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CorMatrix(R) Cor Patch is intended for epicardial tissue support and repair.

CorMatrix Cor Patch is intended for epicardial tissue support and repair.

CorMatrix Cor Patch is derived from the same multi-laminate SIS-ECM material as the CorMatrix Tyke (2-ply, non-pressed). The CorMatrix® Cor Patch will be supplied as a 4-ply, lyophilized, sterilized sheet of SIS-ECM. With the exception of the differing layer counts and a change to the manufacturing process for the Cor Patch which does not result in a change to the fundamental technology of the device, the device design and construction are identical to the FDA-cleared CorMatrix® Tyke™ (K152127).

This document is a 510(k) premarket notification for a medical device called CorMatrix Cor Patch. It describes the device, its intended use, and argues for its substantial equivalence to a previously cleared predicate device, the CorMatrix Tyke.

However, this document does not contain the information required to answer your specific questions regarding acceptance criteria and a study proving a device meets these criteria in the context of an AI/ML medical device.

Here's why and what's missing:

• Device Type: The CorMatrix Cor Patch is a biological patch made from porcine extracellular matrix material for epicardial tissue support and repair. It is a physical medical device, not an AI/ML algorithm or software.
• Study Type: The "Non-clinical Testing" section describes material property testing (tensile strength, suture retention, burst strength) to demonstrate adequate material properties, not a clinical study involving human or even simulated human-in-the-loop performance with an AI system.
• Acceptance Criteria: The document mentions that the testing "demonstrates that the sterile SIS-ECM of the Cor Patch possesses adequate material properties for use in the indicated applications" and "exceeds the biomechanical requirements for its intended use." However, it does not provide a specific table of acceptance criteria with quantitative thresholds for AI performance metrics (like sensitivity, specificity, AUC, human reader improvement).
• Ground Truth, Experts, Adjudication, MRMC, Standalone Performance: These concepts are relevant to the evaluation of AI/ML algorithms, where the performance of the algorithm is compared against a "ground truth" established by human experts, pathology, or outcomes data. This document does not describe such studies because the device is a physical patch.
• Sample Size (for AI training/test sets): The document refers to "testing" but does not specify sample sizes in the context of test or training sets for an AI algorithm.
• Data Provenance: Not applicable in the context of material property testing for a physical device.

In summary, the provided text is about a physical medical device (a tissue patch) and its material properties, not about an AI/ML medical device and its performance evaluation against established acceptance criteria.

Therefore, I cannot extract the requested information from this document. If you provide a document that describes the development and validation of an AI/ML medical device, I would be happy to help answer your questions.

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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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The CorMatrix PROTECT ECM Envelope is intended to securely hold an implantable electronic device to create a stable environment when implanted in the body. The devices that may be used with the CorMatrix PROTECT ECM Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices.

The CorMatrix PROTECT ECM Envelope is intended to securely hold a cardiac implantable electronic device (CIED) in order to create a stable environment when implanted in the body. The devices that may be used with the CorMatrix PROTECT ECM Envelope include pacemaker pulse generators, defibrillators, or other CIEDs.

The CorMatrix PROTECT ECM (extracellular matrix) Envelope is constructed from two perforated, multilaminate sheets (4-ply) of decellularized, non-crosslinked, lyophilized ECM derived from porcine small intestinal submucosa. The 3 mm perforations are spaced evenly at 10 mm apart to allow exit of any exudate. The ECM is assembled into pouch form using with violet 5-0 polydioxanone (PDS) suture.

The provided text describes a 510(k) premarket notification for a medical device called the CorMatrix PROTECT ECM Envelope. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a comprehensive study with acceptance criteria and device performance in the way a clinical trial or a novel AI device study would.

Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, expert involvement, and ground truth establishment, which are typical for an AI/ML device or a novel clinical device, is not directly applicable or available in this document.

What is available is information about non-clinical testing (an animal study) to support the substantial equivalence claim.

Here's an attempt to answer the questions based on the provided text, while acknowledging the limitations:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission based on substantial equivalence, explicit "acceptance criteria" for specific performance metrics (like sensitivity, specificity, accuracy, etc.) for a human-in-the-loop or standalone AI device are not defined or reported in the document. The "performance" assessment is primarily focused on demonstrating biocompatibility and functional equivalence to predicate devices in a non-clinical setting.

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

• Sample Size: Not explicitly stated as a number of subjects. The study was conducted on a "New Zealand White rabbit." The number of rabbits or implants used is not specified.
• Data Provenance: The study was an animal study conducted on a New Zealand White rabbit model. No country of origin is specified. It is a prospective study as it involves implanting the device into the animal for assessment.

