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Transorb™ Self-Gripping Resorbable Mesh is intended to be used for the reinforcement of abdominal wall soft tissues where weakness exists in open procedures involving ventral hernia repair.

Transorb™ Self-Gripping Resorbable Mesh is designed for ventral hernia repair when placed in an extraperitoneal space by open surgical approach. Transorb™ Self-Gripping Resorbable Mesh is made of a fully resorbable bi-dimensional Poly-L-lactide, poly-trimethylene carbonate copolymer (PLLA/TMC) monofilament textile with monofilament PLLA/TMC absorbable grips on one side. Transorb™ Self-Gripping Resorbable Mesh is available in different shapes and sizes. Transorb™ Self-Gripping Resorbable Mesh is a macro-porous mesh knitted from resorbable monofilament PLLA/TMC yarns. It has been designed to reinforce soft tissues where weakness exists by providing strength and tissue integration throughout the expected healing period. Transorb™ Self-Gripping Resorbable Mesh has absorbable PLLA/TMC grips on one side that facilitate positioning and contribute to fixation. The PLLA/TMC mesh and grips degrade and resorb in vivo by hydrolysis in 36 to 60 months and are metabolized by the body into CO2 and H₂O.

The provided text describes a 510(k) premarket notification for a medical device called "Transorb™ Self-Gripping Resorbable Mesh." This submission is to demonstrate substantial equivalence to a predicate device, not to prove the device meets specific acceptance criteria for a new claim typically associated with AI/ML devices or novel therapies. Therefore, the information typically requested in your prompt regarding acceptance criteria, study types, ground truth, and expert involvement for AI/ML performance is not present in this regulatory document.

However, I can extract the performance data and "acceptance" (pass/fail) criteria as presented for the biocompatibility and bench testing components of this surgical mesh.

Here's the information based on the provided text, structured as much as possible according to your request, but acknowledging the inherent differences in regulatory submissions for a surgical mesh versus an AI/ML diagnostic tool:

1. Table of Acceptance Criteria and Reported Device Performance

For this medical device (surgical mesh), "acceptance criteria" are implied by compliance with established standards and the outcome of "Pass" for various tests. The reported device performance is that it passed these tests, thus meeting the implied criteria.

Notes on Acceptance Criteria: The primary "acceptance criterion" for this 510(k) submission is to demonstrate substantial equivalence to the predicate device (TIGR® Matrix Surgical Mesh K191749), showing that differences do not raise new questions of safety or effectiveness. For biocompatibility tests, the criterion is to "Pass" the specific ISO 10993 standard. For bench tests, the conclusion is frequently stated as "substantially equivalent" to the predicate.

2. Sample Size for Test Set and Data Provenance

• Test Set Sample Size: Not explicitly stated for each test in terms of a numerical count of units or animals. The text mentions broad categories like "PLLA/TMC monofilament yarn (up to 21g)" for composition and lists different product codes/sizes (e.g., TSB1510, TSB2020, TSB3030, TSB4030) that imply various units were tested across the different evaluations. For animal studies, it mentions "large animal model" (porcine) and "rabbit study."
• Data Provenance: The studies were internal preclinical (bench and animal) tests conducted by the manufacturer or their testing partners. There is no specific country of origin mentioned for the data, beyond the manufacturer being based in France. The studies are prospective in nature, designed specifically for this submission.

3. Number of Experts and Qualifications for Ground Truth

• Not Applicable in the context of your question. This document pertains to a physical medical device (surgical mesh) and its performance in bench and animal studies, not an AI/ML device requiring expert adjudication of outputs to establish ground truth from clinical images or data. The "ground truth" here is the physical and biological reality as measured by the various test methods (e.g., breaking strength, tissue ingrowth observations).

4. Adjudication Method for Test Set

• Not Applicable for the reasons stated above. Adjudication methods like "2+1" or "3+1" are typically used to establish a consensus ground truth in clinical evaluations, especially for AI/ML diagnostic tools. For this surgical mesh, performance is measured against established scientific and engineering principles via tests (e.g., ISO standards, ASTM standards, histological examination).

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

• No, a MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (especially AI/ML-assisted ones) to assess the impact of the device on human reader performance. This submission is for a surgical implant, where such studies are not typically performed or required to demonstrate substantial equivalence. The document explicitly states: "This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence."

6. Standalone (Algorithm Only) Performance Study

• No, a standalone performance study was not done. This concept is specific to AI/ML algorithms evaluated independently of human interaction. The Transorb™ mesh is a physical implant, not a software algorithm. Its performance is evaluated through physical, chemical, and biological testing, outlined as biocompatibility, bench testing, and animal studies.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is established through:

• Compliance with International Standards: For biocompatibility (ISO 10993 series) and some physical properties (e.g., ISO 3801, ISO 9073-2, ISO 13934-1, ISO 4674).
• Predicate Device Comparison: For mechanical properties and physical aspects, the device's performance is compared to the predicate device (TIGR® Matrix Surgical Mesh, K191749), with substantial equivalence being the goal.
• Histology/Pathology: For animal studies, tissue repair, tissue integration, local tissue effects, and degradation profile were assessed via histological examination.
• Direct Measurement: For parameters like pore size, surface density, thickness, bursting strength, suture pull-out strength, etc., direct measurements are taken.

8. Sample Size for the Training Set

• Not Applicable. This device is a physical surgical mesh, not an AI/ML algorithm that requires a training set. The term "training set" is not relevant in this context.

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

• Not Applicable. As there is no training set for this device, the question of how its ground truth was established is not relevant.

