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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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XYLOS™ Vessel Guard is indicated as a cover for vessels during anterior vertebral surgery.

XYLOS™ Vessel Guard is a flexible, non-resorbable, implantable sheet composed of microbialderived cellulose. The device is presented ready-to-use in a sterile double-pouched package. It is intended for one time use.

The provided K100984 510(k) summary for the XYLOS™ Vessel Guard focuses on demonstrating substantial equivalence to predicate devices through material similarity and biomechanical testing, rather than clinical performance based on a study with acceptance criteria often associated with AI/software devices. Therefore, a direct response to some of the specific questions is not possible from the provided text, as they pertain to aspects that are not relevant to this type of medical device submission.

However, I can extract the relevant information and indicate where details regarding AI-specific criteria are not applicable.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

This information is not applicable/not provided in the context of this 510(k) submission. The device is a physical implantable sheet, and its substantial equivalence was demonstrated through benchtop biomechanical testing and material comparison, not through a clinical study with a "test set" of patient data or clinical outcomes.

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

This information is not applicable/not provided. Ground truth, in the context of AI or diagnostic studies, refers to a definitive diagnosis or outcome, usually established by experts. For this device, "ground truth" would relate to the established material properties and biomechanical performance standards of the predicate devices. These are typically assessed by engineers and materials scientists in laboratory settings.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. Adjudication methods (like 2+1 or 3+1) are used to resolve discrepancies in expert opinions when establishing ground truth in clinical or image-based studies. Since this submission relies on benchtop testing and material comparisons, such adjudication is not relevant.

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. This type of study is relevant for diagnostic devices or AI algorithms that assist human readers in interpreting data or images. The XYLOS™ Vessel Guard is an implantable surgical aid, and its effectiveness is demonstrated through its physical properties and biological compatibility, not through an assessment of human reader performance.

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

No, a standalone performance study was not done. This concept applies to AI algorithms that operate independently. The XYLOS™ Vessel Guard is a passive physical device.

7. The Type of Ground Truth Used

The "ground truth" in this context is based on:

• Established Material Composition: The chemical and biological identity to the predicate MTA™ Protective Sheet.
• Established Biomechanical Performance Standards: The tensile strength and suture pull-out performance as demonstrated by the predicate devices (Replication Medical Vessel Guard, PRECLUDE® IMA Sleeve, PRECLUDE® Vessel Guard).

Essentially, the ground truth for this submission is the well-characterized properties and performance of the legally marketed predicate devices.

8. The Sample Size for the Training Set

This information is not applicable/not provided. The concept of a "training set" applies to machine learning or AI models, where data is used to teach the algorithm. This device is a physical product, not an algorithm.

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

This information is not applicable/not provided for the same reasons as #8.

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This device is intended for implantation to reinforce soft tissue including, but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, prolapse repair, reconstruction of the pelvic floor, hernias, suture-line reinforcement and reconstructive procedures. The device is intended for one-time use.

Xylos® Porous Surgical Mesh is a sterile, non-resorbable product composed of solvent-dehydrated, microbial-derived cellulose. The implantable unit is presented in sterile double-pouched packages for appropriate removal in preparation for surgery.

The provided text describes a 510(k) premarket application for the Xylos® Porous Surgical Mesh, which is a modification of a previously cleared device. The "study" referenced is an evaluation of this modification, rather than a clinical trial in the traditional sense, focusing on establishing substantial equivalence to the predicate device.

Here's an analysis based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The submission states, "The verification and validation tests that were performed confirmed that the Xylos® Porous Surgical Mesh met the acceptance criteria. Therefore the device should perform as intended." However, it does not explicitly list the specific acceptance criteria or the numerical performance results from these tests.

The primary "acceptance criterion" demonstrated in this 510(k) summary is that the additional perforation processing step does not adversely affect the safety or effectiveness of the device compared to the predicate. The performance in this context is deemed acceptable if this equivalence is maintained.

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

The document refers to "verification and validation tests" but does not specify the sample size used for these tests.
The data provenance is not explicitly detailed but would likely originate from laboratory and engineering testing conducted by Xylos Corporation, not from patient data (retrospective or prospective) in a clinical setting.

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

This type of information is not applicable to this 510(k) submission. "Ground truth" established by human experts, especially for clinical endpoints, is generally associated with clinical trials or diagnostic device evaluations. This submission focuses on engineering and material characteristics to demonstrate substantial equivalence for a manufacturing process change.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3. Adjudication methods are relevant in clinical studies where expert consensus is needed to resolve discrepancies in diagnoses or assessments.

