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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 SIS Inguinal Hernia Repair Graft is intended for implantation to reinforce soft tissues where weakness exists, including the repair of inguinal hernias. The graft is supplied sterile and is intended for one-time use.

The SIS Inguinal Hernia Repair Graft is a flat sheet constructed of an animal sourced bioabsorbable, extracellular matrix collagen membrane derived from porcine Small Intestinal Submucosa, (SIS). It is intended for soft tissue repair with sizes and shapes appropriate for the repair of inguinal hernias. SIS Inguinal Hernia Repair Graft contains collagens I, III, IV and VI. The device is packaged in a dried state and supplied sterile in a sealed double pouch system.

The provided document describes the Cook Biotech Incorporated's SIS Inguinal Hernia Repair Graft (K142887) and its substantial equivalence to predicate devices, supported by biocompatibility, mechanical, and clinical testing. The document does not describe the conventional acceptance criteria and device performance in the way typically seen for AI/ML-enabled devices, but rather focuses on demonstrating the device's safety and effectiveness compared to existing market devices.

However, I can extract the relevant performance data from the clinical studies to present it in a similar structure:

1. Table of "Acceptance Criteria" (represented by clinical outcomes) and Reported Device Performance:

Since this is a traditional medical device (surgical mesh) and not an AI/ML device, the concept of "acceptance criteria" is not defined as specific performance metrics and thresholds like sensitivity/specificity for a diagnostic AI. Instead, substantial equivalence is established through demonstrating that the device is as safe and effective as predicate devices, often using clinical outcomes like recurrence rates and adverse events. Below, I've summarized the key clinical outcomes from the provided studies.

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

• US Randomized Clinical Trial (Bochicchio GV, et al., 2014):

  • Sample Size: 95 male patients (45 SIHRG, 50 Polypropylene). Originally 100 randomized, but 5 in SIHM group withdrawn.
  • Data Provenance: United States (one center, Baltimore VA hospital).
  • Retrospective/Prospective: Prospective (randomized double-blinded trial).

• OUS Randomized Clinical Investigation 1 (Puccio F, et al., 2005):

  • Sample Size: 45 patients (randomized into Polypropylene, Polyglactin, and SIHRG groups, specific breakdown for SIHRG not explicitly stated, but outcomes for SIHRG are reported).
  • Data Provenance: Outside US (1 OUS Center).
  • Retrospective/Prospective: Prospective (randomized clinical investigation).

• OUS Randomized Clinical Investigation 2 (Ansaloni L, et al., 2009):

  • Sample Size: 70 patients (randomized to Polypropylene or SIHRG).
  • Data Provenance: Outside US (1 OUS Center).
  • Retrospective/Prospective: Prospective (randomized controlled trial).

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

• For surgical mesh devices, "ground truth" for clinical outcomes (like recurrence) is established through medical diagnosis during patient follow-up, which involves surgeons, physicians, and possibly imaging specialists evaluating patients post-surgery.
• Bochicchio GV, et al. (US Study): "7 investigators including 4 surgeons." The qualifications of these specific surgeons (e.g., years of experience, subspecialty) are not detailed beyond their role.
• Puccio F, et al. (OUS Study 1): "5 investigators." No specific qualifications provided.
• Ansaloni L, et al. (OUS Study 2): "2 investigators." No specific qualifications provided.

4. Adjudication Method:

The document does not explicitly state an "adjudication method" in the context of resolving discrepancies in diagnoses, as would be common for image-based AI studies. Instead, clinical outcomes (recurrence, pain, adverse events) were recorded by investigators as part of the study protocol. The double-blinded nature of the US study (Bochicchio et al.) for a year could imply a degree of objective assessment, but details on how conflicting diagnoses of recurrence were handled are not provided.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is specific to evaluating diagnostic systems, particularly AI-enabled ones, where multiple readers interpret cases with and without AI assistance. The studies presented here are clinical trials comparing a medical device (surgical mesh) with a comparator (another mesh) for treatment effectiveness and safety outcomes in patients.

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

• Not applicable. The device is a surgical implant (mesh), not an algorithm or diagnostic software. Therefore, there is no "standalone performance" in the context of AI. The performance is the device's clinical outcome when implanted in patients by surgeons.

7. The Type of Ground Truth Used:

The ground truth for the clinical outcomes (e.g., hernia recurrence, pain, adverse events) was established by clinical assessment and follow-up data from the patients in the respective studies. This includes:

• Physical examination by clinicians.
• Patient-reported outcomes (e.g., pain surveys).
• Diagnostic imaging (e.g., ultrasound in Puccio F, et al. study for prosthesis visibility).
• Medical records and direct observation of adverse events.

8. The Sample Size for the Training Set:

• Not applicable for a traditional medical device. The SIS Inguinal Hernia Repair Graft is a physical implant, not an AI/ML model that requires a training set. Its development and testing involve engineering, biocompatibility, and clinical studies, rather than machine learning training.

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

• Not applicable. As stated above, this is not an AI/ML device, so there is no training set or ground truth in that context.

