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MANUKAtex wound dressings are sterile, single-use wound care dressings for use in moist wound management. MANUKAtex wound dressings may be used Over-The-Counter for:

Minor Abrasions
Lacerations
Minor Cuts
Minor Scalds and Burns
Under the supervision of a healthcare professional, MANUKAtex wound dressings may be used for:
Leg Ulcers
Pressure Ulcers
1st and 2nd Degree Burns (Superficial and Partial Thickness)
Diabetic Foot Ulcers
Surgical Wounds
Traumatic Wounds

MANUKAtex wound dressings are sterile, single-use wound care dressings for use in moist wound management. The primary device is Leptospermum scoparium honey from New Zealand impregnated into acetate gauze. MANUKAtex is coated with carboxymethyl cellulose (CMC). The device incorporates 100% active Leptospermum scoparium medical grade Manuka honey that is harvested and processed under controlled conditions.

The provided text is a 510(k) summary for the MANUKAtex wound dressing. It focuses on demonstrating substantial equivalence to predicate devices and detailing non-clinical testing for biocompatibility.

Here's an analysis of the document in relation to your request about acceptance criteria and study details, highlighting what information is present and what is missing:

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

Missing Information: The document states that "all acceptance criteria were met for all tests conducted," but does not explicitly list the specific quantitative or qualitative acceptance criteria for each test (e.g., specific limits for cytotoxicity, or pass/fail conditions for wound healing studies).

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

Missing Information: The document states that "Standard biocompatibility tests were performed…wound healing studies" but does not specify the sample size for any of these tests. It also does not mention data provenance (e.g., country of origin of data, retrospective or prospective).

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

Missing Information: This information is not applicable as the studies described are non-clinical (biocompatibility, sterilization, shelf-life, packaging validation) and do not involve human expert assessment for ground truth.

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

Missing Information: This information is not applicable as the studies described are non-clinical.

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

Missing Information: This information is not applicable. The device is a wound dressing, not an AI-assisted diagnostic tool, and the studies described are non-clinical.

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

Missing Information: This information is not applicable. The device is a wound dressing, not an algorithm.

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

For the non-clinical tests (biocompatibility, sterilization, shelf-life, packaging validation), the "ground truth" would be established by international standards and validated test methods (e.g., ISO Standard 10993-1 for biological evaluation of medical devices). The document explicitly states, "All tests were performed in accordance with US FDA General Program Memorandum #G95-1 Part-10993-1 of the International Standard Organization (ISO) Standard (Biological Evaluation of Medical Devices) by North American Science Associates, Inc. (NAMSA)."

8. The sample size for the training set

Missing Information: This is not applicable as the device is a medical dressing and not an AI/machine learning model that would require a training set.

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

Missing Information: This is not applicable as the device is a medical dressing and not an AI/machine learning model.

In summary:

The provided document details non-clinical performance criteria and states that the device met these criteria through tests conducted according to international standards (ISO 10993-1). However, it lacks specific quantitative details about the acceptance criteria themselves, sample sizes for the tests, and is not relevant to questions pertaining to AI/ML device evaluations or human expert-led studies.

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MANUKAhd wound dressings are highly absorbent, sterile, single-use wound care dressings, with or without adhesive borders, for use in moist wound management. MANUKAhd wound dressings may be used Over-The-Counter for:

• Minor Abrasions
• Lacerations
• Minor Cuts
• Minor Scalds and Burns

Under the supervision of a healthcare professional, MANUKAhd wound dressings may be used for:

• Leg Ulcers
• Pressure Ulcers
• 1st and 2nd Degree Burns (Superficial and Partial Thickness)
• Diabetic Foot Ulcers
• Surgical Wounds
• Traumatic Wounds

MANUKAhd wound dressings are highly absorbent, sterile, single-use wound care dressings for use in moist wound management. The primary device is a super absorbent polymer (SAP) fibre material impregnated with medical grade Manuka honey and coated with carboxymethyl cellulose (CMC). The device incorporates 100% active Leptospermum medical grade Manuka honey that is harvested and processed under controlled conditions. One version of the product (MANUKAhd Border) has the honey-impregnated pad retained in a central position on an adhesive backing. Another version of the device (MANUKAhd Rope) is identical to the primary device, but spiral cut to provide the care provider flexibility in packing a wound bed.

