(85 days)
BIONECT Hydrogel, Gauze Pads, Foam, Spray, and Clear Hydrogel are indicated for the dressing and munagement 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 these products to delermine whether these conditions exist. BIONECT Hydrogel, Gauze Pads, Fourn, Spray, and Clear Hydrogel 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-operative incisions and donor sites), and second degree burns.
BIONECT Hydrogel is propared 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 was designed to provide a soothing, moist environment that is supportive to wound healing.
The provided text describes the BIONECT® Hydrogel, and its substantial equivalence to predicate devices, rather than a study with specific acceptance criteria and detailed performance metrics. The information focuses on regulatory approval (510(k) summary) and intended use. Therefore, a direct answer to the request for acceptance criteria and a study proving device performance as typically expected from a clinical trial with statistical outcomes is not fully available in the provided text.
Based on the provided text, here's an attempt to answer the questions, highlighting what information is present and what is missing:
1. Table of acceptance criteria and the reported device performance
The provided document is a 510(k) summary and not a clinical study report. It focuses on demonstrating "substantial equivalence" of BIONECT® Hydrogel to already marketed predicate devices based on technological characteristics and intended use. Therefore, explicit, quantitatively defined "acceptance criteria" and direct, statistically reported "device performance" in the sense of a new clinical trial proving efficacy against a predefined benchmark are not presented. The "performance" is primarily described in terms of biocompatibility and safety, and by claiming equivalence to predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety: Biocompatibility (cytotoxicity, dermal irritation, dermal sensitization) | Met: In vitro and in vivo biocompatibility testing performed in accordance with FDA recommendations (ISO-10993). These tests "all support the safe use of BIONECT® Hydrogel as a hydrogel temporary dressing in contact with breached or compromised skin." |
| Met: Clinical experience in approximately 600 patients in 21 clinical trials (18 controlled) conducted in Europe indicates BIONECT® Cream (a related product) is safe for its intended use. (Note: This refers to BIONECT Cream, not directly Hydrogel, but is cited as supporting safety. Specific performance metrics like adverse event rates are not provided.) | |
| Technological Equivalence: Form, occlusion, conformability, bioburden level, moist wound healing, appearance in the wound when hydrated vs. predicate devices. | Met: "The technological characteristics of the device such as form, occlusion, conformability, bioburden level, moist wound healing, and appearance in the wound when hydrated are not different from the predicate devices cited." |
| Intended Use Equivalence: Indications for use being the same as predicate devices. | Met: "These indication statements are not different from the predicate device identified in paragraph (3) of this section." (Paragraph (3) refers to predicate devices like Argidene™ Gel, Carrasyn™ Hydrogel Wound Dressing, and DuoDERM Hydroactive™ Gel). |
2. Sample size used for the test set and the data provenance
- Test Set (for biocompatibility): Not explicitly stated. The document mentions "in vitro and in vivo biocompatibility testing" but doesn't provide specific sample sizes for these tests.
- Test Set (for clinical experience): "approximately 600 patients with various types of ulcers, burns, and surgical wounds" across "21 clinical trials (18 controlled)".
- Data Provenance: Europe (for the clinical experience cited). The text does not specify retrospective or prospective. Given they are "clinical trials," they are typically prospective, but this is not explicitly stated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not provide this information. The clinical experience cited (from Europe) is referred to generally in support of safety, not as a ground-truthed test set for a specific AI or diagnostic device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not provide this information.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No such study is mentioned or implied. This device (BIONECT® Hydrogel) is a wound dressing, not an AI-assisted diagnostic or imaging device that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. BIONECT® Hydrogel is a physical wound dressing, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the biocompatibility tests, the ground truth would be established by the biological responses observed in the in vitro and in vivo models according to established standards. For the clinical experience (cited for safety), "outcomes data" related to safety (e.g., adverse events) would be the ground truth, though details aren't provided.
8. The sample size for the training set
Not applicable. This is a medical device (wound dressing), not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable.
Summary of Limitations from the Text:
The provided text is a 510(k) Premarket Notification summary for a wound dressing. Its purpose is to demonstrate substantial equivalence to existing devices for regulatory approval, primarily based on safety and similar technological characteristics, not to present a detailed clinical study with performance criteria for a novel device or AI. Therefore, most of the specific questions related to acceptance criteria, sample sizes for test/training sets, expert involvement, and advanced study designs (like MRMC) as commonly discussed for AI/diagnostic devices are not addressed in this type of document.
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