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

No, an MRMC comparative effectiveness study was not done. This device is a surgical mesh, not an AI-powered diagnostic or assistive tool for human readers.

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

No, this concept is not applicable as the device is a physical surgical mesh, not an algorithm.

7. The Type of Ground Truth Used

For this specific submission, the "ground truth" would be established through engineering specifications, material science standards, and established test methodologies to evaluate the physical and mechanical properties of the mesh with the new perforation process. This likely includes:

• Mechanical Testing Results: Tensile strength, burst strength, pore size, etc.
• Biocompatibility Testing: According to ISO standards.
• Sterility Assurance: Validation of the gamma irradiation process.

It is not expert consensus, pathology, or outcomes data in a clinical sense for this particular submission, as it's not a de novo device or a major change requiring new clinical data.

8. The Sample Size for the Training Set

This concept is not applicable. The device is not an AI/ML algorithm that requires a training set.

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

This concept is not applicable for the same reason as point 8.

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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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The Securian™ Tissue Reinforcement Matrix is indicated for the management and protection of soft tissue and tendon injuries in which there has been no substantial loss of tendon tissue. Securian™ Tissue Reinforcement Matrix minimizes tissue attachment to the device in case of direct contact with overlying tissues. Securian™ Tissue Reinforcement Matrix is also indicated for reinforcement of soft tissues repaired by suture anchors during tendon repair surgery including reinforcement of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Securian™ Tissue Reinforcement Matrix 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. Securian™ Tissue Reinforcement Matrix reinforces and protects healing soft tissues. The device is indicated for open and endoscopic procedures. Securian™ Tissue Reinforcement Matrix is intended for one-time use.

Securian™ Tissue Reinforcement Matrix is a sterile product composed of microbial-derived cellulose. The implantable device is presented in a sterile double-pouched package for appropriate removal in preparation for surgery. The non-resorbable surgical mesh is used for trauma and reconstructive surgical procedures involving tendons or other soft tissues. Securian™ Tissue Reinforcement Matrix maintains the relative position and stability of soft tissues during the healing period.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Securian™ Tissue Reinforcement Matrix:

It's important to note that the provided documents are a 510(k) summary and an FDA clearance letter for a medical device. This type of regulatory submission typically focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than presenting a novel clinical study with new acceptance criteria for a first-of-its-kind device. Therefore, many of the requested categories for a new AI/software device study (like sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of submission.

The "study" in this context refers to the demonstration of substantial equivalence through a comparison to predicate devices and performance testing.

Acceptance Criteria and Device Performance

"The Securian™ Tissue Reinforcement Matrix is substantially equivalent to legally marketed predicate devices and has the same intended uses and the same or similar indications, technological characteristics, and principles of operation as the predicate devices."

"Performance data demonstrate that Securian™ Tissue Reinforcement Matrix functions equivalently to the predicate devices. Thus, Securian™ Tissue Reinforcement Matrix is substantially equivalent to the predicate devices."

"Securian™ Tissue Reinforcement Matrix met the test requirements, providing reasonable assurance of device performance for its intended use and supporting substantial equivalence." |
| Biocompatibility: Must be biocompatible for its intended use. | "Securian™ Tissue Reinforcement Matrix has the same biocompatibility... to those cited in K081882 [XYLOS Surgical Mesh]." (Implied acceptance based on predicate) |
| Performance for Modified Indications for Use: The device must meet test requirements supporting its modified 'Indications for Use' statement without posing new questions of safety and effectiveness. | "Additional performance testing was performed to support the modified 'Indications for Use' statement."

"Securian™ Tissue Reinforcement Matrix met the test requirements, providing reasonable assurance of device performance for its intended use and supporting substantial equivalence."

"The modified 'Indications for Use' in this submission do not pose new questions of safety and effectiveness." |

Study Details (Based on the provided 510(k) Summary)

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not explicitly stated as a separate clinical test set of patients. The "performance data" refers to comparative testing against predicate devices. The study doesn't involve human clinical trials with a patient test set in the traditional sense for demonstrating primary safety and efficacy, but rather bench testing and comparison to existing data from predicate devices.
   • Data Provenance: Not applicable in the context of a de novo clinical data collection from a test set. The data provenance would be from internal performance testing and data cited in the predicate device clearances.

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

   • Not applicable. This submission relies on demonstrating similarity to already approved devices. There is no mention of "ground truth" established by experts for a novel test set in the provided document.

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

   • Not applicable. There was no independent clinical test set requiring expert adjudication.

