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The SIS Hernia Graft is intended for implantation to reinforce soft tissues where weakness exists. Indications for use include repair of a hernia or body wall defect. The graft is supplied sterile and intended for one time only use.

The SIS Hernia Graft is composed of multiple layers of a bioabsorbable, extracellular collagen membrane matrix (Small Intestinal Submucosa, SIS) that are held together with a biodegradable suture to improve the device handling characteristics at time of implant. The SIS Hernia Graft is identical in its base material to its predicate SIS Hernia Repair Device (K974540/K062697), also manufactured by Cook Biotech Incorporated. The SIS Hernia Graft is substantially equivalent to its predicate in its technology in that it has the ability to be incorporated into the body. The device is substantially equivalent to its predicate in its intended use for reinforcement and repair of hernias or a body wall defect. The device is packaged in a dried state and supplied sterile in a sealed double pouch system.

The provided document describes the 510(k) premarket notification for the "SIS Hernia Graft." This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed device performance metrics in the way one might find for a novel diagnostic or AI-driven device.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert consensus, and reader studies are not applicable or not provided in this type of regulatory submission.

However, I can extract the relevant information and structure it as much as possible according to your request categories, noting where information is not available from the provided text.

Acceptance Criteria and Device Performance (Based on Substantial Equivalence)

The acceptance criteria for this 510(k) submission are fundamentally based on demonstrating substantial equivalence to a previously legally marketed device (the predicate device). This means the device must meet similar performance standards and safety profiles as the predicate. The "performance" is demonstrated through various tests and comparisons rather than numerical thresholds for a specific diagnostic accuracy.

Table 1: Acceptance Criteria (Demonstration of Substantial Equivalence) and Reported Device Performance

Additional Information on Studies (Not Directly Applicable/Provided for 510(k))

This 510(k) submission is for a medical device (surgical graft), not a diagnostic algorithm or AI system. Therefore, many of the requested items related to AI/diagnostic study design are not relevant to this type of submission.

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

   • Biocompatibility Tests: Performed on sterilized SIS devices (base material). No specific "test set" size is given beyond "SIS devices."
   • Mechanical Testing: Performed on "SIS Hernia Graft material." No specific "test set" size or data provenance is detailed.
   • Animal Testing:
     • Pig hernia model: Two separate studies mentioned. No specific number of animals provided for each study.
     • Mouse study: One study mentioned. No specific number of animals provided.
   • Data Provenance: Not specified, but likely proprietary internal testing given the nature of the device and testing. All tests are prospective.

2. 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. Ground truth for biocompatibility and mechanical tests is determined by standardized laboratory methods and observations (e.g., cell viability, tensile strength, histopathology readings). For animal studies, expert pathologists would have interpreted the findings, but their number and qualifications are not specified in this summary.

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

   • Not applicable. This concept pertains to consensus among human readers for diagnostic interpretation, which is not part of this device's submission.

4. 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 or diagnostic device.

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

   • Not applicable. This is a physical surgical graft, not an algorithm.

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

   • Biocompatibility: In vitro and in vivo test results against ISO 10993-1 standards (e.g., cell viability, systemic toxicity markers, inflammation scores).
   • Mechanical Testing: Objective measurements from testing equipment (e.g., force required for tear, ultimate tensile strength).
   • Animal Testing: Gross and histopathological findings from implanted tissue, angiogenesis assessments. Considered direct evidence of tissue response and material integration.

7. The sample size for the training set:

   • Not applicable. There is no "training set" in the context of this physical medical device. This term is primarily relevant for machine learning or AI algorithm development.

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

   • Not applicable.

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The Diaphragmatic Hernia Graft is intended for implantation to reinforce soft tissues where weakness exists, including the repair of diaphragmatic/hiatal hernias. The graft is supplied sterile and intended for one time use.

