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The HEMASHIELD Vascular Grafts are indicated for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease. The prosthesis is also recommended for use in patients requiring systemic heparinization prior to, or during, surgery.

The HEMASHIELD Vascular Grafts are Woven Double Velour polvester grafts impregnated with highly purified collagen. The HEMASHIELD Vascular Grafts are designed to reduce . bleeding at implant and thereby eliminate the operative preclotting step. The collagen is designed to be gradually resorbed by the patient. In addition to collagen, the grafts also contain glycerol as a softening agent.

HEMASHIELD Woven Vascular Grafts - Acceptance Criteria and Study Details

The provided document describes the acceptance criteria and study performed to demonstrate substantial equivalence for the HEMASHIELD Woven Vascular Grafts. As this is a 510(k) submission for a predicate device modification, the focus is on non-clinical bench testing rather than clinical trials with human readers or AI algorithms.

1. Acceptance Criteria and Reported Device Performance

The document states that the results of non-clinical tests meet the specified acceptance criteria and are substantially equivalent to the predicate device. However, the exact quantitative acceptance criteria for each test and the reported numerical performance values for the proposed device are not explicitly provided in the given text. The tests performed are listed as:

2. Sample Size and Data Provenance for Test Set

• Sample Size: The document does not specify the exact sample size (number of grafts) used for each of the bench tests.
• Data Provenance: The data is from bench testing conducted by MAQUET Cardiovascular LLC. The context of a 510(k) submission implies this testing was done internally by the manufacturer to support regulatory submission. No country of origin is explicitly stated, but the company address is in Wayne, New Jersey, USA. The testing is prospective in the sense that it was conducted specifically to evaluate the modified device against predetermined criteria.

3. Number of Experts and Qualifications for Ground Truth of Test Set

• Not Applicable. This study is a non-clinical bench test evaluating physical properties of a vascular graft, not a diagnostic or AI device that requires expert review for ground truth establishment.

4. Adjudication Method for Test Set

• Not Applicable. As this is a non-clinical bench test, there is no need for expert adjudication of results. Each test would have objective measurement outcomes.

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

• No. An MRMC study was not performed. This type of study is relevant for diagnostic devices involving human readers and potentially AI assistance, which is not the nature of this vascular graft evaluation.

6. Standalone (Algorithm Only) Performance Study

• No. This is not an AI algorithm or software-only device. The evaluation focuses on the physical properties of a medical implant.

7. Type of Ground Truth Used

• The "ground truth" for the bench tests would be the objective measurements obtained from established testing standards and methodologies (e.g., ISO or ASTM standards, or equivalent internal validated methods). The results of these measurements were then compared against predetermined acceptance criteria, likely derived from the predicate device's performance or relevant standards.

8. Sample Size for Training Set

• Not Applicable. This is a non-clinical bench test, not a machine learning model that requires a training set.

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

• Not Applicable. As there is no training set, this question is not relevant.

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The AlboGraft Double Velour Knitted or Woven Vascular Prosthesis (peripheral indication) are indicated for use in the replacement or repair of arteries affected with aneurismal or occlusive disease.

Albograft Vascular Prosthesis is a knitted/woven tubular polyester fabric, impregnated with bovine collagen.

The provided text describes a 510(k) summary for the Albograft™ Vascular Prosthesis, but it does not contain acceptance criteria or a study designed to explicitly prove the device meets acceptance criteria in the typical sense of a diagnostic or AI device study.

Instead, this document describes a pre-market notification for a medical device (a vascular prosthesis) seeking substantial equivalence to a predicate device. The "study" mentioned is a retrospective clinical review to demonstrate the device's performance in a real-world setting.

Here's a breakdown of the requested information, addressing what is present and what is absent:

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

This document does not define explicit acceptance criteria in the format of specific thresholds for performance metrics (e.g., sensitivity, specificity, accuracy) that are then directly tested against in a controlled study.

Instead, the "Summary of Retrospective Clinical Review" provides real-world performance data for the Albograft™ Vascular Prosthesis. The implicit "acceptance" for this type of device in a 510(k) process is demonstrating substantial equivalence to a predicate device, which is often supported by showing comparable clinical outcomes. The clinical outcomes presented are intended to support the safety and effectiveness of the device when used for its intended purpose.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The "Acceptance Criteria" column is filled with "Implicit" as the document does not explicitly define quantitative thresholds that were pre-defined as regulatory "acceptance criteria" for the clinical review. These are observed clinical outcomes. The determination of "substantial equivalence" would involve comparing these outcomes with those expected or reported for the predicate device, or generally accepted clinical outcomes for such procedures.

2. Sample size used for the test set and the data provenance

• Sample Size (Test Set): 66 consecutive patients
• Data Provenance:
  • Country of Origin: Not explicitly stated, but the submission is from LeMaitre Vascular, Inc. in Burlington, MA, USA, and the clinical review spans from Jan 1, 2007, to March 31, 2009. The retrospective nature suggests a single clinical site or registry.
  • Retrospective or Prospective: Retrospective Clinical Review

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

This information is not provided in the document. As this is a retrospective review of patient outcomes related to a surgical implant, the "ground truth" would generally be established by the clinical records, diagnostic tests, and assessments made by the treating physicians and hospital staff. There is no mention of an independent panel of experts establishing ground truth for the purpose of a study evaluating a diagnostic device.

