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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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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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Surgisis is intended for implantation to reinforce soft tissue. The device is intended for one-time use.

Surgical mesh

This document is a Special 510(k) Premarket Notification for a medical device called Surgisis®, a surgical mesh. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that the device meets specific acceptance criteria based on performance during testing.

Here's an analysis based on the provided text:

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

The provided document does not contain a table of acceptance criteria nor reported device performance data in the typical sense of a clinical or performance study. Instead, it focuses on demonstrating substantial equivalence to a predicate device through a comparison of characteristics. The document states:

• "Both pass the same set of internal tests and release criteria."
  However, the specific "internal tests and release criteria" are not detailed, nor are the quantitative results of these tests provided.

Therefore, a table of acceptance criteria and reported device performance cannot be generated from the given text.

2. Sample size 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. The submission hinges on substantial equivalence based on material and process similarities, not on a test set of data from a study.

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 and therefore not provided. Since there is no described test set involving human assessment, there are no experts establishing ground truth in this context. The determination of substantial equivalence is made by the FDA based on the provided technical information.

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

This information is not applicable and therefore not provided. There is no described test set requiring human 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

A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned and is not applicable here. This document is for a surgical mesh, not an AI-assisted diagnostic or therapeutic device.

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

This is not applicable as Surgisis® is a physical surgical mesh, not an algorithm or AI system.

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

This is not applicable in the context of the provided document. The regulatory submission relies on demonstrating that the device is "substantially equivalent" to an already approved predicate device, meaning it has the same intended use, operating principles, basic design, materials, shelf-life, and passes the same internal tests and release criteria. The "ground truth" here is the established safety and effectiveness of the predicate device, which is inferred by the similarities.

8. The sample size for the training set

This is not applicable as this is not an AI/ML device requiring a training set.

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

This is not applicable as this is not an AI/ML device requiring a training set.

Summary of Acceptance Criteria and Study:

The provided document is a Special 510(k) submission for a surgical mesh (Surgisis®). The regulatory pathway for this device, a 510(k), primarily focuses on demonstrating "substantial equivalence" to a legally marketed predicate device rather than conducting new, elaborate clinical or performance studies with specific statistical acceptance criteria for device performance as one might see for novel high-risk devices or AI/ML technologies.

The "acceptance criteria" and "study" in this context are interpreted as the comparison points and the process of demonstrating substantial equivalence:

The "study" that proves the device meets these "acceptance criteria" is the Special 510(k) submission itself, which presents a direct comparison between the new Surgisis® device and its identified predicate. The "proof" lies in the detailed technical information provided to the FDA (which is not fully available in this excerpt) asserting these similarities and justifying that a process change did not affect specifications or performance. This is a regulatory assessment, not a scientific study with a traditional experimental design, test sets, or ground truth adjudication by experts in the sense of AI/ML or diagnostic device validation.

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The modified SIS Fistula Plug is for implantation to reinforce soft tissue for repair of recto-vaginal fistulas. The device is supplied sterile and is intended for one-time use.

The modified SIS Fistula Plug is manufactured from porcine small intestinal submucosa (SIS) supplied in a tapered configuration with a button 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.

The provided text details a 510(k) submission for a modified medical device, the SIS Fistula Plug. However, it does not contain a study that demonstrates the device meets specific acceptance criteria in terms of performance (e.g., efficacy, accuracy, or clinical outcomes). The submission focuses on demonstrating substantial equivalence to a predicate device, specifically addressing modifications made to the original SIS Fistula Plug.

Therefore, many of the requested sections about acceptance criteria, device performance, sample sizes for test/training sets, expert involvement, and ground truth cannot be extracted from this document as such studies were not part of this 510(k) submission.

Here's an analysis of what can be extracted and an explanation of what cannot:

1. Table of acceptance criteria and the reported device performance

• Acceptance Criteria for this submission: The primary "acceptance criterion" for this 510(k) submission is to demonstrate substantial equivalence to the predicate device (the original SIS Fistula Plug [510(k) No. K050337]). This is achieved by showing that the modified device has similar intended use, materials, and technological characteristics, and that any modifications do not raise new questions of safety and effectiveness.
• Reported Device Performance: The document states that the modified device underwent:
  • Biocompatibility testing
  • Viral inactivation testing
  • Mechanical testing
  • An analysis of risk factors.
  • Outcomes: "Outcomes show the device to be biocompatible, adequately disinfected, and with appropriate mechanical characteristics." Also, "Outcomes from the evaluation of the modified SIS Fistula Plug provide evidence of its suitability for use in soft tissue reconstruction and substantial equivalency to the predicate device in terms of intended use and 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)

• This information is not provided because this submission relies on demonstrating substantial equivalence through bench testing, biocompatibility testing, and risk analysis, rather than a clinical efficacy study with a test set of patients or data. The testing mentioned (biocompatibility, viral inactivation, mechanical) would typically involve laboratory samples, not human patient data sets.