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

Not applicable/mentioned. This type of study (animal model for biocompatibility and device stabilization) would typically involve veterinary expertise and histopathological assessment, but the document does not detail the number or qualifications of experts involved in establishing a "ground truth" in the way it's understood for diagnostic AI.

4. Adjudication Method for the Test Set

Not applicable/mentioned. Adjudication methods (like 2+1, 3+1) are common in clinical studies where multiple human readers interpret data, often for diagnostic accuracy. This animal study doesn't involve such a human reader assessment.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation and would assess the impact of the device on human reader performance. The CorMatrix PROTECT ECM Envelope is a surgical mesh envelope designed to hold implanted electronic devices, not a diagnostic tool.

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

Yes, in a sense. The "performance" described relates to the physical characteristics and biological interaction of the device itself (stabilization, isolation, biocompatibility) without direct human intervention in its function subsequent to implantation. However, it's not "standalone" in the context of an AI algorithm performing a task without human involvement.

7. The Type of Ground Truth Used

The "ground truth" in this context is based on the outcome and tissue response observed in the animal model, likely through methods such as:

• Visual inspection of the implanted site.
• Histopathological examination of surrounding tissues for biocompatibility assessment.
• Observation of the stability of the pacemaker.

8. The Sample Size for the Training Set

Not applicable. This is a medical device, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.

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

Not applicable. As there is no training set for an AI/ML model, this question is not relevant.

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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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The CorMatrix® ECM® for Carotid Repair is intended for use as a patch material for vascular reconstruction and repair of the carotid artery, including patch closure following carotid endarterectomy and suture line buttressing.

The CorMatrix ECM for Carotid Repair is an extracellular matrix (ECM) scaffold derived from porcine small intestinal submucosa (SIS). SIS is developed from a select layer of tissue that is recovered from porcine small intestine. During processing, the inner and outer muscle layers of the material are removed, leaving an intact submucosa with a portion of the tunica propria layer attached to the outer surface. Following processing, the remaining acellular ECM material is cut to specific shapes and sizes, lyophilized, and terminally sterilized using Ethylene Oxide gas. The CorMatrix ECM for Carotid Repair is derived from the same SIS-ECM material as CorMatrix's two commercially available products, the CorMatrix ECM for Pericardial Closure and the CorMatrix ECM for Cardiac Tissue Repair. The CorMatrix ECM for Carotid Repair will be supplied as a multilaminate, Iyophilized, sterilized sheet of SIS-ECM. The CorMatrix ECM will be provided in four sizes: 1x10cm, 1x15cm, 2x10cm and 2x15cm sheets.

This looks like a 510(k) premarket notification for a medical device called the CorMatrix ECM for Carotid Repair. Based on the provided text, there is no acceptance criteria or study of an AI/ML powered device. This document describes the "substantial equivalence" of a biologic patch material to predicate devices. Therefore, a table of acceptance criteria and device performance for an AI/ML powered device, an MRMC study, or a standalone study are not applicable and cannot be extracted from this text.

Here's an analysis of what is provided, framed in terms of the closest relevant aspects, and explicitly stating where information requested is not present for an AI/ML device:

Analysis of CorMatrix® ECM® for Carotid Repair

This document describes a 510(k) premarket notification for a medical device. The device is a patch material for vascular reconstruction and repair of the carotid artery, derived from porcine small intestinal submucosa. The submission focuses on demonstrating "substantial equivalence" to existing predicate devices through nonclinical bench and animal testing. This is not an AI/ML powered device.

Therefore, most of the requested information related to AI/ML device acceptance criteria, study design, and ground truth establishment (especially for AI models) is not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

Note: This device is a biologic patch material, not an AI/ML algorithm. The "acceptance criteria" here refer to performance specifications for the physical properties of the patch, not diagnostic accuracy metrics typically associated with AI/ML.

Disclaimer: The document explicitly states that the collective results "demonstrate that the CorMatrix ECM for Carotid Repair meets the established specifications necessary for consistent performance for its intended use" and "does not raise new questions of safety or efficacy." However, specific numerical acceptance thresholds and the exact measured performance values are not detailed in this summary.

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 for test set: Not applicable in the context of an AI/ML test set. The testing involved nonclinical bench tests and animal studies. Specific "sample sizes" for these tests (e.g., number of patches tested for suture retention, number of animals in the in vivo study) are not provided in this summary.
• Data provenance: Not applicable in the context of human clinical data for an AI/ML device. The testing was nonclinical (bench and animal). The country of origin for the animals or bench test materials is not specified.

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 the ground truth here refers to the physical and biological properties of a material, established through standardized testing procedures, not expert interpretation of diagnostic images or data for an AI/ML algorithm.

