(304 days)
Silverlon™ Wound Packing Strips are sterile, non-adherent, silver wound dressings. The Prescription Professional indications: Control of local wound bleeding and nasal hemorrhage, to encourage draining by wicking fluids from a body cavity, infected area, or abscess, and to help remove necrotic tissue from ulcers or other infected wounds when used as a "wet-to-dry" packing.
Silverlon® Wound Packing Strips are made of flexible, sterile, r non-adherent fabric of a knitted continuous nylon fiber substrate with a metallic silver surface containing approximately 1% silver oxide. Silverlon® Wound Packing Strips are designed to intimately contact the wound as a primary dressing and permit the passage of fluids. The silver provides effective protection of the dressing against microbial contamination. The nylon fabric permits the passage of oxygen and fluids to and from the wound. The surface of the nylon fibers in Silverlon® Wound Packing Strips consists of a thin layer of metallic silver containing approximately 1% silver oxide that provides effective protection of the dressing against microbial contamination.
The provided text focuses on the 510(k) premarket notification for Silverlon™ Wound Packing Strips, determining its substantial equivalence to predicate devices, and outlining its intended use and functional characteristics. However, it does not contain information related to acceptance criteria or a study proving device performance against such criteria in the manner typically seen for complex medical devices requiring such studies (e.g., AI algorithms, diagnostic tests).
Instead, the document details:
- Device Description: What the Silverlon™ Wound Packing Strips are made of (silver-nylon), how they function (intimate wound contact, fluid passage, antimicrobial protection), and their physical properties.
- Intended Use/Indications for Use: Control of local wound bleeding/nasal hemorrhage, encouraging fluid drainage, and helping remove necrotic tissue, especially in "wet-to-dry" packing.
- Predicate Devices: Argentum Research's Silverlon™ Contact Wound Dressing (K981299) and Johnson and Johnson's Nu Gauze Packing Strips.
- Substantial Equivalence Claim: The technological characteristics are substantially equivalent to predicate devices.
- Performance Data Assessment (Biocompatibility): The fabric was subjected to standard in vitro and in vivo biocompatibility tests (cytotoxicity, sensitization, acute intracutaneous reactivity, acute systemic toxicity, and tissue compatibility via muscle implantation study) according to ISO 10993. These studies, performed by North American Science Associates, Inc. (NAMSA), indicated safety for intended use.
Therefore, I cannot populate the requested table or answer most of the questions because the document does not provide acceptance criteria, performance metrics (like sensitivity, specificity), ground truth establishment, sample sizes for test/training sets, or details of efficacy studies in the context of clinical performance or AI/software.
The provided text describes a submission for a wound dressing, and the "performance data" mentioned refers to biocompatibility testing, not clinical efficacy metrics or performance criteria as might be expected for a diagnostic or AI-driven device.
Based on the provided text, the requested information cannot be fully extracted as it is not present. The document focuses on regulatory approval (510(k)) via substantial equivalence and biocompatibility, not a clinical trial proving a specific performance metric against acceptance criteria.
Summary of what can be inferred from the text:
- Acceptance Criteria & Reported Device Performance: Not explicitly stated in terms of quantitative clinical performance metrics (e.g., sensitivity, specificity, accuracy). The implicit "acceptance criterion" for the 510(k) process is "substantial equivalence" to predicate devices and acceptable biocompatibility.
- Biocompatibility Study: The study mentioned is a series of in vitro and in vivo biocompatibility tests (cytotoxicity, sensitization, acute intracutaneous reactivity, acute systemic toxicity, tissue compatibility via muscle implantation).
- Sample Size for Test Set: Not specified for biocompatibility studies beyond mentioning "tests."
- Data Provenance: Studies performed by North American Science Associates, Inc. (NAmSA), Northwood, Ohio. These are laboratory/animal studies, not human clinical trials.
- Number of Experts/Qualifications: Not specified; typically, such tests are conducted by trained laboratory personnel following standard protocols.
- Adjudication Method: Not applicable for standard biocompatibility testing.
- MRMC Comparative Effectiveness Study: Not applicable; this is for assessing human reader performance.
- Standalone Performance: The biocompatibility tests are for the material itself.
- Type of Ground Truth: For biocompatibility, the ground truth is established by the standard protocols of ISO 10993 (e.g., absence of cytotoxicity, sensitization, etc.).
- Sample Size for Training Set & Ground Truth for Training Set: Not applicable for this type of submission. The device is a physical dressing, not an AI/software.
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