The Diaphragmatic Hernia Graft is composed of multiple layers of a bioabsorbable, extracellular collagen membrane matrix (Small Intestinal Submucosa, SIS) that are held together with a biodegradable suture to improve the device handling characteristics at the time of implant. The Diaphragmatic Hernia Graft is identical in its base material to its predicates SIS Hernia Repair Device (K974540/K062697) and Surgisis Staple Line Reinforcement (K022044), also manufactured by Cook Biotech Incorporated, and similar to its predicate Permacol™ Surgical Implant (K120605), manufactured by Covidien.

The Diaphragmatic Hernia Graft is substantially equivalent to its SIS predicates in that its technology is able to be incorporated into the body. The device is also substantially equivalent to its predicates in its intended use for reinforcement and repair of diaphragmatic/hiatal hernias. The device is packaged in a dried state and supplied sterile in a sealed double pouch system.

This document describes a 510(k) premarket notification for the "Diaphragmatic Hernia Graft" manufactured by Cook Biotech Incorporated. The submission aims to demonstrate substantial equivalence to previously marketed predicate devices.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Diaphragmatic Hernia Graft are primarily demonstrated through substantial equivalence to predicate devices in terms of intended use, materials, and technological characteristics. The performance is assessed across several categories:

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

The document does not explicitly state the numerical sample sizes for the "test set" in the traditional sense of a randomized controlled trial comparing the new device against a control. Instead, it relies on:

• Biocompatibility Testing: Performed on "sterilized SIS devices," which are "identical in base material to the Diaphragmatic Hernia Graft." The specific number of samples for each test is not detailed.
• Mechanical Testing: Performed on "The Diaphragmatic Hernia Graft material." The specific number of samples for each test is not detailed.
• Animal Testing: The SIS material has been "tested in animal studies for diaphragmatic/hiatal hernia repair." No specific sample size (number of animals) or data provenance (country, retrospective/prospective) is provided.
• Clinical Testing: Refers to "several different clinical studies" for Surgisis (same base material) and "further clinical evidence" for the specific configurations of the Diaphragmatic Hernia Graft. No specific sample sizes, patient demographics, or data provenance (country, retrospective/prospective) are provided for these studies.

This submission focuses on demonstrating substantial equivalence by referring to existing data on the constituent material (SIS) and limited, non-comparative clinical data specific to the device's configurations, rather than a single, large-scale comparative test set for the new device.

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

This type of information (number and qualifications of experts for ground truth establishment) is not applicable or provided in this 510(k) submission. Medical device submissions for materials like surgical mesh typically rely on objective measurements (e.g., mechanical strength, biocompatibility assays) and clinical outcomes (e.g., healing, adverse events) rather than expert consensus on subjective interpretations like image analysis.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1 or 3+1) are typically used in studies involving subjective interpretations (e.g., radiology reads). This is not relevant to the types of tests (biocompatibility, mechanical, animal studies, general clinical outcomes) described for the Diaphragmatic Hernia Graft.

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

No MRMC comparative effectiveness study is mentioned or appears relevant to this type of medical device (surgical mesh). This study design is typically used for diagnostic or screening devices where human readers interpret medical images.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study

Not applicable. The Diaphragmatic Hernia Graft is a physical surgical mesh, not an algorithm or AI system. Therefore, an algorithm-only standalone performance study was not conducted or mentioned.

7. Type of Ground Truth Used

The "ground truth" for the performance of the Diaphragmatic Hernia Graft is established through a combination of:

• Objective Test Results: Biocompatibility test results (e.g., specific assay outcomes), mechanical strength measurements (e.g., numerical values for suture retention, burst strength).
• Histopathological & Biological Observations: Observations from animal studies and clinical studies regarding tissue integration, inflammatory response, and healing, though specific details are not provided.
• Clinical Outcomes Data: Safe and biocompatible performance, as evidenced in clinical studies, likely including absence of severe adverse events, successful repair, and tissue reinforcement. This is referenced as "clinical outcomes."

8. Sample Size for the Training Set

Not applicable. As this is a physical medical device and not an AI/ML algorithm, there is no "training set" in the context of machine learning. The data supporting its safety and efficacy comes from prior biocompatibility, mechanical, animal, and clinical studies of the material (SIS) and the device configurations.

