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The DuraSure consists of one piece of bovine pericardial tissue that has been selected for minimal tissue blemishes. The tissue is treated with a glutaraldehyde process which crosslinks the collagen fibers and minimizes antigenicity. The DuraSure is liquid chemical sterilized and packaged in a plastic jar containing sterile glutaraldehyde storage solution. The DuraSure is designed to repair the body's natural organs.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the DuraSure Biologic Patch, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	DuraSure Biologic Patch Performance	Predicate Device Performance
Tensile Strength	≥ 2 MPa	Mean: 11.9 MPa	Not explicitly stated (implied to meet acceptance criteria, but specific value for predicate device not given, only "mean of tensile strength of the predicate device was [value not provided]" in text)
Elongation	5% - 50% elongation	Mean: 25% elongation	Mean: 32% elongation
Burst Strength	≥ 12 PSI	Mean: 127 PSI	Mean: 59 PSI
Suture Retention	≥ 300 gf	Mean: 970 gf	Mean: 978 gf
Thickness	0.35 mm - 0.75 mm	Passed acceptance criteria	0.32 mm - 0.71 mm
Biocompatibility	Satisfactory biocompatibility (implied, by comparison to predicate)	Satisfactory biocompatibility results	Established biocompatibility
Sterilization	Chemically sterilized according to ISO14160: 2011 with 10⁻⁶ SAL	Chemically sterilized according to ISO14160: 2011 with 10⁻⁶ SAL	Chemically sterilized with 10⁻⁶ SAL
Animal Study Conclusion	Test article is locally non-toxic and performs equivalently to control in dural repair model.	Test article is locally non-toxic; performed equivalently to control.	Control article deemed locally non-toxic and performed equivalently to test article.

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

The document focuses on "pre-clinical" testing, which includes both in-vitro (bench) testing and an in-vivo animal study.

Bench Testing (Tensile, Elongation, Burst Strength, Suture Retention, Thickness):
- Sample Size: Not explicitly stated for each test (e.g., "All DuraSure patches passed the acceptance criteria"). However, results are given as "mean" values, implying multiple samples were tested for each characteristic.
- Data Provenance: Not specified, but generally refers to laboratory testing conducted by the manufacturer or contracted labs. The country of origin is not mentioned. This is retrospective data collected for the 510(k) submission.
In-vivo Animal Study:
- Sample Size: Forty-nine (49) rabbits.
- Data Provenance: Not explicitly stated, but implies a controlled laboratory setting for animal research. This is prospective data collected during the study.

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

Bench Testing: No experts are typically used to establish ground truth for this type of quantitative functional testing. The "ground truth" is defined by the physical measurement methods and the device specifications.
In-vivo Animal Study:
- Number of Experts: At least one. The document states, "All slides were evaluated by a veterinary pathologist for neuropathological changes in brain tissue, dural integrity, neoduralization and local tissue reaction according to ISO 10993-6 and FDA Guidance."
- Qualifications: "veterinary pathologist." No further details on years of experience or specific sub-specialties are provided.

4. Adjudication Method for the Test Set

Bench Testing: Not applicable. These are objective measurements following established test methods.
In-vivo Animal Study: Not explicitly described. It states "All slides were evaluated by a veterinary pathologist." This implies a single expert assessment. If multiple pathologists were involved, no method for resolving disagreements (e.g., 2+1, 3+1) is mentioned.

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

No, an MRMC comparative effectiveness study was not done. The studies presented are pre-clinical (bench and animal studies) and do not involve human readers evaluating cases.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

No, this question is not applicable. The DuraSure Biologic Patch is a physical medical device (surgical patch material), not an AI algorithm or software device. Therefore, a standalone performance evaluation of an algorithm is not relevant.

7. The Type of Ground Truth Used

Bench Testing: The ground truth is based on objective quantitative measurements obtained using standardized test methods (e.g., Instron for tensile/elongation/suture retention, pressure sensors for burst strength, thickness gauges).
In-vivo Animal Study: The ground truth for the animal study was established through histopathological evaluation by a veterinary pathologist, based on internationally recognized standards (ISO 10993-6) and FDA guidance for dural substitute devices. This includes macroscopic and microscopic evaluations, with scoring.

8. The Sample Size for the Training Set

This question is not applicable. The DuraSure Biologic Patch is a physical medical device, not a machine learning model. Therefore, there is no "training set" in the context of AI.

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

This question is not applicable, as there is no training set for a physical medical device.

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