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The Biomerix Composite Surgical Mesh is intended for repair and/or reinforcement of soft tissues where weakness exists in plastic and reconstructive surgery.

Biomerix Composite Surgical Mesh is a non-absorbable porous polymer scaffold (polycarbonate polyurethane urea) incorporating knitted polypropylene monofilament fibers.

Here's a breakdown of the acceptance criteria and the study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document does not specify the exact sample sizes for the material testing, bench testing, biocompatibility testing, or animal testing. It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective) for any of these tests.

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

This information is not applicable and not provided in the document. The studies described are focused on material, mechanical, and biological properties of the device, not on diagnostic or clinical interpretation by human experts.

4. Adjudication Method for the Test Set

This information is not applicable and not provided in the document, as the studies are not based on human interpretation or consensus.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable and not provided in the document. The device is a surgical mesh, not an AI-assisted diagnostic tool.

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

This information is not applicable and not provided in the document. The device is a physical surgical implant, not an algorithm.

7. The type of ground truth used

• Material Properties: The ground truth would be established by industry standards and engineering specifications for material strength, elasticity, porosity, etc.
• Device Performance (Bench Testing): The ground truth would be established by the device's pre-defined performance specifications (e.g., tensile strength, burst strength, suture retention strength as relevant for a surgical mesh).
• Biocompatibility: The ground truth is established by the criteria outlined in ISO 10993-1 standards (e.g., absence of cytotoxicity, sensitization, irritation).
• In-vivo Response (Animal Testing): The ground truth is established through histological examination and expert pathology assessment for parameters like tissue integration, foreign body response, and degradation, relative to expected normal healing and established safety benchmarks for implantable materials.

8. The Sample Size for the Training Set

This information is not applicable and not provided in the document. The device is a physical product, not an AI model that requires a training set.

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

This information is not applicable and not provided in the document.

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Biomerix ASSURE™ is intended for repair and/or reinforcement of soft tissues where weakness exists in plastic and reconstructive surgery. The resorbable protective film minimizes tissue attachment to the device.

Biomerix ASSURE is a sterile, composite mesh comprised of three layers: 1) a thin sheet of the Biomerix Biomaterial™, 2) a layer of knitted polypropylene monofilament fibers and 3) a resorbable lactide-caprolactone film.
The resorbable film separates the permanent mesh from underlying tissues and organ surfaces, and it is designed to minimize the risk of tissue attachment to the device during the wound healing period.
ASSURE is provided sterile for single use and is available as individually packaged thin sheets in various shapes and sizes.

The medical device in question is the Biomerix ASSURE™ Polymeric Surgical Mesh. The provided text describes the 510(k) summary for this device, which focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria in a clinical study.

Here's an analysis of the provided information concerning acceptance criteria and study details:

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

Based on the provided text, specific quantitative acceptance criteria (e.g., minimum tensile strength, specific rates of tissue attachment) are not explicitly stated in a numerical or categorical format with corresponding reported device performance values. Instead, the performance data section generally mentions:

Table: Performance Data Summary

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

• Test Set Sample Size: Not specified for any of the tests (material, bench, biocompatibility, or animal).
• Data Provenance: Not specified for any of the tests. The text does not indicate country of origin or whether the data 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)

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

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

• Adjudication Method: Not specified. This typically applies to clinical studies involving human interpretation or assessment, which is not described here.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. The device is a surgical mesh, not an AI-powered diagnostic or assistive tool for human readers. Therefore, there is no mention of human reader improvement with or without AI.

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

• Standalone Performance: Not applicable. The device is a physical surgical mesh, not an algorithm.

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

• For material and bench testing, the ground truth would be the defined engineering specifications and regulatory standards (e.g., tensile strength, pore size, integrity).
• For biocompatibility testing, the ground truth is defined by the ISO 10993-1 standards and the biological responses observed in the tests.
• For animal testing, the "ground truth" for equivalence regarding tissue attachment and histological response would be the direct observation and histological examination of the tissue in the animal models, compared against the predicate device's known performance in similar animal models or historical data. This usually involves microscopic analysis by veterinary pathologists.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

• Ground Truth Establishment for Training Set: Not applicable, as there is no training set for this type of medical device.

Study Proving Acceptance Criteria:

The studies mentioned that "prove" the device meets the implied acceptance criteria are:

1. Material testing: Demonstrated suitable material properties.
2. Bench testing: Demonstrated the device meets performance specifications as manufactured.
3. Biocompatibility testing: Conducted according to ISO 10993-1, demonstrating biocompatibility.
4. Animal testing: Demonstrated equivalent performance to a predicate device in terms of minimizing tissue attachment and histological response.

