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

Durepair® Dura Regeneration Matrix is a collagen implant for the repair of defects in the dura mater. Durepair is supplied sterile, in a double-peel package, and is intended for single (one-time) use-only. Durepair is available in a variety of sizes intended to be cut by the surgeon to the desired shape.

The document describes the Durepair Dura Regeneration Matrix, a collagen implant for repairing dura mater defects. This is a 510(k) submission, meaning the device is seeking clearance by demonstrating substantial equivalence to a legally marketed predicate device, rather than proving de novo safety and effectiveness.

Here's an analysis of the acceptance criteria and supporting studies, based on the provided text:

Key Takeaway: The entire submission focuses on demonstrating that a manufacturing process change for the Proposed Durepair Device does not alter its fundamental technological characteristics, material, indications for use, or safety and effectiveness compared to the Predicate Durepair Device. Therefore, the "acceptance criteria" discussed are largely related to ensuring the proposed device performs comparably to the predicate across various physical, mechanical, and biological properties.

1. Table of Acceptance Criteria and Reported Device Performance

The document provides "Table 2 – Summary of Bench Top Testing" and "Table 3 – Summary of Biocompatibility Testing" which directly address acceptance criteria and the performance of the Proposed Durepair device.

2. Sample Size for Test Set and Data Provenance

• Sample Size for Test Set: The document does not explicitly state the exact number of samples (e.g., individual devices or specimens) used for each bench or biocompatibility test. It often refers to "All samples," "each skin," or "each lot."
  • For Sizes, "All samples met the acceptance criteria, measured with digital calipers and were inspected 100%." This implies every unit or a statistically representative sample for dimension checking.
  • For Tensile Strength and Tensile Stiffness, "All skins were sampled at the two thinnest corners of each skin."
  • For Suture Retention Strength, "Two suture retention samples were taken from the thinnest (weakest) areas of each skin."
  • For Safety (Pyrogenicity) and Bioburden, "per each production lot."
  • For Calcification, "Samples implanted into weanling rats."
  • For Cytotoxicity, "Lots tested."
  • For animal studies (Skin Sensitization, Irritation, Acute Systemic Toxicity, Intramuscular Implantation), it refers to "test animals," "rabbits," "mice," "weanling rats," but does not explicitly state the number of animals per test.
• Data Provenance (Country of Origin, Retrospective/Prospective): The document does not provide information on the country of origin of the data or whether the studies were retrospective or prospective. Given the nature of bench and biocompatibility testing for a 510(k) submission, these are typically prospective laboratory/animal studies conducted by the manufacturer or contracted labs to evaluate the specific proposed device.

3. Number of Experts and Qualifications for Ground Truth

• This device is not an AI/ML-based diagnostic or imaging device, so the concept of "ground truth established by experts" in the context of diagnostic performance does not directly apply here.
• The "ground truth" for the tests performed (e.g., tensile strength, biological reaction) is derived from objective, quantitative measurements (e.g., MPa, N, °C, % hemolytic index) and standardized histological or macroscopic observations following established ISO or internal test methods.
• For histological evaluations (e.g., Calcification, Intramuscular Implantation), implicit "experts" would be pathologists or histotechnicians interpreting the tissue slides, but their number or qualifications are not specified, as this is standard practice for such tests.

4. Adjudication Method for Test Set

• Not applicable in the context of this device. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies or reader studies for diagnostic devices where disagreement among human readers needs to be resolved to establish a consensus ground truth. Here, the tests are primarily objective measurements or standardized biological assays.

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

• No, an MRMC comparative effectiveness study was not done. This type of study assesses how human readers perform with vs. without AI assistance, which is relevant for diagnostic AI tools. The Durepair Dura Regeneration Matrix is a physical implant, not an AI diagnostic.
• The study design focuses on bench testing (physical and mechanical properties) and biocompatibility testing to demonstrate the proposed device is substantially equivalent to a predicate, especially given a manufacturing process change.

6. Standalone (Algorithm Only) Performance

• Not applicable. This is a physical medical implant, not a software algorithm or AI device.

7. Type of Ground Truth Used

The "ground truth" for these tests comes from:

• Objective Measurements: Directly measured quantitative values for physical and mechanical properties (e.g., length, width, tensile strength, stiffness, suture retention, shrink temperature, hydration rate).
• Standardized Analytical Results: Quantitative results from analytical methods (e.g., pyrogenicity [EU/device], bioburden [CFU]).
• Histopathology/Biological Assay Standards: Qualitative and semi-quantitative assessments based on established biological safety standards (ISO 10993 series) interpreted by trained personnel (e.g., absence of cells/debris, calcification, specific grades of reactivity, absence of toxicity/sensitization, hemolytic index).
  • For calcification, histology images were likely the "ground truth."
  • For cytotoxicity, the "grade of reactivity" based on cell culture observations.
  • For genotoxicity, the "number of revertants" compared to controls.

8. Sample Size for the Training Set

• Not applicable. This is not an AI/ML device that requires a training set. The "Proposed Durepair device" is a physical product designed and validated through engineering and biological testing, not trained on data.

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

• Not applicable. As established in point 8, there is no "training set" for this device.

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Durepair® is indicated as a dura substitute for the repair of the dura mater.

The Durepair Dura Regeneration Matrix is a collagen implant for the repair of defects in the dura mater. Du epair is supplied sterile in sheet form in a variety of sizes to be trimmed and sutu red by the surgeon to meet the individual patient's needs.

This 510(k) summary (K052211) for the Durepair® Dura Regeneration Matrix does not contain information about acceptance criteria or a study proving that the device meets such criteria. Instead, it focuses on demonstrating substantial equivalence to a previously cleared predicate device (Durepair® Dura Regeneration Matrix, K041000).

The summary explicitly states:
"Medtronic Neurosurgery submits that the collagen material, sourcing specification, fundamental scientific technological attributes, device labeling, and the intended use of the device are the same as the previously reviewed and cleared Durepair."

This indicates that the submission is based on the premise that the new device is essentially identical to the predicate, and therefore, its safety and effectiveness are established by the predicate's prior clearance. There is no mention of a new performance study or acceptance criteria.

Therefore, I cannot provide the requested information from the provided text.

Ask a specific question about this device

Durepair® is indicated as a dura substitute for the repair of the dura mater.

Durepair® Dura Regeneration Matrix is a collagen implant for the repair of defects in the dura mater. Durepair® is supplied sterile in sheet form in a variety of sizes to be trimmed and; sutured or onlayed by the surgeon to meet the individual patient's needs.

The provided text is a 510(k) summary for the Durepair® Dura Regeneration Matrix, a collagen implant for dura mater repair. It outlines the device's description, indications for use, and a statement of substantial equivalence to predicate devices (Dura-Guard® and DuraGen™).

However, the document does not contain information about:

• Acceptance criteria in terms of specific performance metrics or thresholds.
• A "study" describing device performance against such criteria.
• Sample sizes for test sets or training sets.
• Data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or type of ground truth.

The document states that "Safety of the Durepair® device to the predicate products was demonstrated in biocompatibility studies in accordance with ISO 10993, in vitro testing, animal studies, and clinical data." This vaguely mentions "clinical data" but provides no details about the design, results, or specific metrics from these studies that would allow for an evaluation of acceptance criteria or performance.

Therefore, I cannot fulfill the request for a table of acceptance criteria, reported device performance, or detailed study information based solely on the provided text. The document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance study results that would typically include such metrics.

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