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SignaDRESS is intended for chronic wounds-pressure ulcers (Stage I-IV) and leg ulcers. SignaDRESS is also indicated for use on acute wounds-surgical wounds (post-operative wounds and donor sites), traumatic wounds (minor abrasions and lacerations), burns (first and second degree), and dermatological excisions.

SignaDRESS is a hydrocolloid dressing consisting of an inner (wound contact) layer of hydrocolloids contained within an adhesive polymer matrix and an outer layer of polyurethane backing film. The dressing also has a product identification mark (ConvaTec registered tear drop trademark) and a visible (SignaDRESS) change indicator guide printed on the film backing. The dressing adheres to dry and moist tissue and provides a barrier against bacteria and other external contamination as long as the dressing is intact. SignaDRESS is featured with a delivery system that allows clinicians to apply the dressing without touching the adhesive mass. A visible change indicator printed on the polyurethane backing film helps simplify wound dressing management for the care giver.

This document describes a 510(k) Premarket Notification for a medical device, which typically focuses on demonstrating substantial equivalence to an existing predicate device rather than conducting extensive clinical studies to establish novel performance criteria or improvements over human performance.

Therefore, many of the requested elements, such as those related to AI algorithm performance, multi-reader multi-case studies, ground truth establishment for a training set, and detailed clinical study designs with sample sizes and expert adjudication, are not applicable to this type of submission.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The "acceptance criteria" here are defined by the performance of the predicate device (Coloplast's Comfeel Plus Ulcer Dressing) in specific bench tests. The "reported device performance" refers to how SignaDRESS performed in those same tests.

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

The document refers to "comparative bench testing" for the performance characteristics and "biocompatibility testing."

• Sample Size: The document does not specify the sample size for these bench tests (e.g., number of dressings tested for absorbency, peel adhesion, etc.). This level of detail is typically found within the test reports themselves, which are referenced as being in "section 5a" or "Item 5" of the application but are not provided in this summary.
• Data Provenance: The data is generated from bench testing and biocompatibility testing of the SignaDRESS device and its predicate (Comfeel Plus Ulcer Dressing). This is not clinical data, so concepts like "country of origin" or "retrospective/prospective" don't apply in the clinical sense.

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

Not applicable. Bench testing and biocompatibility testing do not involve expert-established "ground truth" in the way clinical studies with human readers or image interpretation might. The "ground truth" for these tests is based on standardized test methods and measurable physical properties.

4. Adjudication Method for the Test Set

Not applicable. See point 3. Bench tests follow protocols, and biocompatibility tests involve laboratory analysis, not human adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This is a 510(k) submission for a hydrocolloid dressing, not an AI or imaging device that would typically undergo an MRMC study. The goal is to show equivalence to a predicate, not to demonstrate improved human reader performance with AI assistance.

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

Not applicable. This is a physical wound dressing, not an algorithm.

7. The Type of Ground Truth Used

For the bench tests (coefficient of friction, absorbency, peel adhesion, bacterial barrier), the "ground truth" is based on objective measurements defined by standard laboratory test methods.

For biocompatibility testing, the "ground truth" is based on the results of standardized biological assays (e.g., cytotoxicity, irritation tests) performed according to ISO 10993 Part 1.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI algorithms. Its performance is demonstrated through physical and chemical testing.

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

Not applicable. See point 8.

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