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Cytal® Wound Matrix is intended for the management of wounds including: partial and full thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunnel/undermined wounds (donor sites/grafts, post-Mohs surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, and skin tears), and draining wounds. The device is intended for one-time use.

Cytal® Burn Matrix is intended for the management of wounds including: second-degree burns, partial and full thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, tunnel/undermined woundermined wounds, surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, and skin tears), and draining wounds. The device is intended for one-time use.

The UBM devices are composed of a resorbable porcine-derived extracellular matrix (ECM) scaffolds, containing epithelial basement membrane, known as urinary bladder matrix (UBM). Cytal devices are supplied in single or multi-layer sheet configurations (1 to 6 layers) in sizes up to 10 cm x 15 cm (1-, 2, and 6-Layer, K152721) or 16 x 35 cm (3-Layer, K192725). Cytal sheets are provided with fenestrations in both lyophilized (1- and 2-Layer) and vacuum pressed (3- and 6-Layer) configurations. The devices are packaged in double peel-open pouches. The devices are terminally sterilized using electron beam irradiation and are intended for one-time use. UBM devices are pre-hydrated with sterile saline and applied to the wound. The devices can be cut to size and/or used in conjunction with other extracellular matrix derived scaffolds indicated for wound management, such as MicroMatrix® UBM Particulate. The devices are sloughed from the skin during the normal wound healing process or are incorporated (remodeled) into the wound bed via enzymatic degradation, cellular infiltration, capillary growth, and/or integration by the surrounding host tissue.

The provided text is a 510(k) summary for ACell, Inc.'s Cytal® Wound Matrix and Cytal® Burn Matrix devices. It describes modifications to an existing device rather than a new device requiring extensive clinical trials to prove effectiveness. Therefore, the information about acceptance criteria and studies largely focuses on bench testing to demonstrate that the modified device remains substantially equivalent to its predicates.

Here's a breakdown of the requested information based on the provided text:

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

The document does not explicitly state numerical acceptance criteria for each test. Instead, it provides a general "Meets Acceptance Criteria" for each performance benchmark.

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

The document does not specify the sample size used for each bench test. Given that these are bench tests for product modification, the data provenance is assumed to be from ACell, Inc.'s internal testing labs, likely in the US, and is prospective, as it's conducted to support a new submission.

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)

This information is not applicable. The studies mentioned are bench tests evaluating physical and material properties of the device, not clinical performance requiring expert ground truth or assessment.

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

This information is not applicable, as there is no mention of a test set requiring adjudication in a clinical or diagnostic context.

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 MRMC comparative effectiveness study was done. The document explicitly states: "No clinical studies were required as appropriate verification of the subject devices was achieved based on the comparison to the predicate devices and from the results of the bench testing and engineering analysis."

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

No standalone performance study of an algorithm was done. This device is a physical medical device (wound matrix), not an AI/software as a medical device.

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

This information is not applicable in the context of the bench tests performed. The "ground truth" for these tests would be established by validated measurement standards and physical/chemical analytical methods, not clinical expert consensus, pathology, or outcomes data.

8. The sample size for the training set

The concept of a "training set" is not applicable here as the device is not an AI/ML algorithm.

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

This information is not applicable.

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MicroMatrix® UBM Particulate is intended for the management of wounds including: partial and full thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunnel/undermined wounds, surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, and skin tears), and draining wounds. The device is intended for one-time use.

The subject device is composed of a resorbable porcine-derived extracellular matrix (ECM) scaffolds, specifically known as urinary bladder matrix (UBM). MicroMatrix devices are supplied as a dry, absorbent, white to off-white particulate with two particle size distributions, specifically

The provided text is related to an FDA 510(k) premarket notification for a medical device called MicroMatrix® UBM Particulate. This notification is for a device (a medical product), not an AI algorithm.

Therefore, many of the requested categories related to acceptance criteria and studies for AI algorithms (such as sample size for test/training sets, data provenance, ground truth establishment, expert qualifications, MRMC studies, and standalone performance) are not applicable to this document.

The document primarily focuses on demonstrating substantial equivalence to a predicate device based on nonclinical testing (bench tests) and that no animal or clinical studies were required.

Here's a breakdown of what can be extracted from the document:

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

The document lists "Performance Bench Test Results" and states that for each test, the device "Meets Acceptance Criteria." It does not provide the specific numerical acceptance criteria themselves, only the conclusion that they were met.

