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The OTC Manuka Honey Wound Dressing is indicated for minor cuts, minor abrasions, minor scalds and minor burns.

OTC Elasto-Gel Manuka dressings are supplied as a gel (amorphous) a thickened viscosity honey or a gel sheet. OTC Elasto-Gel Manuka Honey sheet dressing is the same composition and identical to the Parent Product . The dressings will be supplied in many sizes, for example: 2x3, 4x4, 6x8, and possibly other additions sizes and shapes.

The amorphous gel is a mixture of a super absorbent crosslinked sodium polyacrylic acid, glycerine, honey and water. The crosslinked polyacrylamide polymer is insoluble in the wound fluid but has a relatively high capacity for absorption of the wound fluid, while releasing the glycerine, honey, and water into the wound fluid to establish a chemical equilibrium. The OTC Elasto-Gel Manuka Honey Amorphous gel dressing, is formulated to produce a high viscosity fluid mixture suitable for surface wounds cuts, scrapes and abrasions. The gel sheet is a moderately adhesive soft gel sheet that will protect the wound from shear, friction and pressure, suitable as a protective padding and cushioning device as well as functioning as a dressing. The OTC Elasto-Gel with Manuka Honey are limited to a slight change in indications and over the counter use.

The products will not dry out or become stuck to the wound. In most cases soon after application to the wound the pain level will be diminished . The provide a moist healing environment and will aid in the healing process.

This document is a 510(k) summary for the ELASTO-GEL OTC MANUKA HONEY WOUND DRESSING. It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence.

Based on the provided document, here's an analysis of the acceptance criteria and supporting study information:

Analysis of Acceptance Criteria and Study Information:

The provided document is a 510(k) submission summary to the FDA. For medical devices, particularly those seeking substantial equivalence, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are generally demonstrated through a rigorous comparison to legally marketed predicate devices, along with performance testing to show that differences do not raise new questions of safety or effectiveness.

In this case, the acceptance criteria are not explicitly stated in a quantitative manner as one might find for a software algorithm, but are implicitly met by demonstrating substantial equivalence to existing predicate devices for the intended use. This is common for wound dressings, where the focus is on material properties, biocompatibility, and intended use as compared to similar, already approved products.

The "study" proving the device meets these criteria is primarily the comparison to predicate devices presented in the table and the stated information that the "OTC Elasto-Gel Manuka Honey sheet dressing is the same composition and identical to the Parent Product."

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a substantial equivalence claim for a wound dressing, the "acceptance criteria" are not numerical performance metrics like sensitivity/specificity. Instead, the acceptance criteria are linked to the properties and intended use of the legally marketed predicate devices. The "reported device performance" is the description of the new device that aligns with these criteria.

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

• None provided. The document is a 510(k) summary for a wound dressing, which typically relies on material characterization and comparison to predicate devices rather than clinical "test sets" in the manner of diagnostic algorithms. Data provenance is not applicable here as it's not a study involving patient data.

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

• Not applicable. There is no "test set" in the context of expert-adjudicated ground truth for a wound dressing 510(k) submission.

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

• Not applicable.

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 document describes a wound dressing, not an AI-assisted diagnostic device.

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

• Not applicable. This describes a physical medical device (wound dressing), not a software algorithm.

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

• For the purpose of this 510(k), the "ground truth" is the established safety and effectiveness of the predicate devices as determined by their prior FDA clearance. The new device demonstrates "ground truth" by showing substantial equivalence to these products in terms of materials, indications, and performance characteristics.

8. The sample size for the training set:

• Not applicable. This is not a machine learning or AI device that requires a training set.

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

• Not applicable.

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Elasto-gel Manuka Honey wound Dressings are indicated for use in management of wounds. Full and partial thickness wounds, pressure ulcers, (stages 1 -IV) venous stasis ulcers, diabetic ulcers, abrasions, surface wounds, traumatic wounds (healing by secondary intention), donor site wounds, and surgical wounds

Elasto-Gel Manuka dressings are supplied as a gel(amorphous) or gel sheet. Elasto-Gel Manuka Honey sheet dressing is a sterile primary single use dressing comprised of aninsoluble polyacrylamide polymer matrix in the form of a continuous sheet with plasticizer of glycerine, honey, and water. The dressings will be supplied in many sizes, for example: 2x3", 4x4,6x8, and possibly other additional sizes and shapes The amorphous gel is a mixture of a super absorbent crosslinked sodium polyacrylic acid, glycerine, honey and water. The crosslinked polyacrylamide polymer is insoluble in the wound fluid but has a relatively high capacity for absorption of the wound fluid, while releasing the glycerine, honey, and water into the wound film to capit establish a chemical equilibrium. The Elasto-Gel Manica Honory and Match Houng Informulated to produce a high viscosity fluid mixture suitable for filling wound cavities. The gel sheet is a moderately adhesive soft gel sheet that will protect the wound from shear friction and pressure, suitable as a protective padding and cushioning device as well as functioning as a dressing.

