a vascular graft, not an AI/algorithm-based diagnostic or prognostic tool requiring expert review of data for ground truth establishment.

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

Not applicable. This is not an AI/algorithm study requiring adjudication of expert interpretations.

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. No AI component is described.

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

Not applicable. No algorithm is described.

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

Not applicable. For the nonclinical tests mentioned (physical, biocompatibility, chemical characterisation, animal performance study), the "ground truth" would be established by the defined test methodologies and objective measurements for each test, compared against predetermined specifications or predicate device performance. For example, for biocompatibility, it would be compliance with ISO standards (e.g., ISO 10993).

8. The sample size for the training set

Not applicable. There is no algorithm or AI model requiring a training set.

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

Not applicable. There is no algorithm or AI model requiring a training set.

Ask a specific question about this device

Indicated for thoracic reconstruction procedures for replacement of the thoracic aorta in cases of aneurysm, dissection, or coarctation.
Indicated for repair or replacement of damaged and diseased vessels of the abdomen in cases of aneurysmal or occlusive disease.
Indicated for the repair or replacement of damaged and diseased thoracic aorta in cases of aneurysm, dissection or coarctation.
Indicated for repair or replacement of damaged and diseased vessels of the abdomen and thoracic aorta in cases of aneurysm, dissection or coarctation.
Repair or replacement of damaged and diseased vessels of the thoracic aorta in cases of aneurysm, dissection or coarctation.
Gelweave branched vascular prostheses, including Siena™ vascular prostheses 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™ vascular prostheses are gelatin sealed woven polyester grafts, designed for vascular repair.
The Vascutek Gelweave polyester vascular graft family, which is the subject of this pre-market notification, is based on woven polyester textile technology.

The provided document is a 510(k) Summary for the Vascutek Gelweave™ Vascular Grafts. It discusses substantial equivalence to previously marketed devices and the non-clinical testing performed. However, it does not contain the specific information required to answer your request regarding acceptance criteria and performance studies of a medical device AI/ML algorithm.

The document pertains to a physical medical device (Gelweave Vascular Grafts) and its material change (new gelatin supplier), not an AI/ML system. Therefore, details like AI model performance, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance are not applicable and not present in this document.

In summary, none of the requested information to describe the acceptance criteria and study proving device meets the acceptance criteria for an AI/ML device is available in the provided text.

Ask a specific question about this device

Gelweave™ branched vascular grafts: "Repair or replacement of damaged and diseased vessels of the abdomen and thoracic aorta in cases of aneurysm, dissection or coarctation".

"Gelweave™ branched vascular grafts, including Siena™ grafts can also be used for debranching i.e. reconstruction of the aortic vessels and associated Hybrid procedures".

Not Found

The provided document is a 510(k) premarket notification letter from the FDA regarding the "Gelweave™ Branched Vascular Grafts with Radiopaque Markers." This document officially clears the device for marketing based on substantial equivalence to predicate devices. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methodologies that would be typically found in a clinical study report or a detailed technical submission.

Therefore, I cannot provide the requested information from the given text.

The document primarily states:

• The device name and its classification (Class II, Product Code DSY).
• The indications for use (repair or replacement of damaged/diseased vessels of the abdomen and thoracic aorta, and debranching/hybrid procedures).
• That the FDA has determined the device is substantially equivalent to legally marketed predicate devices.
• General regulatory requirements for the manufacturer.

To answer your questions, one would need to review the actual 510(k) submission document (which is typically much more extensive than this clearance letter) or a separate clinical study report from the manufacturer.

Ask a specific question about this device

Creation of subcutaneous arteriovenous conduits for blood access, bypass or reconstruction of occluded or diseased arterial blood vessels.

Not Found

The provided text is a letter from the FDA regarding the clearance of a medical device, Vascutek Maxiflo and Taperflo ePTFE Vascular Prostheses. It is a regulatory document and does not contain any information about acceptance criteria, study details, or device performance data.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from this document. My response is based solely on the provided text.

Ask a specific question about this device

"bypass or reconstruction of peripheral arterial blood vessels".
The Vascutek Cobrahood™ vascular grafts are still intended for prescription use only.

Vascuteks ePTFE vascular grafts were originally cleared by FDA in 1999 (K992832: unsealed and K993667: gelatin sealed). In 2004, Vascutek received clearance for the application of an external ePTFE wrap to the original FDA cleared ePTFE vascular graft range (K041528). As a result of development in line with design control procedures, it became possible to flare the end of a standard wrapped ePTFE graft to create the Cobrahood™ design as shown in Figures 1a and 1b of this submission. The intended use is, "bypass or reconstruction of peripheral arterial blood vessels".

All Vascutek ePTFE grafts are manufactured from virgin expanded polytetrafluoroethylene resin, including the ePTFE external wrap. Cobrahood™ ePTFE vascular grafts are not sealed, i.e. do not have an external gelatin coating. The grafts are available with or without an external support constructed of PTFE. This is identical to the support present on the predicate devices, cleared by FDA in 2005 (K041528).

All Vascutek ePTFE vascular grafts are supplied sterile. The method of sterilization is Ethylene Oxide. A shelf-life of five years has been established. All related parameters remain unchanged to the predicate grafts.