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: Not specified for the bench tests. The document only states "All testing was performed on production equivalent devices."
• Data Provenance: Not applicable/not specified. These are laboratory bench tests on physical devices, not clinical data.

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. Ground truth for AI algorithms is not relevant for physical device bench testing. The "ground truth" here is the established test methodology and the specifications the device is designed to meet, verified by laboratory personnel.

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

Not applicable. Adjudication methods are typically for resolving discrepancies in expert labeling or diagnoses in AI studies.

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 not an AI algorithm. No MRMC study was conducted.

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

Not applicable. This is not an AI algorithm.

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

Not applicable in the context of AI. For the bench tests, the "ground truth" relates to the predetermined specifications and standards that the device must meet, verified through objective measurements and observations in a laboratory setting. For example, particle size analysis would have a specified acceptable range, and the "ground truth" is whether the measured particle size falls within that range. Similarly, package integrity tests have defined parameters for success.

8. The sample size for the training set

Not applicable. This is not an AI algorithm.

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

Not applicable. This is not an AI algorithm.

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MicroMatrix® Flex is intended for the management of wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds (donor sites/grafts, post-Mohs surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, partial thickness burns, skin tears), and draining wounds. The device is intended for one-time use.

The MicroMatrix® Flex device is a dual-syringe system for the mixing and delivery of a paste for the management of wounds. The particulate component of the device is composed of porcine-derived extracellular matrix known as urinary bladder matrix. The particulate component is identical to that particulate in the predicate device, MicroMatrix® UBM Particulate (K172399), with the standard particle size of

The provided FDA 510(k) summary for the MicroMatrix® Flex device does not describe specific acceptance criteria in the typical sense of a diagnostic device (e.g., sensitivity, specificity, AUC). Instead, this submission focuses on demonstrating substantial equivalence to a predicate device (MicroMatrix® UBM Particulate) by showing that the new device has identical intended use, similar technological characteristics, and similar principles of operation, with minor differences not raising new safety or effectiveness issues.

The "acceptance criteria" here are therefore related to demonstrating that the new device performs equivalently to the predicate in various aspects.

Acceptance Criteria and Reported Device Performance

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The MatriStem UBM™ Pericardial Patch is intended for the reconstruction and repair of the pericardium.

The MatriStem UBM Pericardial Patch is a 4-layer multi-laminate device comprised of stacked urinary bladder matrix (UBM) sheets. The Pericardial Patch serves as a patch to reconstruct the pericardium and restore the native anatomy. The Pericardial Patch is available in three sizes: 7x10 cm, 7x15 cm, and 10x15 cm. Each device is packaged in a double peel-open pouch and an outer carton. The device is terminally sterilized using electron-beam irradiation.

This document describes the regulatory submission for the MatriStem UBM™ Pericardial Patch, a medical device intended for the reconstruction and repair of the pericardium. It is a 510(k) premarket notification, which means the manufacturer (ACell, Inc.) is seeking to demonstrate that their device is substantially equivalent to legally marketed predicate devices, and therefore does not require a full premarket approval (PMA).

The information provided covers bench testing and an animal study to support the substantial equivalence claim. However, it's important to note that this submission does not involve an AI/ML-based device and therefore the questions relating to AI-specific acceptance criteria, multi-reader multi-case studies, expert adjudication methods, and training/test set ground truth establishment for an AI algorithm are not applicable to this document. The device is a biological patch, not a diagnostic or prognostic AI tool.

Therefore, many of the requested items regarding AI/ML aspects will be answered as "Not Applicable" or "No" as the study described is for a physical medical device.

Here's the breakdown based on the provided text:

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

Since this is a physical medical device and not an AI model, the acceptance criteria are based on physical, chemical, and biological properties, and functionality in an in vivo model.

Note: Specific quantitative acceptance criteria for most bench tests are not provided in this public summary but are typically part of internal design control documentation and would have been submitted to the FDA. The document states "All acceptance criteria were met" for the animal study, indicating the successful completion of the pre-defined endpoints.

2. Sample sizes used for the test set and the data provenance

• Test Set Sample Size (Animal Study):

  • Total pigs: 12
  • Sham group (no repair): 2 pigs
  • ACell MatriStem UBM Pericardial Patch group: 5 pigs
  • Predicate CorMatrix Pericardial Patch group: 5 pigs

• Data Provenance: The study was a "90-day Good Laboratory Practices (GLP) animal study" performed in a porcine (pig) model. The country of origin is not specified but generally, GLP studies adhere to international standards. It is a prospective animal study designed to evaluate the device.

