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Innovative Technologies Hydrucolloids & Intelligent Hydrocolloids can be used for the management of wounds including, minor scalds and burns, superficial wounds such as abrasions, lacerations and minor cuts and as a protective dressing for such uses as minor blisters. This wound dressing may also bo used under the care of a health care professional for such wounds as, partial - full thickness wounds i. o. artorial ulcers, venous ulcers and diabetic ulcers, post operative surgical wounds. donor sites. If at any time you are unsure of the above conditions or the type of wound consult a health care professional. Discontinue use if any infection of the wound is suspected and seek guidance from a health care professional

Highly floxible and conformable gol formula dressings, which absorb wound exudate producing a soft, gel mass which allows pasy removal of the dressing roducing the potential for delicate peri- wound tissue damage during dressing changes. Innovative Technologies Intelligent wound dressings utilize an intelligent film which allows moisture to transpire the hydrocolloid whilst providing a barrier to water and bacteria

The provided document is a 510(k) premarket notification for Hydrocolloid and Intelligent Hydrocolloid Wound Dressings. It outlines the device's description, intended use, and indicates substantial equivalence to a previously cleared device. However, it does not contain information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement in a study to prove the device meets acceptance criteria.

The document primarily focuses on the regulatory submission process and the FDA's determination of substantial equivalence. It confirms that "Biocompatability results presented in 510(k) K971126 remain current, no changes to raw materials or components which would require the submission of new toxicity data." This suggests that previous testing for the predicate device K971126 is being leveraged, but the specifics of that testing are not detailed here.

Therefore, I cannot provide the requested information from the given text.

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Innovalive Technologies' Hydrocolloid & Intelligent Hydrocolloid Wound Dressings may be used for the management of wounds including.

• Partial full thickness wounds, ie artenal, venous, diabetic ulocrs .
• Post-operative surgical wounds
• Donor Eiles
• Trauma Wounds
• Dermal Lesions
• Profective dressing

Innovative Technologies' Hydrocolloid Wound Dressings, are highly conformable, sterile, primary wound dressings-intended to provide an environment ideally suited for chronic wound management. The dressings are soft conformable hydrocolloid preparations for heavy to light exuding partial-full thickness wounds. The hydrocolloid preparations react with wound exudate to form an gelatinous mass providing for a moist healing environment. The dressing may easily be lifted away from the wound, reducing the potential for delicate peri-wound tissue damage during dressing changes. Dressings are supplied sterile in single use blister packs.

The provided text is related to a 510(k) submission for "Innovative Technologies' Hydrocolloid & Intelligent Hydrocolloid Wound Dressings." This document is a regulatory submission for medical devices, specifically seeking clearance to market a device based on its substantial equivalence to a legally marketed predicate device.

Key Observation:
The document does not describe a study that proves the device meets specific acceptance criteria. Instead, it outlines the regulatory review process for a 510(k) submission. In a 510(k) submission, the primary goal is to demonstrate "substantial equivalence" to a predicate device, meaning the new device is as safe and effective as the predicate. This is typically achieved by comparing the new device's technological characteristics, indications for use, and performance data (if available and relevant for equivalence) to the predicate device. It does not generally involve a new clinical study with pre-defined acceptance criteria in the same way a PMA (Premarket Approval) submission would for novel devices.

Therefore, I cannot extract the requested information as it is not present in the provided text. The document focuses on:

• Device Description: Hydrocolloid and Intelligent Hydrocolloid Wound Dressings.
• Intended Use: Management of various wounds (dermal ulcers, superficial wounds, burns, donor sites, post-operative wounds, protective dressings).
• Comparison to a Predicate Device: Duoderm CGF / Extra Thin Hydrocolloid Dressings manufactured by Convatec, highlighting similarities in composition, surface, indications for use, transparency, self-adhesiveness, and sterilization method.
• Safety Assertions: Biocompatibility testing completed.
• Regulatory Clearance: A letter from the FDA determining substantial equivalence, along with limitations on labeling claims.

To directly answer your request based on the provided text, while acknowledging the absence of a detailed study report:

Acceptance Criteria and Device Performance Study (Not Applicable as a standalone study report is not provided)

The provided document describes a 510(k) submission, which focuses on demonstrating "substantial equivalence" to a legally marketed predicate device rather than presenting a standalone study with defined acceptance criteria and performance metrics. The implicit "acceptance criteria" for a 510(k) submission is that the device is as safe and effective as the predicate device.

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

Since no specific acceptance criteria for a new study are outlined, and no new performance data comparing against such criteria is presented, this table cannot be created from the text. The document does, however, provide a comparative table between the applicant's device and the predicate device, showing their similar characteristics:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. The document does not describe a clinical "test set" in the context of a new study designed to meet specific performance criteria. The evaluation is based on a comparison to a predicate device and existing regulatory standards (e.g., for sterilization and biocompatibility).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No "ground truth" establishment for a test set is described as part of a clinical performance study. The expertise cited is related to quality assurance and regulatory affairs (Priscilla Whitehead, Director of QA/RA for Innovative Technologies).

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

Not applicable. No test set requiring expert adjudication 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. The device is a wound dressing, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to "human readers improving with AI" is not relevant to this device.

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

Not applicable. The device is a wound dressing, not an algorithm.

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

Not applicable. For this 510(k) submission, the "ground truth" for demonstrating safety and effectiveness relies on the established regulatory approval and safety profile of the legally marketed predicate device (Duoderm CGF / Extra Thin Hydrocolloid Dressings by Convatec), combined with the Innovative Technologies' device meeting relevant standards for sterilization and biocompatibility.

8. The sample size for the training set

Not applicable. There is no mention of a training set as this is not a machine learning or diagnostic algorithm device.

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

Not applicable. There is no mention of a training set.

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