(85 days)
BIONECT® Clear Hydrogel provides a moist wound environment that is supportive to wound healing. It indicated for the dressing and management of minor burns; superficial cuts, lacerations, and abrasions; and minor irritations of the skin. A health care professional may be consulted prior to the first use of this product to determine whether these conditions exist. BIONECT Clear Hydrogel may also be used under the care of a health care professional for wounds such as partial to full thickness dermal uicers (pressure ulcers, venous stasis ulcers, arterial ulcers, diabetic ulcers), surgical wounds (post-operative incisions and donor sites), and second degree burns.
BIONECT® Clear Hydrogel is a clear, colorless, hydrogel that is prepared from sodium hyaluronate and purified water to form a hydrogel dressing. Sodium hyaluronate is a polysaccharide biopolymer that can increase the viscosity of the gel. BIONECT® Clear Hydrogel, since it is a hydrogel dressing, provides a soothing, moist environment that is supportive to wound healing.
The provided text describes the 510(k) summary for BIONECT® Clear Hydrogel and related devices. However, it does not contain a study report with specific acceptance criteria and detailed performance results in the format requested. The document focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and safety data.
Here's a breakdown of the information available and what is not present:
A. Acceptance Criteria and Device Performance Table:
| Criteria/Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Safe for use as a hydrogel temporary dressing in contact with breached or compromised skin (implied by "support the safe use") | Passed in vitro and in vivo tests (cytotoxicity, dermal irritation, dermal sensitization) in accordance with FDA recommendations. Clinical experience in 22 trials (17 controlled) in Europe supports safety. |
| Technological Characteristics (vs. Predicate) | Not different from the predicate device | Form, occlusion, conformability, moisture level, moist wound healing enhancement, and appearance when hydrated are not different from the predicate device (BIONECT® Hydrogel). |
| Intended Use | Provides a moist wound environment supportive to wound healing | Serves as a dressing and management for minor burns; superficial cuts, lacerations, and abrasions; minor irritations of the skin. Can also be used under professional care for partial to full thickness dermal ulcers, surgical wounds, and second-degree burns. |
B. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not explicitly stated as a separate "test set" in the context of the requested performance study. The document mentions "clinical experience with BIONECT® Hydrogel and BIONECT® Hydrogel Gauze Pads in 22 clinical trials (17 controlled) conducted in Europe in patients with various types of ulcers, burns, and surgical wounds." The specific number of patients across these trials is not provided.
- Data Provenance: Europe (clinical trials). The data is described as "clinical experience," which implies retrospective analysis of previously conducted trials, though it doesn't explicitly state "retrospective" or "prospective." Given the timeframe (1999 submission), it's highly likely this refers to data already collected.
C. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The document refers to "clinical experience" and "health care professionals" for indications but does not detail how ground truth was established for the clinical trials.
D. Adjudication method for the test set:
- This information is not provided in the document.
E. 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:
- This information is not applicable and not provided. The device is a hydrogel dressing, not an AI-powered diagnostic or assistive tool for human readers.
F. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
- This information is not applicable and not provided. The device is a medical product, not an algorithm.
G. The type of ground truth used:
- For the biocompatibility tests: Laboratory test results (cytotoxicity, dermal irritation, dermal sensitization).
- For the clinical experience: Implied clinical outcomes and observations by healthcare professionals in Europe. The document doesn't specify if this involved pathology, objective outcome measures, or expert consensus as a formal "ground truth" definition in the context of a modern AI study.
H. The sample size for the training set:
- This information is not applicable and not provided. The device is not an AI model that requires a "training set."
I. How the ground truth for the training set was established:
- This information is not applicable and not provided.
Summary of Missing Information:
The provided document is a 510(k) summary for a medical device (hydrogel dressing), not the report of a study designed to evaluate an AI algorithm's performance against specific acceptance criteria. Therefore, many of the requested details related to sample sizes for training/test sets, expert adjudication, MRMC studies, and AI-specific ground truth establishment are not present because they are not relevant to this type of medical device submission. The performance assessment primarily relies on biocompatibility testing and existing clinical experience with similar products to demonstrate safety and substantial equivalence.
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