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Biodesign Anal Fistula Plug: For implantation to reinforce soft tissue where a rolled configuration is required, for repair of anal, rectal and enterocutaneous fistulas.
Biodesign Fistula Plug: For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas.
Biodesign Plastic Surgery Matrix: For implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic or reconstructive surgery.
Biodesign Tissue Graft: For implantation to reinforce soft tissue.

All four subject devices of this bundled submission are part of a family of devices manufactured by Cook Biotech Incorporated (CBI) consisting of processed porcine small intestinal submucosa (SIS), a three-dimensional, acellular, collagen-based extracellular matrix (ECM) material. SIS is manufactured by first removing the tunica mucosa from the inner intestinal surface and the serosa and tunica muscularis from the outer surface of the porcine small intestine. Further processing removes the cells and renders the material virally inactive. leaving behind a three- dimensional, decellularized, collagen-rich extracellular matrix.

This document does not contain an acceptance criteria table or a study proving the device meets specific performance criteria. Instead, it is a 510(k) premarket notification of intent to market for several Biodesign devices. The submission aims to demonstrate substantial equivalence to already marketed predicate devices, not to prove performance against specific acceptance criteria.

The core of the submission, as per the snippets provided, is that the subject devices are largely identical to their predicate devices, with the only change being the inclusion of additional rehydration fluid options in the instructions for use (IFUs).

Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is absent:

1. A table of acceptance criteria and the reported device performance:
* Absent. This document does not present specific acceptance criteria with corresponding performance data. The submission focuses on demonstrating substantial equivalence to predicate devices, which implies that the device's performance is expected to be similar or equal to that of the predicates. The closest information is a comparison of characteristics between the subject devices and predicate devices (Table 5-3 on page 8).

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
* Absent. The document mentions "Mechanical testing (burst strength, tensile strength, suture retention strength and delamination testing) performed on devices rehydrated with new rehydration fluid options" to demonstrate no negative effects on mechanical properties. However, it does not specify the sample size used for these tests, the data provenance, or whether the study was retrospective or prospective.

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 / Absent. This type of information is typically relevant for studies involving human interpretation (e.g., diagnostic imaging). This submission describes mechanical testing of a medical device (surgical mesh), not expert-based assessment.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
* Not applicable / Absent. Similar to point 3, adjudication methods are usually for expert consensus on results, which is not described here for mechanical testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
* Not applicable. This submission pertains to a surgical mesh, not an AI-assisted diagnostic device. Therefore, no MRMC study or AI-related effectiveness analysis is presented.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
* Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
* The "ground truth" for the mechanical testing would be the measured mechanical properties (burst strength, tensile strength, suture retention strength, delamination) of the device. The aim was to show that these properties, when rehydrated with new fluid options, were comparable to those rehydrated with saline. The text states: "...demonstrate the devices still performed as expected and there were no negative effectives on the mechanical properties."

8. The sample size for the training set:
* Not applicable. There is no "training set" as this is not an AI/machine learning device.

9. How the ground truth for the training set was established:
* Not applicable. As there is no training set, this information is not relevant.

In summary, the provided document is a 510(k) summary focused on demonstrating substantial equivalence for modifications to existing surgical mesh devices, primarily concerning rehydration fluid options. It describes mechanical testing performed to ensure the modified devices retain expected properties but does not detail acceptance criteria or study specifics in the format requested, which is typical for performance studies of AI/diagnostic devices.

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The Biodesign® Fistula Plug is for implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas.

The Biodesign® Fistula Plug is a fistula repair device made from porcine SIS, a collagen rich, bioresorbable, extracellular matrix (ECM)-based biomaterial. The device design consists of a tapered SIS cylinder (plug body) and an SIS flange/button connected together using biodegradable polyglycolic acid (PGA) surgical suture. The function of the plug body is to fill the fistula tract and the function of the flange/button is to anchor the device at the internal fistula opening. Three different size offerings (2mm, 5mm and 7mm) are available based on the diameter of the primary end of the plug.

This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving device meets acceptance criteria. Therefore, most of the requested information cannot be fully extracted or is not applicable in this context.

Here's what can be inferred or directly stated from the provided document:

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

The document describes non-clinical testing performed to demonstrate substantial equivalence but does not explicitly list acceptance criteria values for each test. Instead, it states that "The results of the testing confirm that the subject device does not pose new or different biocompatibility risks and can withstand the expected mechanical forces on the device."

Specific tests performed:

• Biocompatibility testing: Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Acute Systemic Toxicity, Subchronic Toxicity, Genotoxicity, Implantation (on SIS and PGA suture).
• Performance Testing Bench: Extrusion resistance testing, Tensile strength testing, Plug suture retention strength.

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

The document does not provide details on sample sizes for the non-clinical tests (e.g., number of samples for extrusion resistance, number of animals for biocompatibility). It also does not discuss data provenance for these tests (country of origin, retrospective/prospective), as these are typically laboratory bench and animal studies, not human clinical trials.

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

Not applicable. This is a non-clinical submission, not an image-based diagnostic device or one involving human expert interpretation for ground truth.

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

Not applicable for a non-clinical submission.

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 a physical medical device (fistula plug), not an AI-based diagnostic system.

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

Not applicable, as it is not an algorithm/AI device.

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

For biocompatibility, the "ground truth" would be established by standard biological assays and observation for adverse reactions in animal models, comparing to established safety profiles of materials. For mechanical tests, the "ground truth" is based on engineering specifications and physical test methods.

8. The sample size for the training set:

Not applicable, as this is not an AI/machine learning device.

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

Not applicable, as this is not an AI/machine learning device.

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