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The Derma Sciences Medihoney Wound Gel helps maintain a moist environment. Moist wound environment was shown to be conducive to wound healing.

For over the counter use, Medihoney Wound Gel may be used for:

• minor abrasions
• lacerations
• minor cuts
• minor scalds and burns.

Under the supervision of a healthcare professional, Medihoney Wound Gel helps maintain a moist environment. Moist wound environment was shown to be conducive to wound healing and are indicated for non-draining to moderately exuding wounds. The Medihoney Wound Gel is intended for the management of the following:

• diabetic foot ulcers
• leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology)
• pressure ulcers / sores (partial and full thickness)
• 1st and 2nd degree partial thickness burns
• donor sites, and traumatic and surgical wounds.

The primary component of the Medihoney Wound Gel is Active Leptospermum Honey. The purpose of this 510(k) is to obtain clearance for a slightly modified version of the Derma Sciences Medihoney Wound Gel Dressings subject of K101793. The original Medihoney Gel Dressings contain Active Manuka Honey, Myristate, and Plantacare. The proposed Medihoney Gel Dressings contains a slightly different formulation than the original Medihoney Gel Dressings in that Sodium Benzoate has been added as a preservative to the formulation. Due to the limitations in hermetically sealing the Wound Gel jar lids, this product will be Gamma Irradiated at 25-45kGy dosage, which will help reduce the product bioburden. However this product will not be claimed sterile. Gamma Irradiation will aid in reducing the product bioburden and the preservative Sodium Benzoate will act as a preservative within the gel.

This document is a 510(k) premarket notification for a medical device called Medihoney Wound Gel. It explicitly states that the device is "Unclassified" and establishes substantial equivalence to legally marketed predicate devices rather than proving a device meets specific performance criteria through a study.

Therefore, the information requested in the prompt regarding acceptance criteria and performance studies, such as:

1. A table of acceptance criteria and the reported device performance: Not applicable. This document is about demonstrating substantial equivalence, not meeting performance criteria through a quantitative study.
2. Sample sizes used for the test set and data provenance: No test sets are described for performance evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications: Not applicable. No ground truth establishment for a test set is described.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This is not an AI-assisted device, nor is it a comparative effectiveness study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable. This device is not an AI/ML model that requires training data.
9. How the ground truth for the training set was established: Not applicable.

Instead, the document focuses on:

• Device Description: The Medihoney Wound Gel contains Active Leptospermum Honey, with a slightly modified formulation (addition of Sodium Benzoate as a preservative) and gamma irradiation (though not sterile).
• Intended Use: Maintains a moist wound environment for minor abrasions, lacerations, minor cuts, minor scalds and burns (over-the-counter), and under professional supervision, for diabetic foot ulcers, leg ulcers, pressure ulcers/sores, 1st and 2nd degree partial thickness burns, donor sites, traumatic and surgical wounds.
• Substantial Equivalence: The primary argument is that the device is substantially equivalent to existing Medihoney Gel Dressings With Active Manuka (K101793) and BioTD S.A. Ross Ru Skin Discontinuities (K131176). The key argument for equivalence is that the modification (addition of sodium benzoate as a preservative and non-sterile status) does not affect the safety or effectiveness of the device, as sodium benzoate is a GRAS substance and the function of the gel remains the same (providing a moist wound environment).
• Performance Testing (Safety, not Efficacy):
  • The Medihoney Wound Gel has been subjected to cytotoxicity, sensitization, irritation, and implantation testing. These are general biocompatibility tests, not clinical efficacy studies.
  • The document also notes that the original Medihoney Wound Gel devices have been on the market since 2011 with no unanticipated adverse events, implying a history of safe use supports the current device.

In summary, this document is a 510(k) submission that demonstrates substantial equivalence of a modified medical device to existing predicate devices, primarily through justification of material changes and historical safety data, rather than through a a clinical study with specific acceptance criteria as you might see for a novel AI/ML device.