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Phasix ST Mesh with Open Positioning System is indicated for use in the reinforcement of soft tissue, where weakness exists, in procedures involving soft tissue repair, such as for the repair of hernias.

The open positioning system is intended to facilitate the placement, positioning and fixation of the mesh during open ventral hernia repair.

Phasix™ ST Mesh with Open Positioning System is a sterile, single-use device for prescription use only. It is a bi-layer mesh comprised of Phasix™ ST Mesh (K173143, forms posterior layer) and Phasix™ Mesh (K161424, forms anterior layer) stitched together with a 10 mil P4HB monofilament. The combination of the two distinct layers forms a pocket to accommodate a preinserted removable accessory. The subject device is designed for reinforcement of soft tissue deficiencies during open ventral hernia repair. The subject device and reference device have identical intended use for the mesh i.e. soft tissue repair/ reinforcement.

The removable open positioning system is an accessory with polypropylene (PP) handle attached to a Polytetrafluoroethylene (PTFE) guide. The accessory comes preinserted into the mesh pocket to aid with placement, positioning, and fixation. The center marking on the positioning guide will aid with proper centering and orientation over the defect. The accessory is removed following the initial fixation and then discarded. The intended use of the accessory is similar to the SorbaFlex Memory Technology utilized in the Ventrio™ ST Hernia Patch (K101920).

The provided text is a 510(k) summary for the Phasix ST Mesh with Open Positioning System, a surgical mesh device. The document details the device's characteristics, indications for use, comparison to predicate devices, and performance data used to demonstrate substantial equivalence.

Based on the information provided, here's a description of the acceptance criteria and the study that proves the device meets them:

No specific acceptance criteria table or quantitative performance metrics are explicitly stated in the provided document beyond qualitative "Pass" results for biocompatibility and statements that performance tests "successfully met the established acceptance criteria." The document primarily focuses on demonstrating substantial equivalence to pre-existing predicate devices through various tests rather than setting and meeting independent quantitative acceptance criteria for device performance.

However, we can infer the types of acceptance criteria that were likely in place based on the tests conducted and the general regulatory framework for medical devices. The "study" proving the device meets these (largely implied) acceptance criteria refers to the various performance tests and animal studies conducted.

1. Table of Acceptance Criteria and Reported Device Performance

As noted, the document does not provide a specific table of quantitative acceptance criteria with corresponding performance values. Instead, it reports qualitative "Pass" results for biocompatibility and states that "performance test results demonstrate that subject device successfully met the established acceptance criteria."

Here's a conceptual representation based on the tests mentioned:

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

• Biocompatibility Testing: The specific sample sizes for each in vitro biocompatibility test (e.g., number of cells for cytotoxicity, number of animals for systemic toxicity/sensitization) are not explicitly stated in the summary.
• Product (Bench) Testing: The specific sample sizes (n-values) for each mechanical test (e.g., number of meshes tested for tear strength, number of accessories for removal force) are not explicitly stated.
• Animal Studies: The study was "a comprehensive 4 week GLP study in a porcine model." The number of porcine subjects is not specified.
• Data Provenance: All data appears to be prospective testing conducted specifically for this 510(k) submission. The country of origin for the data generation (where the tests were performed) is not specified, but given the submitter (Davol Inc., C. R. Bard, Inc. located in Warwick, RI, USA), it's highly likely the studies were conducted in the USA or by labs compliant with US regulations.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• This information is not applicable in the context of this 510(k) summary. The device is a physical surgical mesh, not an AI/software device that requires ground truth derived from expert consensus for image interpretation or diagnosis. The "ground truth" for the performance sections is established through validated laboratory testing methods and histological/mechanical evaluation in the animal study.
• For the "Design Validation Usability Test," it implicitly involves users (likely surgeons or medical professionals) to validate the device's usability, but the number or their qualifications are not specified.

4. Adjudication Method for the Test Set

• This information is not applicable as it typically refers to the process of reconciling disagreements among multiple human readers for diagnostic interpretation (e.g., in AI studies).
• For the bench and animal studies, "adjudication" would involve standard laboratory practices for data collection, analysis, and statistical evaluation, overseen by internal quality systems. The specific mechanisms for resolving data discrepancies, if any, are not detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC comparative effectiveness study was not done. This type of study is primarily relevant for diagnostic imaging AI devices where the performance of human readers with and without AI assistance is evaluated. The Phasix ST Mesh is a physical surgical device, not a diagnostic tool.

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

• No, this is not applicable. The device is a surgical mesh; it does not involve algorithms or AI that would have a standalone performance. Performance is evaluated through bench testing and preclinical animal models.

7. The Type of Ground Truth Used

• Biocompatibility Testing: Ground truth is established by standard, recognized in vitro and in vivo biological assays with predefined endpoints and pass/fail criteria (e.g., cytotoxicity, systemic toxicity, sensitization).
• Product (Bench) Testing: Ground truth is established by engineering specifications, material science principles, and validated test methods to measure physical and mechanical properties. The "acceptance criteria" for these tests would be derived from these engineering specifications and comparison to predicate device characteristics.
• Animal Studies: Ground truth is established by histopathological evaluation, gross anatomical observation (e.g., tissue attachments, mesh contracture), and mechanical testing of tissue samples (e.g., T-peel analysis) by qualified personnel (e.g., pathologists, veterinary specialists), against predefined biological response expectations and comparative analysis with predicate devices.

8. The Sample Size for the Training Set

• Not applicable. The Phasix ST Mesh is not an AI/machine learning device; therefore, there is no "training set." The testing performed is for device validation and verification, not for training a model.

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

• Not applicable. As there is no training set, this question is irrelevant.

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