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The Hollister Thin Film Wound Dressings are intended to provide a moist wound healing environment to facilitate the normal wound healing process. The Hollister Thin Film Wound Dressings provide a barrier to bacteria and external contaminates such as urine and feces. The Hollister Thin Film Wound Dressings are also intended to be used on IV sites or as secondary fixation devices for products such as alginates, gels and foam dressings used for venous stasis and diabetic ulcers.

Indications for Use:
OTC:

• minor burns
• superficial cuts, lacerations and abrasions
• minor irritations of the skin

Under the care of a health care professional:

• non-exuding to minimally exuding wounds
• pressure sores
• lacerations/abrasions
• partial and full thickness wounds
• post-operative surgical wounds
• second degree burns
• donor sites
• IV sites
• secondary fixation device

The Hollister Incorporated Thin Film Wound Dressings are transparent polyurethane films that are backed with a pressure sensitive acrylic adhesive. An unique closed cell foam application grid allows for easy handling of the film dressing during application to the wound sites. The Hollister Thin Film Wound Dressings are designed to have a ligh moisture vapor transmission rate and are intended to provide a moist wound healing environment to facilitate the normal wound healing process. The Hollister Thin Film Wound Dressings provide a barrier to bacteria and external contaminates such as feces and urine.

The dressings are also intended to be used on IV sites or as secondary fixation devices for products such as alginates, gels, and foams used for venous stasis and diabetic ulcers.

The Hollister Thin Film Wound Dressings are presented sterile and are available in a variety of sizes to accommodate various sizes of wounds.

The Hollister Transparent Film Dressings are comprised of two parts: A transparent film dressing with removable backing paper and a foam application grid. The Transparent Film Dressings are permeable to moisture vapor and oxygen. The films transmit water, but retain other exudate components creating the ideal environment for wound healing.

Here's an analysis of the provided text, focusing on acceptance criteria and the study proving device performance:

This document is a 510(k) premarket notification for the Hollister Thin Film Wound Dressings, seeking substantial equivalence to predicate devices. It does not contain a study proving the device meets specific acceptance criteria in the traditional sense of a clinical trial with performance metrics. Instead, it demonstrates substantial equivalence to predicate devices based on technological characteristics and intended use, which is a different regulatory pathway.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts, MRMC study, standalone performance) are not applicable to the information provided in this 510(k) submission.

Here's what can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't define "acceptance criteria" in terms of specific performance metrics that need to be met by the Hollister device in a study. Instead, it compares the technological characteristics and indications for use of the proposed device against predicate devices to establish substantial equivalence.

Note: The "acceptance criteria" here are essentially the characteristics and performance of the legally marketed predicate devices, which the new device aims to be substantially equivalent to.

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

Not applicable. This is a 510(k) submission based on comparison to predicate devices, not a clinical study involving a "test set" of patient data for performance evaluation in the way a diagnostic AI would use it. The regulatory pathway of substantial equivalence relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device.

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

Not applicable. This is a 510(k) submission for a wound dressing, not a diagnostic device requiring expert interpretation of a test set for ground truth.

4. Adjudication Method for the Test Set

Not applicable. As above, there's no "test set" in the context of a performance study as described in your prompt.

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 pertains to a physical wound dressing, not an AI-powered diagnostic or assistive tool for human readers.

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

Not applicable. This document pertains to a physical wound dressing, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context is the safety and effectiveness of the predicate devices, as established through their prior regulatory clearance (or grandfathered status). The Hollister device demonstrates substantial equivalence to these established predicate devices.

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. As above, there is no training set for this type of device submission.

In summary, the provided document describes a 510(k) premarket notification for a wound dressing. The "study" proving the device meets acceptance criteria (in the context of regulatory approval) is the submission itself, which demonstrates substantial equivalence to predicate devices based on a comparison of fundamental technological characteristics, intended use, and biocompatibility. It does not involve performance studies with test sets, experts, or AI algorithms as implied by many of your prompt's questions.

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