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Advanced Medical Solutions Group plc Spyrogel Hydrogel Wound and Burn Dressing SA is intended for OTC use on: Superficial wounds such as, minor cuts, lacerations and minor burns and scalds

Advanced Medical Solutions Group plc Spyrogel® Hydrogel Wound and Rurn Dressing SA are supplied individually packaged in medical graum fuil pouches suitable for gamma irradiation. They are supplied to the market place as sterile dreasings. The intelligent film is as comercially distrubuted in the USA under 510(k) (K981753) June 30, 1998. The dressings are sterilized by gamma Irradiation. Isotron Laboratories provided Dose Mapping per ISO 11137, validation was undertaken in accordance with ISO 11137 Mothod 1. The verification dose required for a Sterllity Assurance Level (SAL) of 10-6 is 23.4 kGy. Starilization velidation data is on file at Isotron Laboratories. Biooompatability tosting has boon performed in accordance with ISO10983-1 Biological Evaluation of Medical Devices -- Part 1 Guidance on Selection of Tests First Edition. Data and Safety evaluation is as that submitted with aiready sporoved 510(k)'s K881753 and K982804. No components or raw materials have changed therefore no resubmission of loxicity data its required.

The provided document is a 510(k) premarket notification for a medical device called "Spyrogel® Hydrogel Wound and Burn Dressing SA." It describes the device, its intended use, and states that it has been determined substantially equivalent to legally marketed predicate devices.

However, this document does not contain the information requested regarding detailed acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment for an AI-powered device. The document is for a hydrogel wound dressing, not an AI/ML device.

Therefore, I cannot provide accurate answers to the questions based on the provided text. The questions are specifically tailored for an AI/ML device's validation process, which is not described in this regulatory filing for a wound dressing.

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The Advanced Medical Solutions Silicone Scar Management Sheet intended for the management of old and new hypertrophic and keloid scarring on scars resulting from burns, general surgical procedures and trauma wounds.

Advanced Modical Solutions Silicone Gel Scar Management Sheet is intended for OTC use for the management of: Old and new hypertrophic and keloid scarring on scars resulting from burns, general surgical procedures and trauma wounds.

Advanced Medical Solutions Silicone Scar Management Gel sheet is a soft, self-adhesive, semi-occlusive sheet made from medical grade silicone with a polyurethane film backing paper and a non siliconised polyester release paper.

The primary function of the dressing is to aid in the management of both existing and new hypertrophic and keloid scarring on scars resulting from burns, general surgical procedures and trauma wounds.

The Advanced Medical Solutions Silicone Scar Management Sheet comes in two sizes 3in. x 4in. and 1in. x 4in. the sheet maybe cut or trimmed to the desired shape or size prior to placement on the scar, also two or more sheets may be placed together to cover a scar area that is greater than the area of a single sheet.

The Advanced Medical Solutions Silicone Scar Management Sheet is self adhesive but can also be secured by a lightly conforming bandage or tape if so desired.

The gel sheets are supplied either sterile or non-sterile in foil laminated sterilizable pouches.

The provided text is a 510(k) premarket notification for a medical device: "Advanced Medical Solutions Silicone Scar Management Sheet." This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study with specific acceptance criteria and performance metrics for the novel device itself.

Therefore, many of the requested details about acceptance criteria, specific study design, sample sizes, expert qualifications, and ground truth establishment cannot be extracted from this document as such information is typically part of a clinical trial or performance study report, which is not included here.

However, I can extract information related to the device's intended use and the predicate device used for comparison, which indirectly touches upon performance similarities.

Here's a breakdown of what can be inferred or explicitly stated from the document:

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

This document does not provide a table of acceptance criteria and reported device performance in the way a clinical study report would. The core of this 510(k) submission is to demonstrate "substantial equivalence" to a legally marketed predicate device. The "acceptance criterion" for a 510(k) is essentially that the new device is as safe and effective as a predicate device and does not raise new questions of safety or effectiveness.

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

This document does not describe a test set or clinical study with a specified sample size. The substantial equivalence argument relies on comparing the device's characteristics (materials, design, intended use, operating principles) to a predicate device, rather than new clinical data from a test set.

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, as no test set or clinical study to establish ground truth is described.

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

Not applicable, as no test set or clinical study 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. This device is a silicone gel sheet for scar management, not an AI-assisted diagnostic tool.

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

Not applicable, as this is not an AI algorithm.

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

Not applicable, as a clinical study requiring ground truth is not described. The "ground truth" for this submission is the established safety and effectiveness of the predicate device.

8. The sample size for the training set

Not applicable, as no training set for an algorithm is relevant to this device.

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

Not applicable.

What can be inferred or directly stated from the document:

• Device Intended Use/Indications for Use:

  • Acceptance Criterion (Implicit): The device functions effectively for the management of old and new hypertrophic and keloid scarring on scars resulting from burns, general surgical procedures, and trauma wounds.
  • Reported Device Performance (Implicit via substantial equivalence): The device is expected to perform similarly to other silicone gel sheeting products already on the market for these indications. The document states, "The Advanced Medical Solutions Silicone Scar Management Sheet Is essentially similar to other devices approved by the FDA under the device classification. Elastomer, Silicone for scar management."

• Predicate Device:

  • The predicate device used for comparison is the Spenco Silicone Gel Sheet (510(k) K981902), manufactured by Spenco Medical Corp. The substantial equivalence claim is based on the new device being similar to this already approved device.

• Safety Considerations:

  • The document implies that the device meets certain safety criteria related to sterilization residuals (ETO: 100ppm, ECH: 100ppm, EG: 2000ppm).
  • Warnings and Contraindications: Discontinue use if infection is suspected, not for use on third-degree burns, not to be used on open wounds, not for patients with dermatological conditions that disrupt skin integrity in areas of coverage. These are implicit safety acceptance criteria.

In summary, this document is a regulatory submission focused on substantial equivalence, not a study report detailing specific performance metrics against pre-defined acceptance criteria for a novel clinical trial. It uses an established predicate device as its benchmark for safety and effectiveness.

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