(88 days)
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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