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Relimesh prostheses are intended for use in the reconstruction of soft tissue deficiencies, such as but not limited to the repair of hernias and chest wall defects

Relimesh prostheses are dual component meshes made of non-absorbable monofilament polypropylene mesh on one side and a layer of ePTFE on the other side.
Relimesh is warp knitted in such a way that the mesh may be cut into preshaped designs without unraveling and will maintain excellent isotropic properties because of its knitted construction. The ePTFE layer is heat sealed to the polypropylene layer
These meshes have the necessary strength, flexibility, and durability for the various stresses which may be encountered in the body.
The devices are supplied as sterile, single-use surgical meshes.

This document describes the premarket notification (510(k)) for the Herniamesh Relimesh, a surgical mesh intended for the reconstruction of soft tissue deficiencies. The device's acceptance criteria and the study proving it meets these criteria are established through a comparison to legally marketed predicate devices, Composite Mesh (C.R. Bard Inc.) and Hermesh 7 (Herniamesh Srl).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Relimesh device are based on demonstrating substantial equivalence to predicate devices through functional and material characteristic comparisons. The specific acceptance criteria are that the Relimesh device's performance characteristics (suture retention, burst strength, tensile strength) are comparable to or better than the predicate devices, and that its material properties and intended use are similar. The reported device performance is shown in the table below:

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The T-Sling is intended to be used in females to position a mesh for the treatment of Genuine Stress Urinary Incontinence (SUI), mixed incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency, and vaginal vault prolapse.

The T-sling is intended to be used in females to position a polypropylene mesh for treatment of Genuine Stress Urinary Incontinence (SUI), mixed incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency.

The T-Sling is made of monofilament polypropylene warp knitted into composite mesh construction. The T-Sling is a sterile, single-use pubourethral sling for the treatment of stress urinary incontinence (SUI).

The provided text is a 510(k) Summary for the Caldera Medical T-Sling, a surgical mesh device. This document focuses on demonstrating substantial equivalence to predicate devices, primarily through comparison of design, materials, and intended use, rather than presenting clinical study data with acceptance criteria and performance metrics typically seen for AI/ML-based medical devices or devices that require extensive clinical efficacy studies.

Therefore, many of the requested items (acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or not provided in this type of regulatory submission for this specific device.

Based on the provided text, here's what can be extracted:

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

This document does not specify quantitative acceptance criteria or detailed device performance metrics (e.g., sensitivity, specificity, accuracy, or other clinical outcomes) in the way a clinical study report for an AI/ML device would. The "acceptance" for this type of device in a 510(k) submission primarily revolves around demonstrating substantial equivalence to legally marketed predicate devices, meaning it has the same intended use, fundamental technological characteristics, or, if different, those differences do not raise new questions of safety and effectiveness.

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

Not applicable. This document is a 510(k) Summary for a surgical mesh device, not an AI/ML device, and it does not present a clinical study with a "test set" in that context. The evaluation is based on material properties, design, and comparison to predicates.

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. Ground truth establishment by experts is not a component of this type of regulatory submission for this device.

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

Not applicable. Adjudication methods are not described as this is not a study involving human review of 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. This is not an AI/ML device, and no MRMC study is mentioned.

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

Not applicable. This is not an AI/ML device.

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

Not applicable. Clinical ground truth, in the sense of a diagnostic or predictive algorithm, is not directly discussed. The "truth" in this context is the safety and effectiveness profile established by the predicate devices.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, and no training set is mentioned.

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

Not applicable. This is not an AI/ML device.

Summary regarding the device and its regulatory pathway:

The Caldera Medical T-Sling is a surgical mesh made of monofilament polypropylene, warp knitted into a composite mesh. It is intended as a sterile, single-use pubourethral sling for the treatment of:

• Genuine Stress Urinary Incontinence (SUI) in females.
• Mixed incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency.
• Vaginal vault prolapse.

The 510(k) submission (K050516) sought to demonstrate substantial equivalence to existing legally marketed predicate devices. The listed predicate devices are:

• Herniamesh T-Sling (K020652)
• Tyco Healthcare IVS Tunneller (K010035)
• Ethicon TVT (K012628)

The FDA's review concluded that the T-Sling is substantially equivalent to these predicate devices for its stated indications for use. This means that based on comparison of materials, design, intended use, and potentially bench testing data (which is not detailed in this summary), the FDA determined the device is as safe and effective as a legally marketed device.