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Medihoney Calcium Alginate Dressing with Active Leptospermum Honey are indicated for the management of moderate to heavily exuding wounds by providing a moist environment, which is conducive to wound healing, and supports and aids autolytic debridement. These dressings are intended for the management of the following:

• · Diabetic foot ulcers
• · Leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology)
• · Pressure ulcers/sores (partial and full thickness)
• · 1st and 2nd degree partial thickness burns
• donor sites
• · traumatic and surgical wounds

Medihoney Adhesive and Non-Adhesive Honeycolloid Dressings with Active Leptospermum Honey are indicated for the management of light to moderately exuding wounds by providing a moist environment, which is conducive to wound healing, and supports and aids autolytic debridement. These dressings are intended for the following:

• · Diabetic foot ulcers
• · Leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology)
• · Pressure ulcers/sores (partial and full thickness)
• · 1st and 2nd degree partial thickness burns
• donor sites
• · traumatic and surgical wounds

Medihoney Dressings with Active Leptospermum Honey are indicated for the management of light to moderately exuding wounds by providing a moist environment, which is conducive to wound healing, and supports and aids autolytic debridement. These dressings are intended for the management of the following:

• · Diabetic foot ulcers
• · Leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology)
• · Pressure ulcers/sores (partial and full thickness)
• · 1st and 2nd degree partial thickness burns
• donor sites
• · traumatic and surgical wounds

Medihoney Gel Dressing with Active Leptospermum Honey are indicated for the management of light to moderately exuding wounds by providing a moist environment, which is conducive to wound healing, and supports and aids autolytic debridement. These dressings are intended for the management of the following:

• Diabetic foot ulcers
• · Leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology)
• · Pressure ulcers/sores (partial and full thickness)
• · 1st and 2nd degree partial thickness burns
• donor sites
• traumatic and surgical wounds

The Medihoney Adhesive and Non-Adhesive Hydrogel Colloidal Sheet with Leptospermum Honey are indicated for the management of non-draining to lightly exuding wounds by providing a moist environment, which is conducive to wound healing, and supports and aids autolytic debridement. These dressings are intended for the following:

• Diabetic foot ulcers
• · Leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology)
• · Pressure ulcers/sores (partial and full thickness)
• · 1st and 2nd degree partial thickness burns
• donor sites
• traumatic and surgical wounds

The primary component of the Medihoney Family of Dressings is Active Manuka Honey. The composition, formulation and materials of the Medihoney Dressings are described below. The Medihoney Family of Dressings are provided sterile to the user and are NOT required to be sterilized.

Calcium Alginate Dressing with Active Leptospermum Honey: comprised of 95% Active Manuka Honey and 5% Calcium Alginate. As wound exudate is absorbed, the alginate forms a gel, which assists in maintaining a moist environment that aids and supports the autolytic debridement. Sizes: ¾"x 12"/2"x2"/4"x5"

Adhesive/Non-Adhesive Honevcolloid Dressing with Active Leptospermum Honey: comprised of 80% Active Manuka Honey and 20% Sodium Alginate Powder (hydrocolloid sheet) As wound exudate is absorbed, the alginate forms a gel, which assists in maintaining a moist environment that aids and supports the autolytic debridement. Sizes: 2"x2,"/4"x5" (non-adhesive)/2"x2"/4.5"x4.5" (adhesive)

Dressing with Active Leptospermum Honey: comprised of 100% Active Manuka Honey and are sterile wound dressings for use in moist wound management. The Medihoney Dressing comprised of 100% Active Manuka Honey helps to maintain a moist environment. The Medihoney Dressing with Active Manuka Honey is offered in several sizes including 0.5, 1, and 1.5 oz. tube sizes.

Gel Dressing with Active Leptospermum Honey: comprised of 80% Active Manuka Honey, 15% Myristyl Myristate and 5% Plantacare 810. As wound exudate is absorbed, the dressing forms a gel, which assists in maintaining a moist environment that aids and supports autolytic debridement. The Medihoney Gel Dressings are offered in 0.5 and 1.5 oz sizes

Adhesive/Non-Adhesive Hydrogel Colloidal Sheet with Leptospermum Honey: comprised of 63% Leptospermum Honey and hydrogel both with and without an adhesive border. As wound exudate is absorbed, the dressing forms a gel, which assists in maintaining a moist environment that aids and supports autolytic debridement. The Medihoney Hydrogel Sheet Dressings are offered in 1.8'x1.8"/2.4"x2.4"/4.3"x4.3"/8"x12" (adhesive) 2.8"x2.8"/4.5"x4.5" (non-adhesive)

This document is a 510(k) Pre-market Notification for a medical device, specifically a family of Medihoney wound dressings. It is a submission to the FDA seeking to demonstrate substantial equivalence to previously cleared devices. It does not describe a study proving a device meets specific acceptance criteria for a new AI or diagnostic device.

Instead, this document focuses on demonstrating that modifications to existing wound dressings (by adding a specific indication for "aiding autolytic debridement") do not change the device's fundamental characteristics or safety/effectiveness, thus maintaining substantial equivalence to previously cleared predicate devices.