The provided text clearly states, for each of these tests, that the results demonstrated the device met the specifications or was equivalent to the predicate, leading to the conclusion of substantial equivalence for 510(k) clearance. However, the specific, quantitative criteria and the detailed methodology of these studies are not elaborated in this summary.

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The Biomerix Ventral Hernia Repair Mesh is intended for the reconstruction of hernias and soft tissue deficiencies and for the temporary bridging of fascial defects. The resorbable protective film minimizes tissue attachment to the device in case of direct contact with the viscera.

The Biomerix Ventral Hernia Repair Mesh is a sterile, composite mesh comprised of three layers: 1) a thin sheet of the Biomerix Biomaterial™, 2) a layer of knitted polypropylene monofilament fibers and 3) a resorbable lactide-caprolactone film. The resorbable film separates the permanent mesh from underlying tissues and organ surfaces, and it is designed to minimize the risk of a tissue attachment to the device during the wound healing period. The Biomerix Ventral Hernia Repair Mesh is provided sterile for single use and is available as individually packaged thin sheets in various shapes and sizes.

The Biomerix Ventral Hernia Repair Mesh is a medical device, and the provided text describes its acceptance criteria and the studies performed to demonstrate its substantial equivalence to predicate devices, rather than a study proving the device meets specific performance criteria as would be typical for an AI/software device. Therefore, a direct mapping to the requested table and sections for AI/software is not fully possible. However, I will extract the relevant information from the document as best as the content allows.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a "test set" in the context of data for an AI/software device. The studies mentioned are:

• Bench testing: Involves physical testing of the mesh material. No data provenance or sample size for a "test set" is applicable in the AI sense.
• Biocompatibility testing: Involves evaluating the biological response to the material. No data provenance or sample size for a "test set" is applicable in the AI sense.
• Animal testing: Used to assess tissue attachment and histological response. The sample size for the animal study is not specified, nor is the "provenance" in the geographical sense. It is a prospective study using animal models.

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

This information is not applicable as the device is a physical surgical mesh, not an AI/software device that relies on expert interpretation for its ground truth.

4. Adjudication Method for the Test Set

This information is not applicable for a physical medical device. The "ground truth" for the performance of this device is established through objective physical, chemical, biological, and animal model testing.

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

This is not applicable as the device is a physical surgical mesh, not an AI/software device intended to assist human readers.

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

This is not applicable as the device is a physical surgical mesh, not an AI algorithm. Its performance is inherent to the material and design.

7. The Type of Ground Truth Used

For this physical device, the "ground truth" for its performance is established by:

• Bench test specifications: Objective engineering and material properties.
• ISO 10993-1 standards: Objective biological safety criteria.
• Comparative animal study results: Histological and tissue attachment observations in animal models, compared to a predicate device.

8. The Sample Size for the Training Set

This is not applicable as the device is a physical surgical mesh and does not involve AI model training.

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

This is not applicable as the device is a physical surgical mesh and does not involve AI model training.

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Biomerix Composite Surgical Mesh is intended to assist in the repair and/or reinforcement of hernia and other soft tissue defects requiring additional support of a nonabsorbable implant during and after wound healing.

Biomerix Composite Surgical Mesh is a non-absorbable porous polymer scaffold (polycarbonate polyurethane urea) incorporating knitted polypropylene monofilament fibers.

The provided text describes the Biomerix Composite Surgical Mesh, a medical device, and its journey through FDA 510(k) clearance. However, the document does not contain information about "acceptance criteria" in the format of specific performance metrics (e.g., sensitivity, specificity, accuracy) or details about a study designed to prove the device meets these criteria in the context of an AI-powered diagnostic or decision support system.

The content focuses on demonstrating substantial equivalence to predicate devices through various tests relevant to a surgical mesh, rather than the performance of a software algorithm.

Here's a breakdown of the available information given the context of the provided text, and where specific requested information is missing:

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

• Acceptance Criteria: Not explicitly stated as quantifiable performance metrics (e.g., sensitivity, specificity, or specific thresholds for biomechanical properties). The acceptance criteria are broadly implied by the tests performed to establish substantial equivalence.
• Reported Device Performance:

  Test Category	Performance Outcome
  Material Testing	Demonstrates material properties are suitable for intended use.
  Bench Testing	Demonstrates that manufactured devices meet performance specifications. Test results show the device meets specifications and is acceptable for clinical use.
  Biocompatibility Testing	Performed per ISO 10993-1. Demonstrates the material is safe and biostable.
  Animal Testing	Exhibits a well-tolerated long-term histomorphologic response with good integration, minimal foreign body response, and no evidence of device degradation or adjacent tissue necrosis.

