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FortaGen Oral Membrane is intended to be used during guided bone regeneration (GBR) and guided tissue regeneration (GTR) procedures as a biodegradable barrier membrane for:

• Ridge augmentation for later implant insertions;
• . Simultaneous ridge augmentation and implant insertions;
• . Ridge augmentation around implants inserted in delayed extraction sites;
• . Ridge augmentation around implants inserted in immediate extraction sites;
• . Alveolar ridge preservation consequent to tooth (teeth) extraction(s);
• Over the window in lateral window sinus elevation procedures; .
• . In implants with vertical bone loss due to infection, only in cases where satisfactory debridement and implant surface disinfection can be achieved;
• . In intra bony defects around teeth;
• . For treatment of recession defects, together with coronally positioned flap;
• . In furcation defects in multi-rooted teeth.

FortaGen Oral Membrane consists of a multi-laminate sheet predominantly of Type I porcine collagen. The device is supplied hydrated in sheet form in sizes ranging from 13 mm x 25 mm to 40 mm x 50 mm in sterile double layer peelable packaging.

The provided text describes a 510(k) premarket notification for the FortaGen Oral Membrane. This document focuses on demonstrating substantial equivalence to pre-existing devices rather than outlining specific acceptance criteria and a detailed study proving performance against those criteria.

Therefore, many of the requested sections (Table of acceptance criteria, sample size for test set, number of experts for ground truth, adjudication method, MRMC study, sample size for training set, ground truth for training set) cannot be fully addressed from the provided text.

Here's an analysis based on the available information:

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

The document does not explicitly state a table of acceptance criteria with numerical targets. Instead, it relies on demonstrating "substantial equivalence" to predicate devices based on technological characteristics and performance data. The reported "performance" is qualitative, asserting similarity to existing devices.

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 describe a specific "test set" in the context of a clinical study with a defined sample size. The substantial equivalence argument appears to be based on pre-clinical data (biocompatibility) and material characteristics, implicitly compared against established knowledge of the predicate devices. No information on data provenance (country of origin, retrospective/prospective) is provided in relation to a formal test set.

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 document does not describe a clinical study with a "test set" requiring expert-established ground truth. The demonstration of equivalence primarily relies on material science and manufacturing process attributes, and general biological function.

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

Not applicable, as no described test set requiring adjudication is present.

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 resorbable dental barrier membrane, not an AI software or diagnostic imaging device that would involve human readers or AI assistance.

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

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

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

The "ground truth" for the FortaGen Oral Membrane appears to be based on:

• Material properties and composition: Verified through standard material characterization tests to confirm it's primarily Type I porcine collagen.
• Biocompatibility: Demonstrated through standard biocompatibility testing methods (likely in-vitro and/or in-vivo animal studies, although specific details are not provided in this summary).
• Resorption profile: Assessed through in-vitro or in-vivo studies (likely animal models) to determine the timeframe for resorption.
• Handling characteristics: Likely evaluated during manufacturing and potentially in pre-clinical settings.
  The "truth" is that these characteristics are "substantially equivalent" to predicate devices, which are already accepted as safe and effective.

8. The sample size for the training set

Not applicable. This refers to training data for algorithms, which is not relevant for this physical device.

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

Not applicable. This refers to ground truth for training data for algorithms, which is not relevant for this physical device.

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The FortaDerm™ Antimicrobial PHMB Wound Dressing is intended for the management of wounds and as an effective barrier to resist microbial colonization within the dressing and reduce microbes penetrating through the dressing. FortaDerm™ Antimicrobial PHMB Wound Dressing may be used for the management of: partial and full thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, and skin tears) and draining wounds.

The device is intended for one-time use.

FortaDerm™ Antimicrobial PHMB Wound Dressing consists of two layers, crosslinked sheet of fenestrated sheet of porcine intestinal collagen coated with 0.1 % Polyhexamethylene Biguanide hydrochloride (PHMB). FortaDerm Wound Dressing is supplied dry in sheet form in sizes ranging from 4 x 4 cm to 12 x 36 cm. The device is packaged in sterile, sealed single pouches.

This 510(k) summary (K051647) describes the FortaDerm™ Antimicrobial PHMB Wound Dressing. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than independent performance claims against specific acceptance criteria. Therefore, much of the requested information regarding a formal study with detailed acceptance criteria, sample sizes, expert involvement, and statistical analysis is not provided in this document.

However, based on the available text, here's what can be extracted:

Acceptance Criteria and Reported Device Performance

Study Details

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

   • Sample Size: Not specified.
   • Data Provenance: Not specified, but likely from in-vitro and/or in-vivo laboratory tests given the nature of the device and testing categories (biocompatibility, performance). It is not stated if this was retrospective or prospective data.