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

Not applicable, as there is no "training set" as understood in AI/ML. The "ground truth" for the underlying scientific understanding of SIS material and the performance of surgical meshes is established through standard scientific and regulatory practices, including:

• Peer-reviewed scientific literature: Supporting the properties and biological interaction of SIS.
• Industry standards: Such as ISO 10993 for biocompatibility.
• Pre-clinical research: Animal models for hernia repair.
• Prior clinical experience: With predicate devices and the SIS material, often documented in clinical registries or studies.

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The Biodesign Onlay Dural Graft is intended for use as a dura substitute for the repair of dura mater. The device is provided sterile and intended for one-time use.

The Biodesign Onlay Dural Graft is composed of a bioabsorbable, extracellular collagen matrix (Small Intestinal Submucosa, SIS). The SIS material that comprises the Biodesign Onlay Dural Graft is identical in composition and technology to that of its predicate Durasis Dural Substitute (K031850), also manufactured by Cook Biotech Incorporated and similar to its other predicate, DuraGen II Dural Regeneration Matrix (K043427) manufactured by Integra LifeSciences. The Biodesign Onlay Dural Graft is implanted as a dura substitute providing a scaffold which becomes infiltrated by the patient's cells and is remodeled into native tissue. The device is packaged in a lyophilized (dried) state and supplied sterile in a sealed double pouch system. The Biodesign Onlay Dural Graft can be placed without sutures during skull base dural repair.

Here's an analysis of the provided text regarding the Biodesign® Onlay Dural Graft, focusing on the acceptance criteria and supporting studies as requested:

Acceptance Criteria and Device Performance

The submission primarily focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel safety and effectiveness criteria through a standalone clinical trial with pre-defined acceptance criteria. The acceptance criteria are implicitly tied to performing "similarly" to predicated devices and meeting established ISO standards for biocompatibility.

Study Details

1. Sample sizes used for the test set and the data provenance:

   • Bench Testing: The document does not specify the sample size for each mechanical test (suture retention, ultimate tensile strength, burst strength).
   • Biocompatibility Testing: The document does not specify the sample size for each biocompatibility test.
   • Animal Study: The document indicates a "rat model" but does not specify the number of rats used.
   • Clinical Studies (mentioned but not detailed): The text mentions "clinical studies using the device in cranial base dural repair" in the context of demonstrating equivalence, but no details of these studies (sample size, design, provenance) are provided in this summary. It's possible these refer to previously cleared clinical data for the predicate Durasis Dural Substitute, as it is from the same manufacturer and uses identical composition.

   Data Provenance:

   • Bench testing and biocompatibility testing were likely conducted in a lab setting by Cook Biotech Incorporated.
   • The animal study was conducted using a rat model, likely at a research institution or contract research organization.
   • The "clinical studies" mentioned are not detailed, so their provenance is unknown from this document.

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

   • This section is not applicable as the studies described (bench, biocompatibility, animal) do not involve human expert interpretation for ground truth establishment in the way, for example, a diagnostic imaging study would. The acceptance criteria are based on objective measurements (mechanical properties, biological responses) or established ISO standard adherence.

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

   • This is not applicable. The studies described are not of a nature that would require human adjudication of results to establish ground truth or compare interpretations.

4. 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. This submission is for a physical medical device (dural graft), not an AI/imaging diagnostic device. Therefore, MRMC studies and AI assistance are not relevant.

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

   • This is not applicable. This is not an algorithmic or AI device.

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

   • Bench Testing: Ground truth is established by standardized mechanical testing protocols and measurement instruments.
   • Biocompatibility Testing: Ground truth is established by adherence to ISO 10993-1 standard methods and predetermined acceptable ranges for various biological responses (e.g., cytotoxicity, hemolysis).
   • Animal Study: Ground truth is established by physiological observation, histological examination, and functional assessment by trained animal researchers/veterinarians, evaluating for "adverse health effects."

