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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.

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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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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BIONECT® Hydrogel Foam 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 Foam is a white foam that is prepared from sodium hyaluronate and purified water to form a hydrogel dressing. BIONECT® Hydrogel Foam, since it is a hydrogel dressing, provides a soothing, moist environment that is supportive to wound healing.

The provided text is a 510(k) Premarket Notification for BIONECT® Hydrogel Foam and does not contain information about acceptance criteria or a study designed to prove the device meets specific performance criteria.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (BIONECT® Hydrogel) by comparing technological characteristics, intended use, and providing a summary of prior biocompatibility testing and clinical experience.

Here's a breakdown of what is and is not in the document, based on your request:

What IS in the document:

• BIONECT® Hydrogel Foam Device Description: It's a white foam prepared from sodium hyaluronate and purified water, designed to provide a soothing, moist environment for wound healing.
• Intended Use: Dressing and management of partial to full thickness dermal ulcers, various wounds (cuts, abrasions, donor sites, post-operative incisions), skin irritations, and first and second-degree burns.
• Predicate Device: BIONECT® Hydrogel.
• Biocompatibility Testing: In vitro and in vivo testing (cytotoxicity, dermal irritation, dermal sensitization) was performed on the bulk solution in accordance with FDA recommendations (ISO-10993). These tests supported safe use. This is a type of performance data, but not framed as meeting specific numerical acceptance criteria.
• Clinical Experience (for predicate device/similar products): "Clinical experience with BIONECT® Hydrogel and BIONECT® Hydrogel Gauze Pads in 22 clinical trials (17 controlled) conducted in Europe in patients with various types of ulcers, burns, and surgical wounds indicates that BIONECT® Hydrogel Foam is safe for its intended use." This is a statement of safety based on past clinical use, but lacks specific statistical performance metrics for the proposed device.
• FDA Clearance: The FDA found the device substantially equivalent to a legally marketed predicate device, with specific limitations on labeling (e.g., not for third-degree burns, no claims of accelerating wound healing).

What IS NOT (or not sufficiently) in the document to fulfill your request:

1. A table of acceptance criteria and the reported device performance: No specific, quantifiable acceptance criteria (e.g., "must demonstrate a 90% wound closure rate by X weeks") are listed, nor are numerical performance results against such criteria. The document relies on substantial equivalence and a general statement of safety from prior clinical experience.
2. Sample size used for the test set and the data provenance: The document mentions "22 clinical trials (17 controlled) conducted in Europe" for related products (BIONECT® Hydrogel and BIONECT® Hydrogel Gauze Pads). This is a general reference to support safety for the intended use of the new foam, not a specific "test set" for the foam itself with detailed provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there isn't a described "test set" with ground truth established by experts in the context of device performance metrics.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and effect size: Not applicable, as this device is not an imaging or diagnostic AI device. The document describes a medical dressing.
6. If a standalone performance study was done: The biocompatibility tests are standalone performance tests for material safety, but not for its clinical efficacy in wound healing against specific benchmarks. The clinical experience refers to related products.
7. The type of ground truth used: Not applicable in the context of quantitative performance ground truth, but implicitly, "safety for its intended use" from clinical trials would have relied on physician assessments of patient outcomes.
8. The sample size for the training set: Not applicable, as this is a medical device (hydrogel foam), not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided submission (K973722) for BIONECT® Hydrogel Foam focuses on demonstrating substantial equivalence to a predicate device and relies on prior biocompatibility testing and general clinical experience with similar hydrogel products to assert its safety and intended use, rather than presenting a study with specific, quantifiable acceptance criteria and performance data for the device itself.

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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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