2. Sample size 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. The document refers to "material testing," "bench testing," "biocompatibility testing," and "animal testing" but does not provide specific sample sizes for these tests.
• Data Provenance: Not specified. The studies are described as lab-based (material, bench, biocompatibility) and animal studies. There is no mention of human clinical data or its provenance.

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)

• Number of Experts & Qualifications: Not applicable/not specified. The "ground truth" for a surgical mesh involves physical, chemical, and biological properties, not a diagnostic interpretation by human experts. The assessment of animal study results would likely be done by veterinary pathologists or similar experts, but the number and qualifications are not detailed.

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

• Adjudication Method: Not applicable/not specified. This concept typically applies to the resolution of discrepant readings in medical image analysis or similar diagnostic tasks, which is not the focus of this device's 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

• MRMC Study: No. This is a surgical mesh, not an AI-powered diagnostic device. Therefore, a MRMC comparative effectiveness study involving human readers and AI assistance is not relevant and was not performed.

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

• Standalone Performance: Not applicable. This device is a physical surgical mesh, not an algorithm or software.

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

• Type of Ground Truth: The "ground truth" for this device's performance would be established through:
  • Physical/Chemical Standards: For material and bench testing (e.g., tensile strength, pore size, degradation rate under specific conditions).
  • Biological Standards/Pathology: For biocompatibility and animal testing (e.g., tissue integration, foreign body response, inflammation levels assessed via histopathology).
  • ISO Standards: For biocompatibility (ISO 10993-1).

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

• Ground Truth Establishment for Training Set: Not applicable. As there is no AI/machine learning component, there is no training set or associated ground truth.

Summary:

The provided 510(k) summary for the Biomerix Composite Surgical Mesh details the regulatory pathway for a conventional medical device (surgical mesh) by demonstrating substantial equivalence to predicate devices. The performance data presented consists of material, bench, biocompatibility, and animal testing results, all aimed at proving the safety and effectiveness of the physical implant. The questions about AI, algorithms, expert consensus, and reader studies are not relevant to this type of device or the information contained in this 510(k) document.

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The Biomerix Surgical Mesh is intended for the reinforcement of the soft tissues which are repaired by suture or suture anchors during rotator cuff repair surgery.

The mesh is not intended to replace normal body structure or provide full mechanical strength to support the rotator cuff. Sutures used to repair the tear, and sutures or bone anchor systems used to attach the tissue to the bone, provide mechanical strength for tendon repair.

The Biomerix Surgical Mesh is a non-absorbable mesh manufactured from a polycarbonate polyurethane-urea matrix and standard polyester suture. The Biomerix Surgical Mesh is provided sterile for single use.

The provided text describes a 510(k) summary for the Biomerix Surgical Mesh, which is a medical device. This type of regulatory submission typically focuses on demonstrating "substantial equivalence" to existing legally marketed devices, rather than establishing specific acceptance criteria and proving performance against them in the same way one might for a novel diagnostic AI algorithm.

Therefore, the information required to populate the requested table and study details (like sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance of an algorithm) is not present in the provided document. The document details the device's physical and biological characteristics and compares them to predicate devices.

Here's a breakdown of why the requested information cannot be extracted from the given text:

1. Nature of the Device: The Biomerix Surgical Mesh is a physical implant (a non-absorbable mesh). It's not an AI/ML diagnostic or predictive algorithm. Therefore, concepts like "acceptance criteria" based on metrics like sensitivity, specificity, accuracy, or AUC, and studies involving "test sets," "training sets," "ground truth established by experts," "adjudication methods," "MRMC studies," or "standalone (algorithm only) performance" are not applicable to this type of device.

2. Regulatory Pathway (510(k)): A 510(k) submission establishes substantial equivalence. This means the manufacturer shows their device is as safe and effective as a legally marketed predicate device. The performance data section focuses on material testing, bench testing, biocompatibility, and animal testing to demonstrate the material properties and functionality are suitable and comparable to predicates, not that an algorithm performs against a diagnostic criterion.

Based on the provided text, the requested information is not available.

