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The Biodesign® Enterocutaneous Fistula Plug is intended for implantation to reinforce soft tissue for repair of enterocutaneous fistulas. The device is supplied sterile and is intended for one-time use.

The Biodesign® Enterocutaneous Fistula Plug is a bioabsorbable, collagen-derived, minimally invasive treatment option for the repair of enterocutaneous fistulas. The device consists of two parts - an implanted device and a delivery system. The implanted device has four components - the small intestinal submucosa (SIS) plug, the flange/gasket assembly, the suture tether and the Molnar Disc. The SIS plug is manufactured from porcine small intestine that has been stripped of its serosal, mucosal, and muscle layers and virally inactivated. The resulting acellular collagenous layer, termed Small Intestinal Submucosa, is manufactured into a rolled, freeze dried plug. The function of the SIS plug is to fill and aid in the healing of the tract. The plug fully remodels into patient tissue over time. The other three components, the flange/gasket assembly, the suture tether and the Molnar Disc are all temporary implants designed to either naturally pass out of the body or fall off the skin. The function of the flange/gasket assembly is to seal the internal opening of the fistula tract and prevent the ingress of any gastric/intestinal fluid from entering the fistula tract. The suture connects the flange assembly at the internal opening of the fistula to the Molnar Disc at the external opening. Tethering the suture to the Molnar Disc provides tension to keep the flange/gasket assembly securely in place. In addition to the implanted device, a delivery system is provided to ensure proper device delivery and deployment.

The provided text describes a 510(k) premarket notification for the Biodesign® Enterocutaneous Fistula Plug and does not contain detailed information about acceptance criteria and a specific study proving the device meets those criteria from an AI/algorithm perspective. Instead, it focuses on demonstrating substantial equivalence to a predicate device through biocompatibility, mechanical testing, and animal testing.

Therefore, many of the requested fields cannot be directly answered from the provided text. However, I can extract information related to the device performance and the studies conducted to support its substantial equivalence.

Here's the breakdown of the information that can be extracted or deduced from the document:

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

The document does not explicitly state acceptance criteria in a quantitative format for each test, nor does it provide detailed raw performance data. It generally states that the device "meets the biocompatibility requirements" and that mechanical tests "ensure the device design is appropriate and the device is able to function as intended."

| Acceptance Criteria Category | Reported Device Performance |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+
| Biocompatibility | The Biodesign® Enterocutaneous Fistula Plug meets the biocompatibility requirements of the ISO-10993 standard. Tests performed on permanent tissue implant components (SIS material) included Genotoxicity, Cytotoxicity, Muscle implantation, Acute intracutaneous reactivity, Skin irritation, ISO sensitization, Acute systemic toxicity, and Subchronic systemic toxicity. |
| Mechanical Testing | Mechanical tests were conducted to ensure the device design is appropriate and able to function as intended. These tests included Leak resistance, Pushability, Deployment, Gasket expansion, and Tensile strength, and Two-plug deployment. All tests were performed on terminally sterilized devices. The same types of testing were used for the predicate device. |
| Animal Testing (Safety & Biological Response) | A GLP animal study in a domestic swine model showed closure of surgically created fistulas, complete incorporation of enterocutaneous fistula plugs at five weeks, with no negative clinical sequelae. The study also evaluated local/regional responses of the intestine and adjacent organs, and the time the flange remained in the luminal surface. |
| Substantial Equivalence | All differences between the subject device (Biodesign® Enterocutaneous Fistula Plug) and the predicate device (Surgisis® Biodesign® Enterocutaneous Fistula Plug, K082682) were analyzed. The conclusion was that these differences did not change the intended use, fundamental mode of action, or introduce new types of questions in risks or effectiveness, thus supporting a determination of substantial equivalence. The subject device is a "design improvement of the predicate device" based on user feedback and clinical experience. |

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:
  • Biocompatibility: Not specified beyond "portions classified to be permanent tissue implant (e.g. the SIS material)" and implied samples for the other components.
  • Mechanical Testing: Not specified for individual tests. The document states "All testing were performed on terminally sterilized devices," implying multiple samples.
  • Animal Testing: "A GLP animal study was performed using the Biodesign® Enterocutaneous Fistula Plug (subject device) in a domestic swine model." The exact number of swine is not specified, but "a domestic swine model" suggests a controlled, prospective study.
• Data Provenance:
  • Biocompatibility & Mechanical Testing: Conducted by the manufacturer (Cook Biotech Incorporated, based in West Lafayette, Indiana, USA), likely in a controlled laboratory setting.
  • Animal Testing: Described as a "GLP animal study," indicating a Good Laboratory Practice compliant prospective study. Location is not explicitly stated but assumed to be in a controlled environment, likely in the US given the manufacturer's location.

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. The studies described are preclinical (biocompatibility, mechanical, animal) and do not involve human expert interpretation for establishing ground truth in the context of clinical performance or diagnostic accuracy. The animal study outcomes (closure of fistulas, incorporation of plugs, no negative clinical sequelae) would be evaluated by veterinary pathologists or researchers.

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

Not applicable, as there is no mention of expert adjudication for clinical or diagnostic performance.

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 physical surgical implant, not an AI or diagnostic algorithm, so MRMC studies are not relevant. This document is a 510(k) submission for a medical device, not an AI product.

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

Not applicable. This device is a physical surgical implant, not an AI or diagnostic algorithm.

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

• Biocompatibility: Based on established international standards (ISO-10993) using biological assays (e.g., cytotoxicity, genotoxicity, systemic toxicity) and tissue reactions observed in animal models (e.g., muscle implantation, acute intracutaneous reactivity).
• Mechanical Testing: Based on engineering specifications and physical measurements (e.g., leak resistance, tensile strength).
• Animal Testing: Based on observed biological outcomes in a live animal model (e.g., fistula closure, tissue incorporation, clinical sequelae, pathological examination of tissues). This would involve macroscopic and microscopic pathology.

8. The sample size for the training set

Not applicable. There is no AI component or training set involved with this physical device.

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

Not applicable. There is no AI component or training set involved with this physical device.

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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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