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Woven Collagen Coated Vascular Prostheses are indicated for surgical repair, bypass or replacement of arteries in the treatment of aneurysmal and occlusive diseases of the aorta, both thoracic and abdominal, visceral arteries, and proximal peripheral arteries . Due to the low porosity of Woven vascular grafts, these products are recommended for use in patients requiring heparinization prior to or during surgery.

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This document is a 510(k) clearance letter from the FDA for a vascular graft. It does not contain information about acceptance criteria or a study proving that a device meets such criteria. Therefore, I cannot fulfill your request with the provided text.

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The InterGard Woven Connector Graft is intended for use in arterial perfusion of the aorta, via femoral or axillary artery, for cardiopulmonary bypass when extracorporeal circulation is required for periods up to six (6.0) hours.

InterGard Woven Connector Graft

I am sorry, but the provided text does not contain the information required to answer your request. The document appears to be an FDA 510(k) clearance letter for a medical device (InterGard Woven Connector Graft) and details its indications for use. However, it does not include any specifics about acceptance criteria, study methodologies, sample sizes, ground truth establishment, or comparative effectiveness studies for the device.

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InterVascular InterGard Knitted Vascular Graft Sizer is an accessory to the InterGard Knitted Vascular Prosthesis and is designed to assist the physician in determining the size of the lumen of the host vessel in order to select the appropriate knitted vascular graft diameter.

The InterVascular Graft Sizer, an accessory to the InterGard Knitted Vascular Prosthesis, consists of a set of 5 disposable dual gauge sizers and 1 disposable single gauge sizer constructed of a biocompatible material. The size indicated on the instrument approximately corresponds to the size of the lumen of the host vessel. The labeled sizes of the instrument are 6, 7, 8, 10, 12, 14, 16, 18, 20, 22, and 24mm. The surgeon makes the ultimate decision on the size of the graft.

The provided text describes a 510(k) submission for the InterVascular InterGard Knitted Vascular Graft Sizer. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than performing comprehensive de novo clinical studies with acceptance criteria, human reader studies, or detailed ground truth establishment as would be common for AI/ML devices. Therefore, much of the requested information regarding acceptance criteria and detailed study design is not applicable or explicitly stated in the provided documents.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Study that proves the device meets the acceptance criteria:

The primary "study" described is the demonstration of biocompatibility and substantial equivalence to a predicate device.

• Biocompatibility Testing: Performed on the finished products and the material itself. This testing demonstrated the device is non-hemolytic and non-cytotoxic, and that the material meets the requirements of U.S. Pharmacopeia (USP) XXIII Class VI-50.

• Substantial Equivalence Argument: The manufacturer, InterVascular, asserted that their device is substantially equivalent to the Meadox Graft Sizer (K854431) based on intended use, composition, and function. The FDA's 510(k) clearance (K022242) signifies their agreement with this determination. This means the FDA found that the new device is as safe and effective as the predicate device.

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

This information is not detailed in the provided text. For a simple medical device like a sizer, a formal "test set" in the context of clinical performance or data-driven AI/ML validation is generally not required for 510(k) clearance. The focus is on material safety and functional similarity to the predicate. Biocompatibility testing typically involves laboratory tests on samples of the device materials.

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)

This information is not applicable/provided. The concept of "ground truth" established by experts for a test set is not relevant for this type of device and 510(k) submission. The device's function is a physical measurement aid, not an diagnostic interpretation.

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

This information is not applicable/provided. Adjudication methods are not relevant for the type of testing described (biocompatibility and substantial equivalence for a physical sizing device).

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

This information is not applicable/provided. The InterVascular InterGard Knitted Vascular Graft Sizer is a physical medical device, not an AI/ML algorithm. Therefore, MRMC studies examining human reader improvement with AI assistance are irrelevant.

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

This information is not applicable/provided. The device is a physical sizer, not an algorithm.

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

The concept of "ground truth" as typically discussed for diagnostic devices or AI algorithms is not directly applicable to this device.