Therefore, the requested information about acceptance criteria, device performance, sample sizes, experts, adjudication methods, MRMC studies, standalone performance, and ground truth for a new device assessment cannot be extracted from this document.

This document is about regulatory approval for a wound care product based on its substantial equivalence to existing products, not a study validating a new diagnostic or AI-driven device.

To directly answer your request based on the provided document, the device described is a wound dressing, not an AI or diagnostic device that would typically have the kind of performance metrics you are asking for.

However, I can extract information related to the device's intended use and the general "proof" presented in this regulatory submission, even though it doesn't align with the detailed "acceptance criteria" framework you've provided for an AI/diagnostic device.

General Information from the Document (interpreting your request in the context of this document):

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

Since this is a 510(k) for a wound dressing and not an AI or diagnostic tool, typical performance metrics like sensitivity, specificity, or AUC are not applicable, and no "acceptance criteria" table as you've defined for such devices is present.

Instead, the "acceptance criteria" are demonstrating substantial equivalence to predicate devices, and the "reported device performance" is the claim that the device is safe and effective for its intended uses, including the added indication of aiding autolytic debridement, as supported by literature and previous clearances.

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

• Sample size for the test set: Not applicable in the context of a prospective clinical trial for this type of submission. The submission references "hundreds of cases" from published clinical literature.
• Data provenance: "clinical data from literature" (implicitly international, as medical literature is global), retrospective. The document does not specify country of origin for the cited literature.

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

• Not applicable as a formal "ground truth" establishment process for a test set is not described for a wound dressing claiming substantial equivalence to predicate devices. The "ground truth" here is derived from existing medical literature and clinical experience with honey-based wound dressings.

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

• Not applicable. There is no specific adjudication method described for a test set as this is not a study assessing reader performance.

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:

• Not applicable. This is not an AI-assisted device, nor is it a diagnostic device where human reader performance is being assessed or improved.

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

• Not applicable. This is not an algorithm or AI-driven device.

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

• The "ground truth" for the claims of safety and effectiveness, including the "aiding autolytic debridement" indication, is based on:
  • Published clinical literature: "clinical data from literature to support the new indications." and "clinical data from literature to support the autolytic debridement indication."
  • Clinical experience with honey-based wound dressings.
  • Prior FDA clearances of substantially equivalent predicate devices.
  • Outcomes data described in the cited literature (implicitly wound healing, debridement effectiveness, etc.).

8. The sample size for the training set:

• Not applicable. This is a medical device, not a machine learning model requiring a training set. If interpreting "training set" as the body of evidence that informs its development, it would be the cumulative clinical and scientific understanding of honey's properties and wound care, which is not quantifiable as a single "sample size."

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

• Not applicable. As above, there's no defined "training set" or a process for establishing its ground truth in the context of an AI model here. The understanding of the device's function is based on existing scientific and medical knowledge and prior regulatory approvals.

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The Derma Sciences Medihoney Hydrogel Sheet Dressings (Adhesive and Non-adhesive) with Leptospermum Honey provides a moist environment conducive to wound healing and are indicated for non-draining to lightly exuding wounds.

For over the counter use, Medihoney Hydrogel Sheet Dressings (Adhesive and Nonadhesive) with Leptospermum Honey may be used for:

• minor abrasions
• minor cuts
• minor scalds
• minor burns

Under the supervision of a healthcare professional, The Derma Sciences Medihoney Hydrogel Sheet Dressings provide a moist environment conducive to wound healing and are indicated for non-draining to lightly exuding wounds. The Medihoney Hydrogel Sheet Dressings are intended for the management of the following:

• diabetic foot ulcers
• leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology)
• pressure ulcers / sores (partial and full thickness)
• 1st and 2nd degree partial thickness burns
• donor sites, and traumatic and surgical wounds

Derma Sciences Medihoney Hydrogel Sheet Dressings with Leptospermum Honey are sterile, single-use wound care dressings for use in moist wound management. The dressings are comprised of 63% Leptospermum Honey and hydrogel both with and without an adhesive border. The Derma Sciences Medihoney Hydrogel Sheet Dressings with Leptospermum Honey are offered in the following sizes: 2 ¼" x 2 ¾", 4 1/3" x 4 1/3", 6" x 9", 4 1/3" x 4 1/3" (adhesive border), 6" x 6" (adhesive border).

This is not a medical device that uses AI/ML, therefore the requested information regarding acceptance criteria, study details, and AI/ML specific questions (like multi-reader multi-case studies, effect size of AI assistance, standalone algorithm performance, training data details) are not applicable.