7. The sample size for the training set:

   • This is not applicable. This device is a physical implant, not an AI model or a diagnostic software, so there is no concept of a "training set" in the context of AI/machine learning. The device itself is "trained" through its manufacturing process and design, informed by historical data and scientific principles, but not in the algorithmic sense.

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

   • This is not applicable for the reasons stated above.

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The Hybrid Graft is for implantation to reinforce soft tissues where weakness exists. Indications for use include the repair of a hernia or body wall defect requiring the addition of a reinforcing or bridging material to obtain the desired surgical result. The graft is supplied sterile and is intended for one-time use.

The Hybrid Graft is composed of a bioabsorbable, extracellular collagen matrix (Small Intestinal Submucosa, SIS) and a polypropylene mesh. The collagen matrix is identical to the predicate SIS Hernia Repair Device (K974540, K062697), manufactured by Cook Biotech Incorporated. The polypropylene mesh is similar to the predicates PROCEED™ Ventral Patch (K061533) and ULTRAPRO® Mesh (K033337), both manufactured by Ethicon, Incorporated. The Hybrid Graft is similar to both PROCEED and ULTRAPRO in that all are made of a composite of a bioabsorbable or collagen-based and synthetic (polypropylene) component. The polypropylene mesh in the Hybrid Graft is layered between six (6) layers of SIS on the side facing the viscera and two (2) layers of SIS on the side facing the body wall. The device is packaged in a vacuum pressed (dried), laminated state and supplied sterile in a sealed double pouch system.

This document is a 510(k) premarket notification for a medical device called the "Hybrid Graft." It's important to note that a 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets new acceptance criteria through extensive clinical studies as one might find for novel AI/software devices.

Instead, the "acceptance criteria" here refer to meeting standards for mechanical performance and biocompatibility to demonstrate that the new device is as safe and effective as existing, legally marketed devices. The "study that proves the device meets the acceptance criteria" refers to bench testing and biocompatibility testing.

Here's the information broken down as requested, with the caveat that the prompt's structure is more aligned with AI/software performance studies, which is not the primary focus of this type of medical device submission.

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

Note on Acceptance Criteria: For a 510(k) submission, the "acceptance criteria" are intrinsically linked to demonstrating substantial equivalence. The device must perform comparably to predicate devices in mechanical tests and meet established biocompatibility safety standards (ISO 10993). Specific numerical thresholds for mechanical properties are not explicitly stated in this summary but are implied by the statement "adequate for the application" and "substantially equivalent."

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 the exact number of devices or material samples used for the bench and biocompatibility testing. It only states "Finished devices were tested" and "The SIS material comprising the Hybrid Graft was tested."
• Data Provenance: Not specified, but generally, such bench and biocompatibility testing would be conducted in a controlled laboratory environment, often by the manufacturer or a contract research organization (like NAMSA, mentioned for biocompatibility). The nature of these tests (mechanical and in vitro/in vivo biocompatibility) is prospective for the specific purpose of this submission. Country of origin for data is not mentioned.

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 question is not applicable to this type of device submission. The "ground truth" here is established by standardized testing protocols (e.g., ISO 10993 for biocompatibility) and engineering principles for mechanical testing, not by expert interpretation of medical images or clinical outcomes. The "experts" would be testing technicians and engineers qualified in these specific laboratory methods.

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

This is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials or studies requiring consensus on subjective interpretations (e.g., image reading). The tests performed are objective laboratory measurements.

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. The Hybrid Graft is a physical surgical mesh, not an AI or imaging device that would involve human readers or MRMC studies.

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

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

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

The "ground truth" for this submission consists of:

• Performance Standards: Established mechanical properties required for surgical meshes (implicitly benchmarked against predicate devices).
• Biocompatibility Standards: Established international standards (ISO 10993) for assessing biological responses to medical devices.
• Predicate Device Performance: The characteristics and performance of the legally marketed predicate devices (SIS Hernia Repair Device, PROCEED™ Ventral Patch, ULTRAPRO® Mesh) serve as a de facto "ground truth" for demonstrating substantial equivalence.

8. The sample size for the training set

This is not applicable. There is no "training set" as this is not a machine learning or AI device.

