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The XenMatrix™ AB Surgical Graft is intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue, including: abdominal plastic and reconstructive surgery; muscle flap reinforcement; hernia repair including abdominal, inguinal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias. The Rifampin and Minocycline coating has been shown in preclinical in vitro and in vivo testing to reduce or inhibit microbial colonization on the device. The claim of reduction of bacterial colonization of the device has not been established with human clinical data, nor has a clinical impact associated with this claim been demonstrated.

The XenMatrix™ AB Surgical Graft is an acellular, sterile, non-pyrogenic porcine dermal matrix for use in the reconstruction of soft tissue deficiencies. The graft is packed dry and must be hydrated prior to use. The proposed XenMatrix™ AB Surgical Graft surfaces are coated with an antimicrobial coating, which is comprised of a bioresorbable L-tyrosine succinate polymer and antimicrobial agents Rifampin and Minocycline. The coating is shaded orange in color due to the color of the antimicrobial agents.

Here's an analysis of the provided text regarding the XenMatrix™ AB Surgical Graft, addressing your specific questions about acceptance criteria and study details.

Important Note: This document is a 510(k) Premarket Notification summary for a surgical mesh, not an AI/algorithm-based diagnostic device. Therefore, many of your questions related to AI performance, ground truth establishment, expert review, MRMC studies, and training sets are not applicable to this type of medical device submission. The device is a physical surgical graft, and its "performance" is evaluated through physical characteristics, functional characteristics, and analytical testing, not through diagnostic accuracy metrics.

1. Table of Acceptance Criteria and Reported Device Performance

For XenMatrix™ AB Surgical Graft (K162193)

Note on Acceptance Criteria: The document frequently states "All samples tested met the established acceptance criteria" and "demonstrated substantial equivalence to the test results of the predicate device." Specific numerical acceptance criteria are not provided in this summary document. This is common for 510(k) summaries, where the focus is on demonstrating equivalence rather than detailing every test parameter and numerical threshold.

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

• Sample Size for Test Set: The document does not specify the exact sample sizes (number of grafts) used for the physical, functional, and analytical product testing. It refers to "All samples tested." These tests would typically involve a statistically appropriate number of units from manufacturing lots.
• Data Provenance: The data is generated from in vitro (bench) testing performed by the manufacturer, Davol Inc./C.R. Bard, Inc., in the USA (Warwick, RI). It is retrospective in the sense that the testing was performed on manufactured devices for the purpose of this submission.
• For Biocompatibility: The biocompatibility data was leveraged from the predicate device (K133223). This implies those tests were also conducted by the manufacturer or a contracted lab to established standards.

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

This question is Not Applicable (N/A). This device is a physical surgical mesh, not a diagnostic algorithm. There is no "ground truth" in the diagnostic sense or a "test set" requiring expert interpretation of results. The performance is based on objective measurements of physical, functional, and chemical properties.

4. Adjudication Method for the Test Set

This question is N/A. Since there's no diagnostic component or expert interpretation, there's no need for an adjudication method.

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

This question is N/A. This device is not an AI system, and no MRMC study was performed or is relevant for this type of medical device. Clinical studies were not performed for this submission.

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

This question is N/A. This device is a surgical graft, not an algorithm.

7. The Type of Ground Truth Used

This question is N/A for diagnostic ground truth. The "ground truth" for this device's performance is established by:

• Engineering specifications and validated test methods for physical and functional properties.
• Analytical chemistry standards for drug content and impurities.
• International standards for biological evaluation (ISO 10993) for biocompatibility.

8. The Sample Size for the Training Set

This question is N/A. This device is a surgical graft, not an AI/machine learning model, so there is no "training set."

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

This question is N/A. No training set exists for this device.

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The XenMatrix™ AB Surgical Graft is intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue, including: abdominal plastic and reconstructive surgery; muscle flap reinforcement; hernia repair including abdominal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias. The Rifampin and Minocycline coating has been shown in preclinical in vitro and in vivo testing to reduce or inhibit microbial colonization on the device. The claim of reduction of bacterial colonization of the device has not been established with human clinical data, nor has a clinical impact associated with this claim been demonstrated.

The XenMatrix™ AB Surgical Graft is an acellular, sterile, non-pyrogenic porcine dermal matrix for use in the reconstruction of soft tissue deficiencies. The graft is packed dry and must be hydrated in sterile saline prior to use. The proposed XenMatrix™ AB Surgical Graft surfaces are coated with an antimicrobial coating, which is comprised of a bioresorbable L-tyrosine succinate polymer and antimicrobial agents Rifampin and Minocycline. The coating is shaded orange in color due to the color of the antimicrobial agents.

The provided document describes the XenMatrix™ AB Surgical Graft, a collagen surgical mesh containing drugs, which is intended for implantation to reinforce soft tissue. However, it does not contain information about acceptance criteria, the specific study that proves the device meets acceptance criteria, sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set sample sizes for an AI/CADe device.

The document is a 510(k) summary for a medical device (surgical mesh) that references preclinical in vitro and in vivo testing to support the claim of reduced microbial colonization. It explicitly states that "The claim of reduction of bacterial colonization of the device has not been established with human clinical data, nor has a clinical impact associated with this claim been demonstrated." This indicates the absence of human clinical trials for this specific claim.

Therefore, I cannot fulfill your request for information related to acceptance criteria, specific study details as you've outlined, or AI/CADe performance metrics, as these are not present in the provided text. The document focuses on regulatory approval (510(k)) based on substantial equivalence to a predicate device and preclinical data.

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Intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue, including: abdominal plastic and reconstructive surgery; muscle flap reinforcement; hernia repair including abdominal, inguinal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias. The Rifampin and Minocycline coating has been shown in preclinical in vitro and in vivo testing to reduce or inhibit microbial colonization on the device. The claim of bacterial colonization of the device has not been established with human clinical data, nor has a clinical impact associated with this claim been demonstrated.

The XenMatrix™ AB Surgical Graft is an acellular, sterile, non-pyrogenic porcine dermal matrix for use in the reconstruction of soft tissue deficiencies. The graft is packed dry and must be hydrated in sterile saline prior to use. The thickness of the device is 1.5 to 2.3mm. The XenMatrix™ AB Surgical Graft surfaces are coated with an antimicrobial coating, which is comprised of a bioresorbable L-tyrosine succinate polymer and antimicrobial agents Rifampin and Minocycline at 180 µg/cm each. The coating is shaded orange in color due to the color of the antimicrobial agents. The bioresorbable L - Tyrosine succinate polymer is essentially absorbed in 12 months based on in vitro studies. The antimicrobial coating present on this device is intended to protect the graft from bacterial colonization.

The provided text describes the XenMatrix™ AB Surgical Graft, a surgical mesh, and its comparison to predicate devices for 510(k) clearance. However, the document does not describe an AI/ML-driven device, nor does it contain information about acceptance criteria and a study proving an AI device meets those criteria.

Instead, the document details the safety and effectiveness summary for a physical medical device (a surgical graft) based on biocompatibility testing, bench testing, in vivo strength determinations, drug content analysis, and animal testing.

Therefore, I cannot fulfill your request for an AI device's acceptance criteria and study information using the provided text. The information requested (multi-reader multi-case study, effect size of human readers with AI, standalone performance, training set details, ground truth establishment methods for training/test sets, expert qualifications) is specific to AI/ML device approval and is not present in this document.

Ask a specific question about this device