Search Results

Indications for use have not changed, and are equivalent to those of the predicate devices cited above.

Coating is a polymeric balloon mounted on a double lumen shaft, a design commonly referred to as a "Gruntzig style catheter". Proximally the product is fitted with a Y-connector system with two female luer fittings, one for passage of a guide wire, and the other for balloon inflation. The product is coated with Meadox's exclusive hydrophilic coating on the balloon, the tip and distal shaft.

This document describes a 510(k) premarket notification for a medical device, the MS CLASSIQUE™ Balloon Dilatation Catheter with HYDROPASS™ Hydrophilic Coating. It's an application for a modified device, not a study performing to derive acceptance criteria for a new device, consequently there is no information about acceptance criteria or specific study data of the type requested in your prompt.

Here's a breakdown of why the requested information cannot be provided from this document:

1. A table of acceptance criteria and the reported device performance: Not available. This document is a summary of a 510(k) submission, which focuses on demonstrating substantial equivalence to a predicate device. It states that the new device "meet currently established performance specifications for uncoated MS CLASSIQUE™ Balloon Dilatation Catheters" but does not detail what those specifications are or present specific performance data against them.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not available. No clinical test set or data provenance is mentioned. The submission relies on demonstrating equivalence through design, materials, and biocompatibility testing, not a de novo performance study.

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. There is no mention of a test set requiring expert ground truth establishment.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as no test set requiring adjudication 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 applicable. This document is for a medical device (catheter), not an AI-powered diagnostic tool. MRMC studies are used for evaluating diagnostic performance, typically of imaging or AI systems.

6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done: Not applicable, as this is a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no clinical study requiring a ground truth is described. The "ground truth" for a device like this would be its physical properties and mechanical performance, which are stated to be equivalent to the predicate.

8. The sample size for the training set: Not applicable. This document is not describing an AI/ML device that requires a "training set."

9. How the ground truth for the training set was established: Not applicable for the same reason as above.

Summary from the provided text:

The document is a 510(k) summary for a modified balloon dilatation catheter. The modification is the addition of a HYDROPASS™ Hydrophilic Coating. The core argument for safety and effectiveness is substantial equivalence to existing predicate devices (K942293, K943298), which are also MS CLASSIQUE™ Balloon Dilatation Catheters but without the new coating.

The key points related to meeting criteria are:

• Biocompatibility Testing: Conducted in accordance with ISO-10993 standard, indicating safety for its labeled indications.
• Indications for Use: Unchanged and equivalent to predicate devices.
• Design Materials: Unchanged and equivalent to predicate devices.
• Performance Specifications: The product "meet currently established performance specifications for uncoated MS CLASSIQUE™ Balloon Dilatation Catheters," and package labeling will specify Mean or Average Burst Pressure.

In essence, the device is considered to meet acceptance criteria because its key characteristics (biocompatibility, indications, materials) are unchanged or proven safe, and its performance (e.g., burst pressure) is equivalent to the already approved predicate devices. There is no "study" in the sense of a clinical trial with a test set of patients/data described here; rather, the "proof" is based on engineering principles, materials science, and a comparison to legally marketed devices.

Ask a specific question about this device

The ePTFEMEADS Vascular access. Mid-Flex grafts are specifically indicated for vascular --access, as are Stepped grafts which are designed to reduce the risk of steal syndrome. Externerally Supported Grafts are used where kinking and compression resistance are desired.

The ePTFEMENOx Vasular Graft is comprised of an expanded polyenced the exterior of the tube. Externally supported grafts have a continuous PTFE spiral support coil wound around a portion of the graft.

This document is a Premarket Notification (510(k)) for a medical device submitted in 1996. It does not describe a study involving an AI/Machine Learning device or software, nor does it contain acceptance criteria or performance data in the context of such studies.

Therefore, I cannot extract the requested information as it is not present in the provided text. The document focuses on establishing substantial equivalence for a physical medical device (ePTFE Vascular Graft) to predicate devices already on the market, based on material, manufacturing, and general performance specifications.

