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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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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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