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Permacol™ Surgical Implant is intended for use as a soft tissue implant to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. It is specifically indicated for the repair of abdominal, inguinal, diaphragmatic, femoral, scrotal, umbilical, incisional, parastomal hernias, muscle flap reinforcement and abdominal wall defects.

Permacol ™ Surgical Implant is a sterile, off-white, moist, tough and flexible, fibrous flat sheet of acellular porcine dermal collagen and its constituent elastin fibers. Presented moist in sterile saline, Permacol ™ Surgical Implant is double vacuum packed and heat sealed peel-open aluminum foil (inner) and peel-open polyester/polyethylene (outer) pouches.

The provided text is a 510(k) summary for the Permacol™ Surgical Implant, a surgical mesh device. The submission explicitly states that "No new performance data has been included in this submission." This means that the 510(k) relies on the substantial equivalence to a predicate device (Permacol™ Surgical Implant, K043366) and does not present new studies with acceptance criteria or device performance data for the current submission.

Therefore, the requested information cannot be filled out from the provided document as it does not contain details of an acceptance criteria study for the current device submission.

However, based on the principle of substantial equivalence for a 510(k) submission, the performance of the predicate device (Permacol™ Surgical Implant, K043366) would have been used to establish its safety and effectiveness, and the current device is deemed to meet those same performance characteristics due to its identical nature. The document explicitly states: "Permacol TM Surgical Implant is identical to the predicate device, Permacol TM Surgical Implant, K043366, in terms of its technological characteristics." and "No material changes are proposed in this submission."

Since no new performance data or study is presented in the provided K120605 submission, the table and other details related to a specific study cannot be extracted.

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Permacol® Surgical Implants are intended for use to support/reinforce soft tissue in surgical procedures. Permacol® Surgical Implant T-pieces are shaped for use in rectal intussusception repair and Permacol® Surgical Implant Rectocele-pieces are shaped for use in rectocele repair.

Permacol® T-piece and Permacol® Rectocele-piece are substantially equivalent to the predicate devices because they have the same intended uses and very similar technological characteristics.

The provided text is a 510(k) summary for the Permacol® Surgical Implant T-piece and Permacol® Surgical Implant Rectocele-piece. It primarily focuses on demonstrating substantial equivalence to predicate devices and does NOT contain information about acceptance criteria and a study proving a device meets those criteria, as typically found in comprehensive performance studies for AI/software devices.

Therefore, I cannot fulfill the request as the necessary information is not present in the provided text. The document states that "Biocompatibility and bench studies have been completed and support the safety and effectiveness" but does not detail the acceptance criteria or specific performance results of these studies in a format that would allow for the requested table and study description. It also explicitly refers to these studies being incorporated by reference, meaning the details are not contained within this particular submission.

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Permacol® Surgical Implant is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists or ruptured soft tissue membranes. It is specifically indicated for the repair of abdominal wall defects and hernias, including but not limited to parastomal hernias.

Permacol® Surgical Implant Crosslinked Porcine Dermal Collagen Mesh

This 510(k) summary (K043366) is for Tissue Science Laboratories, plc's Permacol® Surgical Implant Crosslinked Porcine Dermal Collagen Mesh. The submission primarily focuses on establishing substantial equivalence to predicate devices based on intended use, technological characteristics, and performance data from biocompatibility and bench testing.

Here's an analysis of the provided information against your requested criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not specify sample sizes for biocompatibility or bench testing. It only generally refers to "test results" and "laboratory tests."

The data provenance is not explicitly stated as retrospective or prospective, nor does it mention a country of origin for the data. However, the manufacturer is in the UK, suggesting the tests were conducted under their guidance, possibly in the UK or a contract lab.

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

This information is not provided in the given document. Biocompatibility and bench testing usually rely on standardized protocols and laboratory measurements rather than expert human assessment for ground truth.

4. Adjudication Method for the Test Set:

This information is not applicable and therefore not provided. Adjudication methods are typically used in clinical studies involving human interpretation or subjective assessment, which is not the case for the described biocompatibility and bench tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:

No MRMC comparative effectiveness study was mentioned or indicated. The submission focuses on substantial equivalence based on material and mechanical properties, not clinical efficacy comparisons with human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Not applicable. This device is a surgical mesh, not a medical imaging or AI diagnostic algorithm. Therefore, "standalone algorithm performance" is not relevant.

7. The Type of Ground Truth Used:

For biocompatibility, the ground truth is established by standardized biological assays and observations for cellular response, toxicity, and sensitization, compared against established biological safety limits.

For physical performance and material characterization (bench testing), the ground truth is established by objective measurements of properties like tensile strength, elasticity, pore size, degradation rate, etc., compared against pre-defined engineering specifications or comparisons to predicate devices' known properties.

8. The Sample Size for the Training Set:

Not applicable. This device is a physical medical implant, not an AI algorithm. Therefore, there is no "training set."

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

Not applicable. As there is no training set for a physical device, there is no ground truth to establish for it.

Summary of Device Performance Study:

The provided 510(k) summary indicates that the substantial equivalence of the Permacol® Surgical Implant is supported by:

• Biocompatibility testing: This demonstrated that the materials used are non-toxic and non-sensitizing. The "ground truth" here is the biological response observed in standardized tests, confirming the material's safety for biological contact.
• Bench testing (laboratory tests): These tests confirmed that the device's materials are "consistent with the intended use" and that the product "will meet chosen and the design utilized in manufacturing criteria of performance during their intended use." The "ground truth" here is objective physical and mechanical measurements compared against predetermined specifications and predicate device characteristics.

The submission does not include human clinical trial data, MRMC studies, or AI algorithm performance data, as these are not relevant to the type of device and the pathway chosen for regulatory clearance (510(k) substantial equivalence). The focus is on the device's physical and biological properties.

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