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The PeriBeam® Pericardial Membrane is indicated for the reconstruction or repair of the pericardium.

PeriBeam® is an ion-irradiated, expanded polytetrafluoroethylene (ePTFE) membrane used for reconstruction or repair of the pericardium. This device is intended for use as a temporary or permanent prosthesis for repair of pericardium

The provided FDA 510(k) clearance letter for the PeriBeam® Pericardial Membrane does not contain the detailed acceptance criteria and study results typically required to fully answer your request.

The document primarily focuses on the regulatory clearance process, device description, indications for use, and a general overview of the performance, animal, and biological/toxicological safety testing conducted. It does not provide the specific quantitative acceptance criteria or the reported performance data against those criteria. It also doesn't present an MRMC study or details on ground truth establishment for a standalone algorithm performance test, as this type of device (a physical membrane) would not involve AI or image analysis.

Therefore, I cannot create a table of acceptance criteria and reported device performance, nor can I elaborate on sample sizes for test sets, expert involvement, adjudication methods, MRMC studies, or training set details as these are not relevant for the type of device described.

However, I can extract the information that is present:

Summary of Information Available in the Provided Text:

Device Type: The PeriBeam® Pericardial Membrane is a physical medical device (an ion-irradiated, expanded polytetrafluoroethylene (ePTFE) implant) for reconstruction or repair of the pericardium. It is not an AI algorithm, diagnostic imaging software, or a device that would typically involve acceptance criteria related to classification metrics (e.g., sensitivity, specificity, AUC) or human reader performance.

Therefore, questions pertaining to AI/software performance (e.g., "effect size of how much human readers improve with AI vs without AI assistance," "standalone algorithm performance," "number of experts for ground truth," "adjudication method," "sample size for training set," "how ground truth for training set was established") are not applicable to this device.

The "Performance Testing" section describes types of tests conducted, but not the acceptance criteria or specific results.

1. Table of Acceptance Criteria and Reported Device Performance:

• Not Available in the provided text. The document lists types of performance tests (Tensile Strength, Suture Strength, Accelerated Fatigue, Fibrin Glue, Burst Strength) but does not provide the specific quantitative acceptance criteria for each or the measured performance values.

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

• Nonclinical Performance Testing: The specific sample sizes for tests like Tensile Strength, Suture Strength, Fibrin Glue, and Burst Strength are not explicitly stated, although ISO 2859-1 (Sampling procedures for inspection by attributes) is referenced. This standard relates to sampling plans for quality control, not necessarily the sample size of unique test cases (e.g., patient data).
• Animal Study:
  • Sample Size: "Ten (10) pigs divided into three (3) groups for eight (8) weeks."
  • Data Provenance: Not explicitly stated (e.g., country of origin), assumed to be a controlled laboratory animal study (prospective).

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

• Not Applicable. This is a physical implant device, not an AI or diagnostic device requiring expert interpretation for ground truth establishment. The "ground truth" for its performance relates to its physical, mechanical, and biological properties, which are assessed through laboratory tests and animal studies.

4. Adjudication Method for the Test Set:

• Not Applicable. See point 3.

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 is a physical implant device, not a diagnostic or AI-powered device. MRMC studies are not relevant for this product.

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

• No. This is a physical implant device. Standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used:

• For nonclinical performance testing, the "ground truth" is established through standardized engineering and materials testing methods (e.g., ISO, JIS, ASTM standards for tensile strength, burst strength, etc.).
• For the animal study, "ground truth" was established through direct observation (health condition, feeding, respiration, feces), weight measurement, ultrasonography, macroscopic observations at autopsy (adhesions, effusions, infection, discharge), and histopathology (cellular infiltration, fibroblast amount, fibrosis, bacteria). These are direct biological and pathological assessments.

8. The Sample Size for the Training Set:

• Not Applicable. This is a physical device, not an AI model that requires a training set.

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

• Not Applicable. See point 8.

In conclusion, while the document provides evidence of various tests performed, it does not include the detailed quantitative acceptance criteria and the corresponding measured performance data within the provided sections. The nature of the device (a physical pericardial membrane) means that many of the AI/software-related questions are not applicable.

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Vascutek Cardiovascular Fabric is indicated for vascular repair whenever knitted polyester fabrics are normally indicated.