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

• Not Applicable (N/A) for an AI/ML context. This is a physical medical device.
• For the animal study, the ground truth was established through objective biological and physiological assessments:
  • Histology evaluation: Performed by pathologists.
  • Full necropsy examination: Performed by veterinary pathologists.
  • Echocardiography measurements: Performed by specialists in echocardiography (likely veterinary cardiologists or trained technicians).
  • The document implies that these assessments were performed by qualified personnel as part of a GLP study, but the specific number and qualifications of individuals are not detailed in this summary.

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

• N/A for an AI/ML context. This pertains to consensus among human readers for image interpretation, which is not relevant for this device.
• For the animal study, the "adjudication" of results would rely on standardized GLP protocols for sample collection, pathology, and data analysis to ensure consistency and objectivity. Any disagreements in interpretation (e.g., in histology slides) would typically be resolved by senior pathologists or consensus panels within the pathology group, but this is not an "adjudication method" in the AI sense.

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, an MRMC study was not done. This is a study for a physical implantable medical device, not an AI diagnostic/assistance tool.
• The comparative effectiveness was demonstrated by comparing the subject device to a predicate device and a sham in an animal model based on biological and physiological outcomes, not human reader performance.

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

• N/A. This is a physical medical device, not an algorithm.

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

• Pathology and Outcomes Data (from an animal model).
  • Histology evaluation: Provides microscopic ground truth on tissue response, cellular infiltration, and remodeling.
  • Full necropsy examination: Provides macroscopic ground truth on device integration and tissue health.
  • Echocardiography measurements: Provides functional ground truth on cardiac performance.
  • The "ground truth" for the device's performance in vivo was established by these objective biological and physiological assessments in directly implanted animals.

8. The sample size for the training set

• N/A. This is a physical medical device. There is no "training set" in the context of machine learning.
• The development process for this device would involve extensive internal research and development, materials characterization, and process optimization, but this does not constitute a "training set" for an AI model.

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

• N/A. As there is no AI training set, this question is not applicable.

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Cytal® Wound Matrix 3-Layer is intended for the management of wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunnel/undermined wounds, surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, and skin tears), and draining wounds. The device is intended for one-time use.

Cytal® Wound Matrix 3-Layer is composed of a resorbable, porcine-derived, extracellular matrix (ECM) scaffold containing epithelial basement membrane, specifically known as urinary bladder matrix (UBM). The devices are supplied in fenestrated sheet configurations up to 16 cm x 35 cm and packaged in double peel-open pouches. The devices are terminally sterilized using electron beam irradiation. Cytal Wound Matrix 3-Layer is pre-hydrated with sterile saline and applied to the wound. The device can be cut to different sizes. The device is intended for one time use.

The document provides information on the Cytal® Wound Matrix 3-Layer and its substantial equivalence to a predicate device. However, it does not describe acceptance criteria or a study proving that the device meets those criteria in the typical sense of a diagnostic or AI device performance study.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (ACell, Inc. Cytal® Wound Matrix (K152721)) for regulatory clearance. This involves showing that the new device has "the same intended uses and similar indications, technological characteristics, and principles of operation" and that minor differences "raise no new issues of safety or effectiveness."

Therefore, many of the requested categories for a diagnostic or AI device study are not applicable or not explicitly detailed in this type of submission.

Here's a breakdown based on the provided text, addressing your questions where information is available and noting where it is not:

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

The document does not explicitly state "acceptance criteria" for clinical performance in the way one might for a diagnostic device (e.g., sensitivity, specificity thresholds). Instead, the performance testing aimed to show that the device "met the clinically relevant user needs, design inputs, and specifications" and functioned "as intended," demonstrating substantial equivalence.

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: Not specified. The document refers to "bench testing" and "design validation testing" (clinician feedback and simulated use) but does not provide specific sample sizes for these tests.
• Data provenance: Not applicable in the context of clinical data for performance; this was bench and simulated use testing.

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)

• The document mentions "clinician feedback" for design validation. The number and qualifications of these clinicians are not specified.

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

• None specified. The document briefly mentions "clinician feedback" but does not detail any adjudication method for potential discrepancies or consensus building.