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

This is not applicable as there is no training set.

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The Biodesign Nipple Reconstruction Cylinder is intended for implantation to reinforce soft tissue where weakness exists, in plastic and reconstructive surgery of the nipple. The cylinder is supplied sterile and is intended for one-time use.

The Biodesign Nipple Reconstruction Cylinder is composed of a bioabsorbable, extracellular collagen matrix (Small Intestinal Submucosa, SIS). The SIS material is identical to the predicates SurgiSIS® Mesh (K980431, K062696), SIS Plastic Surgery Matrix (K034039), and SIS Facial Implant (K050246, K070738) all manufactured by Cook Biotech Incorporated. The Biodesign Nipple Reconstruction Cylinder is a rolled SIS mesh and available in sizes from 0.7 cm in diameter and 1.0 cm to 2.5 cm in length. The cylinder is a scaffold which becomes infiltrated by the host cells during the body's natural repair process. The device is implanted using a skin flap procedure that prevents migration of the device. A PET marking template (Class I, 21 CFR 888.4800) and silicone (35A durometer) nipple shield (Class I, 21 CFR 880.5630 ) to be placed over the cylinder post-operatively, are included with the device. The use of the Biodesign Nipple Recosntruction Cylinder, an off-the-shelf graft, is advantageous in that a donor site is no longer necessary.

Here's a breakdown of the acceptance criteria and study information for the Biodesign® Nipple Reconstruction Cylinder, based on the provided 510(k) summary:

This device's submission is for substantial equivalence to existing predicate devices, not for a de novo marketing authorization. Therefore, the "acceptance criteria" are not defined as specific performance thresholds, but rather the demonstration that the new device performs similarly to
its predicates across various tests, without raising new questions of safety or effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission, the "acceptance criteria" are implied to be performance comparable to the predicate devices. The reported device performance is presented as demonstrating this comparability.

2. Sample Sizes and Data Provenance

• Bench Testing: The sample sizes for suture retention strength and ultimate tensile strength are not specified. The tests were performed on "finished, terminally sterilized SurgiSIS® mesh" which forms the device.
• Biocompatibility Testing: The sample sizes for each specific biocompatibility test are not specified. The tests were performed on "sterilized SurgiSIS Mesh."
• Animal Testing: The sample size is not explicitly stated beyond "an animal study" in "a guinea pig model." It is implied to include multiple animals to assess performance over 5 months.
  • Data Provenance: The study was an animal study, likely conducted in a controlled laboratory setting. The country of origin is not specified but presumed to be within the Cook Biotech research facilities or contracted labs. The data is prospective within the context of the animal study.
• Clinical Testing:
  • Sample Size: 2 case studies and anecdotal evidence of 186 device implants (totaling 188 implants).
  • Data Provenance: The document does not specify the country of origin. The data appears to be retrospective (anecdotal evidence from past implants) and possibly some prospective observation for the "2 case studies."

3. Number of Experts and Qualifications for Ground Truth for Test Set

This device's submission relies on demonstrating substantial equivalence to already approved predicate devices. Thus, there isn't a "test set" in the traditional sense of a diagnostic algorithm where expert ground truth is established for novel readings.

• For the clinical testing, the "ground truth" implicitly comes from the clinical outcomes and observations made by the surgeons/clinicians performing the implants and follow-ups. The number of experts and their specific qualifications are not reported. Their assessment of "substantially equivalent to its predicates in its application" is based on their clinical experience.

4. Adjudication Method for the Test Set

Given the nature of the submission (substantial equivalence for a physical implant), there is no mention of an adjudication method in the context of expert review of data from a "test set" for a diagnostic algorithm. The clinical "data" comprises case studies and anecdotal evidence from implants managed by various clinicians.

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

No MRMC comparative effectiveness study was done or reported. This type of study is typical for diagnostic AI devices, not for assessing the substantial equivalence of a physical implant. The focus here is on the material, design, and performance characteristics compared to predicates.