Here's a summary of the provided information about the Derma Sciences Medihoney Hydrogel Sheet Dressings:

1. Acceptance Criteria and Reported Device Performance:

Since this is a 510(k) submission for a wound dressing, the "acceptance criteria" are typically related to demonstrating substantial equivalence to a legally marketed predicate device, rather than specific performance metrics (like sensitivity/specificity for diagnostic AI devices). The reported performance is based on non-clinical testing.

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

• Test Set Sample Size: Not applicable. No clinical testing on human subjects was conducted for this 510(k) submission. The "test set" in this context refers to the non-clinical biocompatibility tests.
• Data Provenance: Not applicable for clinical data. For biocompatibility, it refers to laboratory testing.

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

• Not applicable. This is not a diagnostic device requiring expert interpretation for ground truth. Biocompatibility testing follows established laboratory protocols.

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

• Not applicable. This is not a diagnostic device requiring expert adjudication of test results.

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:

• Not applicable. This is not an AI/ML powered device.

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

• Not applicable. This is not an AI/ML powered device.

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

• For biocompatibility: Laboratory standards and test endpoints (e.g., cell viability for cytotoxicity, physical observation for irritation).
• For substantial equivalence: Comparison to the known characteristics and performance of legally marketed predicate wound dressings.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML powered device, so there's no "training set."

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

• Not applicable.

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The Derma Sciences Medihoney Gel Dressings with Active Manuka Honey provide a moist environment conducive to wound healing and are indicated for light to moderately exuding wounds.

For over the counter use, Medihoney Gel Dressings with Active Manuka Honey may be used for:

• minor abrasions
• lacerations
• minor cuts
• minor scalds and burns

Under the supervision of a healthcare professional, The Derma Sciences Medihoney Gel Dressings provide a moist environment conducive to wound healing and are indicated for light to moderate exuding wounds. The Medihoney Gel Wound Dressings are intended for the management of the following:

• diabetic foot ulcers
• leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology)
• pressure ulcers / sores (partial and full thickness)
• 1st and 2nd degree partial thickness burns
• donor sites, and traumatic and surgical wounds.

Derma Sciences Medihoney Gel Dressings with Active Manuka Honey are sterile, wound care dressings for use in moist wound management. The Derma Sciences Medihoney Gel Dressing with Active Manuka Honey is offered in 10, 20, and 25 oz tubes sizes. The dressings are comprised of honey an emulsifier and a surfactant.

The proposed Medihoney Gel Dressing with Active Manuka Honey contains Active Manuka Honey. As wound exudate is absorbed, the alginate forms a gel, which assists in maintaining a moist environment that aids supports the autolytic debridement for optimal wound healing.

The proposed Medihoney Gel Wound Dressings with Active Manuka Honey are comprised of 80% Active Manuka Honey, 15% Myristyl Myristate and 5% Plantacare 810 compared to the parent Medihoney Primary Dressings which are comprised of 100% honey, 80% Active Manuka Honey and 20% sodium alginate powder or 95% w/w Active Manuka Honey and 5% w/w Calcium Alginate. The addition of the Myristyl Myristate and Plantacare 810 increases the viscosity of the gel which helps to improve adherence to the wound bed.

This document is a 510(k) Summary for a medical device called "Derma Sciences Medihoney Gel Dressings with Active Manuka Honey." It focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing new performance criteria through a standalone clinical study with acceptance criteria and reported performance metrics in the way a novel diagnostic or AI device might.

Therefore, many of the requested elements for a study proving a device meets acceptance criteria are not applicable in this context. The document describes a formulation change and demonstrates biocompatibility and substantial equivalence to existing devices.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This type of data is not provided in the document as it is a 510(k) submission for a device with a formulation change, relying on substantial equivalence to predicate devices, not on proving new clinical efficacy metrics against specific acceptance criteria.

The document states:

• "Biocompatibility testing performed to support the formulation change for the modified dressings demonstrates that the Medihoney Gel Dressings with Active Manuka Honey are safe for their intended use."
• "The biocompatibility testing included cytotoxicity, implantation, sensitization, and irritation testing (repeat patch insult testing)."

There are no quantitative acceptance criteria or reported values for these tests mentioned in the provided text. The output is a qualitative statement of safety for its intended use.

2. Sample size used for the test set and the data provenance

Not Applicable in the context of clinical performance demonstrating efficacy against acceptance criteria. The performance testing mentioned is biocompatibility. Details on the sample size and provenance for the biocompatibility tests are not provided in this summary.