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. There was no "test set" in the context of human data or diagnoses requiring expert ground truth in this 510(k) submission.

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

• Not applicable. No test set requiring adjudication was used.

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 for fistula repair, not an AI-powered diagnostic tool, so MRMC studies are irrelevant here.

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

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

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

• For the assessments performed (biocompatibility, mechanical testing, viral inactivation), the "ground truth" would be established by standard scientific and engineering methodologies, accepted laboratory protocols, and regulatory guidelines for these types of tests, rather than expert consensus on clinical cases or pathology.

8. The sample size for the training set

• Not applicable. There is no mention of "training set" as this is not an AI/ML device.

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

• Not applicable. There is no mention of "training set" as this is not an AI/ML device.

In summary: This 510(k) submission is for modifications to an existing physical medical device (SIS Fistula Plug). The "study" referenced is a series of tests (biocompatibility, viral inactivation, mechanical, and risk analysis) intended to demonstrate that the modified device remains substantially equivalent to its predicate. It does not involve clinical studies with human participants, AI algorithms, or the kinds of intricate data analysis and expert review typically found in submissions for diagnostic AI devices.

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The SURGISIS® Peyronie's Repair Graft is intended for implantation to reinforce soft tissue where weakness exists in the urological anatomy, including but not limited to the repair of tunica albuginea defects, and reinforcement in the repair of Peyronie's disease. This device is supplied sterile and is intended for one-time use only.

The SURGISIS® Peyronie's Repair Graft is manufactured from porcine small intestinal submucosa (SIS) and is nominally supplied in an oval configuration. The device is packaged in a lyophilized (dried) state, and is supplied sterile in a sealed double pouch system.

The applicant, Cook Biotech Incorporated, sought to market the SURGISIS® Peyronie's Repair Graft, a surgical mesh made from porcine small intestinal submucosa (SIS), intended for reinforcing soft tissue in the urological anatomy, specifically for tunica albuginea defects and Peyronie's disease repair.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The provided documentation does not specify a distinct "test set" in the context of an AI/ML device. The "tests" discussed are bench and biocompatibility tests conducted on the physical device itself. Therefore, specific sample sizes for a test set (e.g., number of patient cases) and data provenance (country of origin, retrospective/prospective) are not applicable or provided here. The testing was performed on the manufactured device.

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

Not applicable. This device is a physical surgical mesh, not an AI/ML diagnostic or prognostic tool requiring expert-established ground truth on a test set of data. The ground truth for its performance is established through laboratory and animal testing, evaluated against predetermined scientific standards and regulatory guidelines.

4. Adjudication Method for the Test Set:

Not applicable. The evaluation of test results (biocompatibility, viral inactivation, mechanical properties) for a physical device is based on objective measurements and established scientific protocols, not on an adjudication method involving human interpretation of data in the way one would for a diagnostic study.

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, and therefore no MRMC study looking at human reader performance with or without AI assistance was conducted.

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 for this device's performance is based on:

• Scientific Standards and Regulatory Guidelines: For biocompatibility (e.g., ISO 10993 series), viral inactivation (established methods to ensure safety), and mechanical properties (biomechanical testing standards).
• Bench and Biocompatibility Testing Results: Objective measurements derived from laboratory tests the device underwent.
• Comparison to Predicate Device Performance: Establishing equivalence based on the known safety and effectiveness profiles of already marketed, substantially equivalent devices.

8. The Sample Size for the Training Set:

Not applicable. This device does not involve a "training set" in the context of AI/ML.

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

Not applicable. This device does not involve a "training set." The development and testing of this device relied on established scientific principles, engineering design, and regulatory compliance for medical device manufacturing.

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The SURGISIS Ocular Graft is intended for implantation to reinforce and support the reconstruction of the soft tissue of the eyelid.
The SURGISIS Ocular Graft is intended for implantation to reinforce and aid reconstruction of the eyelid and is labeled for single use.

The SURGISIS Ocular Graft is derived from porcine small intestinal submucosa (SIS). The material is prepared into sheets of various sizes and thicknesses appropriate for the reconstruction and repair of soft tissues. The device is supplied sterile in a dry lyophilized state sealed in a double peel pouch system

The provided text describes the SURGISIS Ocular Graft, an ophthalmic implant made from processed porcine small intestinal submucosa. It details the device's description, indications for use, and a summary that it is identical in material composition to predicate Surgisis devices and has undergone extensive biocompatibility, viral inactivation, and mechanical testing. The text states that these outcomes demonstrate safety and efficacy for soft tissue reconstruction and repair.

