(71 days)
Hydrophilic Wound Dressing is indicated in the dressing and management of minor burns, superficial cuts, lacerations, and abrasions; minor irritations of the skin. A health care professional may be consulted prior to the first use of the product to determine whether these conditions exist. Kytogenics' Hydrophilic Wound Dressing may also be used under the care of a health care professional for wounds such as partial thickness dermal ulcers (pressure sores, venous stasis ulcers, diabetic ulcers), surgical wounds (post operative incisions and donor sites, and second degree burns.
NOCC™ (N,O-Carboxymethylchitosan) Hydrophilic Wound Dressing is a hydrogel that provides a moist wound environment to support wound healing. The gel is clear which aids in visualization of the wound.
This document is a 510(k) summary for the NOCC™ Hydrophilic Wound Dressing. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics for the device itself. Therefore, many of the requested details are not available in the provided text.
Based on the provided text, here's what can be extracted:
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A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or detailed performance metrics from a study for the NOCC™ Hydrophilic Wound Dressing. Instead, it relies on demonstrating substantial equivalence to a predicate device (Bionect Clear Hydrogel). The "performance" is implicitly tied to the predicate's established safety and effectiveness.Acceptance Criteria (Implied) Reported Device Performance (Implied) Similar intended use Same as predicate (dressing and management of various wounds, burns, abrasions). Similar technical characteristics Chitosan-based hydrogel, clear hydrogel form, sterile, moist heat sterilization. Bioresorbable "demonstrated that NOCC is bioresorbable" Biocompatible "demonstrated that NOCC is biocompatible" Bioadhesion "excellent bioadhesion to both soft tissue (mucosal) and hard tissue (bone)" Safe and Effective Substantially equivalent to predicate, which is considered safe and effective. -
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The submission references "Numerous studies, as well as over 10 years of evaluation" for NOCC's bioresorbability, biocompatibility, and bioadhesion, but does not detail these studies' design, sample sizes, or provenance. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided. As no specific test set study with a ground truth is described, there's no mention of experts for this purpose. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. -
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 as the device is a wound dressing, not an AI-assisted diagnostic tool involving human readers. -
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. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the claims of bioresorbability, biocompatibility, and bioadhesion, the ground truth would likely refer to laboratory test results and possibly preclinical (animal) and/or limited clinical outcomes data from the "numerous studies" and "10 years of evaluation" mentioned. Specific details are not provided. -
The sample size for the training set
This information is not provided. If an algorithm were involved, this question would be relevant. For a wound dressing, this concept doesn't typically apply in the same way. -
How the ground truth for the training set was established
This information is not provided and is not applicable in the context of this device and submission type.
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