Search Results

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.

Ask a specific question about this device