The provided text describes a medical device, the "Elasto-Gel Manuka Honey Wound Dressing," and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study designed to prove the device meets specific performance criteria in the way typically expected for an AI/ML medical device.

This document is a 510(k) premarket notification for a wound dressing, which relies on demonstrating substantial equivalence to existing legally marketed devices. The "Performance Testing" section simply states: "The biocompatibility testing and case studies demonstrates that these dressings are safe for then immediation [sic]" (Page 3, Section 7). This implies general safety and efficacy based on established methods for wound dressings, rather than specific performance metrics and a dedicated study to meet those metrics.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness (MRMC) or standalone performance is not applicable or not present in the provided text for this specific device.

However, I can extract what limited information is available and explain why other sections are not covered by the text.

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable in the context of specific performance metrics for an AI/ML device. The document focuses on demonstrating substantial equivalence in terms of indications, materials, and general properties, rather than quantifiable performance criteria like sensitivity, specificity, or image analysis metrics. The "Performance Testing" section (Page 3, Section 7) broadly states that "biocompatibility testing and case studies demonstrates that these dressings are safe."

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

Not applicable. No "test set" in the context of an AI/ML algorithm is described. "Case studies" are mentioned, but no specifics on their size, nature (retrospective/prospective), or data provenance (country of origin) are provided.

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

Not applicable. No "ground truth" establishment by experts for a test set is described.

4. Adjudication method for the test set

Not applicable. No adjudication method 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 device is a wound dressing, not an AI/ML diagnostic or assistive tool. Therefore, no MRMC study or AI assistance comparison is relevant.

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

Not applicable for an AI/ML context. For a wound dressing, ground truth would typically relate to clinical outcomes (healing, infection rates, pain reduction), which are generally assessed in clinical trials or case studies. The document only vaguely refers to "case studies" and "biocompatibility testing."

8. The sample size for the training set

Not applicable. This device is a wound dressing, not an AI/ML model requiring a training set.

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

Not applicable. This device is a wound dressing, not an AI/ML model requiring a training set with ground truth.

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Stimulen™ Collagen is indicated for prolonged use (24 hr to 30 days) in the management of wounds including:

• ·full and partial thickness wounds
• ·pressure ulcers (stages I-IV)
• •venous stasis ulcers
• ·diabetic ulcers
• ·partial thickness burns
• ·acute wounds
• ·abrasions
• •traumatic wounds healing by secondary intention
• •donor sites and other surface wounds

Stimulen™ Collagen is a sterile primary single use dressing comprised of soluble modified bovine collagen base. The Stimulen™ collagen is soluble in the wound fluid and supplied as a powder or gel or sheet.

The provided text describes a 510(k) summary for the Stimulen™ Collagen wound dressing, which establishes substantial equivalence to predicate devices. It does not contain information about acceptance criteria, device performance, or a study showing the device meets acceptance criteria in the format requested.

Here's why and what information is missing:

• Acceptance Criteria & Reported Performance: The document lists "Indications For Use" and compares the Stimulen™ Collagen to predicate devices based on characteristics like material, collagen source, biodegradability, biocompatibility, and sterility. However, it does not provide specific quantitative acceptance criteria (e.g., "device must achieve 90% wound closure by 4 weeks") or reported performance metrics against such criteria. The "Safety" section mentions biocompatibility tests (Primary Skin Irritation Test, Acute Systemic Injection Test, Intracutaneous Test) demonstrated Stimulen collagen to be "non-toxic and non-irritating," but these are general safety findings, not performance metrics against acceptance criteria for efficacy.
• Study Details: There is no description of a study designed to prove the device meets acceptance criteria. The 510(k) process for this device relies on demonstrating "substantial equivalence" to legally marketed predicate devices, not on presenting novel clinical study data for efficacy against predefined acceptance criteria.

Therefore, I cannot populate the requested table or provide the detailed study information regarding sample size, data provenance, ground truth establishment, or multi-reader studies, as this information is not present in the provided text.

The closest I can come to fulfilling your request, based solely on the provided text, is to list the claims made about the device and its characteristics as compared to predicate devices, but these are not "acceptance criteria" for a clinical performance study.

Summary of what cannot be provided from the text:

1. Table of Acceptance Criteria and Reported Device Performance: Not present. The document focuses on demonstrating equivalence in design, function, material, and intended use, not clinical performance metrics.
2. Sample size used for the test set and the data provenance: No performance study data is presented.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no performance study is detailed.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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 device is a wound dressing, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document is a 510(k) summary focused on regulatory clearance through substantial equivalence, which typically does not involve the detailed clinical efficacy studies and performance criteria evaluation you are asking about for a novel device.

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