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

Not Applicable. This document does not describe a study involving expert-established ground truth for a test set. The determination is based on the safety and substantial equivalence of the material.

4. Adjudication method for the test set

Not Applicable. No test set requiring adjudication in the context of clinical performance is described.

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

Not Applicable. This is not an AI device, and no MRMC study is described.

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

Not Applicable. This is a medical dressing, not an algorithm, so standalone performance is not relevant in this context.

7. The type of ground truth used

For biocompatibility testing, the "ground truth" would typically be established by standardized laboratory methods and benchmarks for toxicology (cytotoxicity, irritation, sensitization) and material compatibility (implantation). These are widely accepted scientific standards, not expert consensus, pathology, or outcomes data in the clinical sense.

8. The sample size for the training set

Not Applicable. This document does not describe a machine learning algorithm or a training set.

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

Not Applicable. As above, no training set for a machine learning model is involved.

Summary of Device and Evidence Presented:

The document describes the Derma Sciences Medihoney Gel Dressings with Active Manuka Honey.

• Acceptance Criteria/Performance: The primary "acceptance criteria" for a 510(k) submission of this nature are demonstrating substantial equivalence to existing predicate devices and showing that biocompatibility testing (cytotoxicity, implantation, sensitization, and irritation) supports the safety of the modified formulation for its intended use. The document states that the biocompatibility testing demonstrates that the Medihoney Gel Dressings... are safe for their intended use. There are no quantitative performance metrics against specific acceptance criteria reported in this summary.
• Study: The "study" mentioned is biocompatibility testing. This testing was performed to support a slight formulation change in the product (addition of Myristyl Myristate and Plantacare 810 to increase viscosity and adherence to the wound bed).
• Purpose: The goal was to prove that the new formulation maintains safety and efficacy comparable to the predicate devices, thereby establishing substantial equivalence for the same intended uses.

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For over the counter use, MEDIHONEY™ APIMED, PRIMARY and 100% HONEY Dressings with Active Manuka Honey may be used for:

• minor abrasions
• lacerations
• minor cuts
• minor scalds and burns

Under the supervision of a healthcare professional, The Derma Sciences Apimed (MediHoney) Dressings are all indicated for moderate to heavily exuding wounds. The Medihoney Primary Wound Dressings are indicated for lightly to moderately exuding wounds. The Medihoney 100% Honey Dressings are indicated for nonexuding to moderately exuding wounds. All of the Medihoney Wound Dressings are intended for the management of the following:

• diabetic foot ulcers
• leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology)
• pressure ulcers / sores (partial and full thickness)
• 1st and 2nd degree partial thickness burns
• donor sites and traumatic and surgical wounds.

The Derma Sciences OTC Medihoney Dressings (APIMED, Medihoney Primary and Medihoney 100% Gel) with Active Manuka Honey are designed to provide a moist environment conducive to wound healing and are indicated abrasions, minor burns, minor cuts and minor lacerations.

The Derma Sciences OTC Medihoney Dressings with Active Manuka Honey are sterile, single-use wound care dressings for use in moist wound management. The Derma Sciences OTC Medihoney APIMED Primary Dressings with Active Manuka Honey are offered in several sizes including the following: 2x2, 4x4, % x 12, The OTC Medihoney Primary Dressings with Active Manuka Honey are offered in 1.5" x 2", 2" x 2", 4" x 5", and 2"x3" sizes and are offered both with and without an adhesive backing. The OTC Medihoney 100% Honey Gel Dressings are offered in .5, 1, and 1.5 oz. sizes.

The proposed OTC Medihoney Dressings with Active Manuka Honey are identical in fundamental technology and very similar in indications to the parent API-MED Active Manuka Honey Dressings described in K053095, the Medihoney Primary Dressings with Active Manuka (Leptospermum) Honey in a hydrocolloid sheet (K072956) and the Medihoney Active Manuka (Leptospermum) 100% Honey The dispensed from a tube pending 510(k) premarket notification (K080315). modifications made to the API-MED, Medihoney Primary and Medihoney 100% Gel Active Manuka Honey Dressings to produce the Derma Sciences OTC Medihoney Dressings with Active Manuka Honey are limited to a slight change in indications and over the counter use. The formulation and function are identical to that described in the original 510(k)'s.

This 510(k) summary (K081584) describes a wound dressing and focuses on demonstrating substantial equivalence to previously cleared devices rather than providing detailed performance studies with specific acceptance criteria that are typical for AI/ML devices. Therefore, much of the requested information regarding acceptance criteria, study design, and ground truth for an AI/ML device is not applicable or not present in this document.