Due to its particularly high strength. Gelseal is especially suitable for thoracic use whereas the softer handle of the Gelsoft makes it ideal for peripheral use. The Thin Wall fabric is designed for endaterectorny, particularly of the carotid arteries.

The Vascutek Cardiovascular Fabric are a range of gelatin sealed, knitted, polyester patch fabrics. The range consists of three different patch fabrics which are manufactured using identical materials, processes and procedures but which, because of slight differences in the pattern of the base fabric, exhibit different physical characteristics. This range of products is provided in order to give the implanting surgeon a choice of several different fabrics from which they can chose the most suitable according to their own preferences and according to specific demands of any given surgical situation.

Two of the patches, Gelseal™ and Gelsoft™, are based on fabrics which are currently used in Vascutek's range of tubular vascular prostheses, which have received Premarket approval from the FDA. The only difference between the cardiovascular fabrics and the tubular grafts is that the patches are produced in flat, patch formats (i.e. square or rectangular) and have not been subjected to the crimping process which is used in the production of the tubular prostheses. With this single exception, the manufacturing facilities, equipment, processes and the quality control processes and procedures are identical to those used in the manufacture of the Gelseal™ and Gelsoft™ vascular prostheses.

The third type of patch, the Thin Wall Carotid Patch, is also manufactured using the identical materials, processes and procedures as the other cardiovascular patches but with a slightly modified knit pattern. This new structure has been developed in order to maintain the physical characteristics necessary for general cardiovascular patching but with a reduced wall thickness and characteristics which make it ideally suited to use for parching carotid arteries after endarterectomy procedures.

This is a 510(k) premarket notification for a medical device, not a study evaluating an AI algorithm. Therefore, the requested information about acceptance criteria, study design, expert involvement, and ground truth for an AI device is not available in the provided text.

The document describes the Vascutek Gelseal Patch, Vascutek Gelsoft Patch, and Vascutek Thin Wall Carotid Patch, which are cardiovascular fabric patches. The FDA has determined these devices are substantially equivalent to legally marketed predicate devices.

The "study" referenced in the document is a series of nonclinical tests performed to demonstrate that the device is safe and effective when compared to predicate devices. These tests included:

• Physical testing
• Biocompatibility testing
• Chemical characterization
• An animal performance study

The purpose of these tests was to show that the new devices, with a change in the gelatin supplier, perform as well as the previously approved devices.

Since this is not an AI device, the specific questions about acceptance criteria related to AI performance metrics (like sensitivity, specificity, or AUC), sample sizes for AI training/test sets, expert adjudication, or MRMC comparative effectiveness studies are not applicable and therefore cannot be answered from the provided text.

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The ADAPT® Tissue is indicated for use as a patch in the repair of cardiac defects including intracardiac defects, septal defects, valve and annulus repair.

The ADAPT® Tissue medical device is a bovine pericardial patch prepared from glutaraldehyde-crosslinked bovine pericardium using the ADAPT® TEP technology. It is a sterile, light yellow to beige colored, moist, pre-cut sheet of acellular collagen. The products range in size from 4cm² to 84cm² and can range in thickness from 0.25-0.80mm.

This document is a 510(k) Pre-Market Notification from Admedus Regen PTY LTD for their ADAPT® Tissue device. It primarily focuses on establishing substantial equivalence to previously cleared predicate devices (CardioCel and VascuCel) rather than presenting new performance data for the ADAPT® Tissue itself.

Therefore, many of the typical acceptance criteria and study details for an AI/ML device would not apply here. The key criteria for this submission are focused on demonstrating that "ADAPT® Tissue" is essentially the same device as the "CardioCel", with a minor labeling change (refining the indications for use).

However, I can extract the relevant information based on the document's content:

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

Since this is a substantial equivalence submission based on an existing device (CardioCel), the "acceptance criteria" here are that the ADAPT® Tissue should be functionally equivalent to CardioCel. The reported performance refers to the nonclinical testing already performed for CardioCel.

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

This information is not provided in the document as no new human clinical study was performed for the ADAPT® Tissue's specific submission. The submission relies on "nonclinical testing performed in support of the general intended use for CardioCel." Details about the sample size, provenance, and type of study for the original CardioCel testing are not included in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as this is not an AI/ML diagnostic or image analysis device relying on expert interpretation for ground truth. It's a biocompatibility and performance assessment of a surgical patch.

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

Not applicable for the reasons stated above.

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 device is a surgical patch, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a surgical patch, not an algorithm.

