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• For use in the management of psoriasis and the protection of psoriatic plaques
• As a protective dressing
• For management of superficial, dry to lightly exudating dermal wounds.

Envela™ is substantially similar in terms of component materials, shape, dimensions, and mode of action to existing occlusive wound dressings.

The document provided is a 510(k) summary statement and a clearance letter for a medical device called Envela™ (Hydrohesive™ Occlusive Dressing). This type of document is for regulatory clearance to market a device, not for a clinical study proving performance against acceptance criteria in the way you've outlined for an AI/algorithm-driven device.

Here's why your request cannot be fully answered with the provided text, and what information can be extracted:

• This is a Class I device, subject to General Controls. Class I devices generally do not require extensive clinical studies or performance data like higher-risk devices, especially those involving AI/algorithms. Their clearance is often based on substantial equivalence to existing predicate devices, focusing on materials, dimensions, and known mechanisms of action.
• The document explicitly states "Performance Standards: Not applicable to Class I occlusive dressings; subject to General Controls." This means there are no specific quantitative performance metrics (like sensitivity, specificity, accuracy) defined or evaluated in a study for this type of device within this regulatory pathway.
• The "study" referenced for this type of clearance is primarily a comparison to predicate devices, not a clinical trial to establish efficacy or an AI performance study.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, experts, adjudication methods, or MRMC studies, as these types of evaluations are not typically required or documented for a Class I occlusive dressing seeking 510(k) clearance via substantial equivalence.

However, I can extract information related to the device and its regulatory clearance as presented:

1. Table of Acceptance Criteria and the Reported Device Performance

• Acceptance Criteria (Implicit - Substantial Equivalence): The primary "acceptance criterion" for this 510(k) clearance is substantial equivalence to legally marketed predicate devices. This means the device must be as safe and effective as a legally marketed device that is not subject to premarket approval.
• Reported Device Performance (Implicit - Substantial Equivalence): The reported "performance" is that the device is "substantially similar in terms of component materials, shape, dimensions, and mode of action to existing occlusive wound dressings." This statement serves as the basis for regulatory acceptance, rather than a specific numerical performance metric from a study.

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 / Not provided. The document does not describe a "test set" or a study with a sample size in the context of performance evaluation for an AI/algorithm. The clearance is based on comparison to predicate devices.

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 / Not provided. Ground truth establishment by experts is not described for this type of device clearance.

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

• Not applicable / Not provided. Adjudication methods are not 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

• No. This is not an AI-driven device, and no MRMC study was conducted or is relevant for this
  510(k) clearance.

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

• No. This is not an AI-driven device, and no standalone algorithm performance was assessed.

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

• Not applicable / Not provided. No "ground truth" was established in the context of performance study for this device. The basis for clearance is comparison to predicate devices and their known clinical use.

8. The sample size for the training set

• Not applicable / Not provided. There is no "training set" as this is not an AI/algorithm device.

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

• Not applicable / Not provided. No training set or ground truth for it was established.

In summary, the provided document is a regulatory filing for a Class I medical device based on substantial equivalence to predicate devices, not a performance study for an AI or algorithm that would involve the criteria you listed.

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