6. Standalone Performance Study

This concept of "standalone performance" typically applies to diagnostic algorithms operating independently. Since this is a physical implant, it doesn't have a "standalone" algorithm-only performance. Its performance is assessed through its material properties, biological interaction (in animals), and clinical outcomes (in humans).

7. Type of Ground Truth Used

• Bench Testing: The "ground truth" is based on objective mechanical measurements (suture retention strength, ultimate tensile strength) and comparison to established predicate device performance or industry standards.
• Biocompatibility Testing: The "ground truth" is adherence to ISO 10993-1 standards for various biological responses.
• Animal Testing: The "ground truth" is histopathological analysis and observation of tissue response (minimal inflammation, increased soft tissue volume) in the guinea pig model, compared to expected healthy tissue response and the known behavior of SIS material.
• Clinical Testing: The "ground truth" is based on clinical outcomes, observations, and anecdotal evidence from patients who received the implant. This includes assessment of its ability to reinforce soft tissue in nipple reconstruction, functional outcomes, and reported complications. This is closer to outcomes data and expert clinical assessment rather than a single objective "ground truth" like pathology for a diagnostic image.

8. Sample Size for the Training Set

This submission does not involve a machine learning algorithm, so there is no "training set" in the context of AI. The development of the device (implant) relies on established knowledge of SIS material, previous predicate devices, and pre-clinical/clinical testing.

9. How Ground Truth for the Training Set was Established

As there is no training set for an AI model, this question is not applicable. The underlying "knowledge base" for the device's design and expected performance comes from decades of research and clinical use of SIS extracellular matrix material.

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The COOK® Urological Graft is for implantation to reinforce soft tissues where weakness exists in the urological anatomy, including temporary wound or solid organ support in the kidney. The Urological Graft is supplied sterile and intended for one-time use.

The COOK® Urological Graft is a bioabsorbable, extracellular collagen matrix that is identical to the predicates SURGIS Mesh (K980431) and SURGISIS® Sling (K992159), also manufactured by COOK Biotech Incorporated, and to Vicryl Mesh bag (K051701), manufactured by Ethicon. The device is manufactured from porcine small intestinal submucosa (SIS), packaged in a lyophilized (dried) state and supplied sterile in a sealed double pouch system.

The provided text describes a 510(k) submission for the COOK® Urological Graft and does not contain information about acceptance criteria or a study proving the device meets said criteria in the way typically found for AI/ML medical devices (e.g., performance metrics like sensitivity, specificity, AUC).

Instead, this document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, which is the cornerstone of the 510(k) pathway. The study mentioned refers to the type of testing performed to prove this equivalence, rather than a performance study against specific acceptance criteria for a novel AI/ML algorithm.

Therefore, the requested information cannot be fully provided as the context is different from what the prompt anticipates for AI/ML device studies.

However, I can extract what is relevant to the prompt, even if it's not a direct match to the AI/ML framework:

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

This document does not define specific "acceptance criteria" in terms of quantitative performance metrics (like sensitivity, specificity, or AUC) that an AI/ML model would need to meet. For a 510(k) submission of a traditional medical device like the COOK® Urological Graft, the primary "acceptance criterion" is substantial equivalence to predicate devices.

Reported Device Performance (as it relates to substantial equivalence):

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

The document mentions "bench, animal, biocompatibility and clinical testing" to establish equivalence. However, it does not provide details on:

• The specific sample sizes used for these tests.
• The data provenance (e.g., country of origin, retrospective/prospective nature) for any clinical data.

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 device is a physical surgical graft, not an AI/ML diagnostic or prognostic tool that requires expert-established ground truth on a test set. The "ground truth" for demonstrating equivalence would be derived from the performance and characteristics of the predicate devices and the results of the specific engineering, animal, and clinical tests performed on the COOK® Urological Graft itself.

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

Not applicable for a physical medical device submission demonstrating substantial equivalence. Adjudication methods are typically relevant for human interpretation or AI/ML output assessment where discrepancies might arise.

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 graft, not an AI-assisted diagnostic tool, so MRMC studies or human reader improvement with AI are not relevant.

