(79 days)
DuoDERM Extra Thin CGF Dressings is indicated for use on chronic wounds-dry to lightly exuding dermal ulcers, including diabetic ulcers; acute wounds (e.g., post operative wounds); and as a protective dressing for areas at risk for skin breakdown. DuoDERM Extra Thin CGF Dressing provides a moist wound environment that is necessary for the healing process.
The concept of DuoDERM Extra Thin CGF Dressing is not significantly different from other commercially available absorbent dressings intended to manage exudating wounds.
This document is a 510(k) Pre-Market Notification for a medical device (DuoDERM Extra Thin CGF Dressing). It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the way a diagnostic AI device would.
Therefore, the information requested (acceptance criteria, specific study details, ground truth establishment, sample sizes for training/test sets, MRMC studies, etc.) is not present in the provided text.
Here's a breakdown of why and what information is available:
- Type of Device: DuoDERM Extra Thin CGF Dressing is an absorbent dressing for wound management. It's a physical medical device, not a diagnostic algorithm or AI system.
- Regulatory Pathway: The submission is a 510(k), which aims to show "substantial equivalence" to a legally marketed predicate device. This typically involves comparing characteristics, intended use, and performance data if relevant, but not necessarily a "study that proves the device meets the acceptance criteria" in the sense of an algorithmic performance evaluation.
- Focus of the Document: The document explicitly states: "The concept of DuoDERM Extra Thin CGF Dressing is not significantly different from other commercially available absorbent dressings intended to manage exudating wounds." and "DuoDERM Extra Thin CGF Dressing is substantially equivalent to SignaDRESS Hydrocolloid Dressing. The two products are equivalent in intended use and dressing characteristics."
Information that is available (but doesn't align with the requested table/study details):
- Device Name: DuoDERM® Extra Thin® CGF Dressing
- K-Number: K973716
- Predicate Device: SignaDRESS™ Hydrocolloid Dressing
- Intended Use/Indications: Chronic wounds (dry to lightly exudating dermal ulcers, including diabetic ulcers), acute wounds (e.g., post-operative wounds), and as a protective dressing for areas at risk for skin breakdown. It "provides a moist wound environment that is necessary for the healing process."
- Safety Data Provenance: "Data/information supporting the safety of DuoDERM Extra Thin CGF Dressing was presented in Premarket Notifications K891696 and K925990. All testing was performed in accordance with Good Laboratory Practice Regulations." This indicates prior submissions and GLP compliance for safety, but not a new clinical performance study for this specific 510(k).
- Limitations imposed by FDA: The FDA letter explicitly states limitations on labeling for this device (e.g., not for third-degree burns, not to claim accelerated healing, not as a long-term dressing, not a cure). These are regulatory conditions rather than performance acceptance criteria derived from a study.
In summary, none of the specific points (numbered 1-9) about acceptance criteria and a performance study for an AI/diagnostic device can be answered from the provided text because this document pertains to a physical wound dressing seeking substantial equivalence and does not describe such a study.
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