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, an MRMC study was NOT done. This type of study (comparative effectiveness, human readers, AI assistance) is relevant for diagnostic AI devices. The Cytal® Wound Matrix 3-Layer is a wound dressing, not an AI or diagnostic device, so this type of study is not applicable or performed in this context.

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

• Not applicable. As a wound matrix, there is no "algorithm only" performance to evaluate. The device's performance is inherent in its material properties and interaction with biological systems.

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

• For the technical performance aspects (suture retention, tensile, hydration, etc.), the "ground truth" would be established by engineering and material science standards and specifications.
• For "design validation" via clinician feedback and simulated use, the "ground truth" is implied to be clinician judgment regarding the device functioning as intended and meeting user needs. This is not equivalent to a clinical ground truth like pathology or patient outcomes.

8. The sample size for the training set

• Not applicable. Since this is not an AI/machine learning device, there is no "training set."

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

• Not applicable. There is no training set for this type of medical device.

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Gentrix® Surgical Matrix (3-layer) is intended for implantation to reinforce soft tissue where weakness exists in patients requiring urological, gastroenterological, or plastic & reconstructive surgery. Reinforcement of soft tissue within urological, gastroenterological, and plastic & reconstructive surgery includes, but is not limited to, the following open or laparoscopic procedures: hernia and body wall repair, colon and rectal prolapse repair, and esophageal repair. The Gentrix® Surgical Matrix (3-layer) minimizes tissue attachment to the device in case of direct contact with viscera.

Gentrix® Surgical Matrix and Gentrix® Surgical Matrix Hiatal (6-layer and 8-Layer) are intended for implantation to reinforce soft tissue where weakness exists in patients requiring gastroenterological or plastic & reconstructive surgery. Reinforcement of soft tissue within gastroenterological and plastic & reconstructive surgery includes, but is not limited to, the following open or laparoscopic procedures: hernia (e.g.: hiatal/diaphragmatic) and body wall repair, colon and rectal prolapse repair, tissue repair, and esophageal repair. The Gentrix® Surgical Matrix and Gentrix® Surgical Matrix Hiatal (6-layer and 8-Layer) minimizes tissue attachment to the device in case of direct contact with viscera.

Gentrix Surgical Matrix and Gentrix® Surgical Matrix Hiatal device configurations are composed of porcine-derived extracellular matrix scaffically known as urinary bladder matrix ("UBM"). The implantable biomaterial is a resorbable extracellular matrix scaffold that provides mechanical reinforcement of soft tissue and will incorporate (remodel) into the body through cellular infiltration, capillary growth, and integration by the surrounding host tissue (as demonstrated in porcine models of ventral and hiatal hernia), while minimizing tissue attachment to the device in case of direct contact with viscera (as demonstrated in a preclinical rabbit cecal abrasion model). The devices are supplied in multiple layered sheet configurations in sizes up to 10 cm x 15 cm, and are available in rectangular and u-shape variations. All device configurations are packaged in double peel-open sterile barrier system. The devices are terminally sterilized using electron beam irradiation. The devices are intended for one time use.

The document describes the Gentrix Surgical Matrix and Gentrix Surgical Matrix Hiatal devices. The acceptance criteria and the study that proves the device meets the acceptance criteria are primarily focused on demonstrating substantial equivalence to a predicate device and supporting the expanded indications for use.

Here's an analysis of the provided information based on your requested points:

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

The document does not explicitly state "acceptance criteria" in a quantitative, pre-defined manner typical for AI/ML device performance. Instead, it describes studies conducted to support the substantial equivalence and safety/effectiveness of the device for its intended use, particularly for new indications like laparoscopic use and specific hiatal/diaphragmatic hernia repair, and minimizing tissue attachment.

The closest to acceptance criteria and performance can be inferred from the animal studies on tissue attachment:

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

• Pre-clinical (Animal) Studies Data (Test Set):

  • Porcine Hiatal Hernia Model (U-shape design): 10 pigs. Prospective. Provenance not specified but typically conducted in controlled laboratory settings.
  • Porcine Hiatal Hernia Repair Model (laparoscopic and hiatal/diaphragmatic hernia indications): Number of animals not explicitly stated, but it conducted over a 60-day study duration. Prospective. Provenance not specified.
  • New Zealand White Rabbit Cecal Abrasion Model (tissue attachment): 6 animals per group (Control, GSM 3-Layer, GSM 6-Layer, GSM 8-Layer, Collagen Mesh Control) for Day 14 and Day 90. Total of 30 animals for each time point evaluation (assuming distinct animals for each time point or repeat measurements on same). Prospective. Provenance not specified.

