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BIONECT® Hydrogel Spray 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 Spray 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® Hydrogel Spray is a clear, colorless, aqueous solution that is prepared from sodium hyaluronate and purificd water to form a hydrogel dressing. Sodium hyaluronate is a polysaccharide biopolymer that can increase the viscosity of the gel. BIONECT® Hydrogel Spray, since it is a hydrogel dressing, provides a soothing, moist environment that is supportive to wound healing.

The provided text describes the BIONECT® Hydrogel Spray, a medical device for wound dressing. However, the document is a 510(k) Premarket Notification summary from 1999, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with specific acceptance criteria and performance metrics typically found in recent AI/ML device submissions.

Based on the provided text, the following information can be extracted or reasonably inferred:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly stated in the provided document. The 510(k) submission for BIONECT® Hydrogel Spray relies on demonstrating substantial equivalence to a predicate device (BIONECT® Hydrogel) and general biocompatibility testing. The acceptance criteria for the "device performance" in modern terms (e.g., accuracy, sensitivity, specificity) for an AI/ML device are not applicable here.

The document states:

• "BIONECT® Hydrogel Spray provides a moist wound environment that is supportive to wound healing." (This is the intended function).
• "These indication statements are not different from the predicate device identified in paragraph (3) of this section."
• "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 device cited."

Therefore, the "performance" accepted is that it functions equivalently to the predicate device in providing a moist wound environment and has similar technological characteristics.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: "Clinical experience with BIONECT® Hydrogel Spray in approximately 45 patients with various types of ulcers and surgical wounds..."
• Data Provenance: "...all conducted in Europe..." These were clinical trials, so they were prospective in nature.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document. The document refers to "clinical experience," which implies medical observation and assessment by healthcare professionals, but does not specify how "ground truth" (e.g., wound healing assessment) was established or adjudicated, nor the number or qualifications of experts involved in that process.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically associated with diagnostic imaging or AI/ML devices where the performance of human readers with and without AI assistance is evaluated. The BIONECT® Hydrogel Spray is a wound dressing, not a diagnostic or AI-powered device.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

No, a standalone (algorithm-only) performance study was not done. The device is a physical hydrogel spray, not an algorithm.

7. The Type of Ground Truth Used

The document broadly refers to "clinical experience" and "safe use" based on observations in patients with "various types of ulcers and surgical wounds." This implies that the ground truth was based on clinical assessment and outcomes data (e.g., whether the device was safe and supportive of wound healing in a clinical setting).

8. The Sample Size for the Training Set

This information is not applicable and not provided. The BIONECT® Hydrogel Spray is a physical medical device, not an AI/ML algorithm that requires a training set. The clinical "experience" mentioned (45 patients) would be considered the human-observed performance data, not a training set for an algorithm.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable and not provided as there is no AI/ML algorithm requiring a training set in this context.

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