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The Biodesign Otologic Repair Graft is intended for use as an implant to aid in surgical repairs and as an adjunct to aid in the natural healing process in various otologic procedures, including but not limited to myringoplasty and tympanoplasty. The device is supplied sterile and is intended for one-time use.

The Biodesign Otologic Repair Graft is an absorbable multi-layer biomaterial composed of four layers of laminated extracellular collagen matrix derived from porcine small intestinal submucosa (SIS). The SIS material is lyophilized and then punched into the desired shape. The device is available in 4 mm, 6 mm and 9 mm diameter discs, as well as 2.5 x 2.5 cm and 5 x 5 cm square sheets. Upon implantation, the Biodesign Otologic Repair Graft is infiltrated by the host cells and acts as a scaffold for these cells during the body's natural repair process.

Additionally, the circular configurations of the device are packaged in a dried state and supplied sterile in a tray inside a sealed Tyvek® pouch. The square configurations of the device are also packaged sterile in a dried state inside a sealed Tyvek® pouch.

The provided text describes the Biodesign Otologic Repair Graft and its substantial equivalence to predicate devices, but it does not contain the specific information required to complete the detailed table about acceptance criteria and study design for a device. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to existing devices rather than defining and proving acceptance criteria with specific performance metrics and a detailed study design as might be seen for a novel device or PMA.

Here's a breakdown of what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information/Cannot be extracted:

The document focuses on substantial equivalence based on material properties, biocompatibility, and clinical outcomes, rather than specific, quantified acceptance criteria for novel performance claims. For example, while mechanical strength was tested, the acceptance criterion (e.g., "burst strength must exceed X MPa") is not provided, only the qualitative statement that it was "adequate." Similarly, for efficacy, there's no explicitly stated acceptance criteria (e.g., "myringoplasty success rate must be >90%") before the study results are presented.

2. Sample Size for the Test Set and Data Provenance

• Biocompatibility Tests: The exact number of samples used for each test (genotoxicity, cytotoxicity, etc.) is not specified. The tests were performed on "sterilized SIS devices," which are identical in composition to the Biodesign Otologic Repair Graft.
• Mechanical Testing (Burst Strength): The sample size is not specified.
• Animal Testing:
  • Efficacy study: Chinchilla model (number of animals not specified).
  • Implant study: Mouse model (number of animals not specified).
• Clinical Testing (Prospective Data):
  • Primary Study: 404 patients (217 SIS repairs, 215 temporalis fascia (PTF) repairs).
  • Data Provenance: The study was conducted by D'Eredita, but the country of origin is not explicitly stated. The material was labeled as "Surgisis." The comparison was made against "temporalis fascia (PTF) repairs performed by the same surgeon," implying a clinical setting. The follow-up was 2-11 years (average 7.7 years).
  • Additional Unpublished Data:
    • a) 18 patients (Hsu, DuPage Medical Group, 2015)
    • b) 19 patients (Toh C. et al., Birmingham Heartland Hospital, UK, 2003) - UK origin.
    • c) 32 patients (Ofo E. et al., North West London Hospital, UK, 2009) - UK origin.
    • d) 8 patients (Lalwani A. San Francisco, CA, COSM 2003) - USA origin.
  • Retrospective/Prospective: The 404-patient study is explicitly called "Prospective data." The additional data are referred to as "unpublished data" but their specific prospective/retrospective nature is not detailed.

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

• This information is not provided. Clinical outcomes (e.g., stable tympanic membrane closures, adverse events) would have been assessed by treating physicians, but the document does not detail a specific expert panel/adjudication process for establishing ground truth for the clinical studies mentioned.

4. Adjudication Method for the Test Set

• This information is not provided. For clinical outcomes, the treating surgeon or independent clinicians would typically assess post-operative results, but no specific adjudication method (like 2+1 consensus) is outlined.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC comparative effectiveness study was not done. The clinical studies reported involved a comparison of the device material (SIS) with autologous tissue repair (temporalis fascia) or comparison to a predicate in an animal model, and observations of patient outcomes. These are not MRMC studies as typically understood for AI device assessments involving multiple readers evaluating cases with and without AI assistance to measure reader improvement.

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

• This is not applicable. The Biodesign Otologic Repair Graft is a physical medical device (implantable biomaterial), not an AI algorithm or software device. Therefore, a "standalone algorithm performance" study is not relevant to this product.

7. The Type of Ground Truth Used

• Biocompatibility: In vitro and in vivo test results against ISO 10993-1 standards.
• Mechanical Testing: Measured burst strength.
• Animal Testing: Histological assessment of cellular response and device degradation (observations by researchers), and efficacy observations in chinchilla tympanic membrane repair.
• Clinical Testing: Clinical outcomes data (e.g., stable tympanic membrane closures, occurrence/absence of adverse reactions/events) observed post-operatively by treating physicians or study investigators. This would be considered outcomes data or clinical expert observation.