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

For the "performance" verification of such a device, the "ground truth" would typically involve:

• Biocompatibility testing: In vitro and in vivo studies (animal models) to assess tissue integration, immune response, and toxicity, with outcomes often measured by histological analysis, inflammatory markers, and gross observations.
• Mechanical property testing: Laboratory tests to evaluate tensile strength, elasticity, and suture retention.
• Degradation studies: In vitro and in vivo studies to assess how the material degrades over time in a physiological environment.
• Sterility testing: Laboratory verification of sterility.

These "truths" are established through standard scientific and regulatory testing methods, not expert consensus in the diagnostic sense. The document states "The nonclinical testing performed in support of the general intended use for CardioCel also demonstrates substantial equivalence." This implies a reliance on these types of scientific evaluations performed for the predicate device.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no training set in that context.

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

Not applicable. For the same reason as above.

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PhotoFix Decellularized Bovine Pericardium is indicated for the following uses: intracardiac repair, suture line buttressing and pericardial closure.

PhotoFix® Decellularized Bovine Pericardium is indicated for the following uses: intracardiac repair, great vessel repair, suture line buttressing and pericardial closure.

The PhotoFix® Decellularized Bovine Pericardium ("PhotoFix") is a cardiovascular patch prepared from bovine pericardium which is stabilized using a dye-mediated photooxidation process, 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 plastic container with 22% buffered ethanol solution. The package is designed to facilitate convenient aseptic transfer of the pericardium into the sterile field. Rinsing of the pericardium prior to implantation is not required.

The provided text is a 510(k) summary for the PhotoFix Decellularized Bovine Pericardium device. This document is a premarket notification for a medical device to demonstrate that it is substantially equivalent to a legally marketed predicate device.

Therefore, the request for "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML medical device is not directly applicable to this document. This document describes an implantable tissue patch, not an AI/ML device.

The "Performance Testing" section describes tests related to the physical and biological characteristics of the tissue patch and its packaging, specifically:

• Chemical characterization testing
• Biocompatibility testing (cytotoxicity and hemolysis)
• Packaging shelf-life

The "Conclusion" states that the device is substantially equivalent to its predicate.

To directly answer your questions based on the provided document, in the context of this specific medical device (PhotoFix Decellularized Bovine Pericardium), rather than an AI/ML device:

1. A table of acceptance criteria and the reported device performance:
   The document does not provide a formal table with specific acceptance criteria and detailed performance results (e.g., numerical values for cytotoxicity, hemolysis rates, or specific shelf-life data with pass/fail criteria). It only states that "The results of the testing demonstrated that the packaging is non-cytotoxic, non-hemolytic, and maintains a sterile barrier. The packaging is equivalent to the predicate device."
   Acceptance Criteria (Inferred from regulatory context):
   * Biocompatibility: Non-cytotoxic, Non-hemolytic.
   * Sterility: Sterile barrier maintained for shelf-life.
   * Equivalence: Packaging equivalent to predicate device.
   Reported Performance:
   * Biocompatibility: "non-cytotoxic, non-hemolytic"
   * Sterility/Packaging: "maintains a sterile barrier"
   * Equivalence: "The packaging is equivalent to the predicate device."

2. Sample sizes used for the test set and the data provenance: Not specified in the document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is not an AI/ML device requiring expert ground truth for image interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For biocompatibility and chemical characterization, the "ground truth" would be established by laboratory testing standards and methods (e.g., ISO standards for biocompatibility), not expert consensus in the diagnostic sense. For shelf life, it would be based on real-time or accelerated aging studies.

8. The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established: Not applicable.

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VascuCel is indicated as a patch in great vessel repair, peripheral vascular reconstruction and suture line buttressing.

The VascuCel device is a bovine pericardial patch prepared from glutaraldehyde-crosslinked bovine pericardium using the ADAPT® TEP technology. It is a sterile, light yellow to beige colored, moist, pre-cut sheet of acellular collagen. It is offered in a 2 x 8 cm size and a 0.8 x 8 cm size.

This document is a 510(k) summary for VascuCel, a bovine pericardial patch. It does not describe a study proving a device meets acceptance criteria in the typical sense of a clinical trial or algorithm performance study with specific metrics like accuracy, sensitivity, or specificity. Instead, it argues for "substantial equivalence" to a predicate device based on existing clinical literature and verification/validation testing.

