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The Medigel Z products are indicated for temporary use in the management of hypertrophic scars and keloids resulting from wounds, trauma, or burns. The Medigel Z products are not wound dressings and are not intended to be used on open wounds. It is recommended that the products be used after the closing of a wound (8th to 10th day), or just after the first sign of hypertrophic scars.

The Medigel Z is a combination of a tri-block polymer and mineral oil. Medigel Z sheets are available in two thicknesses, 3 mm and 5 mm. The 3 mm sheets are 4 inches by 4 inches. The 5 mm sheets are available in three sizes: 8 by 8 inches, 12 by 16 inches, and 16 by 20 inches. The 5 mm sheets are lined with a fabric backing.

The Medigel Z is also available in four different sized elastic sleeves. The sleeves are 9.5 inches long and range from 12 to 55 inches in circumference. The Medigel Z is also available as an unlined finger-tube, a fabric lined sternal strap, and an elastic lined glove (open finger tips) and chin strap.

The Medigel Z also is available with an adhesive which eliminates the need for a compression bandage in most cases. The adhesive Medigel Z is available with or without a fabric backing and comes in sheets or circular pads. The "Mammopatch Gel Z" and "Abdopatch Gel Z" are fabric backed versions of the adhesive Medigel Z that are shaped specifically for use on the breast and abdomen.

The provided text describes a 510(k) premarket notification for a medical device called "Medigel Z™ Scar Management Gel." This submission focuses on establishing substantial equivalence to previously marketed devices, rather than presenting a study with specific acceptance criteria and performance data for the device itself. Therefore, many of the requested details about acceptance criteria, performance studies, sample sizes, and expert adjudication are not present in this document.

Here's a breakdown of what can and cannot be extracted from the document based on your request:

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

• Acceptance Criteria: Not explicitly stated in this document. For a 510(k) submission, the primary "acceptance criterion" is demonstrating substantial equivalence to a predicate device. This is achieved by showing similar intended use, technological characteristics, and safety/effectiveness profiles. Specific numerical performance acceptance criteria (e.g., sensitivity, specificity, accuracy) are not typically part of a 510(k) summary for this type of device.
• Reported Device Performance: No specific numerical performance data is reported in this document. The submission asserts that the device has the "same technological characteristics" as the predicate.

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

• Not applicable. This document does not describe a clinical study or a "test set" in the context of diagnostic or AI performance evaluation. It's a regulatory submission for premarket clearance based on substantial equivalence.

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 by experts for a test set is described.

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

• Not applicable. No adjudication method for a test set 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 is not a study involving human readers or AI assistance.

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

• Not applicable. This device is a scar management gel, not an algorithm.

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

• Not applicable in the context of performance metrics. The "ground truth" for a 510(k) is typically the safety and effectiveness of the predicate device. The document implies that the "Medigel Z" has similar effects to the predicate devices because of shared technological characteristics.

8. The sample size for the training set

• Not applicable. There is no "training set" described.

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

• Not applicable. There is no "training set" described.

Summary based on the provided text:

The document is a 510(k) premarket notification for the "Medigel Z™ Scar Management Gel." It aims to demonstrate substantial equivalence to two predicate devices: Silipos® Tri Block Polymer Gel (K942695) and Smith & Nephew Rolyan Cica-Care™ Silicone Gel Sheet (K935803).

The core "study" and "acceptance criteria" discussed (implicitly) are rooted in the 510(k) process:

• Acceptance Criteria (Implicit for 510(k) Substantial Equivalence):

  • Same Intended Use: The device must have the same intended use as the predicate.
  • Same Technological Characteristics OR Different Technological Characteristics with Equivalent Safety/Effectiveness:
    • If the technological characteristics are the same, substantial equivalence can be demonstrated without additional testing.
    • If the technological characteristics are different, adequate scientific evidence (e.g., performance testing) must be provided to demonstrate that the new device is as safe and effective as the predicate.
  • No New Questions of Safety/Effectiveness: The device must not raise new questions of safety or effectiveness compared to the predicate.

• Reported Device "Performance" (Implicit):

  • The document states: "The Medigel Z™ shares the same technological characteristics, and is manufactured with the same materials as the Silipos® Tri Block Polymer Gel, with the exception of the use of an adhesive to attach the device to the patient's skin. The Cica-Care™ gel, like the Medigel Z, uses an adhesive to attach the gel the body."
  • This statement is the basis for claiming substantial equivalence – implying that because the characteristics are similar (or the differences are minor and shared with another predicate), the performance (safety and effectiveness in scar management) is also equivalent to the already cleared predicate devices.

Missing Information: The document does not contain the specific statistical performance metrics, sample sizes for studies, expert qualifications, or ground truth methodologies that would be typical for evaluating the performance of a diagnostic or AI-based device, as it is describing a physical medical product for scar management under a 510(k) pathway.

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