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Local management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and stage I - IV dermal ulcers (vascular, venous, pressure, and diabetic).

The subject device is designed to contact the wound as a primary dressing and permit the passage of fluids. The dressing provides a protective moist environment for the wound passage of nulas. The aronamination in the dressing. The dressing. The subject device is an effective antimicrobial barrier dressing against the following organisms; Pseudomonas aeruginosa, Staphylococcus aureus, Candida albicans, E. faecalis, Aspergillus niger and Escherichia coli. The nylon fabric permits the passage of oxygen and fluids to and from the wound. The surface of the nylon fibers in the subject device consists of a thin layer of metallic silver that provides effective protection of the dressing against microbial contamination. The contact wound dressings are made of flexible, sterile, non-adherent fabric offered in 1 or 4 layers. The wound dressings will be initially available in the following sizes and varieties: 2"x2", 4"x4", 4'x8'', 8"x8", 12"x48", 4" x 60" Elastic Wrap, 8" x 108" Elastic Wrap, Socks. The wound dressings are composed of a Nylon (polyamide) textile fiber substrate with metallic silver surface plating. The elastic wraps and socks also contain elastomer fiber. The wound dressings are made from MedTex P180 and Balingen. Both materials are silver plated Nylon (polyamide) textiles. The materials are identical with the exception that MedTex P180 is used for the stretch wraps and contains elastomer fiber. The raw material used on the device is silver nitrate. SWS 846 method 6010B (ICP) test method is used to determine purity. The purity of the silver in the dressing is 99.9% pure elemental silver, with a measured accuracy of 0.01%. It is anticipated the AgMed Tex material will be offered in additional sizes including contact wound dressings (2"x2", 4"x4", 4"x8", 4"x12", 10"x12", 8"x8", 8"x16", 16"x16", 4"x24", 4"x72", 12"x48"), stretch wrap wound dressing of different sizes (including 4"x24", 4"x60", 4"x72", 4"x108", 8"x108"), strips (in sizes such as 1"x3"). self-adhering bandages, and socks. The socks will use the same silver plated nylon textile material with elastomer fiber. The socks contain 6% silver. The self adhering bandages will include the same silver plated nylon textile material along with an adhesive tape. The adhesive tape will be the Avery Dennison medical grade adhesive tape or similar. Only medical grade, biocompatible, and latex free adhesive tapes will be used. Avery Dennison has these materials on file with FDA as a Drug Master File. The subject devices will be packaged in a standard pre-formed peelable pouch I he subject devices will be packaging. The pouches will be labeled and packed in a labeled SBS box. SBS boxes are commonly used in medical device packaging. The SBS boxes will be packed into corrugated master shipping boxes. The peelable pouches and SBS boxes are compatible with radiation sterilization. The subject devices are sterile single-use devices to be sterilized using a validated The baof of tiering cycle affording an SAL of 106. The devices are not to be reused, therefore cleaning and disinfection instructions are not applicable. The sterilization validation will be performed consistent with the ISO 11137 Standard - Sterilization of Vancation ++++ 0 - Requirements for validation and routine control - Radiation Sterilization. Method 1 will be employed to validate the sterilization process. Products will be sterilized at one of the Isomedix facilities. After sterilization the I roducts will be returned to Select Fabricators under quarantine and subjected to post sterility / final inspection prior to release and distribution. Seal strength testing will be done on a routine basis during raw material receipt, inprocess, and post-sterility processing. Seal strength testing (burst and creep to burst) will be performed using a TEST-A-PACK F100-2600 Seal Strength tester. Test will be applied per ASTM F-1140 or equivalent methods. The routine manufacturing inspection approam will also consist of visual inspection for package integrity. The packaging validation will include Installation Qualification (IQ), Operation Qualification (OQ), and Performance Qualification (PQ). Inspections will be performed by SPC and/or ANSI/ASQ techniques. It is recommended the patient examine the wound every 24 hours and change the dressing as needed. The use of petroleum based materials, materials with the ingredient Papain, and materials with high protein content are not recommended for use with AgMed Tex wound dressings as they may inactivate the silver. The patients are warned against using the wearing the product during MR Imaging.

While the provided text describes the device, its intended use, and claims of equivalence to a predicate device, it does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria, as outlined in your request.

Specifically, the document focuses on the regulatory submission (510(k) Summary) for a wound dressing, which primarily demonstrates substantial equivalence to a legally marketed predicate device rather than presenting detailed performance studies against specific acceptance criteria.

Here's a breakdown of why many of your requested points cannot be extracted from this text:

• Acceptance Criteria Table: No such table is present. The document states general claims about effectiveness.
• Sample size for test set and data provenance: No information on a "test set" in the context of clinical or performance evaluation. The "laboratory tests" mentioned are for antimicrobial effectiveness.
• Number of experts and qualifications for ground truth: Not applicable as no clinical or diagnostic "ground truth" establishment is described.
• Adjudication method: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as this is a wound dressing, not an imaging or diagnostic AI device.
• Standalone (algorithm only) performance: Not applicable.
• Type of ground truth: The "ground truth" mentioned refers to the effectiveness against microorganisms, not clinical outcomes in a structured study. It's based on "laboratory tests."
• Sample size for training set: Not applicable; this device is a physical wound dressing and does not involve AI/machine learning training sets.
• How ground truth for training set was established: Not applicable.

What the document does provide regarding performance:

The document states: "The device was found in laboratory tests to be effective in the reduction of several types of microorganisms including Pseudomonas aeruginosa, Staphylococcus aureus, Candida albicans, E. faecalis, Aspergillus niger and Escherichia coli."

This indicates that some form of in-vitro antimicrobial testing was performed. However, it does not detail:

• The specific method (e.g., zone of inhibition, quantitative reduction).
• The acceptance criteria for "effective in the reduction."
• The sample size of cultures or tests performed.
• The statistical analysis, if any.

It also mentions "ISO 10993-1 biocompatibility testing." This is a standard safety test (biological evaluation of medical devices) and not a performance study in the way you've outlined.

In summary, based only on the provided text, I cannot complete your requested table and detailed study information because the context is a 510(k) submission showing substantial equivalence for a physical medical device (wound dressing), not a detailed performance study for a diagnostic or AI-driven device with specific acceptance criteria.

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