Therefore, the following information, based on the provided text, will address the user's request in the context of a 510(k) submission for substantial equivalence. Many requested fields regarding specific performance metrics, sample sizes for test/training sets, expert consensus, and MRMC studies are not applicable or not provided in the context of this type of regulatory submission.

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

Since this is a submission for substantial equivalence based on a predicate device and established clinical practice, the "acceptance criteria" are primarily related to general safety and effectiveness and comparative performance to the predicate. Specific quantitative performance metrics (like sensitivity/specificity for an AI device) are not present.

2. Sample sized 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 as a separate "test set" in the context of an algorithm or statistical performance study. The submission refers to "clinical data demonstrating the acute safety of VascuCel" but does not give a sample size, provenance, or whether it was retrospective or prospective. For the predicate device, it mentions "clinical performance data that was performed on CardioCel."
• Data Provenance: Not specified for the "clinical data demonstrating acute safety of VascuCel." The predicate device information (CardioCel) likely drew from various clinical studies and literature, which are not detailed here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is not a study requiring expert-established ground truth in the context of image interpretation or diagnostic performance. The device is a patch for surgical repair. The "ground truth" for its safety and effectiveness relies on established medical understanding and clinical outcomes from surgical use.

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

Not applicable. This concept is typically relevant to studies involving multiple expert readers interpreting data for ground truth establishment.

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 device is a surgical patch, not an AI-assisted diagnostic tool.

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

Not applicable. This is a medical device (surgical patch), not an algorithm.

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

The "ground truth" for the claims of safety and effectiveness relies on:

• Established Clinical Literature: The document states, "The safety and effectiveness of bovine pericardial patches for the reconstruction and repair of cardiac and vascular anatomy is well established in clinical literature and is the current standard of care in clinical practice." This implies a broad body of outcomes data and expert consensus over time.
• Verification and Validation Testing: Performed on the predicate device (CardioCel), which would involve various laboratory and potentially animal studies to confirm material properties and biological response.
• Acute Safety Clinical Data: Provided for VascuCel, suggesting actual patient outcome data, though details are absent.

8. The sample size for the training set

Not applicable. This is a medical device, not an AI model requiring a training set.

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

Not applicable.

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The CorMatrix® Tyke™ is intended for use in neonates and infants for repair of pericardial structures, as an epicardial covering for damaged or repaired cardiac structures, as a patch material for intracardiac defect and annulus repair, suture-line buttressing, and cardiac repair.

CorMatrix® Tyke™ is intended for use in neonates and infants for repair of pericardial structures, as an epicardial covering for damaged or repaired cardiac structures, as a patch material for intracardiac defects, septal defect and annulus repair, suture-line buttressing, and cardiac repair.

CorMatrix® Tyke™ is derived from the same multi-laminate SIS-ECM material as the CorMatrix ECM for Cardiac Tissue Repair (4-ply). The CorMatrix® Tyke™ will be supplied as a 2-ply, lyophilized, sterilized sheet of SIS-ECM. With the exception of the differing layer counts, the device design and construction are identical to the FDA-cleared CorMatrix ECM for Cardiac Tissue Repair (K063349).

The provided text describes the 510(k) premarket notification for the CorMatrix® Tyke™ device, a medical implant for cardiac repair in neonates and infants. The document focuses on demonstrating substantial equivalence to a predicate device, the CorMatrix® ECM® for Cardiac Tissue Repair.

However, the information provided does not contain details about acceptance criteria, a specific study proving the device meets those criteria in a typical clinical trial format (e.g., sample size for test set, expert qualifications, adjudication methods for ground truth, MRMC study, training set details, or standalone algorithm performance).

The document primarily discusses non-clinical testing of the material properties and a non-clinical investigational study in an animal model. It does not describe a study involving human subjects or a diagnostic AI/ML device where such details would be relevant.

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

Here's a breakdown of what can be extracted and what cannot, based on the provided document:

1. Table of acceptance criteria and reported device performance:

The document describes performance testing for material properties and an in-vivo non-clinical study, but does not present a table of specific acceptance criteria with corresponding device performance values. It generally states that the device "exceeds the biomechanical requirements for its intended use" and that the in-vivo study showed "optimal healing features" and "no adverse changes recorded."