4. 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 a physical surgical mesh, not an AI/software device used by human readers.

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

   • Not applicable. This is a physical device, not an algorithm.

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

   • Not applicable in the AI/software context. For a physical device, "ground truth" would relate to established scientific and engineering principles, biocompatibility standards, and the performance characteristics (e.g., tensile strength, pore size, degradation rate) of the predicate devices. The "truth" is established by the successful prior clearance of the predicate devices.

7. The sample size for the training set:

   • Not applicable. This device does not use machine learning or a training set.

8. How the ground truth for the training set was established:

   • Not applicable. This device does not use machine learning or a training set.

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This device is intended for implantation to reinforce soft tissue including, but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, prolapse repair, reconstruction of the pelvic floor, hernias, suture-line reinforcement and reconstructive procedures. The device is intended for one-time use.

The XYLOS Surgical Mesh will function as a non-absorbable surgical biomaterial that enables rapid fixation by tissue incorporation. The device incorporates a microporous structure that ensures early fixation to host tissue with minimal foreign body response. The double-pouched, sterile, single use unit is designed to allow maintenance of the sterile field prior to implantation. The material is conducive to size with sterile surgical instruments to avoid excessive tension on the suture line.

The provided text does not contain information about acceptance criteria and a study proving a device meets these criteria. Instead, it is a 510(k) summary for the XYLOS Surgical Mesh, primarily discussing its substantial equivalence to a previously cleared device.

Therefore, I cannot fulfill the request to provide the detailed information about acceptance criteria and a study as requested in the prompt.

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This device is intended for implantation to reinforce soft tissue including, but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, prolapse repair, reconstruction of the pelvic floor, hernias, suture-line reinforcement and reconstructive procedures. The device is intended for one-time use.

XYLOS™ Surqical Mesh is prepared from microbial derived cellulose that undergoes chemical processing inclusive of solvent dehydration. Units are cut in various sizes to meet surgical needs. Each unit is double-pouched, labeled, and gamma sterilized surgical mesh exhibits excellent tensile strength, suture retention and consistent thickness.

The provided document (K023237) is a 510(k) summary for a surgical mesh, which is a medical device and not an AI/ML powered device. As such, the requested information about acceptance criteria, study design elements relevant to AI/ML performance (e.g., sample size for test/training sets, ground truth establishment, expert adjudication, MRMC studies) is not applicable or present in this document.

The document discusses the performance data in a general sense, stating:

"XYLOS™ Surgical Mesh functions as intended when subjected to safety, biocompatibility, toxicity, pyrogenicity, sterility and mechanical strength testing."

However, it does not provide specific acceptance criteria or detailed results from these tests. It merely states that the device meets them.

Therefore, I cannot populate the table or provide the detailed information requested in points 1-9 as this type of information is not included in the provided 510(k) summary for a traditional medical device like a surgical mesh.

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The XCell® Antimicrobial Wound Dressing is intended for use on partial and full-thickness wounds as an effective barrier to resist microbial colonization within the dressing and reduce microbial penetration through the dressing. The XCell® Antimicrobial Wound Dressing is intended to cover a wound or burn on a patient's skin to absorb areas of wound exudates and to provide a moist wound environment that supports the autolytic debridement of areas of the wound that are necrotic. The dressing may be used on minimally exuding, non-exuding and dry wounds as stated in the Instructions-for-use. The wound dressing also protects against abrasion, desiccation, and external contamination. The moist environment has a cooling effect that may reduce pain.

Under the supervision of a health care professional, the XCell® Antimicrobial Wound Dressing is intended for the local management of exuding wounds, including infected and non-infected pressure ulcers, venous ulcers, diabetic ulcers, arterial ulcers, donor sites and other bleeding surface wounds, dermal lesions, trauma injuries or incisions, superficial cuts, minor scalds and burns, minor skin irritations, lacerations and abrasions.

The device is intended for one-time use.

Not Found

This 510(k) summary for the XYLOS™ XCell® Antimicrobial Dressing focuses on establishing substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study with performance metrics. Therefore, many of the requested categories for a study proving acceptance criteria cannot be directly extracted from the provided text.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The 510(k) summary aims to demonstrate substantial equivalence to predicate devices based on similar intended use, technological characteristics, and performance, rather than providing specific performance metrics against pre-defined acceptance criteria for a new clinical study.

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

This information is not applicable to this 510(k) summary as no specific test set data from a study proving device performance is presented. The submission relies on comparison to predicate devices.

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

This information is not applicable for the same reason as above.

