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Under the supervision of a healthcare professional, MANUKA FILL wound dressing is indicated for the management of: > Leg Ulcers A Pressure Ulcers > 1st and 2nd Degree Burns > Diabetic Foot Ulcers > Surgical Wounds > Trauma Wounds MANUKA FILL wound dressing provides a moist wound environment. A moist wound environment allows autolytic debridement of necrotic tissue.
MANUKA FILL wound dressing may be used Over-The-Counter for the management of: > Minor Abrasions > Minor Lacerations > Minor Cuts > Minor Scalds and Minor Burns MANUKA FILL wound dressing provides a moist wound environment. A moist wound environment allows autolytic debridement of necrotic tissue.

MANUKA FILL wound dressing is a sterile, single-use, wound care dressing that helps maintain a moist wound environment conducive to wound healing. The primary device consists of 100% Leptospermum scoparium honey from New Zealand sealed into low-density polyethylene (LDPE) tubes and sterilized using gamma irradiation.

The provided document outlines the acceptance criteria and the study conducted for the MANUKA FILL wound dressing, focusing primarily on nonclinical testing for substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document explicitly mentions a "wound healing study was conducted to assess the impact of repeated application of MANUKA FILL to full-thickness dermal wounds in swine." However, it does not specify the sample size used for this study.

The data provenance for the nonclinical testing appears to be prospective, as it describes tests conducted specifically for the submission of the MANUKA FILL wound dressing. The document states, "All tests were performed by North American Science Associates (NAMSA)," suggesting the data was generated in a controlled, scientific testing environment. The country of origin for the data is not explicitly stated, but NAMSA has facilities in the U.S. and Europe. The honey itself is stated to be from New Zealand.

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

For the nonclinical studies, particularly the biocompatibility and wound healing studies, the "ground truth" refers to the scientific assessment of the device's performance against established standards. The document does not specify the number of experts or their specific qualifications involved in establishing the ground truth or evaluating the results of these nonclinical tests. It only states that "All tests were performed by North American Science Associates (NAMSA)," which is a contract research organization specializing in medical device testing.

4. Adjudication Method for the Test Set

The document does not mention any human adjudication method (like 2+1 or 3+1). The studies described are nonclinical, focusing on laboratory and animal model testing, which typically involves quantitative measurements and adherence to scientific protocols rather than expert consensus on subjective interpretations.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic or imaging devices where human readers interpret data, and the document describes a wound dressing, which is a therapeutic device. There is no mention of comparing human reader performance 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. The MANUKA FILL wound dressing is a physical medical device, not a software algorithm, and therefore this type of study is not applicable.

7. The Type of Ground Truth Used

For the nonclinical tests:

• Biocompatibility: Ground truth was based on established ISO 10993-1 standards and the FDA Biocompatibility Matrix, which define acceptable levels for cytotoxicity, skin irritation, and skin sensitization.
• Wound Healing Study: Ground truth was based on observed healing outcomes in swine models, comparing the device's performance to predicate devices and assessing whether healing was impaired. This is a form of outcomes data in an animal model.
• Sterilization, Shelf-Life, Packaging Validation: Ground truth was based on established industry and regulatory standards for these performance requirements.

8. The Sample Size for the Training Set

The document describes nonclinical studies for substantial equivalence. It does not mention a "training set" because this term is relevant to machine learning or AI algorithm development, which is not applicable to this physical wound dressing device.

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

As there is no training set for this type of device and study, this information is not applicable.

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MANUKA FILL wound dressings are sterile, single-use, wound care dressings for use in moist wound management. MANUKA FILL 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, MANUKA FILL 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

MANUKA FILL 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 that is harvested and processed under controlled conditions. This honey is sealed into low density polyethylene tubes (LDPE) before sterilization using gamma irradiation.

This is a 510(k) premarket notification for the MANUKA FILL wound dressings. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study for a novel device. Therefore, many of the requested categories (like MRMC study, sample sizes for test/training sets, number of experts for ground truth, adjudication methods) are not applicable or not provided in this type of submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

This document primarily describes nonclinical testing for biocompatibility, sterility, shelf-life, and packaging. It does not refer to a "test set" in the context of clinical performance data like a diagnostic algorithm. Therefore, information on sample size for a test set and data provenance (country of origin, retrospective/prospective) is not provided. The biocompatibility tests were likely conducted on laboratory animals and/or in vitro, but specific details are not given.

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

Not applicable. This submission focuses on the safety and effectiveness of a wound dressing through nonclinical testing, not on the performance of a diagnostic algorithm requiring expert-established ground truth.

4. Adjudication Method for the Test Set

Not applicable, as there is no "test set" in the context of a clinical performance study for an algorithm.

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-powered device or a diagnostic algorithm, so an MRMC study is irrelevant.

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

For the nonclinical tests:

• Biocompatibility: The "ground truth" would be the physiological and cellular responses observed in the lab, compared against established biological safety standards (ISO Standard, US FDA General Program Memorandum #G95-1).
• Sterilization, Shelf-life, Packaging: The "ground truth" would be objective measurements and observations confirming sterility, product integrity over time, and packaging effectiveness, compared against defined specifications and regulatory requirements.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device; there is no "training set."

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

Not applicable.

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