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For over-the-counter use, IALUSET HYDROCOLLOID may be applied to:

• abrasions
• lacerations
• minor cuts
• minor scalds
• minor burns
  Under the supervision of a physician, IALUSET HYDROCOLLOID may also be applied to:
• leg ulcers (venous stasis ulcers, arterial ulcers)
• diabetic ulcers
• pressure ulcers (stage I IV)
• surgical wounds (postoperative, dermatological excisions, donor sites)
• burns (first and second degree only)
• traumatic wounds

IALUSET HYDROCOLLOID is a 10 cm x 10 cm wound dressing comprised of an inner layer of hydrocolloids (containing sodium hyaluronate and sodium chondroitin sulfate) which are incorporated into an adhesive matrix and spread between a polyurethane film and a silicone release liner. The dressing absorbs wound exudate, thereby allowing for a moist environment that is conducive to normal wound healing. It does not adhere to the wound, which minimizes both pain and damage to the underlying tissue when the dressing is removed.

The provided text is a 510(k) summary for a wound dressing (IALUSET® HYDROCOLLOID). This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving a new device's efficacy through extensive clinical studies with acceptance criteria in the same way a novel AI algorithm would.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, effect size, standalone performance, training set size, ground truth for training set) are not applicable to this type of device and submission.

The "acceptance criteria" for this device are essentially demonstrating substantial equivalence to existing legally marketed predicate devices in terms of composition, intended use, and technological characteristics, along with biocompatibility.

Here's an attempt to extract relevant information given the limitations of the provided document:

Acceptance Criteria and Device Performance (IALUSET® HYDROCOLLOID)

1. Table of Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for this 510(k) submission are primarily based on demonstrating substantial equivalence to predicate devices, supported by non-clinical biocompatibility data. The performance is compared feature-by-feature to predicate devices rather than against numerical thresholds for efficacy.

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

Not applicable. This is a 510(k) submission for a wound dressing, which relies on demonstrating substantial equivalence to existing devices and non-clinical biocompatibility testing, not a test set of patient data to evaluate an algorithm's performance. The biocompatibility tests would have their own sample sizes for in vitro or in vivo models, but these are not specified in the summary.

Data Provenance (Biocompatibility): The document does not specify the country of origin for the biocompatibility test data. The tests are standard biological evaluation tests (Cytotoxicity, Primary Skin Irritation, Skin Sensitization, Subchronic Toxicity, and Genotoxicity (Ames)), typically performed in a laboratory setting. The study appears to be non-clinical.

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

Not applicable. This device is not an AI algorithm requiring expert ground truth for a test set.

4. Adjudication method 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 is for a wound dressing, not an AI-assisted diagnostic or therapeutic device.

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

For the biocompatibility testing, the "ground truth" would be the established biological responses (e.g., absence of irritation, non-mutagenicity) as determined by validated laboratory assays and compared against control samples. For substantial equivalence, the "ground truth" is the established characteristics and performance of the legally marketed predicate devices.

8. The sample size for the training set

Not applicable. This is not an AI algorithm.

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

Not applicable.

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Innovative Technologies' Hydrocolloid with Zinc Wound Dressings may be used for the management of wounds including:

• Partial full thickness wounds, ie. arterial, venous, diabetic ulcers
• Post-operative surgical wounds
• Superficial burns (1st & 2nd degree)
• Donor Sites
• Trauma Wounds
• Dermal Lesions
• Protective dressing

Innovative Technologies' Hydrocolloid with Zinc Wound Dressings is a combination of two products with existing 510(k)s: 510(k) #K951499, Dermagran-B™ Hydrophilic Wound Dressing manufactured by Derma Sciences, and 510(k) #K971126, Innovative Technologies' Hydrocolloid & Intelligent Hydrocolloid Wound Dressing. Innovative Technologies' Hydrocolloid with Zinc Wound Dressings are highly conformable, sterile, primary wound dressings intended to provide an environment ideally suited for the management of moderate to heavily exuding partial to full thickness wounds. The low profile of the dressing allows for ease in the use of pressure garments and normal clothing. The hydrocolloid dressing may be left in place until the exuding phase is complete. The wound may then be covered with a breathable polyurethane film such as Innovative Technologies' Film Wound Dressing 510(k) #K9204008 which protects the new tissue from mechanical trauma and maceration. Dressings are supplied sterile in single use blisters / pouches. Product is gamma irradiated in accordance with EN 552, JEN556, and ANSI / AAMI / ISO11137-1994, Sterilisation Of Health Care Products - Requirements For Validation and Routine Control - Radiation Sterilisation, 3rd Edition, Method 1 for dosimetric release with a sterility assurance level of 10^-6.

The provided text is a 510(k) premarket notification for a medical device, specifically Innovative Technologies' Hydrocolloid with Zinc Wound Dressing. This document is a regulatory submission for market clearance and does not describe a study that establishes acceptance criteria and proves the device meets them in the way a clinical or performance study would for an AI/ML diagnostic device.

Instead, this document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, which is the regulatory pathway for this type of medical device. The "acceptance criteria" here are essentially the characteristics and performance of the predicate devices. The "study" is the comparison made between the new device and the predicate devices.

Let's break down why this information is not present in the format requested, and then extract what is available:

Why the requested information (for AI/ML diagnostic devices) is not directly applicable:

• Acceptance Criteria & Device Performance Table (for AI/ML): This typically involves performance metrics like sensitivity, specificity, AUC, etc., measured against a gold standard for a diagnostic task. For a wound dressing, performance is assessed differently (e.g., biocompatibility, absorbency, sterility, wound healing environment).
• Sample Size, Ground Truth, Experts, Adjudication, MRMC, Standalone (for AI/ML): These are concepts specifically related to the evaluation of diagnostic algorithms. They do not apply to the evaluation of a physical wound dressing in the same manner.
• Training Set (for AI/ML): This is irrelevant as there's no algorithm being trained.

Information Extracted from the provided document, reframed as closely as possible to the request's intent for a non-AI/ML device:

1. Table of Acceptance Criteria (Predicate Characteristics) and Reported Device Performance (New Device Characteristics):

The document uses a comparative table to show that the new device's characteristics are similar to the predicate devices. The "acceptance criteria" are implied to be the characteristics of the predicate devices, and the "reported device performance" are the characteristics of the Innovative Technologies Hydrocolloid with Zinc.

2. Sample size used for the test set and the data provenance:
This type of information is not applicable to a 510(k) submission for a wound dressing, which relies on demonstrating substantial equivalence to predicate devices rather than a performance study on a specific test set of cases. The "data provenance" for the predicate devices would be their own regulatory submissions and market history.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth as understood in AI/ML is not a concept for wound dressings in this context. Substantial equivalence relies on comparing product design, materials, and intended use as assessed by regulatory bodies.

4. Adjudication method used 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 is not an AI device.

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 purpose of substantial equivalence, the "ground truth" is effectively the established safety and effectiveness of the legally marketed predicate devices. The document states:

• "Previous biocompatibility testing and use in the market place have shown safety and effectiveness of the two products [predicate devices]."
• The device is found "substantially equivalent... to devices marketed in interstate commerce prior to May 28, 1976..."

8. The sample size for the training set:
Not applicable. There is no AI algorithm or training set.

9. How the ground truth for the training set was established:
Not applicable.

In summary: The provided document is a regulatory submission for a physical medical device (wound dressing) seeking market clearance through substantial equivalence. It is not an AI/ML device, and thus the requested specific details regarding AI/ML study design and evaluation metrics are not present or applicable. The "study" for this device is the comparison of its characteristics and indications for use against established predicate devices.

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