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BIONECT® Hydrogel Foam 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 Foam 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-opcrative incisions and donor sites), 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. Sodium hyaluronate is a polysaccharide biopolymer that can increase the viscosity of the gel. BIONECT® Hydrogel Foam, since it is a hydrogel dressing, provides a soothing, moist environment that is supportive to wound healing.

The provided document is a 510(k) summary for the BIONECT® Hydrogel Foam and related products. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria in the way a novel AI diagnostic device might.

Therefore, many of the requested categories for AI/diagnostic device studies (like sample size for test sets, expert qualifications, MRMC studies, ground truth types) are not applicable or not explicitly stated in this type of submission.

However, I can extract information related to performance assessment and "acceptance criteria" as implied by the FDA's review process for substantial equivalence.

Here's a breakdown of the relevant information:

Acceptance Criteria and Reported Device Performance

Note: The "acceptance criteria" here are implied by the FDA's standard for substantial equivalence for this type of medical device (wound dressing), which primarily focuses on safety and efficacy being equivalent to a legally marketed predicate device. Specific quantitative thresholds (e.g., sensitivity, specificity) common in diagnostic device studies are not present.

Study Details

1. Sample size used for the test set and the data provenance:

   • Test set sample size: Not explicitly stated for the BIONECT® Hydrogel Foam directly. The document refers to "22 clinical trials (17 controlled) conducted in Europe" with the predicate devices (BIONECT® Hydrogel and BIONECT® Hydrogel Gauze Pads). The number of patients in these trials is not specified.
   • Data provenance: Europe (for the clinical trials on predicate devices). The data for biocompatibility testing is not specified in terms of origin, but it is implied to be laboratory testing. The submission itself is dated February 1, 1999, making it retrospective relative to the submission date.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For this type of device (wound dressing) and submission (510(k) for substantial equivalence), ground truth is not typically established by expert consensus on specific cases in the same way as for an AI diagnostic algorithm. The safety and efficacy data from clinical trials on predicate devices serve as the basis for comparison.

3. Adjudication method for the test set: Not applicable. There is no mention of adjudication for a test set in the context of this 510(k) submission.

4. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done: No, an MRMC comparative effectiveness study was not done. This type of study is typically for evaluating the impact of AI assistance on human reader performance, which is not relevant for a wound dressing submission focused on substantial equivalence.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No, a standalone algorithm performance study was not done. This device is a physical wound dressing, not an algorithm.

6. The type of ground truth used:

   • For biocompatibility: Laboratory test results (cytotoxicity, dermal irritation, dermal sensitization).
   • For safety/efficacy (by inference from predicate): Clinical outcomes from human patients with various wound types (ulcers, burns, surgical wounds) treated with the predicate devices. This would involve standard clinical assessments, which would serve as the "ground truth" for the predicate's performance.

7. The sample size for the training set: Not applicable. This document describes a physical medical device, not an AI algorithm, so there is no training set in the machine learning sense. Clinical experience with predicate devices serves as the basis for demonstrating similarity.

8. How the ground truth for the training set was established: Not applicable, as there is no training set.

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

The provided text describes the 510(k) summary for BIONECT® Clear Hydrogel and related devices. However, it does not contain a study report with specific acceptance criteria and detailed performance results in the format requested. The document focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and safety data.

Here's a breakdown of the information available and what is not present:

A. Acceptance Criteria and Device Performance Table:

B. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: Not explicitly stated as a separate "test set" in the context of the requested performance study. The document mentions "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." The specific number of patients across these trials is not provided.
• Data Provenance: Europe (clinical trials). The data is described as "clinical experience," which implies retrospective analysis of previously conducted trials, though it doesn't explicitly state "retrospective" or "prospective." Given the timeframe (1999 submission), it's highly likely this refers to data already collected.

C. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This information is not provided in the document. The document refers to "clinical experience" and "health care professionals" for indications but does not detail how ground truth was established for the clinical trials.

D. Adjudication method for the test set:

• This information is not provided in the document.

E. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

• This information is not applicable and not provided. The device is a hydrogel dressing, not an AI-powered diagnostic or assistive tool for human readers.

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

• This information is not applicable and not provided. The device is a medical product, not an algorithm.

G. The type of ground truth used:

• For the biocompatibility tests: Laboratory test results (cytotoxicity, dermal irritation, dermal sensitization).
• For the clinical experience: Implied clinical outcomes and observations by healthcare professionals in Europe. The document doesn't specify if this involved pathology, objective outcome measures, or expert consensus as a formal "ground truth" definition in the context of a modern AI study.

H. The sample size for the training set:

• This information is not applicable and not provided. The device is not an AI model that requires a "training set."

I. How the ground truth for the training set was established:

• This information is not applicable and not provided.

Summary of Missing Information:

The provided document is a 510(k) summary for a medical device (hydrogel dressing), not the report of a study designed to evaluate an AI algorithm's performance against specific acceptance criteria. Therefore, many of the requested details related to sample sizes for training/test sets, expert adjudication, MRMC studies, and AI-specific ground truth establishment are not present because they are not relevant to this type of medical device submission. The performance assessment primarily relies on biocompatibility testing and existing clinical experience with similar products to demonstrate safety and substantial equivalence.

