(274 days)
ACTICOAT FLEX 7 is indicated for use on partial and full-thickness wounds for up to 7 days.
This includes:
First and second-degree burns,
To cover grafts, Surgical sites, Venous ulcers, Pressure ulcers
Diabetic ulcers.
The ACTICOAT FLEX 7 dressing consists of a flexible, low adherent polyester layer coated with nanocrystalline silver.
The ACTICOAT FLEX 7 is a highly conformable dressing, nanocrystalline silver provides an effective barrier to microbial contamination The antimicrobial barrier properties of the ACTICOAT FLEX 7 dressings remain effective for up to 7 days. The antimicrobial barrier properties and the ability of the dressing to allow fluid to pass through without impairment, (in-vitro data) has shown ACTICOAT FLEX 7 to be compatible with negative pressure wound therapy (NPWT) for a period of up to 3 days.
The dressing is low adherent, which helps to minimise wound trauma at dressing changes.
The silver coating is derived from a silver target which 99.99% silver. The coating which is applied to the dressing is predominantly silver with a small number of oxygen atoms trapped within the coating structure. The coatings are highly porous and consist of equiaxed nanocrystals organised into coarse columnar structures. These unique physical structures, in combination with the oxygen atoms/molecules that are trapped in the crystal lattice, contribute to the enhanced solubility of the films.
The provided text does not contain any information about acceptance criteria or a study proving device performance against such criteria for the ACTICOAT FLEX 7 Dressing.
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device, not on presenting novel performance data or acceptance criteria from a clinical study.
Here's a breakdown of why the requested information cannot be extracted:
- Acceptance Criteria and Reported Device Performance: The document states that "No applicable performance standards have been established under Section 514 of the FD&C Act." It mentions biocompatibility tests in conformance with AAMI/ISO-10993 and an animal model study to show "no deleterious effects on wound healing," but these are not presented as acceptance criteria with specific performance metrics.
- Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set): None of these details are present in the provided text. The document describes the device, declares its substantial equivalence, lists predicate devices, and outlines its intended use. There is no description of a clinical study or performance study that would involve these elements.
The text primarily focuses on:
- Device identification and contact information.
- Device classification and predicate devices.
- A brief description of the device's mechanism (nanocrystalline silver as an antimicrobial barrier).
- Biocompatibility testing results (indicating safety, but not specific performance metrics against acceptance criteria).
- A statement of substantial equivalence to predicate devices, implying similar performance rather than proving new performance against defined criteria.
- The FDA's decision letter based on the 510(k) submission.
Therefore, I cannot populate the table or answer the specific questions because the necessary information is not within the provided document.
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