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510(k) Data Aggregation
(266 days)
Biatain Fiber Ag (33570 - 5 cm x 5 cm / 2 in x 2 in); Biatain Fiber Ag (33572 - 10 cm x 12 cm / 4 in
The product is indicated for use on moderate to highly exuding acute and chronic wounds such as:
- · Diabetic ulcers
- · Leg ulcers (arterial ulcers, venous ulcers and leg ulcers of mixed etiology)
- · Pressure injuries (stage 2-4)
- Traumatic wounds
- · Partial thickness (second degree) burns
- · Donor sites
- · Post-operative surgical wounds
- · Exudate absorption in oncology wounds, such as fungoides-cutaneous tumors, fungating carcinoma, cutaneous metastasis, Kaposi's sarcoma, and angiosarcoma
Biatain Fiber Ag is a soft, sterile, primary wound dressing made mainly from non-woven gelling carboxymethyl cellulose (CMC) fibers. In addition, non-gelling bicomponent (BiCo) fibers are incorporated to obtain strength and integrity of the products both in dry and gelled condition. Ionic silver (Ag+) is added for antimicrobial efficacy within the dressing, and ethyl lauroyl arginate (LAE) is added as combined surfactant and chelator within the dressing.
The provided text is a 510(k) summary for the Biatain Fiber Ag wound dressing. This document describes the device, its indications for use, comparison with a predicate device, and performance data to support its substantial equivalence. However, it does not contain information about an AI/ML-enabled medical device study, nor does it describe acceptance criteria and performance in the context of AI/ML algorithms.
Therefore, I cannot provide details on the following, as they are not present in the document:
- A table of acceptance criteria and reported device performance related to AI/ML.
- Sample size used for the test set and data provenance.
- Number of experts and their qualifications for ground truth.
- Adjudication method for the test set.
- MRMC comparative effectiveness study or human reader improvement with AI.
- Standalone algorithm performance.
- Type of ground truth used for AI/ML.
- Sample size for the training set.
- How ground truth for the training set was established.
Instead, the document details the performance data for a traditional wound dressing:
1. Performance Data Provided (Related to a traditional wound dressing):
| Test Category | Acceptance Criteria/Method | Reported Device Performance |
|---|---|---|
| Biocompatibility | Conformance with ISO 10993-1:2018 | Concluded that the dressings have a safe toxicological profile for their intended use. Battery of tests included: Cytotoxicity, Irritation, Sensitization, Acute systemic toxicity, Sub-acute systemic toxicity, Pyrogenicity, Implantation. |
| Physical/Mechanical Properties | Not explicitly stated "acceptance criteria" values, but testing was conducted on key performance parameters. | Absorption capacity, Fluid retention capacity, Wet strength (gelled condition), Lateral shrinkage upon absorption, Volume expansion upon absorption, Lateral spreading of fluid. (No specific numerical results provided in the summary). |
| Antimicrobial Effectiveness within the Dressing | ≥4 log reduction (AATCC 100) antimicrobial effectiveness against specified organisms for up to 7 days. | Confirmed by in vitro tests. Achieved ≥4 log reduction (AATCC 100) against 9 organisms (3 Gram positive bacteria, 4 Gram negative bacteria, 1 yeast, and 1 mold) for up to 7 days within the dressing. |
| Animal Study | Wound healing performance not hindered. | A full thickness wound healing model in porcine study demonstrated that Biatain Fiber Ag and the predicate device did not hinder the wound healing process. |
Summary of Device and Study Type:
The document describes performance data for the Biatain Fiber Ag, which is a wound dressing, not an AI/ML device. The studies listed are standard performance tests for such a product to demonstrate its safety and effectiveness in its intended use, particularly for absorbency, wet strength, and antimicrobial properties.
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