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

   • Number of Experts: Not applicable/not specified. The testing described (biocompatibility, performance) implies laboratory assessments against predetermined standards or methods rather than expert consensus on a 'ground truth' in a clinical diagnostic sense.
   • Qualifications of Experts: Not applicable/not specified.

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

   • Adjudication Method: Not applicable. This type of adjudication is typically used in clinical studies involving interpretation of data by multiple readers, which is not described here.

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:

   • MRMC Study: No. This device is a wound dressing, not an AI-assisted diagnostic tool.

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

   • Standalone Performance: Not applicable. This device is a physical wound dressing, not an algorithm.

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

   • Type of Ground Truth: For "biocompatibility" and "performance" tests, the "ground truth" would be the predefined pass/fail criteria or standards for those specific tests (e.g., ISO standards for biocompatibility, or specific laboratory protocols for antimicrobial efficacy or barrier properties). The document does not detail these specific standards.

7. The sample size for the training set:

   • Sample Size: Not applicable. This is not a machine learning device that requires a training set. The "testing" likely refers to validation against established physical and biological performance characteristics.

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

   • Ground Truth Establishment: Not applicable, as there is no training set for this device.

Summary based on the provided text:

The 510(k) submission for the FortaDerm™ Antimicrobial PHMB Wound Dressing primarily relies on demonstrating substantial equivalence to existing predicate devices (FortaDerm™ Wound Dressing K011026 and Xcell Antimicrobial Cellulose Wound Dressing K024054) in terms of intended use, technological characteristics, materials, and physical construction.

The only "performance data" mentioned is that the device underwent "a number of tests to assess biocompatibility and performance" and "passed the requirements of all tests." However, specific acceptance criteria for these tests, the methodology, sample sizes, or detailed results are not provided in this summary. This is typical for a 510(k) where detailed study reports are usually referenced but not fully included in the public-facing summary. The evaluation focuses on meeting general safety and performance standards for wound dressings, rather than specific quantitative metrics against a defined "ground truth" involving expert interpretation (as would be the case for a diagnostic AI).

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CuffPatch™ surgical mesh is intended for the reinforcement of soft tissues repaired by sutures or suture anchors, during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps or other tendons.

CuffPatch™ surgical mesh is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps quadriceps or other tendons. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the tissue to the bone, provide biomechanical strength for the tendon repair. CuffPatch™ surgical mesh reinforces soft tissue and provides a resorbable scaffold that is replaced by the patient's own soft tissue.

CuffPatch™ consists of laminated sheets of porcine intestinal collagen matrix is primarily Type I porcine collagen, and is free of cells and cell remnants. The product is supplied sterile in doublelayered peelable packaging.

The provided text describes a 510(k) summary for a medical device called CuffPatch™ Surgical Mesh. It does not contain information about acceptance criteria for a study or a study that proves the device meets such criteria in the way typically expected for an AI/ML device.

Instead, the document details the device's intended use, classification, description, and claims of substantial equivalence to legally marketed predicate devices. The "Performance Data" section briefly states that "Evaluation of the device's materials, physical and performance characteristics revealed that CuffPatch™ is substantially equivalent to the predicate devices, and is suitable for its intended clinical applications." This indicates an assessment was made, but the specific acceptance criteria and the detailed study results are not provided.

Therefore, most of the requested information cannot be extracted from this document, as it outlines a regulatory submission based on substantial equivalence, not a detailed performance study with explicit acceptance criteria.

However, I can extract what is implied about the performance assessment rather than explicit acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the document as a 510(k) summary for a conventional medical device (surgical mesh), it does not address AI/ML-specific testing methodologies. Therefore, the following points cannot be answered:

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

• Not applicable/Not provided. The document describes a "Performance Data" section but does not detail a study involving test sets in the context of data-driven performance.

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/Not provided. No ground truth establishment by experts for a test set is mentioned.

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

• Not applicable/Not provided.

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/Not provided. This is a conventional medical device, not an AI/ML diagnostic tool.

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

• Not applicable/Not provided. This is a conventional medical device.

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

• Not applicable/Not provided. The performance assessment was based on comparing material, physical, performance, and biological characteristics to existing predicate devices, rather than a clinical ground truth in the context of an AI/ML model.

8. The sample size for the training set

• Not applicable/Not provided. No training set is relevant for this conventional device.

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

• Not applicable/Not provided. No training set is relevant for this conventional device.