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

• Sample Size: The document mentions a "non-clinical investigational study," which implies an animal study, not human patients. The specific number of animals or data points for this study is not provided.
• Data Provenance: The study was "in vivo," meaning conducted in living organisms, likely animals, but the specific country of origin of the data is not specified. It was a prospective study in the sense that outcomes were observed after implantation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

This information is not applicable/provided as the study described is a non-clinical/animal study examining material properties and biological responses, not a study requiring human expert interpretation for ground truth, like for an AI diagnostic device. Histological techniques were used for evaluation, which would involve pathologists/histologists, but their number and qualifications are not disclosed.

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

This is not applicable/provided. Adjudication methods are typically relevant for human reader studies or when establishing ground truth from multiple expert interpretations, which is not the type of study described here.

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:

This is not applicable/provided. The device is a medical implant, not an AI/ML diagnostic system intended to assist human readers. Therefore, an MRMC study is not relevant to proving its effectiveness.

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

This is not applicable/provided. The device is a physical medical implant, not an algorithm.

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

For the non-clinical in-vivo study, the ground truth was established through histological techniques to evaluate structural integrity and host cellular response. This implies direct observation and analysis of tissue samples, which would typically be interpreted by veterinary pathologists or similar experts.

8. The sample size for the training set:

This is not applicable/provided. There is no mention of a "training set" as this is a physical medical device, not an AI/ML algorithm.

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

This is not applicable/provided. As above, no training set for an algorithm is described.

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PremiPatch PTFE Pledgets are indicated for use in cardiovascular tissue. Pledgets are used to mechanically secure and support sutures in fragile tissue and organ parenchymas, when a non-absorbable suture is indicated. Pledgets are also used to aid in suture buttressing.

The PremiPatch PTFE Pledgets are pre-cut sections of non-absorbable undyed polytetrafluorothylene (PTFE) which are supplied sterile. The PremiPatch PTFE Pledgets are used as a suture buttress for nonabsorbable sutures. The pledgets are available in two application styles: firm and soft and various shapes and sizes. Depending on the size they are available package two or six per pouch.

This document is a 510(k) Premarket Notification from the FDA for the PremiPatch PTFE Pledgets. It is a regulatory document and, as such, does not describe the acceptance criteria or a study that proves the device meets specific performance acceptance criteria in the way a clinical or performance study report would for an AI/machine learning device.

Instead, this document focuses on demonstrating substantial equivalence to a previously cleared predicate device, which is the primary pathway for 510(k) clearance. The performance data mentioned is primarily non-clinical bench testing to ensure the new device performs similarly to the predicate and meets its own specifications, rather than a study against a specific set of clinical performance metrics.

Therefore, many of the requested categories for AI/ML device studies (such as sample size for test/training sets, ground truth establishment, expert adjudication, MRMC studies) are not applicable to this type of medical device submission.

Here's a breakdown of what can be extracted and how it relates to your request:

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

The document states: "The non-clinical test data provided in this submission demonstrated that the PremiPatch PTFE Pledgets meet the performance specifications."

While specific numeric acceptance criteria and detailed performance results are not provided in this summary document, the types of tests conducted are mentioned:

Note: The actual numerical specifications and results would be in the full submission, not this summary. The "acceptance criteria" here are implied by the types of tests performed to establish equivalence and safety/performance.

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

This device is a physical medical device (pledgets), not an AI/ML diagnostic or predictive system. Therefore, there is no "test set" in the context of image data or patient records with specific sample sizes for AI model evaluation.

• Sample Size for Physical Testing: Not explicitly stated in this summary. The bench testing would have involved a sufficient number of device samples to establish performance specifications based on engineering and quality control standards.
• Data Provenance: Not applicable in the context of AI/ML data provenance. The data comes from internal non-clinical bench testing performed by Aesculap, Inc. (Pennsylvania, USA-based company).

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

Not applicable. This is not an AI/ML device requiring expert-established ground truth for a diagnostic task. The "ground truth" for a physical device like a pledget is its material properties and mechanical performance as measured against engineering standards.

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

Not applicable. There is no concept of adjudication for this type of device and testing.

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 an AI/ML device.

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

Not applicable. This is not an algorithm.

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

For the non-clinical performance evaluations, the "ground truth" would be objective measurements from laboratory equipment and established engineering benchmarks/standards for material properties (e.g., tensile strength, flexibility, rupture force) and biocompatibility (e.g., ISO-10993 standards).

8. The sample size for the training set

Not applicable. This is not an AI/ML device with a "training set."

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

Not applicable.

