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The DuraSure Biologic Patch is intended for use as a surgical patch material to close dura mater during neurosurgery.

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.

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

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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PhotoFix is indicated for the following uses: intracardiac repair, suture line buttressing, pericardial closure, and vascular repair and reconstruction (for example: the carotid, iliac, femoral, and tibial blood vessels and arteriovenous access revisions).

The PhotoFix® Decellularized Bovine Pericardium ("PhotoFix") is a cardiovascular patch that is prepared from bovine pericardium, stabilized using dye-mediated photooxidation, processed using ethylene oxide, and sterilized using aseptic processing techniques. The photooxidation process creates crosslinks in the bovine tissue. No aldehyde chemistry is used during any phase of manufacturing including the tissue fixation or sterilization processes.

PhotoFix is intended for single use only and cannot be resterilized. PhotoFix is supplied sterile in a sealed container with 22% buffered ethanol solution. Rinsing of the pericardium prior to implantation is not required.

This document is a 510(k) summary for the PhotoFix Decellularized Bovine Pericardium. It describes the device, its indications for use, and its substantial equivalence to predicate devices based on comparative testing of biomechanical properties. However, it does not contain the specific information required to complete the table or answer the detailed questions regarding acceptance criteria and study particulars for a device performance study in the way a clinical or AI-based diagnostic device submission would.

This document focuses on biomechanical performance testing comparing the new device to existing predicate devices, not on a human-in-the-loop or standalone algorithm performance study typical for AI/ML medical devices.

Therefore, many of the requested fields cannot be filled from the provided text.

Here is the information that can be extracted or deduced:

1. A table of acceptance criteria and the reported device performance

Note on Acceptance Criteria: The document states that testing demonstrated that PhotoFix is substantially equivalent to the identified predicate devices for the biomechanical properties. This implies that the implicit acceptance criterion was meeting a comparable performance standard to these predicate devices, which are already legally marketed. Quantitative acceptance criteria are not explicitly listed in this summary.

Regarding the study that proves the device meets the acceptance criteria:

The study described is a comparative biomechanical testing study.

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

  • Sample Size: Not specified in the provided summary. The study involved comparative biomechanical testing of the PhotoFix device against two predicate devices (XenoSure and CorMatrix). The "test set" would refer to the number of PhotoFix samples tested for each biomechanical property.
  • Data Provenance: Not explicitly stated but clinical data provenance (e.g., country of origin, retrospective/prospective) is not applicable as this was a laboratory biomechanical testing study, not a clinical study. It's an in-vitro/ex-vivo material property study.

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

  • Not applicable. This was a laboratory-based biomechanical performance test, not a study requiring expert consensus for ground truth. The "ground truth" would be the measured physical properties of the materials.

• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

  • Not applicable. This was a laboratory-based biomechanical performance test.

• 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:

  • No. This type of study is for diagnostic devices, particularly AI/ML-based ones. This document describes a tissue patch for surgical repair.

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

  • No. This is not an AI/ML algorithm.

• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

  • The "ground truth" for this type of study would be the measured physical and mechanical properties of the PhotoFix device and the predicate devices, obtained through standardized laboratory testing (e.g., force transducers, tensile testers, etc.). It is not clinical or expert-derived ground truth.

• 8. The sample size for the training set:

  • Not applicable. This is not an AI/ML algorithm that requires a training set.

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

  • Not applicable. This is not an AI/ML algorithm.

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OrthADAPT® PR is intended to be used for implantation to reinforce soft tissue, including but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, hernias. suture-line reinforcement and other reconstructive procedures.

The device is also intended for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons.

OrthADAPT® PR is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps or other tendons. Sutures, used to repair the tear, and sutures or bone anchors. used to attach the tissue to the bone, provide biomechanical strength for the tendon repair.

OrthADAPT® PR is comprised of collagen matrix reinforced by a woven polymer to provide permanent durability. The collagen matrix, which is derived from the same equine pericardial tissue used in the fabrication of its predicate device, the OrthADAPT® Bioimplant, has been decellularized and crosslinked and the entire device has been exposed to a liquid chemical sterilant. The product passes USP sterility testing and satisfies FDA requirements for LAL endotoxin limit for a medical device. The product must be rinsed prior to use following the procedures described in the Instructions for Use.

The provided text describes the OrthADAPT® PR Bioimplant, a surgical mesh device, and its substantial equivalence to predicate devices, rather than a study with acceptance criteria in the typical sense of diagnostic performance metrics (e.g., sensitivity, specificity). This documentation is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, not on proving device efficacy through a comparative performance study with predefined acceptance criteria for AI or diagnostic performance.

Therefore, many of the requested fields cannot be filled as they pertain to a different type of study (e.g., an AI/diagnostic performance study).

Here's the information available from the text, framed within the requested table and addressing the other points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

The "study that proves the device meets the acceptance criteria" in this context refers to the collective body of biocompatibility testing, biomechanical bench testing, and an animal implant study, all performed to demonstrate substantial equivalence to predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test Set Sample Size: Not explicitly stated. The document mentions "biocompatibility testing," "biomechanical bench testing," and "an animal implant study." The sample size for each of these tests is not quantified in the provided text.
• Data Provenance: Not explicitly stated. The document indicates the testing was conducted to support a submission to the FDA (U.S.). It does not specify the country of origin for the animal study or other testing data, nor whether the studies were retrospective or prospective.

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

• Not applicable. This device is a surgical mesh, not an AI or diagnostic device that relies on expert interpretation of results for "ground truth" establishment in a diagnostic accuracy study. The "ground truth" here is established through objective physical and biological tests (e.g., tensile strength for biomechanical performance, histological assessment in animal studies for tissue response).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. This is not a study requiring adjudication of expert opinions for a diagnostic outcome.

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 is not a diagnostic device or an AI-assisted interpretation tool. It is a surgical implant.

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

• Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The "ground truth" for the performance evaluation of the OrthADAPT® PR Bioimplant is based on:
  • Biocompatibility Standards: Meeting established biological safety standards for medical devices.
  • Biomechanical Measurements: Objective quantitative measurements of mechanical properties (e.g., tensile strength, tear resistance) against performance requirements deemed suitable for its intended use and comparable to predicate devices.
  • In Vivo Animal Study Observations: Histological and functional assessments of tissue response, integration, and functionality in an animal model, conforming to expectations for surgical mesh.
  • Sterility and Endotoxin Testing: Objective laboratory tests (USP sterility testing, LAL endotoxin limit).

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device.

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

• Not applicable. This is not an AI/machine learning device.

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