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The Neodyne Dressing is intended for use in the management of closed hyperproliferative (hypertrophic and keloid) scars.

The Neodyne Dressing is a non-sterile, single use adhesive silicone sheet to be used to protect and manage a newly formed, closed scar. The Dressing is pre-strained prior to application and applied over the new scar. The silicone sheeting protects and stress shields the scar.

The Neodyne Dressing is intended for the management of closed hyperproliferative (hypertrophic and keloid) scars. The device's performance relies on both its silicone sheeting material and the stress shielding provided by the pre-strained dressing.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

   Acceptance Criteria	Reported Device Performance
   Substantial Equivalence to predicate devices (Epi-Derm Silicone Sheeting (K003948) and 3M Steri-Strip (K813265))	The Neodyne Dressing is claimed to be as safe and effective as Steri-Strips and Epi-Derm Silicone Sheeting. It shares the same intended uses, similar indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences are stated not to raise new issues of safety or effectiveness. Performance data demonstrates that the Neodyne Dressing functions as intended by providing intended strain relief and stress shielding. This conclusion is based on comparing "technological characteristics, and principles of operation" and "performance data" with predicates. The FDA concurred with this assessment, granting 510(k) clearance based on substantial equivalence.
   Provide intended strain relief	Bench testing confirmed that the Neodyne Dressing provided the intended strain relief.
   Function as intended (stress shielding)	Bench testing confirmed that the Neodyne Dressing functioned as intended by providing stress shielding.

2. Sample size used for the test set and the data provenance:
   The document does not specify a test set sample size or data provenance (e.g., country of origin, retrospective/prospective clinical study details) for a clinical trial evaluating the Neodyne Dressing's effectiveness in scar management. The assessment primarily relies on bench testing results regarding strain relief and stress shielding, and a comparison of technological characteristics with predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This information is not provided. The submission hinges on bench testing and comparison to predicate devices, not on a clinical ground truth established by experts.

4. Adjudication method for the test set:
   This information is not provided as no clinical test set for evaluating the device's clinical efficacy in scar management 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:
   This device is a physical medical dressing, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not conducted.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
   This device is a physical medical dressing, not an algorithm. Therefore, a standalone algorithm performance study is not applicable and was not done.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   For the bench testing, the ground truth was likely established by engineering measurements and specifications for strain relief and stress shielding. For the substantial equivalence argument, the "ground truth" was largely based on a comparison of technological characteristics and intended uses against legally marketed predicate devices, supported by bench test data. There is no mention of clinical outcomes data or pathology as primary ground truth for this 510(k) submission.

8. The sample size for the training set:
   This information is not applicable as the device is not an AI algorithm that requires a training set. The "design" or "development" of the dressing would not typically involve a "training set" in the context of machine learning.

9. How the ground truth for the training set was established:
   This information is not applicable as the device is not an AI algorithm that requires a training set and corresponding ground truth.

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