(216 days)
Coreleader Hydro-clear is indicted for the management of 1st and 2nd degree burns, chronic ulcers, surgical wounds, skin graft and donor sites.
Patient with conditions listed below is considered appropriate for Over-The Counter Use (OTC): for the management of minor cuts, minor burns (1st degree burns), minor lacerations and minor cuts.
Coreleader Hydro-clear is a new product that is made of Hydrocolloid (Sodium carboxymethyl cellulose, Synthetic Elastomer, Tackifier Resins, Mineral Oil and Polyurethane film) by unique production process. With preferable liquid absorbsion ability, gas permeability and ability of water resistant, Hydro-clear is clear of adhesive onto wound, capable to absorb exudates, protect wound site and facilitates would healing process.
The provided document is a 510(k) Summary for the Coreleader Hydro-clear Hydrocolloid Wound Dressing. It describes the device, its intended use, and compares its technological characteristics to a predicate device. However, it does not contain information about a study that assesses the device's performance against acceptance criteria in the context of an AI/algorithm-driven medical device.
The "Technological Characteristics" section lists physical properties like thickness, peeling adhesion, holding power, elongation, and tensile strength. These are likely engineering specifications, not clinical performance metrics derived from a study on patient outcomes or AI accuracy.
Therefore, most of the requested information regarding study details, sample sizes, expert involvement, and ground truth establishment cannot be extracted from this document, as it pertains to the regulatory submission of a physical wound dressing, not an AI-enabled diagnostic or therapeutic tool.
Here's a breakdown of what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes "Technological Characteristics" which serve as specifications for the wound dressing. While these are not explicitly presented as "acceptance criteria" in the context of a clinical study or AI performance evaluation, they represent the product's measured physical properties.
| Characteristic | Acceptance Criteria (from predicate/internal specification) | Reported Device Performance |
|---|---|---|
| Thickness | (Not explicitly stated as criteria, but 0.5 mm is listed) | 0.5 mm |
| Peeling Adhesion | (Not explicitly stated as criteria, but 687 g/25 mm is listed) | 687 g/25 mm |
| Holding Power | (Not explicitly stated as criteria, but 140 min/onch is listed) | 140 min/onch |
| Elongation | (Not explicitly stated as criteria, but 235 % is listed) | 235 % |
| Tensile Strength | (Not explicitly stated as criteria, but 2360 g/25 mm is listed) | 2360 g/25 mm |
Note: The document implies these characteristics are comparable to the predicate device, but specific acceptance criteria (e.g., "must be greater than X" or "within Y range") are not explicitly stated for each characteristic.
The following information cannot be found in the provided document:
- 2. Sample size used for the test set and the data provenance: This document is for a physical wound dressing, not an AI/algorithm device that would have a "test set" of data.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI device is based on expert labels or pathology, which is not part of this submission for a wound dressing.
- 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs. without AI assistance: Not applicable. This is for an AI-assisted diagnostic.
- 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a wound dressing for its characteristics listed.
- 8. The sample size for the training set: Not applicable to a wound dressing.
- 9. How the ground truth for the training set was established: Not applicable to a wound dressing.
In summary: The provided document describes the physical and chemical properties of a wound dressing for regulatory approval. It does not concern an AI/algorithm-driven device and therefore lacks all the study-related details typically required for such a device.
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