Search Results

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device

The Fluoro-Tex™ Cardiovascular Patch is intended to be used for the repair of the cardiovascular system.

Fluoro-Tex Cardiovascular Patch consists of a sheet of porous expanded polytetrafluoroethylene (ePTFE) internally reinforced with fluorinated ethylene propylene (FEP).

Here's an analysis of the provided text regarding the Fluoro-Tex™ Cardiovascular Patch, structured according to your request:

In this case, the device is a cardiovascular patch, and the testing focuses on mechanical and biocompatibility properties rather than algorithm performance. Therefore, questions related to AI/algorithm performance (such as sample size for test/training sets, experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth for training data) are not applicable.

Acceptance Criteria and Device Performance for Fluoro-Tex™ Cardiovascular Patch

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" but rather presents a comparison of the Fluoro-Tex™ Cardiovascular Patch to predicate devices. The implicit acceptance criterion is that the Fluoro-Tex™ patch performs comparably or better than the predicate devices across the measured mechanical properties.

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

• Tensile Strength:
  • Gore-Tex®: n=4
  • IMPRA®: n=4
  • Fluoro-Tex™: n=6
• Suture Strength:
  • Gore-Tex®: n=4
  • IMPRA®: n=4
  • Fluoro-Tex™: n=6
• Burst Strength:
  • IMPRA®: n=5
  • Fluoro-Tex™: n=5
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). This appears to be laboratory-based mechanical testing data.

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

Not applicable, as this is laboratory mechanical testing data, not expert-derived ground truth.

4. Adjudication method for the test set:

Not applicable, as this is laboratory mechanical testing data.

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, as this device is a physical medical patch, not an AI software.

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

Not applicable, as this device is a physical medical patch, not an algorithm.

7. The type of ground truth used:

• Mechanical Tests: The "ground truth" implicitly refers to the measured physical properties of the materials and devices under controlled laboratory conditions, using established engineering test methods.
• Biocompatibility: Demonstrated through cytotox, FTIR, and in-house cleanliness testing, relying on the known safety profile of PTFE, the material used in the device and its predicates.

8. The sample size for the training set:

Not applicable, as this is a physical medical device, not an AI/machine learning model.

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

Not applicable, as this is a physical medical device.

Ask a specific question about this device

The FluoroTex™ Surgical Mesh is intended to be used for the repair of soft tissue and the reconstruction of hernias.

The FluoroTex Surgical Mesh consists of porous expanded polytetrafluoroethylene (ePTFE) reinforced with fluorinated ethylene propylene (FEP).

The provided text describes a 510(k) summary for the FluoroTex™ Surgical Mesh, demonstrating its substantial equivalence to a predicate device, the GORE-TEX® Soft Tissue Patch. It does not contain information about a study proving the device meets acceptance criteria in the sense of a clinical trial or performance evaluation against predefined thresholds for classification (e.g., sensitivity, specificity, accuracy) that are typical for diagnostic or AI-driven medical devices. Instead, the "acceptance criteria" here are implicit in demonstrating substantial equivalence through mechanical and chemical testing.

Here's an attempt to structure the information based on the request, acknowledging the limitations of the provided document for several categories:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the FluoroTex™ Surgical Mesh were implicitly met by demonstrating that its mechanical and chemical characteristics were "substantially equivalent" to those of the predicate device, the GORE-TEX® Soft Tissue Patch. The study involved direct comparison of key material properties.

Study Details:

1. Sample size used for the test set and the data provenance:

   • Sample Size: n=15 for Material Strength and Suture Retention Strength for the FluoroTex™ Surgical Mesh. An identical sample size (n=15) is reported for the predicate device's data, which was sourced from Gore literature.
   • Data Provenance: The FluoroTex™ Surgical Mesh data was generated internally at Bridger Biomed, Inc. labs. The predicate device's data was reported in Gore literature. The country of origin is not specified but given the company names and FDA context, it is likely the United States. The data is retrospective in the sense that the predicate's data already existed, while the new device's data was generated specifically for this submission.

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

   • Not applicable in this context. The "ground truth" for this type of device comparison is based on established engineering and materials science testing standards (ASTM methods) rather than expert consensus on medical image interpretation or clinical outcomes.

3. Adjudication method for the test set:

   • Not applicable. Data was derived from standardized ASTM test methods, not expert adjudication of subjective assessments.

4. 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 describes a medical device (surgical mesh), not an AI-driven diagnostic tool, and therefore no MRMC study was conducted.

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

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

6. The type of ground truth used:

   • Standardized engineering and materials testing (ASTM methods) for mechanical and chemical properties. The "truth" is based on the measurable physical properties of the materials as determined by these validated tests.

7. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device.