Here's an analysis based on the provided text, highlighting what is and is not present:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not specify quantitative acceptance criteria or detailed performance metrics in the way an AI/ML device submission would. The basis for clearance is substantial equivalence to predicate devices.

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

Not applicable. This is a wound dressing, not an AI/ML device evaluating a test set of data. The "test set" in this context would refer to the materials and subjects used in biocompatibility testing. The document states biocompatibility testing was performed, but does not provide details on sample size or data provenance for these tests.

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

Not applicable. This is not an AI/ML device requiring expert-established ground truth for a diagnostic or predictive task.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" in the context of an AI/ML diagnostic or predictive device requiring adjudication for ground truth.

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

No, an MRMC study was not done. This device is a wound dressing, not an AI/ML system that assists human readers.

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

Not applicable. This is not an algorithm or AI system.

7. The Type of Ground Truth Used

For biocompatibility testing, the "ground truth" would be the observed biological response to the materials (e.g., absence of toxic reactions, irritation, etc.), determined through standardized laboratory tests. The document doesn't detail the specific endpoints or how "truth" (e.g., "safe") was established beyond stating the tests were "performed successfully."

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is not an AI/ML device.

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

Not applicable. There is no "training set" for this device.

Summary regarding this specific submission:

This 510(k) submission for Derma Sciences OTC Medihoney Dressings demonstrates substantial equivalence to previously cleared predicate devices (K053095, K072956, K080315). The primary "study" proving the device meets acceptance criteria (for safety and efficacy) is:

• Demonstration of identical fundamental technology, formulation, and function to the predicate devices. The modifications are explicitly stated to be "limited to a slight change in indications and over the counter use."
• Biocompatibility testing: "Cytotoxicity, sensitization, irritation and implantation testing was performed successfully." This indicates that the materials used are safe for their intended use.

The acceptance criterion for clearance via the 510(k) pathway in this case is primarily "substantial equivalence" to a legally marketed predicate device, rather than meeting specific performance metrics derived from a de novo clinical study with pre-defined statistical endpoints.

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The Derma Sciences Medihoney Dressings with Active Manuka Honey provide a moist environment conducive to wound healing and is indicated for the management of light to moderately exuding wounds such as:

• . diabetic foot ulcers
• leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed . etiology)
• . pressure ulcers / sores (partial and full thickness)
• 1st and 2nd degree partial thickness burns ◆
• . donor sites, and traumatic and surgical wounds.

Derma Sciences Medihoney Dressing with Active Manuka Honey are sterile, wound care dressings for use in moist wound management. The Derma Sciences Medihoney Dressing with Active Manuka Honey are offered in several sizes including .5, 1, and 1.5 oz. sizes.
The proposed Medihoney Dressing with Active Manuka Honey contains Active Manuka Honey. As wound exudate is absorbed, the alginate forms a gel, which assists in maintaining a moist environment that aids supports the autolytic debridement for optimal wound healing.

The provided text is a 510(k) Summary for Derma Sciences Medihoney Dressings with Active Manuka Honey. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, the document does not contain a study that proves the device meets specific acceptance criteria in the way a clinical trial or performance study typically would. Instead, it refers to biocompatibility testing.

Here's an attempt to answer your questions based only on the provided text, acknowledging where information is missing:

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

The document does not explicitly state numerical acceptance criteria for performance in the context of efficacy for wound healing. It focuses on biocompatibility.

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

The document mentions "biocompatibility testing." While it refers to "implantation testing," specifics such as the number of subjects (animal or human), data provenance (country, retrospective/prospective), or specific sample sizes for sensitization, irritation, or cytotoxicity tests are not provided.

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 information is not provided. The biocompatibility tests are laboratory-based and likely follow standardized protocols for assessment, rather than relying on expert consensus for "ground truth" in the diagnostic sense.

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

This information is not provided. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which are not detailed here for the biocompatibility tests.

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 MRMC study was mentioned. This 510(k) summary is for a physical wound dressing, not an AI-powered diagnostic device, so an MRMC study is not applicable.

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

Not applicable. This device is a wound dressing, not an algorithm.

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

For the biocompatibility testing:

• Sensitization and Irritation: Likely based on standardized grading scales of physiological reactions.
• Cytotoxicity: Measured in vitro using cell culture reactions.
• Implantation testing: Macroscopic and microscopic assessment of tissue reaction, likely against established criteria for irritancy. This is not "ground truth" in the sense of clinical outcomes, but rather a safety assessment.

