(141 days)
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)
| Test Category | Specific Test | Acceptance Criteria (Implied/General) | Reported Device Performance |
|---|---|---|---|
| Physical Characteristics | Device Thickness | Met established specifications and was identical to predicate device. | Passed; "The proposed XenMatrix™ AB Surgical Graft... remains the same as the previous version of this device." "All samples tested met the established acceptance criteria." |
| Device (Flexural) Stiffness | Met established specifications and was identical to predicate device. | Passed; "The proposed XenMatrix™ AB Surgical Graft... remains the same as the previous version of this device." "All samples tested met the established acceptance criteria." | |
| Functional Characteristics | Burst Strength | Met established specifications and demonstrated equivalence to predicate device. | Passed; demonstrated substantial equivalence to the test results of the predicate device. "All samples tested met the established acceptance criteria." |
| Suture Pullout Strength | Met established specifications and demonstrated equivalence to predicate device. | Passed; demonstrated substantial equivalence to the test results of the predicate device. "All samples tested met the established acceptance criteria." | |
| Tear Resistance | Met established specifications and demonstrated equivalence to predicate device. | Passed; demonstrated substantial equivalence to the test results of the predicate device. "All samples tested met the established acceptance criteria." | |
| Analytical Testing | Drug Content | Met established specifications. | Passed; "All samples tested met the established acceptance criteria." |
| Drug Impurities | Met established specifications. | Passed; "All samples tested met the established acceptance criteria." | |
| Biocompatibility | (Various tests per ISO 10993) | Met established standards for biological evaluation of medical devices. | Leveraged from predicate device (K133223), which was conducted in accordance with FDA Blue Book Memorandum #G95-1 and ISO 10993-1. Implies satisfactory performance. |
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.
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.