(357 days)
BIONECT® Hydrogel Gauze Pads are indicated for the dressing and management of partial to full thickness dermal ulcers (pressure sores, venous stasis ulcers, arterial ulcers, diabetic ulcers), wounds including cuts, abrasions, donor sites, and post-operative incisions, irritations of the skin, and first and second degree burns.
BIONECT® Hydrogel Gauze Pads are sterile cotton gauze pads impregnated with a 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® Hydrogel Gauze Pads, since they are a hydrogel dressing, provide a soothing, moist environment that is supportive to wound healing.
The provided text describes a 510(k) premarket notification for Bionect® Hydrogel Gauze Pads. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than establishing primary effectiveness through new, controlled clinical trials with specific acceptance criteria as might be seen for novel therapeutic devices or diagnostic AI. Therefore, the information requested for AI/diagnostic devices will not be fully present in this documentation.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
Formal acceptance criteria for performance benchmarks (e.g., sensitivity, specificity, accuracy) are not applicable in this 510(k) summary because it is not an AI diagnostic or therapeutic device. The "performance" being evaluated is primarily the safety and technological characteristics in comparison to a predicate device, not diagnostic accuracy or treatment efficacy against a specific metric.
The document states:
- "In vitro and in vivo biocompatibility testing (cytotoxicity, dermal irritation, and dermal sensitization tests) has been performed... These tests all support the safe use of BIONECT® Hydrogel Gauze Pads..."
- "Clinical experience with BIONECT® Hydrogel Gauze Pads in approximately 430 patients... indicates that BIONECT® Hydrogel Gauze Pads are safe for their intended use."
The acceptance criteria here are implicitly:
- Biocompatibility tests pass safety standards.
- Clinical experience shows no unexpected or significant safety concerns.
- Technological characteristics (occlusion, bioburden, moist wound healing) are "not different from the predicate device."
| Acceptance Criteria (Implied for 510(k) - Safety & Equivalence) | Reported Device Performance |
|---|---|
| Biocompatibility (cytotoxicity, dermal irritation, sensitization) meets FDA recommendations. | All tests "support the safe use of BIONECT® Hydrogel Gauze Pads as a hydrogel temporary dressing in contact with breached or compromised skin." |
| Clinical safety in intended use environment. | "Clinical experience... in approximately 430 patients... indicates that BIONECT® Hydrogel Gauze Pads are safe for their intended use." |
| Technological characteristics (occlusion, bioburden level, moist wound healing) are not different from the predicate device. | "The technological characteristics of the device... are not different from the predicate device cited." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Clinical Experience): Approximately 430 patients.
- Data Provenance: The document states "16 clinical trials (13 controlled)." It does not specify the country of origin, but given the submission is to the U.S. FDA, it is likely that at least some, if not all, of these studies were conducted in a manner acceptable for US regulatory purposes. The studies are described as "clinical experience," implying they were prospective observations or trials, though detailed design is not provided. They are prospective data from clinical trials.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable/provided in this 510(k) document. The clinical experience mentioned likely involved medical professionals managing patient wounds, but the context is not about establishing a "ground truth" for an AI algorithm's output. The "ground truth" implicitly would be the clinical assessment of wound healing and safety by treating physicians, but this is not framed as an expert ground truth for evaluating an algorithm.
4. Adjudication Method for the Test Set
This information is not applicable/provided. The clinical experience likely involved physician assessment, but there's no mention of a formal adjudication method for a "test set" in the context of an algorithm or diagnostic performance.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of human readers improving with AI vs. without AI assistance
There was no MRMC comparative effectiveness study and no AI component to this device. BIONECT® Hydrogel Gauze Pads are a physical wound dressing, not an AI-powered diagnostic or therapeutic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
There was no standalone algorithm performance study as this is not an AI device.
7. The type of ground truth used
The closest concept to "ground truth" for this device would be:
- Biocompatibility test results: Objective laboratory measures against established ISO standards.
- Clinical observations/outcomes: Physician's assessment of wound healing, adverse events, and safety during the 16 clinical trials. This is based on expert clinical judgment and patient outcomes.
8. The Sample Size for the Training Set
This is not applicable/provided. There is no AI model, and therefore no training set. The "clinical experience" with 430 patients and biocompatibility tests serve as the data supporting the device's safety and equivalence.
9. How the Ground Truth for the Training Set was Established
This is not applicable/provided. There is no AI model or training set in the context of this device and 510(k) submission.
N/A