However, the provided text does not contain the specific information requested about acceptance criteria and the study that proves the device meets those criteria. The information regarding acceptance criteria, reported performance, sample sizes for test sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth, training set sample size, and how training set ground truth was established is not present in the provided document.

The document focuses on establishing substantial equivalence to predicate devices, listing the predicate devices and their characteristics, rather than detailing the specifics of a study evaluating the performance against predefined acceptance criteria for the SURGISIS Ocular Graft itself in the manner requested. The "Summary of Testing" section is very high-level and does not provide quantitative results or detailed study methodology.

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SURGIS Staple Line Reinforcement II 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 non-anastomotic staplers. The device is supplied sterile and is intended for one-time use.

SURGIS® Staple Line Reinforcement II is manufactured from porcine small intestinal submucosa (SIS) and is nominally supplied in strip sizes (unfolded) of 1.0 x 10.8 cm to 1.2 x 19.8 cm. The device is surface treated to allow it to temporarily adhere to the stapler arms, is packaged in a lyophilized (dried) state, and supplied sterile in a sealed double pouch system.

The provided text describes the 510(k) Premarket Notification for the SURGISIS® Staple Line Reinforcement II device. It includes information about the device's intended use, predicate devices, and a summary of testing for substantial equivalence. However, it does not contain the specific details required to complete your request for acceptance criteria and a study proving those criteria are met.

Here's why and what information is missing:

• Acceptance Criteria and Reported Device Performance: The document states "Outcomes show the device to be biocompatible, manufacturing processes to adequately disinfect the material, and mechanical characteristics to be sufficient." This is a general statement, not a table of specific acceptance criteria (e.g., tensile strength > X MPa, burst pressure > Y mmHg) and the corresponding numerical results obtained from testing.
• Sample Size (Test Set), Data Provenance: This information is not present. The document mentions "extensive biocompatibility testing, viral inactivation testing, and mechanical testing," but does not detail the sample sizes for these tests or the origin of any data (human or animal, retrospective/prospective).
• Number of Experts, Qualifications, Adjudication Method: These points are relevant to studies involving human interpretation or consensus, which are not described here. The tests mentioned are laboratory-based (biocompatibility, viral inactivation, mechanical), not studies requiring human expert adjudication.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: This type of study would compare human performance with and without AI assistance. The SURGISIS® Staple Line Reinforcement II is a physical medical device (surgical mesh), not an AI algorithm. Therefore, an MRMC study is not applicable.
• Standalone (Algorithm Only) Performance: As above, this device is a physical product, not an algorithm.
• Type of Ground Truth Used: For physical device testing, "ground truth" typically refers to established standards and methods for measuring material properties. The document doesn't specify these, beyond general statements about "biocompatibility testing," "viral inactivation testing," and "mechanical testing." It doesn't mention expert consensus, pathology, or outcomes data in the context of establishing a benchmark for performance.
• Sample Size for Training Set & How Ground Truth for Training Set was Established: These points are relevant to machine learning or AI development, which is not applicable to this physical device.

In summary, the provided text describes a 510(k) submission for a physical surgical mesh. The "studies" mentioned are laboratory tests designed to demonstrate that the device is substantially equivalent to predicate devices based on its material properties and safety. It does not involve AI, human expert review, or clinical trials in the way your questions imply.

Therefore, I cannot populate the table and answer the specific questions based only on the provided text. The document is a regulatory summary focusing on substantial equivalence, not a detailed scientific study report with specific performance metrics against defined acceptance criteria.

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The SURGIS Nerve Cuff is intended for the repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity. The device is supplied sterile and is intended for one-time use.

The SURGIS Nerve Cuff is manufactured from porcine small intestinal submucosa (SIS) and is supplied in nominal tube diameters of 2, 5 and 7 mm, and a nominal length of 5 cm. The device is packaged in a lyophilized (dried) state, and supplied sterile in a sealed double pouch system.

Acceptance Criteria and Study for SURGISIS® Nerve Cuff

This document summarizes the acceptance criteria and the studies conducted to demonstrate that the SURGISIS® Nerve Cuff meets these criteria, based on the provided 510(k) summary (K031069).

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided 510(k) summary does not explicitly state the sample sizes used for the in vitro or in vivo test sets for the SURGISIS® Nerve Cuff, nor does it specify the country of origin of the data or whether the studies were retrospective or prospective. It only mentions "extensive biocompatibility testing, viral inactivation testing, mechanical testing, and assessment of in vivo performance."

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

The document does not provide details on the number of experts, their qualifications, or their role in establishing ground truth for any of the tests conducted. The testing appears to be primarily laboratory-based (biocompatibility, viral inactivation, mechanical) and animal-based (in vivo performance), rather than relying on expert clinical assessment of a test set in the way an AI/CAD system might.