However, I can extract the closest information related to performance and testing:

Acceptance Criteria and Device Performance (Not applicable in the typical AI/ML sense)

Study Details (Again, not in the context of an AI/ML algorithm)

1. Sample size used for the test set and the data provenance: Not applicable. The "tests" were material, bench, and animal studies. Specific sample sizes and provenance for these different types of non-human studies are not detailed.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The ground truth (e.g., successful ingrowth, mechanical reinforcement, biocompatibility) would be established by standard methods in materials science, biomechanics, and toxicology, reported and interpreted by the relevant scientific and engineering personnel conducting the tests. Expert consensus for interpreting medical images is not relevant here.
3. Adjudication method for the test set: Not applicable.
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: Not applicable, as this is not an AI/ML diagnostic device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used:
   • Material properties: Measured values from physical and chemical tests.
   • Bench performance: Engineering specifications and measured performance data.
   • Biocompatibility: ISO 10993-1 standards and experimental results (e.g., cytotoxicity, sensitization, irritation, implantation effects).
   • Animal studies: Histological analysis, mechanical testing of repaired tissue, gross observations from animal models, compared to surgical controls.
7. The sample size for the training set: Not applicable. This device does not have a "training set" in the machine learning sense.
8. How the ground truth for the training set was established: Not applicable.

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The Biomerix Vascular Occlusion Device is intended for arterial and venous embolization in the peripheral vasculature.

The Biomerix Vascular Occlusion Device is a cylindrical device made from polycarbonate-urethane. The length of the implant is 15 mm, and it is available in diameters of 4, 6, and 8 mm. The Biomerix Vascular Occlusion Device is provided sterile for single use in its uncompressed state. The device is compressed and delivered to the target location through a commercially available peripheral introducer (5-7 F). A Loader is provided to assist with introducing the implant into the delivery catheter.

The provided text describes the Biomerix Vascular Occlusion Device but does not contain the specific acceptance criteria or a detailed study proving the device meets those criteria in a format that would allow for a precise response to all parts of your request.

Here's an analysis of what information can be extracted and what is missing:

Information Present in the Document:

• Intended Use: The device is "intended for arterial and venous embolization in the peripheral vasculature." This is a key part of what any performance study would need to address.
• Performance Data Overview: The document lists general categories of performance data collected:
  • Material testing to demonstrate suitable material properties.
  • Bench testing to demonstrate the device meets performance specifications for loading, deliverability, and recovery.
  • Biocompatibility testing to demonstrate safety and biostability.
  • Animal testing to demonstrate equivalent performance to Cook Embolization Coils in terms of "time to occlusion, migration, recanalization, and tissue response."

Missing Information (Crucial for a complete answer to your request):

• Specific Acceptance Criteria: The document mentions "performance specifications" for bench testing and "equivalent performance" for animal testing, but it does not quantify these. For example, it doesn't state:
  • What is the specified loading force?
  • What is the acceptable delivery time or force?
  • What is the defined "time to occlusion" in animal studies (e.g., 95% occlusion within X minutes/hours)?
  • What are the acceptable limits for migration or recanalization?
  • What are the specific parameters for "tissue response"?
• Detailed Study Design and Results: The document summarizes that studies were done but lacks the specifics required for your numbered points.

Based on the provided text, here is the information that can be extracted, and where information is missing:

(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)

• Sample Size (Test Set): Not specified.
• Data Provenance: Not specified (studies are generally described as "Material testing," "Bench testing," "Biocompatibility testing," and "Animal testing" without country of origin or retrospective/prospective designation for the animal model).

(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 specified, as this appears to be a medical device performance (mechanical, biological, and animal model) study, not a diagnostic AI study requiring expert adjudication of images.

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

• Not applicable/Not specified, as this appears to be a medical device performance study, not a diagnostic AI study requiring expert adjudication of images.

(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

• No. This study is focused on the physical and biological performance of a vascular occlusion device, not on AI assistance for human readers of medical images.

(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 consensus, pathology, outcomes data, etc)

• For animal testing, the ground truth appears to be direct observation of physiological parameters (time to occlusion, migration, recanalization) and potentially histological examination for tissue response comparison against the predicate device.
• For bench testing, the ground truth would be engineering specifications and measurements.
• For biocompatibility, the ground truth would be established biological safety standards and in-vitro/in-vivo test results.

(8) The sample size for the training set

• Not applicable. This is a physical medical device, not an AI algorithm requiring a training set.

(9) How the ground truth for the training set was established

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

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