The provided document describes the ManukaMed MANUKAhd wound dressings, a medical device. The information details nonclinical testing performed to establish biocompatibility.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states that "Standard biocompatibility tests were performed," including cytotoxicity, intracutaneous reactivity, systemic toxicity, sensitization, and wound healing studies. However, the exact sample size used for each of these tests is not specified in the provided text.

Regarding data provenance:

• Country of origin of the data: Not explicitly stated for each test, but the testing organization, North American Science Associates, Inc. (NAMSA), is implied to be conducting tests in accordance with US FDA guidelines and ISO standards. NAMSA is a global company, but the submission is to the US FDA, suggesting the results would be presented in a US format.
• Retrospective or prospective: Biocompatibility tests are typically prospective studies designed specifically to evaluate the device's interaction with biological systems.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth. Biocompatibility testing often relies on standardized protocols and laboratory analysis performed by trained technicians and overseen by scientific experts (e.g., toxicologists, pathologists), but these details are not present in this summary.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method. Biocompatibility test results are generally interpreted based on predefined criteria within the test protocol and ISO standards, rather than requiring an adjudication process in the way clinical studies or image interpretations might.

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

No, an MRMC comparative effectiveness study was not done. The document describes nonclinical biocompatibility testing, not clinical studies involving human readers or comparative effectiveness with or without AI assistance.

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. This device is a wound dressing, not an algorithm or AI system.

7. The Type of Ground Truth Used

For the biocompatibility tests, the "ground truth" would be established by:

• Standardized biological responses/observations: For cytotoxicity, it would be cell viability; for sensitization, it would be skin irritation scores; for systemic toxicity, it would be physiological parameters and organ histopathology; for wound healing, it would be observations of tissue repair and inflammation.
• Adherence to ISO standards: The tests were performed "in accordance with US FDA General Program Memorandum #G95-1 Part-10993-1 of the International Standard Organization (ISO) Standard (Biological Evaluation of Medical Devices)." These standards define the methods and criteria for evaluating biological responses.

8. The Sample Size for the Training Set

Not applicable. This device is a physical wound dressing, not an AI algorithm, so there is no "training set."

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

Not applicable. As there is no training set, this question is irrelevant.

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Manukapli Wound Dressings are sterile, single-use wound care dressings for use in moist wound management. Manukapli Wound Dressings may be used Over-The-Counter for:

• Minor Abrasions
• Lacerations
• Minor Cuts
• Minor Scalds and Burns

Under the supervision of a healthcare professional, Manukapli Wound Dressings may be used for:

• Leg Ulcers
• Pressure Ulcers
• 1st and 2nd Degree Burns (superficial and Partial Thickness)
• Diabetic Foot Ulcers
• Surgical Wounds
• Traumatic Wounds

Manukapli Wound Dressing consists of a sterile wound dressing designed to promote a moist wound healing environment. The device is constructed using medical grade Manukapli that is harvested and processed under controlled conditions. This Manukapli is sealed into polyethylene tubes before sterilization using gamma irradiation and is intended to be used by medical staff as part of a treatment program for patients with problematic wound care requirements. The device is provided sterile and is designed to be single used only. This is achieved by the tube design having a twist & shear off end cap that cannot be replaced.

The provided text describes a medical device, Manukapli Wound Dressings, and the nonclinical testing performed to demonstrate its biocompatibility. However, it does not include information about acceptance criteria or a study that proves the device meets those criteria in the context of diagnostic accuracy, which is typically what "acceptance criteria" and "device performance" implies for AI/ML devices.

The information primarily focuses on:

• Device Description: What the Manukapli Wound Dressing is.
• Intended Use: The types of wounds it's designed to treat (e.g., minor abrasions, leg ulcers, burns).
• Technology Comparison: Stating substantial equivalence to predicate devices based on function, composition, and intended use.
• Nonclinical Testing (Biocompatibility): Tests performed to ensure the material is safe for contact with the human body.

There is no mention of an AI/ML component, diagnostic capabilities, or any performance metrics like sensitivity, specificity, AUC, or reader studies. Therefore, I cannot construct the requested table or answer the specific questions related to AI/ML device performance and ground truth establishment.

Here's a breakdown of what can be extracted and why other parts cannot be answered based on the provided text:

1. Table of acceptance criteria and the reported device performance

• Acceptance Criteria: The document states, "The Manukapli Wound Dressings met the acceptance criteria for all tests conducted and is considered biocompatible under the conditions tested." However, the specific numerical or qualitative criteria for these biocompatibility tests (e.g., "no cytotoxicity observed," "irritation score

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