(85 days)
BIONECT® Hydrogel Foam 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® Hydrogel Foam may also be used under the care of a health care professional for wounds such as partial to full thickness dermal ulcers (pressure ulcers, venous stasis ulcers, arterial ulcers, diabetic ulcers), surgical wounds (post-opcrative incisions and donor sites), and second degree burns.
BIONECT® Hydrogel Foam is a white foam 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® Hydrogel Foam, since it is a hydrogel dressing, provides a soothing, moist environment that is supportive to wound healing.
The provided document is a 510(k) summary for the BIONECT® Hydrogel Foam and related products. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria in the way a novel AI diagnostic device might.
Therefore, many of the requested categories for AI/diagnostic device studies (like sample size for test sets, expert qualifications, MRMC studies, ground truth types) are not applicable or not explicitly stated in this type of submission.
However, I can extract information related to performance assessment and "acceptance criteria" as implied by the FDA's review process for substantial equivalence.
Here's a breakdown of the relevant information:
Acceptance Criteria and Reported Device Performance
Note: The "acceptance criteria" here are implied by the FDA's standard for substantial equivalence for this type of medical device (wound dressing), which primarily focuses on safety and efficacy being equivalent to a legally marketed predicate device. Specific quantitative thresholds (e.g., sensitivity, specificity) common in diagnostic device studies are not present.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance |
|---|---|
| Biocompatibility: | In vitro and in vivo biocompatibility testing (cytotoxicity, dermal irritation, and dermal sensitization tests) was performed on BIONECT® Hydrogel Foam. |
| - Cytotoxicity | Studies performed. |
| - Dermal Irritation | Studies performed. |
| - Dermal Sensitization | Studies performed. |
| Safety for Intended Use: | Clinical experience with predicate devices (BIONECT® Hydrogel and BIONECT® Hydrogel Gauze Pads) in 22 European clinical trials (17 controlled) involving various types of ulcers, burns, and surgical wounds indicates that BIONECT® Hydrogel Foam is safe for its intended use. |
| Functional Equivalence: | BIONECT® Hydrogel Foam provides a moist wound environment supportive to wound healing, similar to the predicate device. Technological characteristics such as form, occlusion, conformability, bioburden level, moist wound healing, and appearance when hydrated are not different from the predicate device. |
| Intended Use Equivalence: | The indication statements for BIONECT® Hydrogel Foam are not different from the predicate device: dressing and management of minor burns; superficial cuts, lacerations, and abrasions; minor irritations of the skin; and under professional care for partial to full thickness dermal ulcers, surgical wounds, and second-degree burns. |
Study Details
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Sample size used for the test set and the data provenance:
- Test set sample size: Not explicitly stated for the BIONECT® Hydrogel Foam directly. The document refers to "22 clinical trials (17 controlled) conducted in Europe" with the predicate devices (BIONECT® Hydrogel and BIONECT® Hydrogel Gauze Pads). The number of patients in these trials is not specified.
- Data provenance: Europe (for the clinical trials on predicate devices). The data for biocompatibility testing is not specified in terms of origin, but it is implied to be laboratory testing. The submission itself is dated February 1, 1999, making it retrospective relative to the submission date.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For this type of device (wound dressing) and submission (510(k) for substantial equivalence), ground truth is not typically established by expert consensus on specific cases in the same way as for an AI diagnostic algorithm. The safety and efficacy data from clinical trials on predicate devices serve as the basis for comparison.
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Adjudication method for the test set: Not applicable. There is no mention of adjudication for a test set in the context of this 510(k) submission.
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If a multi-reader, multi-case (MRMC) comparative effectiveness study was done: No, an MRMC comparative effectiveness study was not done. This type of study is typically for evaluating the impact of AI assistance on human reader performance, which is not relevant for a wound dressing submission focused on substantial equivalence.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No, a standalone algorithm performance study was not done. This device is a physical wound dressing, not an algorithm.
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The type of ground truth used:
- For biocompatibility: Laboratory test results (cytotoxicity, dermal irritation, dermal sensitization).
- For safety/efficacy (by inference from predicate): Clinical outcomes from human patients with various wound types (ulcers, burns, surgical wounds) treated with the predicate devices. This would involve standard clinical assessments, which would serve as the "ground truth" for the predicate's performance.
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The sample size for the training set: Not applicable. This document describes a physical medical device, not an AI algorithm, so there is no training set in the machine learning sense. Clinical experience with predicate devices serves as the basis for demonstrating similarity.
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How the ground truth for the training set was established: Not applicable, as there is no training set.
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