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The JJ Skinner CareKits™ Wound Care Management/Dressing Change Tray is intended to be used by Healthcare professionals for wound care management, including, cleansing, irrigation, debridement, and dressing changes.

The JJ Skinner CareKits™ Wound Care Management/Dressing Change Tray is an assembly of medical products sterilized within a Tyvek®/polyethylene pouch. The trays are sterile, disposable, and single use. The primary purpose is for the convenience of the Healthcare professional. The trays are custom to the customer, and include a variety of medical devices that are legally marketed, are exempt, or are grandfathered. These components of the tray are commonly used for wound management, and JJ Skinner is not claiming or causing new uses through the intended use of the tray.

The provided text describes a 510(k) summary for the "JJ Skinner CareKits™ Wound Care Management/Dressing Change Tray." It explicitly states: "No clinical evaluations were completed."

Therefore, there is no information available in the given text regarding:

1. A table of acceptance criteria and the reported device performance: No performance data or acceptance criteria are provided.
2. Sample size used for the test set and the data provenance: No test set information is available.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment is described.
4. Adjudication method for the test set: No adjudication method is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No such study was conducted.
6. If a standalone performance (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable as this is not an AI/algorithm device.
7. The type of ground truth used: No ground truth was established.
8. The sample size for the training set: Not applicable as this is not an AI/algorithm device.
9. How the ground truth for the training set was established: Not applicable as this is not an AI/algorithm device.

The submission is based on the device being an assembly of legally marketed, exempt, or grandfathered medical products, and its substantial equivalence to a predicate device through the comparison of similar significant features, components, and intended use.

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The JJ Skinner CareKits™ Minor Surgical Procedure Tray/Kit is intended to be used by Healthcare professionals for minor surgical procedures. Minor surgical procedures are those generally performed on an outpatient basis, under topical anesthetics. These may include dermological excisions or circumcisions.

The devices are an assembly of medical products within Tyvek®/polyethylene breather pouch. The medical products include medical devices, and drugs that are 510(k) approved devices, grandfathered, or exempt. The primary purpose of the assembly is for the convenience of the Medical practitioner. The kit is sterile, single use and disposable. The kits are custom made for the customer, who specifies the name of the kit (i.e.) as well as the contents. Attachment 5 includes a list of the medical components that may be requrested by the customer.

This document is a 510(k) summary for a medical device called "JJ Skinner CareKits™ Minor Surgical Procedure Tray/Kit". It explicitly states "No clinical evaluations were completed." This means there is no study described within this document that proves the device meets specific acceptance criteria based on performance.

Therefore, I cannot provide the requested information.

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