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FortaPerm™ is intended for implantation to reinforce and support soft tissue where weakness exists including, but not limited to the following procedures: pubourethral support, prolapse repair (urethral, vaginal, rectal and colon), reconstruction of the pelvic floor, bladder support, sacrocolposuspension, reconstructive procedures and tissue repair. By providing pubourethral support, FortaPerm may be used for the treatment of urinary incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency. The device is intended for one-time use.

Forta Perm consists of a multi-laminate sheet predominantly of Type I porcine collagen. The device is supplied in sheet form in sizes ranging from 2 x 5 cm to 12 x 36 cm in sterile double laye packaging.

The submitter, Organogenesis Inc., provided limited information regarding the performance data for FortaPerm™ Surgical Mesh. The application states, "FortaPerm was subjected to a panel of tests to assess biocompatibility, integrity, and performance. The device passed the requirements of all tests."

However, specific acceptance criteria and detailed quantitative results of these tests are not explicitly stated in the provided documents. The information is very general and does not allow for a comprehensive breakdown as requested.

Here's what can be extracted and what cannot:

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

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: Not specified.
• Data Provenance: Not specified (e.g. country of origin, 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 as this is a medical device (surgical mesh), not an AI/imaging device requiring expert ground truth for interpretation of results. The "ground truth" would likely be laboratory or animal model assessments of material performance and biocompatibility.

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

• Not applicable for this type of device performance 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 is not an AI-assisted device.

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

• Not applicable. This is not an AI/algorithm-based device.

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

• The "ground truth" for this device would be established by standard scientific and engineering methodologies for evaluating biocompatibility, integrity, and performance of surgical mesh biomaterials (e.g., in vitro mechanical testing, biocompatibility assays, animal implantation studies). Specific details are not provided in the document.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device requiring a training set.

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

• Not applicable. This is not an AI/machine learning device.

Summary of Study (Based on Provided Information):

The submission states that FortaPerm™ was subjected to a "panel of tests to assess biocompatibility, integrity, and performance" and "The device passed the requirements of all tests." No further details on the specific tests, their methodologies, sample sizes, or quantitative results are provided in the excerpt. The substantial equivalence claim is based on its similarity to predicate devices (GraftPatch and Surgisis Sling) in terms of intended use, technological characteristics, materials, physical construction, and performance.

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FortaGen is intended to be used for implantation to reinforce soft tissue including, but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, rectal and vaginal prolapse, reconstruction of the pelvic floor, hernias, suture-line reinforcement and reconstructive procedures. The device is intended for one-time use.

FortaGen consists of a multi-laminate sheet predominantly of Type I porcine collagen. The device is supplied in sheet form in sizes ranging from 5 x 5 cm to 12 x 36 cm in sterile double layer peelable packaging.

The provided text describes a medical device called FortaGen™ Surgical Mesh and its clearance by the FDA based on substantial equivalence to predicate devices. However, the information provided does not contain details about specific acceptance criteria, a study proving the device meets those criteria, or a detailed breakdown of performance data against specific metrics.

The document states:

• "FortaGen was subjected to a panel of tests to assess biocompatibility, integrity, and performance. The device passed the requirements of all tests." This is a general statement that tests were conducted and passed, but no specific criteria, results, or study details are provided.
• The FDA letter confirms that the device is "substantially equivalent" to legally marketed predicate devices, which implies that it meets the safety and efficacy standards demonstrated by those predicates. However, it doesn't detail what specific performance metrics constitute substantial equivalence or how FortaGen™'s performance was directly compared against them in a structured study report.

Therefore, I cannot populate the requested table or answer most of the specific questions about the study design as the information is not present in the provided text.

Based on the available information, here's what can be extracted:

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

   Acceptance Criteria	Reported Device Performance
   Biocompatibility requirements	Device passed all tests
   Integrity requirements	Device passed all tests
   Performance requirements	Device passed all tests
   Substantial Equivalence to predicate devices (GraftPatch (K970561) and Surgisis (K980431))	Determined to be substantially equivalent by FDA

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

   • Sample Size: Not specified.
   • Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document only states "FortaGen was subjected to a panel of tests."

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

   • Not specified. The document does not describe a process involving experts establishing ground truth for a test set. This type of information is typically relevant for diagnostic devices or AI-assisted systems, which this surgical mesh is not.

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

   • Not applicable/Not specified. Adjudication methods are typically used in clinical studies with human interpretation, which is not described here for the device's technical assessment.

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-assisted diagnostic or imaging device. Therefore, an MRMC study comparing human readers with/without AI assistance would not be performed for this product.

