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Xylos® Macro-Porous Surgical Mesh is intended to be used for implantation to reinforce and protect soft tissue including but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, hernias, suture-line reinforcement and other reconstructive procedures. This mesh may be used for the repair of hernia and other fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

Xylos® Macro-Porous Surgical Mesh is also intended for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps or other tendons. Xylos® Macro-Porous Surgical Mesh is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Sutures used to repair the tear, and sutures or bone anchors used to attach the tissue to the bone provide biomechanical strength for the tendon repair.

Xylos® Macro-Porous Surgical Mesh is indicated for open and endoscopic procedures and is intended for one-time use only.

Xylos® Macro-Porous Surgical Mesh is a flexible, non-resorbable implant composed of microbial-derived cellulose; there are no animal or human derived components in the device. Xylos® Macro-Porous Surgical Mesh is strong, conformable, biocompatible and includes macro-pores to facilitate tissue in-growth. The device is not subject to degradation or weakening by the action of tissue enzymes.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:

Disclaimer: This device is a surgical mesh, not an AI-powered diagnostic tool. Therefore, many of the typical questions related to AI device evaluation (such as multi-reader multi-case studies, effect size of AI assistance, standalone performance, and ground truth establishment for training/test sets in an AI context) are not applicable to this submission. The information provided focuses on the regulatory submission for a physical medical device.

Acceptance Criteria and Device Performance for Xylos® Macro-Porous Surgical Mesh

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes performance testing for mechanical properties and biocompatibility. The acceptance criteria are implicit in the claim of "substantial equivalence" to predicate devices, meaning the Xylos® Macro-Porous Surgical Mesh must perform at least as well as, or equivalently to, the predicate devices in the measured physical properties and biocompatibility.

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

• Mechanical Testing: The document does not specify exact sample sizes for the mechanical tests (tensile strength, burst strength, suture pull-out strength). It refers to "mechanical performance tests typical for surgical mesh products."
• Animal Study: The document does not specify the sample size for the animal study.
• Biocompatibility Testing: The document does not specify the sample size for biocompatibility testing, but indicates it was conducted "as defined in ANSI/AAMI/ISO 10993 Biological evaluation of medical devices."
• Data Provenance: The origin of the animals or the specific details of the testing environment (country, etc.) are not provided. The studies appear to be prospective tests conducted specifically for this device's submission.

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

This is not applicable as the submission is for a physical surgical mesh, not an AI device requiring expert interpretation of output. The "ground truth" for this device's performance is established through direct physical and biological testing against established standards and predicate devices.

4. Adjudication Method for the Test Set:

Not applicable for a physical device. Performance is measured objectively through standardized tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

This is not applicable. This is not an AI device.

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

This is not applicable. This is not an AI device.

7. The Type of Ground Truth Used:

• Mechanical Performance: The ground truth is objective measurement against established engineering standards and comparative data from the identified predicate devices.
• Biocompatibility: The ground truth is established through adherence to international standards for biological evaluation of medical devices (ANSI/AAMI/ISO 10993) and comparison to a predicate device with identical material composition that was previously cleared for biocompatibility.
• Physical Strength for Intended Use: The ground truth is derived from the results of an animal study.

8. The Sample Size for the Training Set:

This is not applicable. This is not an AI device that requires a training set in the machine learning sense. The "training" for this device involved its design and manufacturing processes based on knowledge of similar products and materials.

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

This is not applicable. As stated above, this is not an AI device.

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The MTA Protective Sheet is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. MTA Protective Sheet minimizes tissue attachment to the device in case of direct contact with the tissues. The device is indicated for open and endoscopic procedures. MTA Protective Sheet is intended for one-time use.

MTA Protective Sheet is composed of microbial-derived cellulose. The non-resorbable surgical mesh is used for the management and protection of tendon injuries. MTA Protective Sheet minimizes tissue attachment to the device in case of direct contact with the tissues. The implantable device is presented in a sterile double-pouched package for appropriate removal in preparation for surgery.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Acceptance Criteria and Reported Device Performance:

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

The document describes "various performance tests typical for its product code such as material property and suture pull out testing." However, it does not specify the sample size used for these tests.

The data provenance is from bench testing, meaning it was conducted in a laboratory setting, not on human or animal subjects, and is neither retrospective nor prospective in the typical clinical sense.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not provided in the document. The studies conducted were bench tests on material properties, not clinical studies requiring expert consensus for ground truth.

4. Adjudication Method for the Test Set:

An adjudication method is not applicable as the studies were bench tests focused on material properties and biomechanical equivalence, not on interpreting images or clinical outcomes that typically require adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study was mentioned. The document primarily focuses on demonstrating substantial equivalence through material and biomechanical testing against predicate devices.

6. Standalone (Algorithm Only) Performance:

Not applicable. This device is a physical surgical mesh, not a software algorithm, so the concept of standalone performance does not apply in this context.

7. Type of Ground Truth Used:

The ground truth for the performance testing was based on objective measurements from material property and suture pull-out tests, and comparison against the known characteristics and performance of the predicate devices (Securian Tissue Reinforcement Matrix for biocompatibility, and MAST Biosurgery Ortho-Wrap Bioresorbable Sheet for biomechanical properties).

8. Sample Size for the Training Set:

The document does not mention a "training set" as this is not a machine learning or AI-based device. The testing described is for performance validation, not for training an algorithm.

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

As there is no mention of a "training set," this information is not applicable.

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