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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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BIONECT® Hydrogel Spray is 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 is a clear, colorless, aqueous solution 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 Spray, since it is a hydrogel dressing, provides a soothing, moist environment that is supportive to wound healing.

This document, K973724, is a 510(k) Premarket Notification for BIONECT® Hydrogel Spray. It describes the device, its intended use, and claims substantial equivalence to a predicate device, BIONECT® Hydrogel.

Here's an analysis of the provided information concerning acceptance criteria, clinical studies, and data provenance:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" in the typical sense of a medical device's performance metrics (e.g., sensitivity, specificity, accuracy). Instead, the acceptance for BIONECT® Hydrogel Spray appears to be based on:

• Substantial Equivalence: To the predicate device, BIONECT® Hydrogel. This implies that if the predicate device is considered safe and effective, and the new device is substantially equivalent in function, intended use, and technological characteristics, it will also be considered safe and effective.
• Biocompatibility: Showing that the device is not harmful when in contact with the body.
• Safety in Clinical Use: Demonstrating safety in human subjects for its intended use.

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

• Sample Size: "approximately 45 patients" were included in the clinical trials.
• Data Provenance:
  • Country of Origin: "all conducted in Europe."
  • Retrospective or Prospective: Not explicitly stated as retrospective or prospective, but clinical trials are generally prospective studies. Given the context of seeking premarket notification, these would typically be designed as prospective studies to gather safety and efficacy data.

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

This type of information is generally relevant for AI/CAD device submissions where expert consensus or adjudication is needed to define "ground truth" for image interpretation or diagnosis.

For a hydrogel wound dressing like BIONECT® Hydrogel Spray, the "ground truth" for safety and effectiveness is established through standard medical assessments of wound healing progress, adverse events, etc., conducted by treating physicians and medical staff. The document does not specify a number of experts or their qualifications for establishing ground truth in the clinical trials, as this is typically inherent in the conduct of clinical investigations by medical professionals.

4. Adjudication Method for the Test Set

Again, adjudication methods like 2+1 or 3+1 are primarily used in AI/CAD studies where there's a need to resolve discrepancies in expert interpretation of data (e.g., medical images).

For a wound dressing study, clinical outcomes are assessed by the treating physicians and investigators. There is no mention of an explicit adjudication method for the clinical trial results in this document. Any disputes or differing opinions on patient outcomes would typically be resolved through standard clinical practice and protocol adherence, rather than a formal expert adjudication panel as seen in AI studies.

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

No. An MRMC study is relevant for evaluating human reader performance, especially with or without an AI assist, in interpreting medical images or data. BIONECT® Hydrogel Spray is a wound dressing, not an imaging or diagnostic device. Therefore, no MRMC comparative effectiveness study was done or would be applicable for this type of device.

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

No. This concept is applicable to AI/CAD algorithms that provide automated analysis. BIONECT® Hydrogel Spray is a physical medical device (a hydrogel dressing), not an algorithm. Therefore, no standalone performance assessment (in the context of an algorithm) was done.

7. The Type of Ground Truth Used

For the clinical trials, the "ground truth" for the device's safety and effectiveness would be based on:

• Clinical Outcomes Data: This includes observations of wound healing progression (e.g., reduction in wound size, epithelization), resolution of skin irritations, absence of infection, and reporting of adverse events. These are assessed by clinicians following established clinical protocols.
• Patient Feedback: (Implicitly) regarding comfort, pain, and other subjective experiences.

8. The Sample Size for the Training Set

There is no mention of a "training set" as this term is specific to machine learning and AI model development. This device is a hydrogel dressing, not an AI product.

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

Since there is no AI component or "training set," this question is not applicable. The ground truth for the clinical studies (for safety and function) was established through direct clinical observation and assessment by medical professionals in the context of the clinical trials.

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