(293 days)
3M™ Tegaderm™ Matrix dressing is intended for use on chronic, partial thickness wounds and full thickness wounds including: pressure ulcers, venous stasis ulcers and diabetic ulcers. It can also be used on skin irritations, cuts and abrasions.
Description of Device. with a low pH ointment containing 1.93% w/w potassium citrate, 0.008% w/w rubidium with a low pri onlinent consuming 1727, and 0.0002% w/w zinc chloride to constitute a saline chional, 0.000970 m w v valendin omorison and moist environment is known to be conducive to wound healing. This dressing is permeable to both air and wound exudates. Dressings are gamma irradiated for sterility.
The provided text describes a 510(k) premarket notification for the 3M™ Tegaderm™ Matrix Dressing. This document does not contain information about acceptance criteria, device performance tables, sample sizes for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details.
The submission is for a wound dressing, which is a medical device, not an AI/ML-driven diagnostic or image analysis tool. Consequently, standard acceptance criteria and study methodologies relevant to AI/ML or image processing devices (which often involve sensitivity, specificity, reader studies, etc.) are not applicable here.
The document states:
- Non-Clinical Performance Data: "Tegaderm™ Matrix dressing has been tested per ISO 10993-1 and determined to be safe for the intended use." ISO 10993-1 relates to biocompatibility testing, not performance metrics in the context of diagnostic accuracy.
- Clinical Performance Data: "N/A" (Not Applicable). This indicates no clinical performance data was presented in this 510(k) summary for measuring device effectiveness in a clinical setting against a specific ground truth, as would be expected for a diagnostic device.
- Conclusion: "Tegaderm™ Matrix dressing is safe for human use and acceptable for its intended use." This conclusion is based on the non-clinical (biocompatibility) data and similarity to the predicate device.
Therefore, none of the requested information regarding acceptance criteria and studies proving the device meets those criteria (in the context of AI/ML or diagnostic performance) can be extracted from this document. The device is a physical wound dressing and its equivalence was established based on its intended use, indications for use, composition, physical properties, and technological characteristics comparing it to a predicate device, along with non-clinical safety data.
N/A