Ask a specific question about this device

The MEADOX® EXXCEL™ ePTFE Vascular Grafts are designed to repair or replace peripheral arteries and to provide vascular access. Mid-Flex grafts are specifically indicated for vascular access, as are Stepped grafts which are designed to reduce the risk of steal syndrome. Externerally Supported Grafts are used where kinking and compression resistance are desired.

The unwrapped version of the MEADOX® EXXCEL" ePTFE Vascular Graft is comprised of an expanded polytetraffuoroethylene (ePTFE) core tube. Externally supported grafts have a continuous PTFE spiral support coil wound around a portion of the graft.

The provided text describes the safety and effectiveness of the MEADOX® EXXCEL™ ePTFE Vascular Graft. It does not describe an AI device or a study involving human readers or algorithms. Therefore, much of the requested information regarding AI performance, human-in-the-loop studies, ground truth establishment for training data, and expert qualifications is not applicable.

However, I can extract the acceptance criteria and performance related to the device itself based on the provided document.

1. Table of Acceptance Criteria and Reported Device Performance:

The "acceptance criteria" for this medical device are based on compliance with ISO-10993 standards for biocompatibility and AAMI standards (or equivalent) for physical performance. The reported device performance indicates that the device passed all these tests.

The study that proves the device meets these acceptance criteria is detailed in the "SUMMARY OF SAFETY & E" document provided. The document itself is the report of these tests.

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

• Sample Size: The document does not specify the exact sample sizes (number of grafts or test articles) used for each individual biocompatibility or physical performance test.
• Data Provenance: The tests were performed by "Meadox Medicals, Inc." and conducted according to international (ISO-10993) and national (AAMI) standards, implying data generated within a controlled laboratory setting. The country of origin is not explicitly stated for the data generation location, but the sponsor is "Meadox Medicals, Inc." and the submission is to the FDA (implying US jurisdiction). The data would be considered prospective for the purpose of demonstrating device compliance.

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

• Not Applicable. This document describes engineering and biological testing of a physical medical device, not an AI device requiring expert ground truth in the diagnostic sense. The "ground truth" here is objective measurement against established physical and biological standards.

4. Adjudication Method for the Test Set:

• Not Applicable. As per point 3, this is not an AI study requiring adjudication of expert opinions. The adjudication is based on whether the measured performance of the device meets the predefined quantitative and qualitative criteria of the relevant standards (ISO and AAMI).

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 document does not describe an AI device or any human reader studies.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• Not Applicable. This document does not describe an AI algorithm.

7. The Type of Ground Truth Used:

• For Biocompatibility: The ground truth is adherence to the scientific and safety principles outlined in the ISO-10993 standard, demonstrated through in-vitro and in-vivo biological tests.
• For Physical Performance: The ground truth is the quantitative and qualitative specifications defined by the AAMI standards for vascular graft prostheses.

8. The Sample Size for the Training Set:

• Not Applicable. This is not an AI device requiring a training set.

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

• Not Applicable. This is not an AI device requiring a training set.

Ask a specific question about this device

For use in systemic vascular reconstructions, e.g., replacement in the case of aneurysmal or occlusive disease, in the peripheral region.

The HEMASHIELD VANTAGE™ Vascular Graft is a woven polyester graft, impregnated with bovine collagen.

The provided text describes a medical device, the HEMASHIELD VANTAGE™ Vascular Graft, and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML or diagnostic device.

The document details product testing for physical and material properties of the graft (e.g., Burst Strength, Tensile Strength, Integral Water Permeability) to demonstrate equivalence to predicate devices. It also mentions biocompatibility testing. However, these are engineering and material science tests, not performance studies for an AI/ML diagnostic system or a study with a test set, ground truth, or expert readers.

Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving the device meets them, as the provided text pertains to a different type of medical device assessment.

Here's a breakdown of why the requested information cannot be extracted from the given text:

• No AI/ML or Diagnostic Device: The HEMASHIELD VANTAGE™ Vascular Graft is a physical vascular graft for surgical replacement, not a diagnostic tool or an AI/ML system.
• No Acceptance Criteria for Diagnostic Performance: The "acceptance criteria" discussed in the text are implicitly related to the physical and chemical properties of the graft meeting established standards for similar devices, not to diagnostic performance metrics like sensitivity, specificity, or AUC.
• No "Study" in the Requested Sense: The "testing" mentioned (Burst Strength, Tensile Strength, etc.) are laboratory characterizations of a physical product, not clinical or reader studies involving patient data, ground truth, or human expert interpretation.
• No Test Set, Ground Truth, or Expert Readers: These concepts are entirely absent because the device is not a diagnostic or AI system.
• No MRMC or Standalone Performance: These are metrics specific to AI/ML diagnostic device evaluation.
• No Training Set: As it's a physical product, there's no training set in the context of machine learning.

