(183 days)
scaffolene® CL100 Bioresorbable Collagen Matrix is indicated for the management of full and partial thickness wounds in adult patients including:
Pressure ulcers Diabetic ulcers Ulcers caused by mixed vascular etiologies Venous ulcers Second degree burns Donor and graft sites Abrasions Dehisced surgical wounds Traumatic wounds healing by secondary intention
scaffolene® CL100 Bioresorbable Collagen Matrix is a collagen wound dressing provided sterile, which maintains a moist wound environment and supports exudate management. It can be cut to wound size, is a pliable absorbent dressing and can be adapted to irregular wound surfaces. scaffolene® CL100 Bioresorbable Collagen Matrix is resorbable and it can be left in place during secondary dressing changes.
scaffolene® CL100 Bioresorbable Collagen Matrix will typically resorb in about 1-3 days (shown in wound healing study in vivo), although this will be influenced by the patient's overall health. It is not necessary to remove the wound dressing.
This document is an FDA 510(k) clearance letter for a medical device: scaffolene CL100 Bioresorbable Collagen Matrix. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy through large-scale clinical trials that would generate acceptance criteria and performance data as you've requested.
Therefore, the document does not contain the information requested regarding acceptance criteria, device performance, sample sizes for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or specific details about training sets. These details are typically found in clinical study reports for novel devices or those demonstrating effectiveness, not usually in a 510(k) summary which relies on comparing technological characteristics and non-clinical data to a predicate.
The document states:
- "The following non-clinical data/information were provided to support a determination of substantial equivalence: Sterilization and Shelf-Life, Biocompatibility, Animal-Derived Materials Safety Information, Performance Testing Bench, Performance Testing Animal."
- "Non-clinical data demonstrate that scaffolene® CL100 Bioresorbable Collagen Matrix is as safe and as effective as the predicate device."
This indicates that the study focused on non-clinical tests (e.g., in vitro and animal studies) to show similarity in safety and performance to the predicate, rather than human clinical performance metrics.
In summary, none of the requested information about acceptance criteria, device performance metrics, human expert involvement, or training data for an AI/algorithm-based device can be extracted from this 510(k) document because it's a clearance for a collagen matrix based on substantial equivalence, not an AI or diagnostic device that would require such performance claims.
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