• For biocompatibility, the "ground truth" would be established by standardized laboratory assays and their metrics (e.g., cell viability, hemolytic index) measured against established thresholds from standards like USP XXIII Class VI-50.
• For sizing accuracy, while not explicitly detailed as "ground truth" in the text, the device states "The size indicated on the instrument approximately corresponds to the size of the lumen of the host vessel." The ultimate "ground truth" for selecting the correct graft size is presented as the surgeon's clinical judgment.

8. The sample size for the training set

This information is not applicable/provided. The device is a physical medical device, not an AI/ML algorithm that requires a training set.

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

This information is not applicable/provided. As above, there is no training set for this type of device.

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InterGard HemaBridge and InterGard Aortic Arch Collagen Coated Vascular Prostheses are indicated for surgical repair, bypass, or replacement of arteries in the treatment of aneurysmal and occlusive disease of the thoracic and abdominal aorta, visceral arteries, and proximal peripheral arteries. Due to the low porosity of the grafts, these products are recommended for use in patients requiring heparinization prior to or during surgery.

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The provided text does not contain information about the acceptance criteria or a study that proves the device meets specific acceptance criteria.

The document is a 510(k) clearance letter from the FDA for two vascular prostheses: InterGard HemaBridge Collagen Coated Vascular Prosthesis and InterGard Aortic Arch Collagen Coated Vascular Prosthesis. It confirms that the devices are substantially equivalent to legally marketed predicate devices for the specified indications for use.

While the letter mentions the devices are "substantially equivalent" for specific indications, it does not include:

1. A table of acceptance criteria and reported device performance.
2. Details about a specific study proving the device meets acceptance criteria.
3. Sample sizes used for test sets or their data provenance.
4. Number or qualifications of experts used for ground truth establishment.
5. Adjudication methods.
6. Information about Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or effect sizes.
7. Details on standalone algorithm performance.
8. The type of ground truth used.
9. Sample size for the training set or how ground truth for the training set was established.

The letter is a regulatory approval document, not a clinical study report.

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InterGard Collagen Coated and Heparin Bonded vascular prostheses are indicated for surgical repair, bypass, or replacement of arteries in the treatment of aneurysmal and occlusive disease of the abdominal aorta, visceral arteries, and peripheral arteries. Due to the low porosity of the grafts, these products are recommended for use in patients requiring heparinization prior to or during surgery.

The InterGard Knitted Collagen Coated & Heparin Bonded Vascular Prostheses including The InterGard Knitted Ultra-Thin, are Vascular Grafts made of Dacron fabric and coated with bovine collagen. These products are offered in numerous lengths and diameters exceeding 6 mm.

The provided text is a 510(k) summary for the InterGard Knitted Collagen Coated & Heparin Bonded Vascular Prosthesis. It does not describe an AI medical device or a study proving its performance against acceptance criteria in the way requested.

Instead, the document details a medical device (vascular prostheses/grafts) and aims to demonstrate its substantial equivalence to previously marketed predicate devices. The "study" mentioned refers to bench and animal studies to validate specifications and published clinical data, which are typically part of a traditional medical device clearance process, not an AI performance study measuring metrics like sensitivity, specificity, or AUC.

Therefore, I cannot provide the requested information in the format of AI acceptance criteria and study details because the document refers to a non-AI medical device and a different type of regulatory submission.

Here's a breakdown of what the document does describe, aligning with the general themes of your request but not specific to AI:

• Device Type: InterGard Knitted Collagen Coated & Heparin Bonded Vascular Prostheses.
• Purpose: Surgical repair, bypass, or replacement of arteries for aneurysmal and occlusive disease.
• Regulatory Pathway: 510(k) submission, confirming substantial equivalence to predicate devices (InterGard Knitted Collagen Coated Vascular Prostheses and InterGard Knitted Ultra-Thin Collagen Coated Vascular Prostheses).
• Performance Claim (Substantial Equivalence): The device has similar technological characteristics (underlying fabric, collagen coating material) and meets the same strength (circumferential probe burst and radial strength), collagen adherence, and water permeability specifications as the predicate devices.
• Validation: These results were validated by bench and animal studies and further supported by published clinical data.