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SUPPLE PERI-GUARD is intended for use as a prosthesis for pericardial closure.

PERI-GUARD is intended for repair of pericardial structures. PERI-GUARD is also intended for use as a patch for intracardiac defects, great vessel, septal defects and annulus repair, and suture-line buttressing.

SUPPLE PERI-GUARD is prepared from bovine pericardium which is cross-linked with glutaraldehyde. SUPPLE PERI-GUARD has been treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25°C. SUPPLE PERI-GUARD is terminally sterilized using gamma irradiation.

SUPPLE PERI-GUARD is packaged between two pieces of foam within a double sterile barrier pouch system. The contents of the unopened, undamaged package are sterile.

PERI-GUARD is prepared from bovine pericardium which is cross-linked with glutaraldehyde. PERI-GUARD has been treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25°C. PERI-GUARD is terminally sterilized using gamma irradiation.

PERI-GUARD is packaged between two pieces of foam within a double sterile barrier pouch system. The contents of the unopened, undamaged package are sterile.

The provided document is a 510(k) premarket notification for two devices: SUPPLE PERI-GUARD Pericardium Patch and PERI-GUARD Repair Patch. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that the device meets specific acceptance criteria through a comparative effectiveness study with human readers or presenting detailed performance metrics.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria in the context of AI or advanced clinical performance studies.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance in the format requested (likely due to the nature of a 510(k) submission not requiring explicit performance metrics in this way for equivalence).
• Any details about sample sizes used for a test set, data provenance, ground truth establishment, or expert involvement as typically found in studies for AI/diagnostic devices.
• Information on adjudication methods.
• A multi-reader multi-case (MRMC) comparative effectiveness study with effect sizes for human reader improvement with AI.
• A standalone (algorithm only) performance study.
• Sample sizes or ground truth establishment for a training set (as this is not an AI/machine learning device).

Instead, the document focuses on non-clinical testing to demonstrate safety and performance for substantial equivalence. The studies mentioned are:

1. Bench testing: Assessed aspects like suture retention, thickness, burst strength, ultimate tensile strength, collagenase digestion, chemical residuals, pyrogenicity/LAL, sterilization validation, and packaging/shelf-life. The document states, "Bench testing results support the performance requirements."
2. Biocompatibility testing: Performed in accordance with ISO 10993-1: 2009.
3. Animal studies: Conducted to support safety and efficacy.

These studies are conducted to show the new device is "substantially equivalent" to predicate devices, mainly due to changes in packaging and sterilization methods. The document repeatedly states that the devices (SUPPLE PERI-GUARD and PERI-GUARD) are acting as their own predicates.

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VASCU-GUARD is intended for use in peripheral vascular reconstruction including the carotid, renal, iliac, femoral, profunda, and tibial blood vessels and arteriovenous access revisions.

VASCU-GUARD is prepared from bovine pericardium which is cross-linked with glutaraldehyde. VASCU-GUARD has been treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25°C. VASCU-GUARD is terminally sterilized using gamma irradiation.

VASCU-GUARD is packaged between two pieces of foam within a double sterile barrier pouch system. The contents of the unopened, undamaged package are sterile.

The provided document is a 510(k) premarket notification for a medical device called VASCU-GUARD Peripheral Vascular Patch. It demonstrates substantial equivalence to a predicate device, rather than providing a study proving acceptance criteria for a new AI/software device. Therefore, most of the requested information regarding acceptance criteria, study details, expert involvement, and ground truth for an AI/software device is not applicable to this document.

However, I can extract information related to the device's performance evaluation and testing, even if it's not in the context of AI/software acceptance criteria.

Here's an analysis based on the provided text, addressing the applicable points:

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

The document does not present acceptance criteria in a quantitative table with specific target values and reported performance. Instead, it lists the aspects of the device that were evaluated through non-clinical testing. The conclusion states that "Bench testing results support the performance requirements for VASCU-GUARD Peripheral Vascular Patch," and that the device is "substantially equivalent to the referenced predicate device."

Evaluated Aspects of Device Performance (from "Summary/Comparison of Technological Characteristics"):

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

• Sample Size: The document does not specify exact sample sizes for each bench test or animal study. It mentions "various animal studies" without quantification.
• Data Provenance: Not specified. The studies are non-clinical (bench testing and animal studies), not human data, so "country of origin of the data" or "retrospective/prospective" in the human data sense are not directly applicable. These are likely internal laboratory/pre-clinical study results.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable to the non-clinical testing described. This type of information would be relevant for clinical studies involving expert interpretation of medical images or patient outcomes, which are not detailed here.