• Clinical Data (Test Set - from literature review):

  • Retrospective Study 1 (Zografakis et al.): 62 patients. Retrospective. Provenance implied by the authors' affiliation if provided (not in this excerpt), likely US or Europe.
  • Retrospective Study 2 (Howell et al.): 121 patients (56 UBM group, 65 non-UBM group). Retrospective. Provenance implied by the authors' affiliation if provided.
  • Retrospective Study 3 (Sasse et al.): 15 patients. Retrospective. Provenance implied by the authors' affiliation if provided.
  • Retrospective Study 4 (Reznichenko): 1 single patient. Retrospective. Provenance implied by the authors' affiliation if provided.
  • Retrospective Study 5 (Reznichenko): 11 patients (4 reinforced with GSM). Retrospective. Rural community hospital setting, likely US.
  • Retrospective Study 6 (Wang, C.Q. et al.): 37 patients (22 reinforced with GSM, 15 non-reinforced). Retrospective. Poster presentation at a society meeting, likely US.

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)

• Pre-clinical Studies:

  • Porcine Hiatal Hernia Model: An independent clinical pathologist evaluated tissue morphology/health, considered "not clinically significant" the mild narrowing. Specific number of pathologists and their qualifications not stated, but "independent" implies objectivity.
  • Rabbit Cecal Abrasion Model & Porcine Hiatal Hernia Repair Model: The evaluation of attachments, herniation, erosion, trauma, and histological analysis would have been performed by trained personnel (e.g., veterinarians, pathologists). Specific numbers and qualifications are not detailed.

• Clinical Data (from literature):

  • The "ground truth" here is the clinical outcomes reported by the original study authors (surgeons, researchers).
  • Study 1: Single surgeon performing LHR.
  • Study 2: 3 surgeons performing PHH repair.
  • Study 3: Single surgeon performing LHR.
  • Study 4: Single retrospective case.
  • Study 5: Single surgeon performing LHR.
  • Study 6: Same surgeon performing PHH repair.
  • Qualifications of these surgeons are not provided in this summary, but they are implicitly qualified clinicians performing surgical procedures and assessing outcomes.

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

• Pre-clinical Studies: The document does not describe a formal multi-expert adjudication method (like 2+1 or 3+1). Decisions appear to be made by individual evaluators (e.g., "independent clinical pathologist").
• Clinical Data (from literature): Since these are summaries of published clinical studies, specific adjudication methods for their outcomes (e.g., recurrence, complications) were part of the original study designs. The summaries provided here do not detail such methods. Decisions on complications and recurrences were likely made by the treating physicians or study investigators.

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

There is no mention of an AI/ML device in this document. Therefore, no MRMC comparative effectiveness study involving AI assistance for human readers was conducted or reported. This application is for a surgical mesh device, not an AI diagnostic tool.

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

Applicable to AI/ML devices only. As stated above, this is not an AI/ML device, so no standalone algorithm performance was assessed.

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

• Pre-clinical (Animal) Studies:
  • Pathology: Macroscopic and microscopic histological analysis of tissues to assess remodeling, inflammation, and integration.
  • Direct Observation/Measurement: Assessment of herniation, esophageal erosion/trauma, and quantitative measurements of tissue attachments (percentage coverage, diameter, severity score), based on expert observation.
• Clinical Data (from literature):
  • Clinical Outcomes Data: Patient symptoms (shortness of breath, nausea, dysphagia, reflux), intraoperative/postoperative complications, reoperations, radiographic recurrence rates (contrast upper gastrointestinal series), endoscopic evaluations, BMI, HRQL scores, hospital length of stay, 30-day readmissions. These are derived from clinical practice and reported by the treating physicians/researchers.

8. The sample size for the training set

This is not an AI/ML device, so there is no concept of a "training set" in the context of machine learning model development. The document describes pre-clinical (animal) studies and a review of existing clinical data to support the safety and effectiveness of the device.

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

Not applicable, as this is not an AI/ML device and there is no training set mentioned.

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Cytal® Wound Particulate is intended for the management of wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunnel/undermined wounds, surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, and skin tears), and draining wounds. The device is intended for onetime use.