4. Adjudication Method for the Test Set

This information is not applicable for the same reason as above.

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

This information is not applicable. The device is a wound dressing, not an AI-assisted diagnostic tool.

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

This information is not applicable as the device is a wound dressing, not an algorithm.

7. The Type of Ground Truth Used

This information is not applicable as no specific study data or ground truth establishment is detailed for this 510(k) beyond demonstrating equivalence to existing legally marketed devices. The "ground truth" here is effectively that the predicate devices are safe and effective.

8. The Sample Size for the Training Set

This information is not applicable as the device is a wound dressing, not an algorithm that requires a training set.

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

This information is not applicable for the same reason as above.

Summary based on the provided 510(k) information:

The provided document is a 510(k) summary for a medical device (wound dressing) aiming for market clearance based on substantial equivalence to predicate devices. It does not contain details of a specific study designed to meet pre-defined acceptance criteria with quantifiable performance metrics, as would be expected for a novel device requiring such a study. The "proof" is the demonstration of similarity to already cleared devices.

The key points from the document pertinent to its clearance are:

• Intended Use: Similar to predicate devices (partial and full-thickness wounds, absorb exudates, moist wound environment, barrier to microbial colonization/penetration, protection against abrasion, desiccation, external contamination, etc.).
• Technological Characteristics: Implied to be similar to predicate devices.
• Performance: Implied to be similar to predicate devices, but no specific performance data from a new study is provided to establish new acceptance criteria.

The 510(k) process primarily confirms that a new device is as safe and effective as (substantially equivalent to) an already legally marketed device, rather than requiring exhaustive de novo clinical trials to prove performance against specific new criteria.

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X-Cell™, a hydrogel wound dressing is a device intended to cover a wound or burn on a patient's skin to absorb wound exudate, and protect against abrasion, friction, dessication, or external contamination. The moist environment has a cooling effect that may reduce pain.

X-Cell™ wound dressing may be used for the management of:

• Partlal to Full thickness wounds (arterial, venous, pressure and diabetic ulcers); .
• First and Second degree burns (severe sunbum, etc.); .
• Post-operative surgical wounds; .
• Donor sites; .
• Dermal Lesions (cuts, abrasions, exc.) .

X-Cell™, a hydrogel wound dressing

This document is a 510(k) summary for the X-Cell™ Hydrogel Wound Dressing, asserting its substantial equivalence to predicate devices rather than providing a study demonstrating its performance against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics is not available in these provided excerpts.

However, based on the information provided, here's what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

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

This information is not available in the provided document. The 510(k) summary focuses on demonstrating substantial equivalence through biocompatibility testing and comparison to predicates, not a clinical trial with a specific test set.

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

This information is not available. Ground truth establishment by experts is typically relevant for clinical studies, which are not detailed here.

4. Adjudication Method for the Test Set

This information is not available. Adjudication methods are relevant for clinical studies with expert review, which are not outlined.

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

This information is not available. An MRMC study is a type of clinical study focused on reader performance, which is not described.

6. Standalone (Algorithm Only) Performance Study

This information is not available. This type of study would be relevant for AI/algorithm-based devices, but the X-Cell™ Wound Dressing is a physical medical device.

7. Type of Ground Truth Used

The "ground truth" here is the regulatory assessment of biocompatibility and substantial equivalence to predicate devices. This is established through:

• Biocompatibility testing results: The document states the results of these tests show the device to be safe.
• Comparison to predicate devices: The X-Cell™ is compared to NU-GEL and Aquacel wound dressings, implying their established safety and efficacy serve as a benchmark for equivalence.

8. Sample Size for the Training Set

This information is not available. A "training set" is relevant for machine learning algorithms, which are not applicable to this physical wound dressing.

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

This information is not available as there is no training set for a physical wound dressing; this concept applies to AI/ML models.

Summary of what can be inferred from the document:

The 510(k) submission for the X-Cell™ Wound Dressing uses two primary methods to demonstrate its safety and effectiveness for substantial equivalence:

1. Biocompatibility Testing: The results indicated the device is safe for its intended purpose. No specific study details (e.g., sample size, type of tests) are provided in this summary.
2. Comparison to Predicate Devices: The device is presented as substantially equivalent to the NU-GEL hydrogel wound dressing and the Aquacel wound dressing. This implies that the safety and performance profile of these existing, legally marketed devices serve as the "ground truth" for demonstrating equivalence.

The document does not describe a clinical study with a test set of patients or experts, as it is a 510(k) summary focusing on substantial equivalence rather than a full clinical trial report.

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