There is no mention of clinical outcomes data or pathology results specifically for proving the efficacy of this new formulation. The device relies on substantial equivalence primarily due to minor formulation changes and the established safety of manuka honey as a wound dressing.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

Not applicable.

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The Derma Sciences Medihoney Primary Dressing with Active Manuka Honey provides a moist environment conducive to wound healing and is indicated for light to moderately exuding wounds such as:

• . diabetic foot ulcers
• leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed . etiology)
• pressure ulcers / sores (partial and full thickness) .
• . 1st and 2nd degree partial thickness burns
• donor sites, and traumatic and surgical wounds. .

Derma Sciences Medihoney Primary Dressings with Active Manuka Honey are sterile, single-use wound care dressings for use in moist wound management. The Derma Sciences Medihoney Primary Dressings with Active Manuka Honey are offered in several sizes including 2" x 2", ¾ x 12", 4" x 4" and 4" x 5". The dressings are comprised of honey and sodium alginate.
The proposed Medihoney Primary Dressing with Active Manuka Honey contains Active Manuka Honey. As wound exudate is absorbed, the alginate forms a gel, which assists in maintaining a moist environment that aids supports the autolytic debridement for optimal wound healing, and allows intact removal.

The provided document describes a 510(k) premarket notification for a wound dressing, not a medical device that would typically have performance criteria like sensitivity, specificity, or reader studies. The "acceptance criteria" and "study" described in this document relate to demonstrating substantial equivalence to a predicate device, focusing on biocompatibility and formulation changes.

Here's an interpretation based on the provided text, addressing the points where applicable:

1. Table of Acceptance Criteria and Reported Device Performance

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

This section is Not Applicable in the context of the provided document. The "tests" mentioned are biocompatibility tests on the device material itself, not a clinical study involving a "test set" of patients or data, nor does it refer to an AI/algorithm-driven device.

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

This section is Not Applicable. There is no mention of human experts establishing ground truth for a test set in the context of this device's evaluation.

4. Adjudication Method for the Test Set

This section is Not Applicable. There is no "test set" for expert adjudication mentioned.

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 section is Not Applicable. This document does not describe an AI-driven device or an MRMC study.

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

This section is Not Applicable. This document does not describe an AI/algorithm-driven device.

7. The type of ground truth used

This section is Not Applicable in the traditional sense of a clinical or imaging study. The "ground truth" for the performance claims relates to established scientific and regulatory standards for biocompatibility testing to ensure the safety of the device's components.

8. The Sample Size for the Training Set

This section is Not Applicable. There is no "training set" as this is not an AI/algorithm device.

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

This section is Not Applicable. There is no "training set" or establishment of ground truth for such a set.

Summary of the Study Demonstrated for Substantial Equivalence:

The primary "study" described to demonstrate the device meets acceptance criteria (specifically, being substantially equivalent to a predicate device) is Biocompatibility Testing.

• Acceptance Criteria: The device must be safe for its intended use, as demonstrated by meeting standard biocompatibility requirements.
• Study Performed: Cytotoxicity, sensitization, and irritation testing was conducted on the Derma Sciences Medihoney Primary Dressings.
• Results: The testing was "performed successfully," indicating that the device met the biocompatibility standards and was deemed safe for its intended use.
• Purpose: This testing supported the formulation change from the predicate device, confirming that the new composition does not adversely affect safety.

The basis for calling this a "study" is the regulatory requirement to demonstrate that any changes (in this case, formulation) from a predicate do not raise new questions of safety or effectiveness. The successful completion of these standard biological tests served as the evidence for this device.

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Dermagran® Wound Management System (Systerm), when applied to the wound provides a wound cleanser and primary cover and/or filler for wound deficiencies. The System absorbs exudate and creates a moist, mildly acidic wound environment. The moist environment created by the System is conducive to wound healing and autolytic debridement.

The System is useful in the management of various skin injuries which result in lacerations, abrasions, post-surgical wounds, skin ulcerations (pressure, diabetic, venous stasis), surgical incisions, and partial thickness burns.

Dermagran Wound Management System (System) contains two components, Dermagran Wound Cleanser with Zinc and Dermagran-B Hydrophilic Ointment. The Systerm, when applied to the wound provides a wound cleanser and primary cover and/or filler for wound deficiencies. The System absorbs exudate and creates a moist, mildly acidic wound environment. The moist environment created by the System is conducive to wound healing and autolytic debridement.

