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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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SeriScaffold™ surgical mesh is indicated for use as a transitory scaffold for soft tissue support and repair to reinforce deficiencies where weakness or voids exist that require the addition of material to obtain the desired surgical outcome.

SeriScaffold surgical mesh is a knitted, multi-filament, bioengineered, silk mesh. It is mechanically strong, biocompatible, and long-term bioresorbable. SeriScaffold surgical mesh is a sterile, single use only mesh and is supplied in a variety of shapes and sizes ready for use in open or laparoscopic procedures. The device is flexible and well suited for delivery through a laparoscopic trocar due to its strength, tear resistance, suture retention, and ability to be cut in any direction. SeriScaffold surgical mesh provides immediate physical and mechanical stabilization of a tissue defect through the strength and porous (scaffold-like) construction of its mesh.

The provided text is a 510(k) summary for a medical device called "SeriScaffold™ surgical mesh." It describes the device, its intended use, and its substantial equivalence to predicate devices, supported by performance testing, biocompatibility testing, and an in vivo rabbit study.

However, the provided document does not contain the specific type of information requested regarding acceptance criteria, reported device performance in those terms, sample sizes for test and training sets, expert qualifications for ground truth, adjudication methods, or MRMC studies.

The document instead focuses on demonstrating substantial equivalence through:

• Bench testing: "Results from performance testing based on 'Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh', March 2, 1999 demonstrates substantial equivalence of SeriScaffold surgical mesh to predicate surgical mesh products." These likely cover properties like tensile strength, suture retention, and tear resistance, which are typical for surgical mesh.
• In vitro bioresorption study: "Results from an in vitro bioresorption study characterize the bioresorption properties of SeriScaffold surgical mesh versus Vicryl Mesh which support the long-term bioresorption property of SeriScaffold surgical mesh."
• Biocompatibility testing: "Biocompatibility was conducted according to internationally recognized standards and all results indicate the device is biocompatible."
• In vivo rabbit study: "Data from an in vivo rabbit study further support the bioresorption and biocompatibility properties of the device."

Since the request is specific to an AI/ML device evaluation structure (e.g., acceptance criteria for a diagnostic performance, MRMC study effect sizes), and this document is for a physical surgical mesh, the requested information categories are not directly applicable or present in the provided text.

Therefore, I cannot populate the table or answer the specific questions about AI/ML device evaluation as the document describes a traditional medical device submission (surgical mesh) that does not involve artificial intelligence, machine learning, or diagnostic performance metrics with human readers.

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