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The Herniamesh T-sling is a dual-component pubourethral sling for the treatment of stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

Pre-shaped Duel-component mesh Polypropylene and bioabsorbable polymer

The provided text describes a Premarket Notification for the Herniamesh T-Sling, focusing on establishing substantial equivalence to predicate devices rather than directly presenting acceptance criteria and a study proving device performance against those criteria in the context of diagnostic accuracy.

However, from the provided text, we can extract the "acceptance criteria" as the functional requirements and characteristics of surgical meshes that the Herniamesh T-Sling must meet or exceed to be considered substantially equivalent to predicate devices. The "study" refers to the performance data obtained through various tests.

Here's an attempt to structure the information based on your request, acknowledging that the document is a 510(k) submission, not a study report demonstrating diagnostic accuracy:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are implicitly defined by the properties of the predicate devices (Ethicon TVT and Injectx Inc BioSling™). The study demonstrates that the Herniamesh T-Sling's performance "meets or exceeds" these requirements.

Note on Burst Strength & Suture Retention: While the Herniamesh T-Sling's specific values for Burst Strength appear lower than the Ethicon TVT's reported value, and its Suture Retention warp value is lower, the document explicitly states: "the technological differences meet or exceed the functional requirements of surgical meshes compared to the predicate devices" and "The physical and mechanical characteristics of the Hermiamesh T-Sling meet or exceed those of the predicate devices." This suggests that the listed predicate values might not represent a strict lower bound for substantial equivalence, or there are other considerations not fully detailed in this excerpt that support the "meets or exceeds" claim. This highlights a common aspect of 510(k) submissions where the "acceptance criteria" are not always hard numerical thresholds for superiority but rather for safe and effective equivalence.

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

• Sample Size: Not explicitly stated as a number of devices/cases for each test, but implied to be sufficient for mechanical, biocompatibility, and in vivo testing for the Herniamesh T-Sling. For the predicate device data (Ethicon TVT), the Burst Strength and Suture Retention values are presented with standard deviations (e.g., 55 ± 3, 52 ± 9), indicating multiple measurements were taken, likely from a sample of devices.
• Data Provenance:
  • Herniamesh T-Sling: Performance data comes from "mechanical testing, scanning electron microscopy, biocompatibility and in vivo safety and effectiveness testing" conducted on the Herniamesh T-Sling. The location of these tests is not specified, but the applicant is "Herniamesh USA, Inc."
  • Ethicon TVT (Predicate): Values for Prolene TVT were taken from the textbook: Prostheses and Abdominal Wall Hemias by Dr. Robert Bendavid (pages 197, 200). This indicates retrospective data collection from published literature.
  • Injectx Inc BioSling™ (Predicate): Described as "Substantially Equivalent" for most mechanical properties, indicating a comparison against its own predicate or established benchmarks, but no specific values are given. "Not Tested" for Tissue Ingrowth for this predicate.

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

• This information is not applicable to this type of submission. This document describes the characterization of a medical device (surgical mesh) through physical, mechanical, and biological testing, not a diagnostic algorithm where expert ground truth is typically established (e.g., for image interpretation).
• The "ground truth" for the test set here refers to the actual measured physical and biological properties of the device and its predicates, established through standard scientific methods and measurements.

4. Adjudication method for the test set:

• This information is not applicable. Adjudication methods (like 2+1 or 3+1) are used in studies involving human interpretation or subjective assessments, often with multiple readers, to resolve discrepancies and establish a consensus ground truth. This is not relevant for the objective mechanical and biological testing described for a surgical mesh.

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. This document is a 510(k) submission for a surgical mesh, not an AI-based diagnostic device. Therefore, no MRMC study involving human readers or AI assistance was conducted or reported.

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

• This information is not applicable. The device is a surgical mesh, not an algorithm. Therefore, no standalone algorithm performance study was performed.

7. The type of ground truth used:

• The "ground truth" for the Herniamesh T-Sling and the predicate devices is based on objective measurements and observations from:
  • Mechanical Testing: Burst Strength, Suture Retention, Tensile Strength.
  • Microscopy: Pore Size (from scanning electron microscopy).
  • Biocompatibility Testing: Used to assess biological interaction/safety.
  • In Vivo Testing: To assess safety and effectiveness in a living organism, including "Complete tissue incorporation of implant" (which could be verified by histological examination of explanted tissue).