Cytal® Wound Particulate is composed of a resorbable, porcine-derived, extracellular matrix scaffold containing epithelial basement membrane, specifically known as Urinary Bladder Matrix (UBM). The devices are supplied as a dry, absorbent, white to off-white particulate sized

Here's a breakdown of the acceptance criteria and study information for the Cytal Wound Particulate, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a discrete table of acceptance criteria with specific numerical targets. Instead, it describes "performance testing" to address a size change and demonstrate substantial equivalence to a predicate device. The general acceptance criterion implied is that the device "functioned as intended and the results observed were as expected" for each test.

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

The document does not specify the sample sizes used for the "Performance Data" tests (Particle Size Characterization, Dispensing, Sterilization Validation, Endotoxin).

Data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin of the data mentioned. Given the nature of these tests (characterization, deployability, sterilization, endotoxin), they are typically conducted as part of the manufacturing and quality control process, likely at the manufacturer's facilities.

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

This information is not provided in the document. The tests described (e.g., particle size, endotoxin) are objective laboratory measurements, not typically requiring expert consensus for ground truth establishment in the same way clinical or diagnostic studies would.

4. Adjudication Method for the Test Set

This information is not applicable as the tests performed are objective laboratory measurements rather than assessments that would require adjudication among experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document describes performance testing related to product characteristics and manufacturing, not a clinical study involving human readers.

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

This question is not applicable as the device, Cytal Wound Particulate, is a medical device product (an animal-derived extracellular matrix scaffold for wound management), not an algorithm or AI system.

7. The Type of Ground Truth Used

For the described "Performance Data" (Particle Size Characterization, Dispensing, Sterilization Validation, Endotoxin), the "ground truth" would be objective laboratory measurements against established specifications or industry standards for each test. For example, for endotoxin, the ground truth would be the quantitative endotoxin level measured against a defined acceptable limit.

8. The Sample Size for the Training Set

This question is not applicable as the device is not an AI/ML-based system requiring a training set.

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

This question is not applicable as the device is not an AI/ML-based system.

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MicroMatrix® is intended for the management of wounds including; partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunnel/undermined wounds (donor sites/grafts, post-Mohs surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, and skin tears), and draining wounds. The device is intended for one-time use.

MicroMatrix® is composed of a resorbable, porcine-derived, extracellular matrix scaffold containing epithelial basement membrane, specifically known as Urinary Bladder Matrix ("UBM"). The devices are supplied as a dry, absorbent, white to off-white particulate with two particle distributions, specifically

The provided document is a 510(k) premarket notification for a medical device called MicroMatrix®. It describes the device, its intended use, and its comparison to a predicate device. However, it does not contain the specific detailed information typically found in a study proving a device meets acceptance criteria, such as a table of acceptance criteria and reported device performance, sample sizes for test sets, expert details for ground truth, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set sample sizes and ground truth methods.

This document primarily focuses on establishing substantial equivalence to a legally marketed predicate device, rather than presenting a performance study with detailed acceptance criteria and results. The "PERFORMANCE DATA" section states: "Packaging validation, LAL endotoxin, and shelf life studies were submitted in support of the modifications to MicroMatrix® described in this 510(k)." This indicates that performance data related to these specific aspects were provided, but the document does not elaborate on their acceptance criteria or detailed results in a format that would fulfill the request.

Therefore, I cannot provide the requested information from the given text.

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Gentrix Surgical Matrix Thick and Gentrix Surgical Matrix Extend are intended for implantation to reinforce soft tissue where weakness exists in patients requiring gastroenterological or plastic & reconstructive surgery. Reinforcement of soft tissue within gastroenterological and plastic & reconstructive surgery includes, but is not limited to, the following procedures: hernia and body wall repair, colon and rectal prolapse repair, and esophageal repair.

The Gentrix™ Surgical Matrix Thick and Gentrix™ Surgical Matrix Extend devices are composed of porcine-derived extracellular matrix scaffolds, specifically known as urinary bladder matrix. The devices are supplied in an eight-layer sheet configuration in sizes up to 30 cm x 40 cm, and packaged in double peel-open pouches. The devices are terminally sterilized using electron beam irradiation. The implantable biomaterial is a resorbable extracellular matrix scaffold that will incorporate (remodel) into the body through cellular infiltration, capillary growth, and integration by the surrounding host tissue. Animal studies have shown device resorption in approximately 240 days.

This document is a 510(k) premarket notification for a medical device called Gentrix™ Surgical Matrix Thick and Gentrix™ Surgical Matrix Extend. This device is a surgical mesh made from porcine urinary bladder matrix, intended for reinforcing soft tissue in various surgical procedures.

