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BIONECT® Hydrogel Gauze Pads provide a moist wound environment that is supportive to wound healing. They are 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 Gauze Pads may also be used under the care of a health cure 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 Gauze Pads are sterile cotton gauze pads impregnated with a hydrogel that is prepared from sodium hyaluronate and purfied water to form a hydrogel dressing. Sodium hyaluronate is a polysaccharidc 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.

This document is a 510(k) Premarket Notification for BIONECT® Hydrogel Gauze Pads. It concerns the substantial equivalence of this device to a previously cleared predicate device. The information provided is primarily for regulatory approval and does not contain detailed acceptance criteria and study data in the way one might expect for a diagnostic or AI-driven device.

Based on the provided text, here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative "acceptance criteria" in terms of performance metrics like sensitivity, specificity, or accuracy, as would be common for diagnostic devices. Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device and showing safety and efficacy for its intended use through biocompatibility and clinical experience.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: "approximately 430 patients"
• Data Provenance: The document states "Clinical experience... in 16 clinical trials (13 controlled)." It does not specify the country of origin of the data or whether the studies were retrospective or prospective, though "clinical trials" generally implies prospective data collection.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable to the provided document. The "ground truth" for a wound dressing is typically the observed clinical outcome (e.g., wound healing, absence of adverse events), not a judgment requiring experts to establish a "truth" within a test set as would be for an AI diagnostic. The clinical trials themselves, overseen by healthcare professionals, establish the observed safety and efficacy.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable. Adjudication methods like "2+1" or "3+1" are typically used for establishing ground truth in diagnostic studies where multiple readers interpret images or data. For a wound dressing, the clinical outcomes are observed and recorded by the treating clinicians in the clinical trials.

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

This is not applicable to the provided document. The device is a wound dressing, not an AI-driven diagnostic or imaging aid that would involve human readers interpreting cases.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable to the provided document. The device is a physical wound dressing and does not involve an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for demonstrating the performance of BIONECT® Hydrogel Gauze Pads relies on outcomes data from clinical trials, specifically regarding safety and efficacy in wound healing, and biocompatibility testing results. The primary "truth" demonstrated is that the device is "safe for its intended use" and performs similarly to its predicate.

8. The sample size for the training set

This is not applicable to the provided document. As this is not an AI/machine learning device, there is no "training set." The clinical trials served as the basis for demonstrating safety and efficacy for real-world use.

9. How the ground truth for the training set was established

This is not applicable. There is no training set for this type of medical device.

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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."

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.

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