4. Adjudication method for the test set

This information is not provided in the document. Adjudication methods like 2+1 or 3+1 are typically used in studies involving expert readers for diagnostic tasks. This retrospective clinical review focuses on observed patient outcomes, not on interpretation of data by multiple experts needing adjudication.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This document describes a vascular prosthesis (surgical implant), not an AI-assisted diagnostic device. Therefore, no information on human reader improvement with/without AI assistance is applicable or provided.

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

No, a standalone algorithm performance study was not done. This device is a physical surgical implant, not an algorithm.

7. The type of ground truth used

The "ground truth" for this clinical review appears to be patient outcomes data and clinical diagnostics as recorded in medical charts and follow-up visits. This includes:

• Pre-operative diagnoses (aneurysmal or occlusive disease, Fontaine stages, TASC II classification)
• Ankle Brachial Index (ABI) measurements
• Surgical results and post-operative complications (mortality, infection)
• Follow-up assessments (Fontaine stage, ABI, patency rates determined by various clinical methods, limb salvage rate).

8. The sample size for the training set

Not applicable/Not provided. This is not a study of an AI algorithm requiring a training set. The clinical review describes the performance of a physical medical device in patients.

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

Not applicable/Not provided. As stated above, this is not an AI study, and therefore, no training set with associated ground truth was established for this submission.

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The AlboGraft Double Velour Knitted and Woven Grafts are indicated for use in the replacement or repair of Abdominal and Thoracic affected with aneurysmal or occlusive disease.

Not Found

I am sorry, but based on the provided document, there is no information available regarding acceptance criteria and a study that proves a device meets those criteria. The document is a 510(k) premarket notification letter from the FDA to LeMaitre Vascular, Inc. for the AlboGraft™ Double Velour Woven and Knitted Vascular Prostheses.

This letter primarily focuses on:

• Acknowledging the 510(k) submission (K093231).
• Stating that the device has been determined substantially equivalent to legally marketed predicate devices.
• Outlining the regulatory class (Class II) and product code (MAL).
• Listing general controls provisions of the Act that apply to the device.
• Providing information on how to obtain further regulatory advice.
• Presenting the Indications for Use for the AlboGraft Vascular Prosthesis.

The document does not contain details about:

1. A table of acceptance criteria or reported device performance.
2. Sample sizes, data provenance, or study types (retrospective/prospective).
3. Number or qualifications of experts for ground truth establishment.
4. Adjudication methods.
5. Multi-reader multi-case (MRMC) comparative effectiveness studies.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Training set sample size or how its ground truth was established.

Therefore, I cannot fulfill your request for this specific information using the provided text.

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The HEMASHIELD PLATINUM™ Vascular Graft is indicated for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease. The prosthesis is also recommended for use in patients requiring systemic heparinization prior to, or during, surgery.

The Hemashield Platinum WDV grafts are woven double velour vascular grafts impregnated with a highly purified collagen. The Hemashield Platinum WDV grafts minimize bleeding at implant and thereby eliminate the operative preclotting step, including cumbersome autoclave techniques. The collagen is gradually resorbed by the patient. The CONCENTRICRIMP® pleat and GUIDELINE® are also featured. In addition to collagen, the graft also contains glycerol as a softening agent.

The provided document describes a 510(k) premarket notification for a medical device called the "Hemashield Platinum Woven Double Velour TAAA graft configuration." This is a vascular graft used for the replacement or repair of arteries.

However, the provided text does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria. It is a submission for substantial equivalence, comparing the new device to existing predicate devices.

Specifically, the document states:

• "The Hemashield Platinum WDV TAAA configuration has been tested and compared to the predicate devices. All data gathered demonstrate this device is substantially equivalent. No new issues of safety or efficacy have been raised."
• "We have reviewed your Section 510(k) premarket notification of intent to market the indicati We have reviewed your Section 910(x) premained is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule..."

Since this is a 510(k) submission, the primary goal is to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a de novo study with defined performance metrics in the way a PMA might. The biocompatibility section mentions ISO 10993 testing, which implies testing was done but doesn't detail the acceptance criteria or results.

Therefore, I cannot fulfill the request to provide acceptance criteria and study details based on this document. The information requested (sample size, data provenance, number of experts, adjudication, MRMC studies, standalone performance, ground truth types, training set size, and ground truth establishment for the training set) are typically found in clinical study reports or more detailed verification and validation documents, which are not present in this summary.

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The Hemashield Platinum vascular grafts are indicated for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease. The prosthesis is also recommended for use in patients requiring systemic heparinization prior to, or during, surgery.

