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The device is indicated as a dura substitute for the repair of dura mater.

The proposed device is composed of bovine pericardium processed through a proprietary tissue preservation and sterilization process which includes gamma irradiation. The proposed device is composed of collagenous connective tissue with three-dimensional intertwined fibers and can be fixed regardless of the direction of the device. Collagenous connective tissue with multidirectional fibers retains the mechanical strength and elasticity of the native tissue, while providing the basic structure to support replacement by new endogenous tissue. The proposed device in its unopened, undamaged package is sterile.

The provided document describes the K132850 submission for a Bovine Pericardium Suturable Dural Graft, Tutopatch™ DM Graft, or Tutoplast® Bovine Pericardium DM. The submission focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel acceptance criteria with a specific study framework for entirely new performance standards.

Here's a breakdown based on the information provided, tailored to your request but highlighting the context of a 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

In a 510(k) submission for substantial equivalence, "acceptance criteria" are typically defined by demonstrating performance comparable to legally marketed predicate devices, rather than predefined absolute thresholds for a novel device. The document uses predicate device performance as the benchmark for "substantial equivalence."

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

• In-vitro tests (Cytotoxicity, Suture Pull-out, Burst Strength, Shrink Temperature, Max Load, Pyrogenicity): The document does not specify the exact sample sizes (n-numbers) for these in vitro tests. This is common in 510(k) summaries where detailed raw data is often in the full submission, not the summary.
• Pre-clinical Implantation Study (Animal Model): The sample size for the animal model is not specified. The data provenance is "animal model" (prospective, experimental).
• Sabatino et al. (2014):
  • Sample Size: Not explicitly stated how many patients received the proposed device, but it was a "prospective cohort study" comparing the proposed device (Tutopatch) to autologous galea-pericranium.
  • Data Provenance: The study was published in "Clin. Neuro and Neurosurgery," indicating it was a clinical study. It appears to be prospective data, and the device was marketed as "Tutopatch" in the European market.
• Filipi et al. (2000):
  • Sample Size: 32 patients.
  • Data Provenance: Retrospective evaluation of patients who received Tutoplast bovine pericardium dural grafts (the proposed device as marketed in ex-US countries). The study was published in "Neurosurg Rev."

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

This type of information (number and qualifications of experts for ground truth) is typically relevant for diagnostic or AI-based devices where human interpretation is the "ground truth." For a dural graft product like this, the "ground truth" is established by:

• Biomechanical properties: Objective measurements from standardized laboratory tests.
• Biocompatibility: Established by standardized cytotoxicity and pyrogenicity assays.
• Animal study: Assessment by veterinary pathologists/researchers.
• Clinical studies: Assessment by neurosurgeons or clinicians involved in the patient follow-up, observing outcomes like CSF leakage, adverse events, surgical handling, etc. The studies cited (Sabatino et al., Filipi et al.) describe methodologies where clinical outcomes are observed and reported by medical professionals, implicitly establishing the "ground truth" for clinical performance. The number and specific qualifications of the adjudicating experts for these clinical studies are not detailed in this 510(k) summary.

4. Adjudication Method for the Test Set

As this is not a diagnostic device or imaging-based assessment where consensus reads are common:

• In-vitro tests: No adjudication method as these are objective measurements.
• Animal study: Adjudication is typically part of the pathology review process, but not explicitly described here.
• Clinical studies (Sabatino et al., Filipi et al.): No formal "adjudication method" like 2+1 or 3+1 is typically used for overall clinical outcomes in these types of surgical device studies. Clinical outcomes are recorded by treating physicians or study investigators, and significant events might undergo review, but not in the sense of a consensus ground truth reading.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC comparative effectiveness study is designed for evaluating the impact of a diagnostic tool (often AI) on human reader performance for diagnostic tasks. This device is a surgical implant (dural graft). The clinical studies cited evaluate the performance of the graft itself, not its impact on human reader accuracy.

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

This question is not applicable. This device is a passive surgical implant, not an algorithm or AI system.

7. The Type of Ground Truth Used

• Biomechanical properties: Objective measurements (e.g., N for force, °C for temperature).
• Biocompatibility: Results of standardized biological assays (e.g., cell culture, LAL assay).
• Animal study: Gross pathology, histopathology, and clinical observation data.
• Clinical studies (Sabatino et al., Filipi et al.): Clinical outcomes data (e.g., absence of CSF leakage, adverse events, ease of use, material integration, resorption, overall clinical judgment by surgeons).

8. The Sample Size for the Training Set

This question is not applicable as this is not an AI/ML device that requires a training set. The data presented are for evaluating the performance of the physical dural graft.

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

This question is not applicable as there is no training set for an AI/ML device.

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DuraGen™ Dural Graft Matrix is indicated as a dura substitute for the repair of dura mater.