8. The Sample Size for the Training Set

• This is not applicable. The Biodesign Otologic Repair Graft is a physical medical device (biomaterial), not an AI algorithm. Therefore, there is no "training set" in the context of machine learning. The device itself is manufactured using a specific process and its properties are inherently defined by its material and design, not by being "trained" on data.

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

• This is not applicable for the reasons stated in point 8.

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The Biodesign® ENT Repair Graft is intended to separate tissue or structures compromised by surgical trauma, help control minimal bleeding, and act as an adjunct to aid in the natural healing process. The device is indicated for use where an open wound dressing material is required in the nasal and/or sinus cavities following nasal and/or sinus surgery where separation of tissues or structures is desired. The device is supplied sterile and is intended for one-time use.

The Biodesign ENT Repair Graft is composed of a bioabsorbable, extracellular collagen membrane matrix (Small Intestinal Submucosa, SIS). The Biodesign ENT Repair Graft is similar to its predicate MeroGel™ Control Gel ENT Surgical Dressing (K002972) which is a biomaterial composed of HYAFF®, an ester of hyaluronic acid, a natural occurring constituent of extracellular matrix. The device is available in multilayered sheets with sizes from 1 cm by 2 cm to 20 cm x 40 cm. The Biodesign ENT Repair Graft is a scaffold which becomes infiltrated by the host cells during the body's natural repair process. The Biodesign ENT Repair Graft can be shaped by the physician to the appropriate size for the desired indication. The Biodesign ENT Repair Graft is similar to its MeroGel predicate in its technology in that it has the ability to be incorporated into the body. The device is packaged in a lyophilized (dried) state and supplied sterile in a sealed double pouch system.

Here's an analysis of the provided text regarding the Biodesign ENT Repair Graft, focusing on acceptance criteria and supporting studies:

This submission is for a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to a predicate device, rather than proving efficacy against a set of predefined performance endpoints. Therefore, the "acceptance criteria" here are primarily about demonstrating that the new device is as safe and effective as the predicate, based on similar intended use, materials, and technological characteristics. There isn't a conventional "device performance" described in terms of specific metrics like sensitivity or accuracy in the way it would be for a diagnostic AI device.

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: Direct numerical "device performance" metrics (e.g., specific tensile strength values, degradation rates, quantitative clinical outcomes) are not provided in this summary. The focus is on qualitative equivalence ("adequate," "substantially similar," "evidence that...").

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

• Biocompatibility Testing: The text states "sterilized SIS devices (which have already been cleared in multiple applications)" were used. The specific number of devices tested for each biocompatibility test is not mentioned.
• Mechanical Testing: Specific sample sizes for suture retention strength and ultimate tensile strength tests are not mentioned.
• Preclinical Testing (Mouse Study): The number of mice used in the subcutaneous study is not mentioned.
• Clinical Testing: The number of patients included in the clinical study for nasal septal perforation repair is not mentioned. The provenance (e.g., country of origin, retrospective/prospective) of the clinical data is not mentioned, though the study was performed using SIS material (Surgisis), implying it could have been a previously conducted study.

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

This type of information is not applicable to this 510(k) submission. For this medical device (a surgical graft), "ground truth" is not established by expert consensus on interpretations as it would be for an AI diagnostic device. Instead, the "truth" is determined by established scientific/engineering test methods (e.g., ISO standards for biocompatibility) and clinical observation of outcomes, which are assessed by medical professionals in the context of a clinical study. The document does not specify the number or qualifications of experts who interpreted the results of the biocompatibility, mechanical, or preclinical tests. For the clinical study, the results would typically be analyzed by clinical researchers and physicians, but their specific roles or number establishing "ground truth" (e.g., pathology confirmation of repair) are not detailed.

4. Adjudication Method for the Test Set

This is not applicable in the context of this device and testing. Adjudication methods (like 2+1 or 3+1) are typically used in studies where multiple human readers interpret data (e.g., medical images) and their discrepancies need to be resolved to establish a robust ground truth. Here, the "test sets" involve physical, chemical, and biological measurements or clinical outcomes, not interpretations requiring 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

This is not applicable. This submission is for a surgical graft, not an AI-assisted diagnostic or therapeutic device. Therefore, no MRMC study involving human readers and AI assistance was conducted or would be relevant.

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

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

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" for demonstrating substantial equivalence for this device is based on a combination of:

• Standardized Biocompatibility Test Results: Adherence to ISO 10993-1 standards for various biological responses, with results indicating "meets biocompatibility requirements."
• Mechanical Testing Results: Measurements of physical properties like suture retention and tensile strength, deemed "adequate."
• Preclinical (Animal) Observations: Post-implant observations in a mouse model regarding tissue separation, cellular ingrowth, and degradation.
• Clinical Outcomes Data: The clinical study on nasal septal perforation repair using SIS material implies evaluation of patient outcomes such as healing, complication rates, and efficacy in achieving the intended purpose. The specific endpoints or type of data forming this "ground truth" are not detailed (e.g., surgical success rate, re-perforation rate, symptomatic improvement).

8. The Sample Size for the Training Set

This information is not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."

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

This information is not applicable, as there is no training set for this device.

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