Not Found

The provided text describes a Special 510(k) submission for a device modification, not a study proving a device meets acceptance criteria through performance evaluation. The submission focuses on demonstrating substantial equivalence to a predicate device, meaning the modified device is as safe and effective as a legally marketed device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment is not present in the provided document.

Here's why and what information is available:

• Focus of the Document: The core of this document is a 510(k) premarket notification. These notifications primarily aim to show that a new device is "substantially equivalent" to a predicate device already on the market. This often means demonstrating identical or very similar characteristics and performance.
• Lack of Acceptance Criteria and Performance Data: The document states that the "Hemashield Platinum grafts are different from the Hemashield Gold grafts only in the label claim for permeability." All other aspects are listed as "identical." This implies that the modification did not necessitate new performance studies against specific acceptance criteria for most features, as they are considered identical to a previously approved device.
• Summary of Substantial Equivalence: The document explicitly lists the following similarities between the modified device and the predicate device, which serve as the basis for claiming substantial equivalence rather than new performance data:
  • Identical indications for use
  • Identical labeling
  • Identical manufacturing process flow
  • Identical operating principle
  • Incorporate identical materials
  • Have the identical shelf-life (5 years)
  • Are packaged and sterilized using identical packaging materials and processes

To directly answer your request based only on the provided text, I must state that the information is not available. The document does not describe a study with acceptance criteria and device performance in the way you've outlined.

Here's a breakdown of why each specific point you requested cannot be fulfilled by this document:

1. A table of acceptance criteria and the reported device performance: Not present. The document focuses on declaring identity with a predicate device for most specifications and a specific difference in label claim for permeability, without providing quantitative performance data against laid-out acceptance criteria.
2. Sample sized used for the test set and the data provenance: Not present. No specific test set or study data are detailed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present. There is no mention of expert involvement in establishing ground truth for a test set.
4. Adjudication method for the test set: Not present. No test set is described.
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 relevant and not present. This is a 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 relevant and not present. This is a vascular graft, not a software algorithm.
7. The type of ground truth used: Not present, as no new performance study generating ground truth is described.
8. The sample size for the training set: Not present, as no computational model requiring a training set is described.
9. How the ground truth for the training set was established: Not present.

In summary, this document is a regulatory submission for a device modification based on substantial equivalence, not a performance study report.

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For use in the replacement or repair of arteries affected with aneurysmal or occlusive disease. which is substantially equivalent to the currently marketed devices.

The HEMASHIELD® CARDIOVASCULAR GRAFTS are knitted and woven polyester grafts. impregnated with bovine collagen.

Here's an analysis of the provided text regarding the acceptance criteria and study for the device, organized according to your requested information.

Please note that this document is a 510(k) summary for a medical device and not a detailed clinical study report for an AI/ML device. Therefore, some of the requested information (especially points 2, 3, 4, 5, 8, and 9) is not applicable or cannot be extracted from this type of regulatory submission. The device described is a traditional medical device (vascular grafts) and not an AI/ML powered device.

Acceptance Criteria and Device Performance

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

The document states that the proposed devices ("HEMASHIELD® MICROVEL® Double Velour Knitted" and "HEMASHIELD® Woven Double Velour Vascular Grafts" with modified collagen manufacturing) were tested for various characteristics to demonstrate substantial equivalence to their currently marketed PMA approved predicate devices. The acceptance criterion for each test was effectively "equivalent to marketed product."

Additionally, "Biocompatibility Testing" was performed to demonstrate safety for intended use and substantial equivalence in biocompatibility to the currently marketed PMA approved devices.

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

The document does not specify the sample sizes for the various mechanical and material tests conducted. There is no mention of data provenance (e.g., country of origin) or whether the data was retrospective or prospective. Given the nature of the tests, it's typically laboratory testing of manufactured devices.

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 to the type of device and testing described. The ground truth for mechanical/material properties is established through standardized laboratory testing methods, not by expert consensus in the clinical sense.

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

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for clinical image interpretation or diagnostic performance studies involving human readers, which is not the case here.

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

No, an MRMC comparative effectiveness study was not done. This device is a vascular graft, not an AI-powered diagnostic tool, and involves no human readers in its functional assessment.

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

Yes, a standalone performance assessment was done, as the testing described (Burst Strength, Tensile Strength, etc.) evaluates the device's physical and material properties directly, without human interaction with the device during the test itself. This is not an "algorithm only" standalone performance as in AI, but rather a direct characterization of the physical product.

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

The ground truth for the test set was established by the characteristics and performance of the predicate devices (currently marketed PMA approved HEMASHIELD® devices). The studies aimed to show that the new devices were "equivalent to marketed product" across a range of physical, mechanical, and material properties. This is a "predicate comparison" ground truth rather than a clinical ground truth like pathology or outcomes data.

8. The sample size for the training set

This information is not applicable. There is no mention of a "training set" as this is not an AI/ML device. The "training" for such a device would be the manufacturing process development itself, not a data-driven model training.

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

This information is not applicable, as there is no training set mentioned or implied for this type of medical device submission.

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