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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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Permacol™ - Crosslinked Porcine Dermal Collagen Surgical Mesh ("Permacol™ ") is intended to be used for reinforcement of the soft tissues which are repaired by suture or suture anchors limited to the supraspinatus during rotator cuff repair surgery.

Permacol™ is available in sheet form.

The provided text describes a 510(k) submission for a surgical mesh, Permacol™ - Crosslinked Porcine Dermal Collagen Surgical Mesh. The submission focuses on demonstrating substantial equivalence to predicate devices rather than a study proving the device meets specific acceptance criteria based on detailed performance metrics.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states "Mechanical testing of Permacol™ has been performed in accordance with FDA's Surgical Mesh 510(k) Guidance. The results demonstrate that Permacol™ provides appropriate tensile strength, elasticity, stiffness, suture pullout strength, tear resistance, and puncturability, for use in soft tissue repair."

However, specific quantitative acceptance criteria (e.g., minimum tensile strength of X MPa, elasticity range of Y-Z%) or the exact reported performance values are NOT provided in the submission summary. The FDA's 510(k) summary only states that the device "provides appropriate" values, implying that it met internal or guidance-recommended criteria without listing them.

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

• Sample Size: The document does not specify the sample size used for the mechanical testing.
• Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It only mentions "Mechanical testing of Permacol™ has been performed..."

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

This information is not applicable as the "test set" in this context refers to mechanical properties of a medical device, not a diagnostic or clinical performance study requiring expert ground truth for interpretation (e.g., radiology images or pathology slides). The assessment is based on physical material properties.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reasons as #3. Mechanical testing results are objective measurements, not subject to expert adjudication.

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 relevant for diagnostic devices where human readers interpret cases with and without AI assistance. This submission is for a surgical mesh, a physical implant.

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

This information is not applicable. The device is a surgical mesh, not an algorithm. The performance described relates to the physical characteristics of the mesh itself.

7. The Type of Ground Truth Used:

The "ground truth" here would be the objective measurements of the physical and mechanical properties of the Permacol™ mesh. This would involve laboratory-based testing methods to determine:
* Tensile strength
* Elasticity
* Stiffness
* Suture pullout strength
* Tear resistance
* Puncturability

These are intrinsic material properties and do not rely on expert consensus, pathology, or outcomes data in the way a diagnostic device would.

8. The Sample Size for the Training Set:

This information is not applicable. The Permacol™ mesh is a manufactured medical device, not an AI or algorithm that requires a "training set" in the computational sense. The document refers to its manufacturing process and testing of its final product properties.

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

This information is not applicable for the same reasons as #8.

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Permacol™ is indicated for use to provide soft tissue repair or reinforcement in plastic and reconstructive surgery of the face and head.

Permacol™ tissue is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue in plastic and reconstructive surgery of the face and head.

Permacol™ consists of a sterile, tough, off-white, moist, flexible, fibrous flat sheet comprised of acellular crosslinked porcine dermal collagen and elastin. Each impermeable inner pack contains a small quantity of saline to maintain its moistness and flexibility. The product is available in thicknesses of 0.5-1.5 mm and dimensions of 0.8 x 0.8 to 4 x 6 inches.

The provided 510(k) summary for Permacol™ Crosslinked Porcine Dermal Collagen Surgical Mesh does not contain the information requested regarding acceptance criteria or a study proving the device meets said criteria.

The document is a premarket notification for a Class II medical device, essentially asserting its substantial equivalence to previously cleared predicate devices. It focuses on:

• Device Identification and Classification: Naming the device, its sponsor, and its classification.
• Predicate Devices: Listing similar devices already on the market.
• Intended Use: Stating the purpose of the device (soft tissue repair/reinforcement in plastic and reconstructive surgery of the face and head).
• Technological Characteristics: Describing the material, form, and how it is used.
• Summary Basis for Substantial Equivalence: Arguing that the new device is sufficiently similar to existing ones and does not raise new questions of safety or effectiveness. This is the core of a 510(k) submission.

The information about specific acceptance criteria, performance data from a study, sample sizes, expert involvement, ground truth, or comparative effectiveness studies (MRMC) is typically not included in a 510(k) summary. These details would be part of a more extensive submission to the FDA, which is not publicly available in this format, or would appear in a full study report.

