(274 days)
IODOSORB is indicated for use in managing wet ulcers and wounds such as venous stasis ulcers, pressure sores, and infected traumatic and surgical wounds. IODOSORB assists in wound area protection and in reducing the microbial load in the wound dressing, retards eschar formation and keeps the lesion soft and pliable.
IODOSORB consists of 0.1mm diameter biodegradable spherical hydrophilic beads of cadexomer which incorporate 0.9% weight per weight iodine mixed with polyethylene glycols and poloxamer. The beads are composed of a three dimensional network of macromolecular chains of cross-linked cadexomer which is large enough to allow substances with a molecular weight of less than 1,000 to enter freely. As with all products having these characteristics, substances with a molecular weight of 1000 - 5000 enter the beads less freely, while those with a molecular weight greater than 5000 remain in the interspaces between the beads.
I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a medical device called IODOSORB. It primarily addresses the regulatory approval process and states that the device is substantially equivalent to a predicate device.
Specifically, the document does not include:
- Acceptance criteria for device performance.
- Results of a study proving the device meets acceptance criteria.
- Sample sizes for test or training sets.
- Data provenance (country of origin, retrospective/prospective).
- Number or qualifications of experts for ground truth establishment.
- Adjudication methods.
- Information about multi-reader multi-case (MRMC) studies or effect sizes.
- Stand-alone algorithm performance data.
- Type of ground truth used (e.g., pathology, outcomes data).
- How ground truth for training data was established.
The "Comparison of Technological Characteristics with the Predicate Device" section explicitly states: "No changes have been made to the product other than labeling changes (e.g. contraindications, precautions/warnings). As the changes to the labeling do not affect the product performance, the product remains substantially equivalent to the predicate device." This suggests that extensive performance studies, as you've requested, were likely not required for this 510(k) submission, as the fundamental device itself (IODOSORB) was already cleared as a predicate device (IODOSORB GEL- K905069).
Therefore, I cannot generate the table or answer the specific questions based on the provided text.
N/A