Ask a specific question about this device

The HEMASHIELD FINESSE™ Ultra-Thin, Knitted Cardiovascular Patch is indicated for cardiac and vascular patch grafting. The fabric is also recommended for use in patients requiring systemic heparinization prior to, or during, surgery.

The HEMASHIELD FINESSE™ Ultra-Thin, Knitted Cardiovascular Patch is a knitted polyester fabric, impregnated with bovine collagen and contains glycerol as a softening agent.

Here's an analysis of the provided text based on your request:

In this 510(k) summary, the device being described is a medical patch, not an AI/ML powered device, therefore many of the requested categories related to AI/ML studies are not applicable.

Acceptance Criteria and Study to Prove Device Meets Criteria

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify the exact sample sizes used for each individual test (Burst Strength, Wall Thickness, etc.). It generally states that "Testing has been performed."
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). Given the nature of material testing for a medical device (polyester fabric), the data would likely be from laboratory testing of manufactured samples, not patient data.

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

• This is not applicable, as the tests are for physical material properties of a medical device (patch) and do not involve human interpretation or subjective assessment that would require expert "ground truth." The "ground truth" here is the direct measurement of physical properties.

4. Adjudication method for the test set

• Not applicable for the type of physical material testing described. Adjudication methods are typically used in clinical studies or AI algorithm evaluations where human interpretation or consensus is required.

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 type of study is relevant for diagnostic or interpretive AI devices, not for a cardiovascular patch.

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 medical implant, not an AI algorithm.

7. The type of ground truth used

• The "ground truth" for the material tests (Burst Strength, Wall Thickness, etc.) is direct measurement of physical properties. For biocompatibility, the ground truth is the demonstrated safety and biocompatibility of the predicate device based on ISO 9000 standards.

8. The sample size for the training set

• Not applicable. This device is not an AI/ML model, so there is no concept of a "training set" in the context of its development and validation.

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

• Not applicable, as there is no training set for this device.

Ask a specific question about this device

The MEADOX® ePTFE Vascular Grafts are designed to repair or replace peripheral arteries and to provide vascular access. Mid-Flex grafts are specifically indicated for vascular access, as are Stepped grafts which are designed to reduce the risk of steal syndrome. Externally Supported Grafts are used where kinking and compression resistance are desired.

The ePTFESSENDOS, Vascular Graft is comprised of an expanded polytetrafluoroethylene (ePTFE) core tube reinforced by a multi-filament PTFE yarn helically wound around the exterior of the tube. Externally supported grafts have a continuous PTFE spiral support coil wound around a portion of the graft.

The provided text describes a medical device, the Meadox Medicals, Inc., Expanded Reinforced PTFE Vascular Graft, and its characteristics, rather than an AI/ML powered device. Therefore, the requested information regarding acceptance criteria and a study proving an AI/ML device meets them (including details like sample size for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details) is not applicable to this document.

The document focuses on:

• Device Description: Material composition (ePTFE core with PTFE yarn reinforcement, optional external support coil).
• Biocompatibility Testing: Demonstrates the device passed various tests (Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Sub-chronic Toxicity, Genotoxicity/Mutagenicity, Implantation, Hemocompatibility, Chronic Toxicity) in accordance with ISO-10993 standards.
• Predicate Devices: Lists similar commercially available devices to establish substantial equivalence.
• Performance Specifications: States that the device's performance specifications (e.g., Internodal Distance, Water Entry Pressure, Tensile Strengths, Burst Strength, Suture Retention, Kink Diameter, Crush Resistance) are "Equivalent to marketed products" (predicate devices).

Therefore, I cannot extract the requested information as it pertains to AI/ML device evaluation, which is not described in this document.

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device

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.

Ask a specific question about this device