(609 days)
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.
| Acceptance Criteria (Implicit for 510(k)) | Reported Device Performance (Claimed for Medihoney Dressings) |
|---|---|
| Technological Characteristics: Identical or substantially similar materials, composition, and function to predicate devices. | "NO changes have been made to the design or technological characteristics... they are identical in configuration and function to those previously cleared." "Identical to the predicates since they are all comprised of sterile honey based substrates..." |
| Intended Use: Similar to predicate devices, with the new indication being a "general to specific" extension of existing uses. | "new indications are consistent with standard wound care practices and intended uses and is in line with the predicate device indications for use." "addition of autolytic debridement to the indications represents a general to specific indication." |
| Safety and Effectiveness: Supported by previous clearances and scientific literature. | "The Medihoney Family of Dressings was shown to be safe and effective as a wound dressing as shown in the published clinical studies that utilized the proposed indications." "extensive safety and effectiveness evidence demonstrated in both the non-clinical and published clinical testing support the safe use for the proposed indication." |
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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