DuraGen™ Dural Graft Matrix is an absorbable implant for repair of dura mater. DuraGen [M is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix. DuraGen™ is supplied sterile, nonpyrogenic, for single use in double peel packages in a variety of sizes. DuraGen™ is manufactured from bovine achilles tendon, which is classified by European Standards as Class IV material, no detectable infectivity for Bovine Spongiform Encephalopathy (BSE). The bovine tendon is known to be one of the purest sources of Type I Collagen that is commercially available. The collagen used to manufacture DuraGen™ is currently used in the manufacture of an artificial skin, absorbable hemostatic sponges, and absorbable wound dressings. The manufacturing process for DuraGen134 meets the United States Food and Drug Administration's Guidance document and European Standards for animal tissue sourcing, handling and inactivation of BSE. This process involves a treatment with sodium hydroxide that is a recognized method of inactivation of Spongiform Encephalopathy (SE). The bovine tendon is only obtained from facilities in the United States of America that have been inspected by the United States Department of Agriculture (USDA). Bovine Spongiform Encephalopathy (BSE) is not known to exist in the United States of America, therefore, the United States of America is considered by the European Union as a low risk country for bovine sourced materials. A viral inactivation study for the DuraGen™ manufacturing process was conducted by an independent certified laboratory. In this study, the sodium hydroxide treatment was evaluated for its ability to inactivate the following viral strains: I luman Immunodeficiency Virus Type I (HIV), Bovine Viral Diarrhea (BVD), Infectious Bovine Rhinotracheitis (IBR), Parainfluenza Virus Type 3 (P13). Vesicular Stomatitis (VSV). For these viruses, the sodium hydroxide treatment reduced the viral titer to non-detectable levels.

The provided text is a 510(k) Premarket Notification Summary for the Integra LifeSciences Corporation DuraGen™ Dural Graft Matrix. This document focuses on demonstrating substantial equivalence to existing devices rather than meeting specific performance acceptance criteria for a new, novel device. As such, the information you've requested regarding acceptance criteria, a study proving device meeting criteria, sample sizes for test/training sets, ground truth establishment, expert qualifications, and MRMC studies, is not present in the provided text.

Specifically:

1. Acceptance Criteria and Reported Device Performance: This information is not explicitly stated as "acceptance criteria" in the traditional sense of a new device coming to market. The submission focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and safety/effectiveness data. The "Clinical Studies" section notes that the device "performed safely and effectively as a dura substitute" based on clinical evaluations, but no numerical performance metrics or acceptance thresholds are given. The "TABLE 1: Substantial Equivalence Comparison Chart" compares technical characteristics (materials, absorption time, non-pyrogenic status) to predicate devices, but these are characteristics, not performance metrics against acceptance criteria.

2. Sample Size for Test Set and Data Provenance:

   • The "Clinical Studies" section mentions "Clinical evaluations involving more than 1,000 patients." It also states, "biopsies of the collagen implant were available from 100 patients for macroscopic and histological examination." It is unclear if these 1,000+ patients constitute the "test set" for the primary clinical evaluation or a broader set of patients where the collagen sponge was used.
   • The provenance of the data (country of origin, retrospective/prospective) is not specified.

3. Number of Experts and Qualifications: This information is not provided.

4. Adjudication Method: Not provided.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not performed or described. This type of study is more common for diagnostic imaging AI devices, whereas DuraGen™ is a surgical implant.

6. Standalone Performance Study: Not described in the context of an "algorithm only" performance. The clinical studies described involved human evaluation of the device's performance in patients.

7. Type of Ground Truth Used:

   • For the clinical study, the text states "biopsies of the collagen implant were available from 100 patients for macroscopic and histological examination." This suggests histology/pathology was used to assess outcomes like graft encapsulation, neomembrane formation, delayed hemorrhage, or foreign body reactions.
   • The "Clinical evaluations" also likely relied on clinical outcomes data (e.g., integrity of the dura repair, complications).

8. Sample Size for Training Set: Not applicable as this is a physical medical device, not an AI/ML algorithm requiring a training set in that context. The "training" in this case refers to prior experience with the material in other products. The manufacturing process does undergo viral inactivation studies, but this is a process validation, not a training set.

9. How Ground Truth for Training Set Was Established: Not applicable.

Summary of available information formatted as requested (with caveats):

Study Information:

• Study Proving Device Meets Criteria: A "long-term clinical study" and "clinical evaluations involving more than 1,000 patients" were conducted.
• Sample Size (Test Set):
  • "More than 1,000 patients" for general clinical evaluations.
  • "100 patients" had biopsies available for macroscopic and histological examination.
• Data Provenance: Not specified (country, retrospective/prospective).
• Number of Experts for Ground Truth: Not specified.
• Qualifications of Experts: Not specified.
• Adjudication Method: Not specified.
• MRMC Comparative Effectiveness Study: No.
• Standalone Performance Study: No (not applicable in the AI context).
• Type of Ground Truth Used: Clinical outcomes and macroscopic/histological examination of biopsies (pathology).
• Sample Size for Training Set: Not applicable (physical device).
• How Ground Truth for Training Set was Established: Not applicable.

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