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

Not applicable. Adjudication methods are typically used in clinical studies with human assessors to establish a consensus ground truth, which is not what is being described for these non-clinical tests.

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 pertains to a physical medical device (vascular patch) and its non-clinical performance, not an AI or software device that assists human readers.

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

Not applicable. This is not an AI algorithm.

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

For the non-clinical tests, the "ground truth" would be established by the specifications and measurement standards for each test (e.g., specific force required for suture retention, material integrity under enzymatic digestion, absence of pyrogens in LAL test, histological findings from animal studies). These are objective measurements against predefined standards, and the "ground truth" is inherent in the test methodology and expected outcomes.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

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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The CorMatrix® ECM® for Vascular Repair is intended for use as a patch material for repair and reconstruction of peripheral vasculature including the carotid, renal, iliac, femoral, and tibial blood vessels. The CorMatrix ECM for Vascular Repair may be used for patch closure of vessels, as a pledget, or for suture line buttressing when repairing peripheral vessels.

The CorMatrix ECM for Vascular Repair is an extracellular matrix (ECM) scaffold derived from porcine small intestinal submucosa (SIS). The device is constructed of a multilaminate (6-ply), decellularized, non-crosslinked, lyophilized ECM cut to specific shapes and sizes and terminally sterilized using Ethylene Oxide gas.

The 6-ply CorMatrix ECM for Vascular Repair is derived from the same multilaminate SIS-ECM material as the CorMatrix ECM for Carotid Repair (6-ply), the Cook Biotech Surgisis Peripheral Vascular Patch (4-ply), and the CorMatrix ECM for Cardiac Tissue Repair (4-ply). The CorMatrix ECM for Vascular Repair will be supplied as a 6-ply, lyophilized, sterilized sheet of SIS-ECM. The device design, construction, and configurations are identical to the FDA-cleared CorMatrix ECM for Carotid Repair (K111187).

The CorMatrix® ECM® for Vascular Repair, a medical device for vascular repair, did not undergo a standalone study with acceptance criteria and reported device performance in the provided 510(k) summary. Instead, the submission relies on the substantial equivalence to previously cleared predicate devices and non-clinical testing performed for a related device, CorMatrix ECM for Carotid Repair (K111187).

Here's a breakdown of the requested information based on the provided text:

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

No explicit "acceptance criteria" table with corresponding "reported device performance" from a dedicated study for the CorMatrix ECM for Vascular Repair is presented in the document. The document states that the new device's performance is supported by the non-clinical testing of the predicate device (CorMatrix ECM for Carotid Repair, K111187). The performance claims are comparative to a control device in an animal study.

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

• Sample Size for Test Set: Not explicitly stated for either bench testing or animal testing. The animal study for the CorMatrix ECM for Carotid Repair (K111187) is mentioned, but the number of animals used is not provided.
• Data Provenance: Not explicitly stated. The studies were performed for a prior 510(k) submission (K111187).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as the studies described are for mechanical and biological properties in an animal model, not for diagnostic interpretation by human experts.

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

This information is not applicable.

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

This information is not applicable. The device is a physical vascular patch, not an AI-powered diagnostic tool requiring human reader studies.

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

A "standalone" study in the sense of a comprehensive performance evaluation specifically for the CorMatrix ECM for Vascular Repair was not done. Instead, the submission leveraged non-clinical testing (bench and animal) performed for its predicate device, the CorMatrix ECM for Carotid Repair (K111187). The document explicitly states: "All non-clinical testing performed for the CorMatrix ECM for Carotid Repair (K111187) supports the CorMatrix ECM for Vascular Repair as the device materials are identical."

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

For the animal study:

• Angiographic stenosis, tissue integration, calcification, and re-endothelialization: These would typically be determined by histological examination (pathology) and imaging (angiography) by experts in veterinary pathology or similar fields.
• Adverse events: Clinical observation and potentially pathological examination.

For bench testing:

• Suture Retention Strength, Probe Burst Strength, Tensile Strength: These are objective physical measurements with established testing standards.

8. The sample size for the training set

This information is not applicable. The device is a physical medical device, not an AI algorithm that requires a "training set."

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

This information is not applicable.

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