The information provided focuses on demonstrating "substantial equivalence" to a previously cleared predicate device (Gentrix™ Surgical Matrix 8-Layer, K162554), rather than establishing novel acceptance criteria against a clinical outcome or a new performance standard. Therefore, the concept of "acceptance criteria" in the context of an AI/ML device's performance metrics (like sensitivity, specificity, etc.) is not directly applicable here. The "reported device performance" is primarily comparative to the predicate device.

However, I can extract the types of tests performed and the general findings which serve as proof of substantial equivalence.

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

Since this is a substantial equivalence submission for a traditional medical device (surgical mesh) and not an AI/ML device, the "acceptance criteria" are not reported as specific performance metrics (like sensitivity, specificity, or AUC with threshold values). Instead, the acceptance criteria are implicitly that the new devices perform equivalently to the predicate device across various tests.

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

• Bench Testing (Biocompatibility, Mechanical, Material Characterization): Not specified in terms of sample size or data provenance. These are typically in-house laboratory tests on material samples.
• Animal Testing: A "pre-clinical porcine model" was used. The number of animals or specific details of the study are not provided. Data provenance is implied to be from a laboratory setting.
• Clinical Data: "No Clinical data was provided in support of this clearance." This implies a sample size of zero for 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 submission does not involve ground truth established by experts for performance evaluation in the way an AI/ML device would. The evaluation is based on laboratory and animal tests against established scientific and engineering principles for surgical mesh materials.

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

Not applicable. There is no adjudication method described as this is not an AI/ML device or a study involving human readers/interpreters.

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/ML device.

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

Not applicable. This is not an AI/ML device.

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

The "ground truth" for this device's performance is based on:

• Established scientific standards for biocompatibility (e.g., ISO-10993).
• Direct measurement of physical properties (tensile strength, tear strength, stiffness, etc.) of the device material.
• Biological observations in an animal model (tissue integration, remodeling, degradation).
• Comparison to the known and accepted performance characteristics of the predicate device.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no training set.

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

Not applicable. This is not an AI/ML device.

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Gentrix™ Surgical Matrix 2-layer and 3-layer are intended for implantation to reinforce soft tissue where weakness exists in patients requiring urological, gastroenterological, or plastic & reconstructive surgery. Reinforcement of soft tissue within urological, gastroenterological, and plastic & reconstructive surgery includes, but is not limited to, the following procedures; hernia and body wall repair, colon and rectal prolapse repair, and esophageal repair.

Gentrix™ Surgical Matrix 6-layer and 8-Laver are intended for implantation to reinforce soft tissue where weakness exists in - patients requiring - gastroenterological or plastic & reconstructive surgery. Reinforcement of soft tissue within gastroenterological and plastic & reconstructive surgery includes, but is not limited to, the following procedures: hernia and body wall repair, colon and rectal prolapse repair, tissue repair, and esophageal repair.

Gentrix™ Surgical Matrix 2-Layer, 6-Layer, 8-Layer devices are composed of porcinederived extracellular matrix scaffolds, specifically known as urinary bladder matrix. The devices are supplied in multi-layer sheet configurations in sizes up to 10 cm x 15 cm, and packaged in double peel-open foil pouches. The devices are terminally sterilized using electron beam irradiation.

The provided text is a 510(k) Premarket Notification for a medical device called "Gentrix™ Surgical Matrix." This document is a regulatory submission for a Class II medical device, primarily focusing on demonstrating substantial equivalence to existing predicate devices.

It does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML device.

The performance data included in the document pertains to:

• Biocompatibility Testing: According to ISO-10993-1 for a permanently implanted device.
• Mechanical Testing: Including tensile strength, suture retention strength, ball burst strength, delamination strength, tear strength, and stiffness.
• Material Characterization: Including moisture content, hydration uptake, and hydrated onset temperature.

These tests aim to demonstrate that the Gentrix™ Surgical Matrix is "substantially equivalent" to predicate and reference devices and performs adequately throughout its labeled shelf life. This is typical for a 510(k) submission, where the focus is on comparing a new device to an already legally marketed one.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria, as there is no specific AI/ML component or associated study described in this document.

The document discusses validation of the packaging system (ANSI/AAMI/ISO 11607-1 and -2) and substantial equivalence to predicate devices based on material, manufacturing, and performance characteristics for surgical mesh, not an AI/ML system.

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