4. Adjudication Method for the Test Set

Not applicable. The types of tests described (biocompatibility, viral inactivation, mechanical, in vivo animal studies) do not typically involve an adjudication method by human experts in the context of establishing a clinical ground truth for a test set.

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

No. The summary describes a medical device (nerve cuff) and its performance, not an AI or CAD system. Therefore, an MRMC comparative effectiveness study involving human readers with or without AI assistance is not applicable to this device.

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

Not applicable. This device is a physical implantable nerve cuff, not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth for the various tests can be inferred as follows:

• Biocompatibility: Established through standardized in vitro and in vivo biocompatibility testing methods, likely involving cellular responses, tissue reactions, and toxicology assessments.
• Viral Inactivation: Established by validated laboratory assays to detect viral agents following the manufacturing process.
• Mechanical Properties (Tensile Strength, Suture Retention, Compressive Forces): Established through standardized engineering and materials testing methods using calibrated equipment.
• In Vivo Performance (Axonal Growth and Myelination): Established through histological analysis, immunohistochemistry, and potentially functional recovery assessments in an animal model, compared to control groups (e.g., empty cuff or direct repair).

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI or machine learning model that requires a training set of data.

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

Not applicable, as there is no training set for this type of device.

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The Surgisis 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, bullectomy, bronchial resection, segmentectomy, pneumonectomy, 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. The device can also be used for abdominal and thoracic wall repair, muscle flap reinforcement, trans-abdominal rectal and vaginal prolapse repair, trans-abdominal reconstruction of the pelvic floor, and repair of hernias (e.g., diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal, umbilical). The Surgisis Staple Line Reinforcement may be used with anastomotic staplers or with non-anastomotic staplers. The device is supplied sterile and is intended for one-time use.

The Surgisis Stable Line Reinforcement is manufactured from porcine small intestinal submucosa and supplied in nominal strip sizes (unfolded) of 1 x 10.7 cm, 1.2 x 13.2 cm, and 1.2 x 17.3 cm. The device is packaged sterile, sealed double pouches.

Here's a breakdown of the acceptance criteria and the study information based on the provided text for the Cook Biotech Incorporated Surgisis® Staple Line Reinforcement:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state numerical acceptance criteria. Instead, it refers to meeting test requirements and demonstrating substantial equivalence to predicate devices.

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

The provided text does not specify a sample size for a test set or data provenance for any clinical or performance study that would resemble a "test set" in the context of an AI/ML device. The document describes tests conducted on the material itself ("The material comprising the Surgisis Staple Line Reinforcement was subjected to a panel of tests...").

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

This information is not applicable to this 510(k) submission. This device is a surgical mesh, not an AI/ML device that generates diagnoses or interpretations requiring expert-established ground truth. The "ground truth" for this medical device would relate to its physical and biological properties.

4. Adjudication Method for the Test Set

This information is not applicable as there is no mention of a test set requiring adjudication in the context of expert review.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done and is not applicable to this type of medical device (surgical mesh). This type of study is relevant for diagnostic devices, particularly those involving human interpretation, often with AI assistance.

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

No, a standalone performance study in the context of an algorithm or AI system was not done and is not applicable. This document describes a physical medical device.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on:

• Biocompatibility testing: Conforming to ISO 10993-1 standards.
• Disinfection efficacy: Demonstrating effective disinfection.
• Performance characteristics: Meeting mechanical and functional requirements relevant to its intended use as a surgical mesh.
• Comparison to predicate devices: Demonstrating similar intended use, materials, and technological characteristics to legally marketed devices.

These are established through laboratory testing and validated regulatory standards, rather than expert consensus, pathology, or outcomes data in the way an AI diagnostic device would use those terms.

8. The Sample Size for the Training Set

The provided text does not mention a training set sample size. A "training set" is typically associated with AI/ML model development, which is not relevant to this device.

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

This information is not applicable as there is no mention of a training set or AI/ML model development.

Summary of the Study that Proves the Device Meets the Acceptance Criteria:

The study proving the Surgisis® Staple Line Reinforcement meets its (implied) acceptance criteria is described as a panel of tests conducted on the material itself. These tests assessed:

• Biocompatibility: In accordance with ISO 10993-1 standards.
• Disinfection: To ensure effective sterilization.
• Performance Characteristics: Likely including mechanical properties and structural integrity relevant for its use as a soft tissue reinforcement.

The document states that the "material met the test requirements," providing "reasonable assurance of device performance for its intended use and supporting substantial equivalence." The overall conclusion drawn from these tests was that the device is "substantially equivalent" to existing predicate devices (Surgisis® Soft Tissue Graft, Surgisis® Peripheral Vascular Patch, Peri-Strips® Staple Line Reinforcement-Strip, and Seamguard® Staple Line Reinforcement Material) with respect to intended use and technological characteristics. This substantial equivalence is the primary basis for its 510(k) clearance.

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