8. How the ground truth for the training set was established:

   • Not applicable. This is not an AI/machine learning device.

Ask a specific question about this device

The Bridger Biomed Dura-Patch™ is intended for replacement or repair of the dura.

Dura-Patch™ Dura Substitute is a 100% ePTFE membrane, which is intended to be used as a replacement for dura tissue deficiencies.

The provided text is a 510(k) summary for the Dura-Patch™ Dura Substitute, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed studies with acceptance criteria and performance data as might be found for novel devices or software.

Therefore, many of the requested technical details regarding acceptance criteria and study methodologies (like sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) are not applicable to this 510(k) submission.

Here's a breakdown based on the provided information:

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

This 510(k) summary does not present formal acceptance criteria or performance metrics in the way one might expect for an AI/software device. Instead, it focuses on demonstrating substantial equivalence to an existing predicate device based on comparative technological characteristics and safety & efficacy through material biocompatibility and established clinical use of ePTFE.

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

Not applicable. This 510(k) relies on a comparison to a predicate device and the long-established safety and efficacy of ePTFE as a material. There is no mention of a specific test set or clinical study conducted on the Dura-Patch™ itself in this summary. The data provenance related to ePTFE's clinical use is global (implied by "over 25 years of clinical use" and "virtually all major tissue types"), and retrospective (historical clinical data).

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. No ground truth establishment by experts for a specific test set is described. The "ground truth" for this submission is the accepted safety and efficacy of ePTFE and the predicate device.

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

Not applicable. No specific test set or adjudication method 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 is not an AI/software device, and no MRMC study was conducted or referenced.

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

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

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

The "ground truth" implicitly used for this submission is:

• Historical clinical outcomes data / established safety profile for ePTFE: "over 4,000,000 long-term ePTFE devices implanted to date," "In over 25 years of clinical use, and exposure to virtually all major tissue types, there have been no known adverse reactions to the material."
• Biocompatibility testing results: "biocompatibility assays including U.S.P. Class VI, carcinogenicity studies, hemocompatibility studies, and others."
• Performance characteristics of the predicate device: The Dura-Patch™ is stated to have comparable characteristics (strong, supple, flexible, impermeable to CSF, pore size) to the predicate device, Preclude™ Dura Substitute.

8. The sample size for the training set:

Not applicable. No training set is relevant for this physical device and its 510(k) submission.

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

Not applicable. No training set or associated ground truth establishment process is relevant.

Ask a specific question about this device

Fluoro-Tex154 Surgical Membrane is an implant material which is intended to be used for the repair or replacement of the peritoneum and pericardium.

The Bridger Biomed Fluoro-Tex™ Surgical Membrane is substantially equivalent to Gore-Tex® Surgical Membrane. Both devices consist of a sheet of porous expanded polytetrafluoroethylene (ePTFE), approximately 0.1 millimeters thick. The Fluoro-TexTM Surgical Membrane and the predicate device are intended for the repair or replacement of the peritoneum.

This document is a 510(k) premarket notification for a medical device, the Fluoro-Tex™ Surgical Membrane. The primary focus of a 510(k) is to demonstrate substantial equivalence to a predicate device, not necessarily to establish new acceptance criteria or conduct extensive studies demonstrating de novo performance.

Therefore, the requested information focuses on aspects that are not typically the subject of a traditional 510(k) submission for a device like a surgical membrane. Many of the fields you've requested (e.g., sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, training set details) are relevant to the evaluation of AI/ML-driven devices or diagnostic tools, which is not what this document describes.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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 describes non-clinical mechanical and chemical tests, not a clinical study with a "test set" in the context of, for example, diagnostic imaging.
• Therefore, specific sample sizes for a patient-derived test set are not applicable and not reported.
• Data provenance (country, retrospective/prospective) is not applicable as there were no patient data sets for testing.

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

• Not applicable. Ground truth in the context of expert consensus on medical images or diagnoses is not relevant for this type of device (a surgical membrane). The "ground truth" here would be the physical and chemical properties of the materials themselves, evaluated through standard engineering and materials science methods.

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

• Not applicable. Adjudication methods are used to resolve disagreements among human readers/experts, which is not relevant for the non-clinical testing 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:

• No. This is not an AI/ML-driven device or a diagnostic tool that would typically undergo an MRMC study.

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

• No. This is not an algorithm; it's a physical medical device.

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

• The "ground truth" for the device's performance was established through non-clinical mechanical and chemical tests, comparing its inherent material properties and performance characteristics (e.g., strength, porosity, material identification) directly against those of the predicate device.

8. The sample size for the training set:

• Not applicable. This device does not use a "training set" in the context of AI/ML or statistical modeling.

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

• Not applicable. See point 8.

Ask a specific question about this device