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

Not applicable. The device is a physical surgical graft, not an algorithm.

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

For this type of device, the "ground truth" for demonstrating substantial equivalence would be based on:

• Material properties data: Bench testing results on tensile strength, bioabsorption rates, pore size, etc.
• Biocompatibility data: Standardized tests for cytotoxicity, sensitization, irritation, etc., according to ISO standards.
• Animal study data: In vivo performance in terms of tissue integration, host response, strength, and degradation over time.
• Clinical safety and performance data (if collected): Surgical outcomes, adverse event rates, and efficacy in repairing or reinforcing tissues, compared to predicates. This data would be against established clinical endpoints and observations from healthcare professionals and patient outcomes.

8. The sample size for the training set

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

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

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

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The modified SIS Fistula Plug is indicated for implantation to reinforce soft tissue for repair of enterocutaneous fistulas.

The modified SIS Fistula Plug is manufactured from porcine small intestinal submucosa (SIS) supplied in a tapered configuration with a flange to provide increased retention of the plug and improved blockage of the fistula. The device is packaged in a lyophilized (freeze-dried) state, and supplied sterile in a sealed double pouch system.

This submission is for a Special 510(k) for a modified version of an existing device, the SURGISIS® Biodesign™ Enterocutaneous Fistula Plug. Special 510(k)s rely heavily on substantial equivalence to a predicate device, rather than new clinical studies with defined acceptance criteria and performance targets.

Here's a breakdown of the requested information based on the provided text, with notable absences for items not typically found in a Special 510(k) for a material modification:

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

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

The document does not specify a "test set" in the context of a clinical performance study. The tests mentioned are bench testing and biocompatibility testing. Sample sizes for these types of tests are not provided in this summary. Data provenance (country of origin, retrospective/prospective) is also not specified, as this primarily relates to clinical data, which is not the focus of this Special 510(k).

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 Special 510(k) is based on bench and biocompatibility testing, not expert-adjudicated clinical data to establish ground truth for a diagnostic or therapeutic performance claim.

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

Not applicable. There was no clinical test set requiring expert adjudication.

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 mesh, not an AI-powered diagnostic or decision support system.

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

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

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

For the tests performed:

• Biocompatibility: Likely evaluated against established biological safety standards.
• Viral inactivation: Assessed against standards for viral clearance.
• Mechanical testing: Compared to predetermined specifications for the device's physical properties.
• Substantial Equivalence: Ground truth is the performance and characteristics of the legally marketed predicate device (SIS Fistula Plug, K050337).

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The "training" for such devices typically refers to the manufacturing process and quality controls.

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

Not applicable, as there is no training set in the AI/ML context.

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DynaMatrix™ is intended for use to aid in guided tissue regeneration and guided bone regeneration procedures. It may be used for bone regeneration and healing of periodontal defects, for gingival augmentation, to maintain or enhance alveolar ridges, or to contain and prevent migration of graft material. The device is provided sterile and intended for one-time use.

DynaMatrix™ is a bioabsorbable, extracellular collagen membrane matrix that is identical to the predicate SURGISIS® Periodontal Membrane (K010952), also manufactured by Cook Biotech Incorporated. This premarket notification is being submitted to expand the indications for use and to introduce a new product name.

The provided text is a 510(k) summary for a medical device called DynaMatrix™. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving the device meets specific acceptance criteria through a comparative study with a strict set of performance metrics.

Therefore, the document does not contain the information requested regarding acceptance criteria, reported device performance, sample sizes for test or training sets, expert qualifications, ground truth establishment, or multi-reader multi-case studies.

Instead, the submission focuses on establishing substantial equivalence based on:

• Device Description: DynaMatrix™ is described as a bioabsorbable, extracellular collagen membrane matrix that is identical to a previously cleared predicate device, SURGISIS® Periodontal Membrane (K010952).
• Intended Use: The intended uses are provided, which expand upon those of the predicate device while maintaining the same design principles. These uses include guided tissue regeneration, guided bone regeneration, healing of periodontal defects, gingival augmentation, maintaining/enhancing alveolar ridges, and containing/preventing graft material migration.
• Equivalence to Marketed Device: The core of the 510(k) is the claim that DynaMatrix™ is substantially equivalent in indications and design principles to existing predicate devices. This implies that the safety and effectiveness are established by the predicate devices, rather than through new performance studies against specific acceptance criteria.