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

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

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

   • For the device's performance tests (biocompatibility, integrity, performance), the ground truth would be established by validated test methods and established standards/specifications for medical devices, rather than expert consensus on diagnostic images or pathology. The document does not specify the exact methods or standards used for these tests.

8. The sample size for the training set:

   • Not applicable. This is a physical surgical mesh, not an AI model that requires a training set.

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

   • Not applicable. This is a physical surgical mesh, not an AI model.

In summary, the provided text indicates that the FortaGen™ Surgical Mesh passed a panel of tests for biocompatibility, integrity, and performance and was deemed substantially equivalent to predicate devices by the FDA. However, it does not offer the granular detail requested about specific acceptance criteria values, study designs, sample sizes, or methods for establishing ground truth, which are more typically provided for diagnostic devices or those involving interpretation of data.

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FortaFlex™ Surgical Mesh is intended to be used for implantation to reinforce soft tissue including, but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, rectal and vaginal prolapse, reconstruction of the pelvic floor, hernias, suture-line reinforcement and reconstructive procedures. The device is also intended for reinforcement of the soft tissues which are repaired by suture or sutere anchors, limited to the supraspinatus, during rotator cuff repair surgery. The device is intended for one-time use.

FortaFlex Surgical Mesh consists of a multi-laminate sheet predominantly of Type I porcine collagen. The device is supplied in sheet form in sizes ranging from 5 x 5 cm to 12 x 36 cm in sterile double layer peelable packaging.

The provided text describes the FortaFlex™ Surgical Mesh, a Class II device intended for soft tissue reinforcement. The submission is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to legally marketed predicate devices, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria and performance metrics.

Therefore, the document does not contain the information requested regarding acceptance criteria, a study proving device meets acceptance criteria, sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

The "Performance Data" section merely states: "FortaFlex Surgical Mesh was subjected to a panel of tests to assess biocompatibility, integrity, and performance. The device passed the requirements of all tests." This is a high-level statement without any specific details of the tests, their acceptance criteria, or the actual results.

The 510(k) process focuses on demonstrating similarity to an already approved device. The FDA's letter confirms substantial equivalence, which means they believe the new device is as safe and effective as the predicate device(s) for the stated indications, based on similar technological characteristics, materials, and intended use as presented in the submission. It does not involve proving the device meets specific new performance acceptance criteria through the kind of study described in the prompt.

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The GraftPatch® is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists.

GraftPatch® is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists, e.g., hernia repairs. The device is composed of heat-laminated layers of crosslinked porcine collagen. GraftPatch® is similar in design, materials, function, and intended use to other surgical meshes which are currently in U.S. commercial distribution.

The provided 510(k) summary for the GraftPatch® device does not contain specific acceptance criteria or a detailed study description in the way one might expect for a diagnostic or AI-driven device. This submission focuses on establishing substantial equivalence to predicate surgical meshes.

Therefore, many of the requested data points (such as acceptance criteria tables, sample sizes, expert qualifications, and AI-specific study details) are not explicitly present in the provided text.

Here's an attempt to answer the questions based on the available information:

1. 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 submission mentions "Animal implant studies" and "Biocompatibility testing." However:

• Sample Size: Not specified for any of the studies mentioned.
• Data Provenance: Not specified (e.g., country of origin). The studies appear to be pre-market internal testing.
• Retrospective or Prospective: These would likely be considered prospective studies designed to support the 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 device is a surgical mesh, not an diagnostic imaging device. "Ground truth" in the context of expert consensus for diagnostic interpretation is irrelevant here. The studies involved animal model evaluations and material biocompatibility testing. The "experts" would be the scientists and veterinarians conducting and evaluating these technical studies. Their specific number and qualifications are not listed in the 510(k) summary.

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

Not applicable. This concept is typically relevant for studies involving human interpretation (e.g., radiology reads) where discrepancies need to be resolved. For animal implant and biocompatibility studies, the evaluation would follow established scientific and regulatory protocols for data collection and interpretation.

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 and does not involve AI or human readers for diagnostic interpretation. Therefore, an MRMC comparative effectiveness study is not relevant.

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

Not applicable. This device does not involve any algorithm or AI.

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

For the studies mentioned:

• Animal Implant Studies: The "ground truth" would be determined by direct observation in the animal models, potentially histology/pathology of explanted tissues, and clinical signs of the animals over time.
• Biocompatibility Testing: The "ground truth" for biocompatibility is established by the results of standardized tests conforming to Tripartite and ISO 10993 recommendations (e.g., cell viability, irritation scores, immunological responses).

8. The sample size for the training set

Not applicable as this is not an AI/ML device.

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

Not applicable as this is not an AI/ML device.

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