To directly answer your specific questions in the context of the provided document (even though it's not applicable to AI):

1. Table of acceptance criteria and the reported device performance:

   • Acceptance Criteria (from document): Same strength (circumferential probe burst and radial strength), collagen adherence, and water permeability specifications as the predicate devices.
   • Reported Device Performance (from document): "[The products] meet the same strength (circumferential probe burst and radial strength), collagen adherence, and water permeability specifications as the predicate devices."

2. Sample sized used for the test set and the data provenance: Not specified in the provided summary for bench/animal/clinical studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/specified. The performance is based on physical/material properties compared to predicate devices.

4. Adjudication method: Not applicable/specified.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This is a traditional medical device, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.

7. The type of ground truth used: For the device's technical characteristics, the "ground truth" would be established physical and material property standards and performance benchmarks set by the predicate devices, likely through laboratory testing. For "clinical data," it would refer to patient outcomes from previous studies.

8. The sample size for the training set: Not applicable to this type of device and submission.

9. How the ground truth for the training set was established: Not applicable to this type of device and submission.

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InterGard Woven collagen coated vascular prostheses are indicated for surgical repair, bypass, or replacement of arteries in the treatment of aneurysmal and occlusive disease of the thoracic and abdominal aorta, visceral arteries, and proximal peripheral arteries. Due to the low porosity of the grafts, these products are recommended for use in patients requiring heparinization prior to or during surgery.

InterGard Woven Collagen Coated Vascular Prostheses

This document is a 510(k) clearance letter from the FDA for a medical device called "InterGard Woven Collagen Coated Vascular Prostheses." It declares the device substantially equivalent to legally marketed predicate devices, but it does not contain any information about acceptance criteria, device performance studies, or clinical trial data.

Therefore, I cannot provide the requested information based on the input text. The document is strictly a regulatory clearance and does not delve into the technical validation of the device.

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InterGard Knitted Ultra Thin Vascular Graft

• InterGard knitted Ultra Thin collagen coated vascular grafts are indicated for surgical repair, bypass, or replacement of arteries in the treatment of aneurysmal and occlusive disease of the proximal peripheral arteries. Due to the low porosity of the grafts, these products are recommended for use in patients requiring heparinization prior to or during surgery.
  HemaCarotid Patch Ultra Thin
  The HemaCarotid Patch Ultra Thin is indicated for cardiac and vascular patch graft angioplasty. Due to the low porosity of the fabric, these products are recommended for use in patients requiring heparinization prior to or during surgery.

InterGard™ Knitted Ultra Thin Collagen Coated Vascular Grafts and Patches

This document is a 510(k) clearance letter from the FDA, which declares substantial equivalence for the InterGard™ Knitted Ultra Thin Collagen Coated Vascular Grafts and Patches. It does not contain information about specific acceptance criteria or a study proving the device meets those criteria in the way a clinical trial report or a performance study would.

Therefore, I cannot provide the requested information based on the provided text, as this document type typically does not include the details of performance studies or acceptance criteria tables. The FDA 510(k) clearance process relies on demonstrating substantial equivalence to a predicate device, rather than requiring extensive new performance studies in all cases.

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InterGard woven vascular prostheses are indicated for surgical repair, bypass, or replacement of arteries in the treatment of aneurysmal and occlusive disease of the abdominal aorta, visceral arteries, and proximal peripheral arteries. Due to the low porosity of the grafts, these products are recommended for use in patients requiring heparinization prior to or during surgery.

InterGard™ Woven Collagen Coated Vascular Prostheses

The provided document is a 510(k) clearance letter from the FDA for the InterGard™ Woven Collagen Coated Vascular Prostheses. This document does not contain information on acceptance criteria, reported device performance, or any study details that would demonstrate the device meets acceptance criteria.

The letter primarily:

• Confirms that the device is substantially equivalent to legally marketed predicate devices.
• Outlines post-market surveillance study requirements under Section 522(a) of the act.
• Details device tracking requirements under Section 519(e) of the act.
• Provides general information on regulatory responsibilities.
• Includes an "Indications for Use" statement for the device.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study details.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. Ground truth establishment for the training set.

Ask a specific question about this device

Ask a specific question about this device