The System is useful in the management of various skin injuries which result in lacerations, abrasions. post-surgical wounds, skin ulcerations (pressure, diabetic, venous stasis), surgical incisions, and partial thickness burns.

The provided 510(k) summary for the Dermagran Wound Management System (K970660) describes the device and its intended use, but it does not contain the level of detail typically found in modern AI/ML device submissions regarding acceptance criteria, specific performance metrics, or detailed study methodologies that would be required to answer all the questions comprehensively.

This submission predates the widespread use of AI/ML in medical devices and focuses on demonstrating substantial equivalence to predicate devices through comparisons of characteristics and general safety testing.

Here's an analysis based on the information provided, highlighting what is present and what is missing:

Acceptance Criteria and Study for Dermagran Wound Management System (K970660)

The submission for K970660 does not present a formal table of quantitative acceptance criteria with corresponding device performance metrics in the way a modern AI/ML submission would. Instead, the "acceptance criteria" are implied by demonstrating substantial equivalence to existing predicate devices (Dermagran Wound Cleanser with Zinc and Dermagran-B Hydrophilic Wound Ointment) and demonstrating safety. The "study" mentioned consists of a series of non-clinical and limited clinical evaluations.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Toxicity Studies (Rabbits, Guinea Pigs): The document states "components were tested to determine the acute and sub-chronic toxicity in rabbits" and "Delayed contact hypersensitivity was determined in the guinea pig model." Specific sample sizes for these animal studies are not provided.
• Dermal Sensitivity (Human Volunteers): "Human volunteers were tested for dermal sensitivity." The number of human volunteers is not specified.
• Clinical Studies: "several clinical studies were performed which demonstrated that the components when used as a system provide the same benefit as the predicate devices." The number of patients/cases in these clinical studies is not specified.
• Data Provenance: Not explicitly stated, but the studies were conducted by Derma Sciences, Inc. or their contractors. Given the 1997 submission date, it's highly likely these were retrospective or concurrent studies commissioned for the submission, likely from the USA (where Derma Sciences, Inc. is located).

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

This information is not provided as the concept of "ground truth" established by experts for performance evaluation (as would be done for an AI/ML device) is not directly applicable to this type of device and submission. The clinical studies likely relied on standard clinical assessments by treating clinicians rather than a panel of independent experts establishing a "ground truth" for an algorithm's output.

4. Adjudication Method for the Test Set

This information is not applicable/provided. Adjudication methods like 2+1 or 3+1 are typically used in studies where multiple human readers independently interpret images or data, and their disagreements need to be resolved to establish a ground truth for algorithm comparison. This was not the nature of the studies described for the Dermagran Wound Management System.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not done.
• This type of study is relevant for diagnostic devices (especially imaging-based AI) where the aid enhances human reader performance. The Dermagran system is a topical wound management product, not a diagnostic AI device. The comparison was to predicate devices to establish substantial equivalence in function and patient benefit.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

• No, standalone performance was not done.
• This concept is specific to AI algorithms. The Dermagran system is a physical product (wound cleanser and ointment) designed for direct application, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" in this context would implicitly be clinical observation of wound healing/management outcomes and the absence of adverse events, assessed by clinicians using standard medical practice. For the safety studies, the "ground truth" was derived from direct physiological responses in animal models (toxicity, hypersensitivity) and human volunteers (dermal sensitivity). For effectiveness, it was based on the observed benefits of wound cleansing, creation of a moist environment, and contribution to healing, in comparison to the known effects of the predicate devices.

8. Sample Size for the Training Set

• Not applicable/provided. The Dermagran Wound Management System is a physical product, not an AI model that requires a "training set."

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

• Not applicable/provided. As it is not an AI model, there is no "training set" or ground truth for it.

Summary of Device and Evidence:

The Dermagran Wound Management System is a combination of an existing wound cleanser and an existing hydrophilic wound ointment, marketed together for convenience. The 510(k) submission primarily relies on demonstrating that:

1. The components are identical to previously cleared predicate devices.
2. The combined system maintains the safety profiles of its individual components (demonstrated through animal toxicity, hypersensitivity studies, and human dermal sensitivity tests).
3. The system, when used together, provides the same benefits and characteristics as the individual predicate devices (e.g., cleansing, moist environment, exudate absorption, conducive to healing for various wound types), supported by "several clinical studies."

The FDA's clearance (K970660) indicates that the agency found the device to be substantially equivalent to the predicate devices based on this evidence, with specific labeling limitations added to prevent overstating claims (e.g., no labeling for third-degree burns, no accelerating effect on healing, not a long-term dressing or artificial skin, not a treatment/cure).

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