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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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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

The provided text describes a 510(k) submission for the BIONECT® Clear Hydrogel. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove the device meets specific acceptance criteria. This type of submission relies on comparisons to already approved devices.

Therefore, many of the requested details about acceptance criteria, specific study design, and performance metrics are not explicitly provided in the text. Here's a breakdown of the information available:

1. Table of Acceptance Criteria and Reported Device Performance:

No specific, quantitative acceptance criteria or corresponding performance results are provided in the document. The submission focuses on demonstrating that the new device is "substantially equivalent" to an existing predicate device (BIONECT® Hydrogel) in terms of function, intended use, and technological characteristics.

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

No explicit test set or sample size data is provided for the BIONECT® Clear Hydrogel itself.

However, the document states: "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® Clear Hydrogel is safe for its intended use."

This refers to studies on the predicate devices, not the new device. The data provenance is Europe, and the studies were clinical trials. It's not specified if these were retrospective or prospective, though clinical trials are typically prospective.

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

This information is not provided. The submission relies on existing clinical data from the predicate devices which would have had outcomes assessed by clinical staff, but the specific number and qualifications of experts for establishing ground truth are not detailed.

4. Adjudication Method for the Test Set:

This information is not provided.

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

No MRMC study is mentioned. The submission is a 510(k) for substantial equivalence, not a comparative effectiveness study of human readers with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Not applicable. This is a medical device (hydrogel dressing), not an AI algorithm.

7. The Type of Ground Truth Used:

For the "clinical experience" mentioned for the predicate devices, the ground truth would be based on clinical outcomes data (e.g., wound healing, absence of adverse events) observed directly in patients.

For the biocompatibility testing of the BIONECT® Clear Hydrogel, the ground truth would be established by the results of standardized in vitro and in vivo tests (cytotoxicity, dermal irritation, and dermal sensitization tests) against established safety benchmarks.

8. The Sample Size for the Training Set:

Not applicable as this is not an AI/algorithm-based device requiring a training set.

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

Not applicable.

Summary of what is available from the text:

• Device Performance (Claimed): The device functions by providing a soothing, moist environment supportive of wound healing, and is safe for its intended use.
• Proof of Performance (Implicit from 510(k) process): Substantial equivalence to predicate devices is claimed based on:
  • Similar function and intended use.
  • Similar technological characteristics (occlusion, bioburden level, moist wound healing).
  • Biocompatibility testing on the bulk solution of the BIONECT® Clear Hydrogel (in vitro and in vivo cytotoxicity, dermal irritation, and dermal sensitization tests) showing safe use.
  • Clinical experience with the predicate devices (BIONECT® Hydrogel and BIONECT® Hydrogel Gauze Pads) from 22 clinical trials (17 controlled) conducted in Europe.

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BIONECT® Cream 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. The dressing is intended to cover a wound or burn on a patient's skin, and protect against abrasion, friction, and desiccation.

BIONECT® Cream acts to provide a moist wound environment and protect the wound. BIONECT® Cream was designed to provide a soothing, moist environment for easy application to various types of wounds as a hydrogel dressing. BIONECT® Cream 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® Cream was designed to provide a moist wound healing environment.

The provided text describes a medical device called BIONECT® Cream, a hyaluronic acid sodium salt hydrogel dressing. It mainly focuses on its description, intended use, and comparison to predicate devices, rather than a detailed study with acceptance criteria often seen for AI/ML devices.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable (N/A) based on the provided document as they relate to performance evaluation methodologies for AI/ML or complex diagnostic devices, which BIONECT® Cream is not.

Here's the information that can be extracted from the provided text:

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

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: Approximately 600 patients.
• Data provenance: Conducted in Europe across 21 clinical trials (18 controlled). The text does not explicitly state if the trials were retrospective or prospective, but clinical trials are generally prospective.

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)

• N/A. The assessment relies on clinical trials and biocompatibility testing, not on establishing ground truth via expert consensus in the way an AI/ML diagnostic would for a test set. The "experts" involve the clinicians conducting the trials, but their roles in "establishing ground truth" for a specific test set, as defined for AI/ML, are not applicable here.

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

• N/A. This concept is specific to resolving discrepancies in expert labeling or diagnoses for test sets, which is not relevant to the evaluation of a wound dressing.

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

• N/A. This type of study is relevant for AI-assisted diagnostic devices, not for a wound dressing.

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

• N/A. This is a wound dressing, not an algorithm.

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

• The "ground truth" for safety and intended use was established through:
  • Biocompatibility testing: Standardized tests demonstrating material safety.
  • Clinical outcomes data: Observation of patient outcomes and safety profiles in clinical trials involving approximately 600 patients with various wounds and burns.

8. The sample size for the training set

• N/A. This device does not involve a "training set" in the context of machine learning.

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

• N/A. This device does not involve a "training set" in the context of machine learning.

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