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

• This is not applicable for the type of bench and animal testing described. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human experts in interpreting data, which is not the nature of the testing performed for this device.

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, an MRMC comparative effectiveness study was not done. This device is a surgical patch, not an AI/ML diagnostic or assistive tool. Therefore, the concept of human readers improving with AI assistance is not applicable.

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

• No, a standalone study was not done. This concept is only relevant for AI/ML algorithms, which this device is not.

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

• The "ground truth" for this device's performance is established through standard nonclinical testing methodologies (e.g., ASTM standards for material strength, biocompatibility assays, in vivo animal model observations for biological response and vessel burst pressure). It is based on objective measurements and observations from these tests.

8. The sample size for the training set

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

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

• Not applicable. As this is not an AI/ML algorithm, there is no training set or associated ground truth generation process.

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The CorMatrix® Patch for Cardiac Tissue Repair is indicated for use as an intracardiac patch or pledget for tissue repair (i.e., arterial septal defect (ASD), ventricular septal defect (VSD), etc.) and suture-line buttressing.

The CorMatrix Patch for Cardiac Tissue Repair is manufactured from porcine small intestinal submucosa (SIS) and is supplied in four (4)-ply sheets with varying dimensions.

This 510(k) premarket notification for the CorMatrix Patch for Cardiac Tissue Repair does not describe a study involving an AI/ML device. Instead, it pertains to a medical device made from porcine small intestinal submucosa (SIS) intended for cardiac tissue repair.

Therefore, many of the requested criteria, such as "acceptance criteria and the reported device performance" in the context of an AI/ML algorithm, or details about training sets, test sets, and expert adjudication, are not applicable to this submission.

The document focuses on demonstrating substantial equivalence to existing predicate devices based on:

• Intended Use: The CorMatrix Patch for Cardiac Tissue Repair is intended for use as an intracardiac patch or pledget for tissue repair (e.g., atrial septal defect (ASD), ventricular septal defect (VSD)) and suture-line buttressing.
• Product Description: It is manufactured from porcine small intestinal submucosa (SIS) and supplied in four (4)-ply sheets.
• Predicate Devices: Several existing cardiac patches and surgical meshes are listed as predicate devices.
• Testing: The document states that "The performance and safety of the SIS material used in the CorMatrix Patch for Cardiac Tissue Repair was evaluated through extensive biocompatibility, bench and animal testing." The collective results are said to have demonstrated substantial equivalence regarding safety and efficacy. However, specific details of these tests, including acceptance criteria and reported performance metrics (like those one would expect for an AI algorithm - e.g., sensitivity, specificity, AUC), are not provided in this summary.

Therefore, I cannot fulfill the request to provide the acceptance criteria and study details as they would apply to an AI/ML device, as this document is not about an AI/ML device. The document explicitly states it's about a physical medical device and its substantial equivalence to other physical medical devices.

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The CorMatrix Pericardial Patch is intended for the reconstruction and repair of the pericardium.

The CorMatrix Pericardial Patch is manufactured from porcine small intestinal i he Conviatiix refleardial is manufactures are a seets with varying dimensions.

The provided text is a 510(k) summary for the CorMatrix Pericardial Patch. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific acceptance criteria through a study with performance metrics in the way a clinical trial for a novel therapy might.

Therefore, the document does not contain the information requested in the prompt regarding:

• A table of acceptance criteria and reported device performance.
• Sample size and data provenance for a test set.
• Number and qualifications of experts for ground truth.
• Adjudication method for a test set.
• MRMC comparative effectiveness study results or effect size.
• Standalone (algorithm only) performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

Instead, the document focuses on:

• Intended Use: The CorMatrix Pericardial Patch is intended for the reconstruction and repair of the pericardium.
• Predicate Devices:
  • Cook Biotech, Inc., SurgiSIS (K980431)
  • TEI Biosciences, Inc., TISSUEMEND (K020455)
  • W.L. Gore & Associates, Inc., Preclude Pericardial Membrane (K012098)
  • PM Devices, Inc., Peripatch Sheet (K031948)
• Substantial Equivalence: The claim is that the device's proposed indications for use and technological characteristics are substantially equivalent to the predicate devices, and that any differences do not raise new issues of safety or efficacy.
• Testing in Support of Substantial Equivalence Determination: The only mention of testing is that "the biological material in the CorMatrix Pericardial Patch was evaluated through extensive biocompatibility and animal testing." No specific performance metrics or clinical study results are detailed.

In summary, this 510(k) document does not report on a study designed to meet specific acceptance criteria with performance metrics as typically found in evaluations of AI/ML-based devices or complex diagnostic tools. It's a regulatory submission demonstrating equivalence for a Class II medical device, primarily based on its similarity to existing, legally marketed products.

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