Therefore, for each of your requested points, the answer based solely on the provided text is:

1. A table of acceptance criteria and the reported device performance: Not provided. The document states "these differences do not raise any new questions of safety or effectiveness, as confirmed by preclinical and clinical evaluation," but does not give specific criteria or performance metrics.
2. Sample sizes used for the test set and the data provenance: Not provided. The document mentions "preclinical and clinical evaluation" in a general sense but gives no details on studies, test sets, or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
4. Adjudication method for the test set: Not provided.
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 document describes a surgical mesh, not an AI-assisted diagnostic or imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithmic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not provided.
8. The sample size for the training set: Not applicable (not an AI/ML device) and not provided if referring to a general study.
9. How the ground truth for the training set was established: Not applicable and not provided.

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Permacol™ is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. It is specifically indicated for use in the following types of soft tissue repair procedures: abdominal, inquinal, diaphragmatic, femoral, scrotal, . umbilical, and incisional hernias; . colon, rectal, urethral, and vaginal prolapse: muscle flap reinforcement; . . reconstruction of the pelvic floor; sacrocolposuspension; and . . urethral sling.

Permacol™ is a sterile, tough. off-white. moist. flexible, fibrous flat sheet solely comprised of acellular crosslinked porcine dermal collagen and elastin

The prompt requests information on acceptance criteria and study details for a device, but the provided text describes a surgical mesh (Permacol™) and its 510(k) premarket notification. This type of medical device submission typically focuses on demonstrating substantial equivalence to existing predicate devices rather than establishing specific quantitative acceptance criteria or conducting studies as would be done for a novel diagnostic algorithm.

Therefore, many of the requested data points (such as sample sizes for test sets, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, and training set details) are not applicable or available in this type of submission. The provided text outlines biocompatibility testing and clinical experience used to support substantial equivalence and safety/effectiveness, but not a controlled clinical trial with specific numerical outcome measures against acceptance criteria in the way a diagnostic AI would have.

However, I can extract the information that is present and explain where the requested details are not provided.

Here's a breakdown based on the provided text:

Acceptance Criteria and Device Performance for Permacol™ Porcine Collagen Surgical Mesh

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Human Clinical Experience: "several hundred patients in Europe" for general clinical safety and tolerance.
• Sample Size for Detailed Case Histories: 60 patients for detailed evaluation of handling and clinical outcomes.
• Data Provenance: Clinical experience in Europe (specifically mentioned). The studies referenced appear to be retrospective collections of "case histories" rather than a prospective, randomized controlled trial.
• Animal Study Sample Size: Not explicitly stated, but mentioned as "implantation in rats."

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

• Not Applicable / Not provided: This type of information is typically associated with diagnostic device evaluations, especially those involving expert interpretation of medical images or data. For a surgical mesh, "ground truth" would be established through direct clinical observation of patient outcomes and histological analysis, not through expert consensus on diagnostic interpretations. The document references "clinical experience" and "histological evaluation" which implies medical professionals (surgeons, pathologists) were involved, but the specific number or qualifications are not detailed as they would be for a diagnostic study.

4. Adjudication method for the test set

• Not Applicable / Not provided: Adjudication methods (e.g., 2+1, 3+1) are typically used in diagnostic studies where multiple readers interpret data and discrepancies need to be resolved. This is not relevant for the type of clinical experience and biocompatibility 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

• Not Applicable: An MRMC comparative effectiveness study, especially concerning AI assistance, is not relevant to a surgical mesh like Permacol™. This device is not an AI-powered diagnostic tool.

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

• Not Applicable: Permacol™ is a physical surgical mesh, not an algorithm. Standalone algorithm performance is not relevant.

7. The type of ground truth used

• Biocompatibility Studies: Laboratory test results (e.g., cell viability, hemolytic index, mutagenicity assays) and histological findings from animal implantation.
• Clinical Experience: Direct observation of patient safety (adverse events), tolerance, and surgical outcomes (e.g., successful repair, ease of handling). These would be derived from clinical records and surgeon's assessments.

8. The sample size for the training set

• Not Applicable: Permacol™ is a manufactured device, not an AI model that requires a "training set."

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

• Not Applicable: As there is no AI model or training set, this question is not relevant.

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