In summary, the document states that the device is substantially equivalent to a predicate device, which allows it to be marketed. It does not provide the details of a study with acceptance criteria and measured performance as requested.

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The SURGISIS® Biodesign Tissue Graft is intended to reinforce soft tissues where weakness exists. Indications for use include the repair of a hernia or body wall defect.

The SURGISIS® Biodesign Tissue Graft minimizes tissue attachment to the device in case of direct contact with viscera.

This device is intended for one-time use.

The SURGISIS® Biodesign Tissue Graft is manufactured from porcine small intestinal submucosa (SIS) and is nominally supplied in a range of sizes. The device is packaged in a dried state, and is supplied sterile in a sealed double pouch system.

This 510(k) summary describes a medical device, the SURGISIS® Biodesign Tissue Graft, and its substantial equivalence to a predicate device. It does not contain information about acceptance criteria and a study proving the device meets those criteria in the way a diagnostic AI/ML device submission would. This submission is for a material (surgical mesh), not a software algorithm.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, sample size for training set, how ground truth for training set was established, standalone performance) are not applicable to this type of device submission.

Here's an interpretation based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified in the provided text. The document refers to "a number of animal studies."
• Data Provenance: "animal studies from published and unpublished literature." The country of origin is not specified but Cook Biotech Incorporated is based in West Lafayette, IN, USA. The studies would be considered prospective for the specific claims they aimed to prove.

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

• This information is not provided. The studies are animal studies, so the "ground truth" would likely be based on pathological and gross examination findings by veterinarians or researchers, rather than expert human interpretation of images or signals.

4. Adjudication method for the test set

• Not applicable as this is not an AI/ML diagnostic study. The "ground truth" would be determined by direct observation and scientific assessment in animal studies.

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 AI/ML device.

7. The type of ground truth used

• The "ground truth" was established through direct observation and measurement in animal studies, focusing on outcomes like tissue attachment to viscera.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device. There is no concept of a "training set" for this type of medical device submission.

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

• Not applicable.

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The SURGISIS® SLR™ Staple Line Reinforcement is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers. The device may be used for buttressing and reinforcing staple lines during lung resection (e.g., wedge resection, blebectomy, lobectomy, bullectomy, bronchial resection, segmentectomy, pneumonectomy/pneumectomy, pneumoreduction) and other incisions and excisions of the lung and bronchus. The device can be used for the reinforcement of the gastric staple line during the bariatric surgical procedures of gastric bypass and gastric banding, and for reinforcement of staple lines during small bowel, mesentery, colon, and colorectal procedures. The device may be used with anastomotic staplers or with non-anastomotic staplers. The device is supplied sterile and is intended for one-time use.

The SURGIS & SLR™ Staple Line Reinforcement device is produced from porcine small intestinal submucosa (SIS") that has been disinfected and treated for surgical use. The modified device is coated with an adhesive that eliminates the need for the application of a hydrogel to affix the device to the stapler arms. The device is supplied on a foam applicator, suspended in a form-fitting tray, and packaged in a sealed foil pouch to maintain sterility.

I am sorry, but based on the provided text, I cannot extract the information required to describe the acceptance criteria and the study that proves the device meets them. The document is a 510(k) clearance letter and a 510(k) summary for a medical device (Modified SURGISIS® SLR™ Staple Line Reinforcement).

While it mentions "performance bench and biocompatibility testing" and "Discussion of Tests and Test Results", it does not provide the specific details of these tests, their acceptance criteria, the reported device performance, sample sizes, ground truth establishment, or any information related to human reader studies (MRMC, standalone algorithm performance).

The text focuses on establishing substantial equivalence to a predicate device, rather than detailing the specifics of the actual performance studies themselves.

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