8. The sample size for the training set:

• This information is not applicable. This document focuses on demonstrating the performance of a physical medical device (surgical mesh) through testing, not on training a machine learning algorithm.

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

• This information is not applicable. As there is no machine learning model involved, there is no training set or associated ground truth establishment process.

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All meshes made by Hemiamesh are made of monofilament polypropylene. The meshes are designed to be used in the surgical repair of abdominal wall hernias such as primary or recurrent inguinal hernias, femoral hernias, inscisional hernias as well as thoracic wall defects.

Herniamesh products Hertra 1. 2 & 2A and Hermesh 3, 4 & 5 have the same intended uses as Trelex Mesh and Marlex Mesh. All are used in the repair of primary or recurrent inguinal hernias (particularly when facial structures are weak), primary or recurrent inscisional hernias so large that the fascial edges of the hernial ring cannot be approximated (generally one-fourth of the abdominal wall), femoral hernias, or chest wall defects where it is not possible to use autogenous tissue to prevent or correct lung herniation.

Herniamesh Plugs T1, T2 & T3 have the same intended use as the Marlex Mesh Dart which is used for the repair of hernias with a three dimensional shape i.e. femoral, inguinocrueal or large recurrent inguinal hernias.

This document is a 510(k) premarket notification for Herniamesh surgical meshes, demonstrating substantial equivalence to predicate devices (Trelex Mesh and Marlex Mesh). It doesn't report on an AI/ML device or a study with typical acceptance criteria like sensitivity, specificity, accuracy, etc. Instead, the "acceptance criteria" here are questions related to establishing substantial equivalence for a medical device submitted under a 510(k) pathway.

Therefore, the requested information elements (1-9) which are typically associated with performance studies for AI/ML devices or clinical trials, are not applicable to this document. The document focuses on demonstrating equivalence in terms of indications, intended use, and technological characteristics.

Here’s a breakdown of why each requested point isn't directly applicable in the context of this 510(k) summary:

• 1. A table of acceptance criteria and the reported device performance: This document doesn't present a study with quantitative performance metrics for the Herniamesh products as it's a submission for substantial equivalence based on material, design, and intended use, not clinical efficacy or diagnostic accuracy. The "acceptance criteria" are the four questions posed by the FDA's decision-making process for substantial equivalence.
• 2. Sample size used for the test set and the data provenance: Not applicable. There is no "test set" in the context of a performance study described here. The evaluation is a comparison against existing predicate devices.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no "ground truth" to establish through expert consensus in this type of submission.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for the same reasons as points 2 and 3.
• 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/ML device, and no MRMC study or human reader improvement is discussed.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm or AI device.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. "Ground truth" is not a concept that applies to this type of substantial equivalence submission.
• 8. The sample size for the training set: Not applicable. There is no training set as this is not an AI/ML device.
• 9. How the ground truth for the training set was established: Not applicable.

Summary of the document's approach to "acceptance criteria":

The document defines "acceptance criteria" (though not explicitly called that) as the four questions from the FDA's "substantial Equivalence" Decision-Making Process:

1. Does New Device Have Same Indication Statement?
   • Reported performance/Finding: Yes. All indications are identical to predicate devices (repair of abdominal wall hernias, femoral hernias, chest wall defects).
2. New Device Has Same Intended Use and May be "Substantially Equivalent"?
   • Reported performance/Finding: Yes. Intended uses are the same as predicate devices (e.g., repair of primary/recurrent inguinal hernias, incisional hernias, femoral hernias, chest wall defects).
3. Does New Device Have Same Technological Characteristics, e.g., Design, Materials, etc.?
   • Reported performance/Finding: Yes. Made of the same material (polypropylene monofilament of various thickness). Design and structure (monofilament knitted into a mesh design, flat or three-dimensional) are the same as predicate devices.
4. Are The Descriptive Characteristics Precise Enough to Ensure Equivalence?
   • Reported performance/Finding: Yes. Since materials, design, and structure are the same, the descriptive characteristics applying to predicate devices also apply to Herniamesh products. Process validation will ensure properties are maintained.

Conclusion:

Based on answering "Yes" to all four questions, the Herniamesh surgical meshes are deemed "Substantially Equivalent" to the predicate devices. This is the "study" and "proof" provided within this 510(k) submission for regulatory acceptance.

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