The Cobrahood™ ePTFE vascular graft range is detailed fully in Table 2 of this submission. Manufacturing drawings are provided in Attachment I.

The document provided is a 510(k) summary for the Vascutek Cobrahood™ ePTFE Vascular Grafts and the FDA's clearance letter. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device, rather than explicit acceptance criteria and performance against those criteria in a typical clinical study.

Therefore, the information regarding acceptance criteria and a study proving the device meets those criteria will be interpreted in the context of a 510(k) submission, specifically focusing on bench testing for substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "All samples tested" for bench testing, but does not provide the number of Cobrahood™ grafts or predicate grafts used.
• Data Provenance: The bench testing was conducted by Vascutek Ltd. in Scotland. It is a retrospective comparison against previously cleared predicate devices.

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

This section is not applicable in the context of this 510(k) submission. The "ground truth" for demonstrating substantial equivalence against predicate devices is established through engineering and performance specifications, and comparison of physical characteristics and bench test results, rather than expert consensus on clinical outcomes or images. The "ground truth" is effectively the established performance and characteristics of the predicate devices.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human interpretation or clinical adjudication. Substantial equivalence is determined by comparing design, materials, and performance data from bench 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 graft, not an AI-powered diagnostic or interpretive tool. No MRMC study was conducted.

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

Not applicable. This device is a physical medical implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the bench testing was primarily the engineering specifications and established performance characteristics of the predicate devices, against which the Cobrahood™ graft's physical and performance data were compared. The objective was to show that the new design (flared outflow) did not alter the safety and effectiveness, and that the performance remained unchanged, thereby achieving substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI model requiring a training set.

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

Not applicable.

Ask a specific question about this device

Gelweave "M branched vascular graffs: "Repair of replacentent of damaged and diseased vessels of the abdomen and thoracic aorta in cases of anewrysm, dissection or courclation". Sicua TM grafts vascular with and without Gelweave radiopaque markers: "Repair or replacement of damaged and diseased vessels of the thoracie aorta in cases of anew ysm, dissection or coarctation". "Gelweave" brunched vascular grafts, including Siena" grafts can also be used for debranching i.e. reconstruction of the aortic vessels and associated Hybrid procediires".

The design and all other properties of the Vascutek Gelweave™ branched vascular grafts and Gelweave Siena™ vascular grafts with and without radiopaque markers remain unchanged. The Vascutek Gelweave™ branched vascular grafts and Gelweave Siena™ vascular grafts with and without radiopaque markers function as vascular grafts manufactured from standard polyester and gelatin sealant technologies.

The provided document describes the Vascutek Gelweave™ branched vascular grafts and Gelweave Siena™ vascular grafts with and without radiopaque markers. This submission (K090987) is for an expanded indication for use of existing devices, not a new device. Therefore, the "acceptance criteria" and "device performance" are focused on demonstrating that the expanded indication does not compromise the safety and effectiveness of the unchanged device.

Here's a breakdown based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is an expanded indication for an existing device with no changes in design, materials, or manufacturing, the acceptance criteria are not in terms of specific performance metrics for the device itself (e.g., accuracy, sensitivity, specificity). Instead, the acceptance criteria revolve around demonstrating that the device's fundamental performance characteristics (sealing properties) are maintained even with procedures related to the expanded indication.

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

• Test Set Sample Size: 21 Gelweave grafts were used for the bench testing.
• Data Provenance: The bench testing was conducted by Vascutek Ltd. (Scotland, United Kingdom). The clinical information provided was a "comprehensive review of the literature in relation to clinical use of standard branched polyester vascular grafts," implying retrospective data from published studies and clinical opinions globally.

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

• Number of Experts: Not explicitly stated as a defined number of individual experts for establishing a ground truth. Instead, the submission relies on "clinical opinion" and "available literature" for the clinical context of the expanded indications.
• Qualifications of Experts: Not specified. It refers to "clinical opinion" generally, implying established consensus within the surgical community regarding debranching and hybrid procedures.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable in the context of this submission. The bench testing involved objective measurement of blood leakage, not a qualitative assessment requiring adjudication. The clinical justification relied on a literature review, not individual case adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

• No. An MRMC comparative effectiveness study was not done. This submission focuses on expanding the indications for an existing physical device, not on the performance of a diagnostic algorithm or a device requiring human reader interpretation.

6. If a Standalone Study Was Done

• Yes, a standalone bench test was done to assess the physical integrity and sealing properties of the device under conditions related to the expanded indication. This test measured blood leakage after mechanical manipulation of a delivery catheter through the graft's side branch.
• The clinical justification was a standalone literature review, not a clinical study involving human subjects for this specific submission.

7. The Type of Ground Truth Used

• For the bench testing, the "ground truth" was quantifiable physical measurement (weight of blood lost) to determine if the graft's sealing properties were maintained.
• For the clinical justification, the "ground truth" was established by expert consensus and outcomes data as reflected in the "available literature and clinical opinion" regarding the standard practice of debranching and hybrid procedures with similar grafts.

8. The Sample Size for the Training Set

• Not applicable. This submission is for an expanded indication of an existing physical medical device, not an AI/ML algorithm that requires a training set.

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

• Not applicable. As stated above, this is not an AI/ML algorithm submission.

Ask a specific question about this device