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The ATLAS Wound Matrix devices intended use is for the management of wounds including:

• partial and full thickness wounds,
  • pressure ulcers,
  • venous ulcers,
• diabetic ulcers.
• chronic vascular ulcers,
• tunneled/undermined wounds.
• surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence),
• trauma wounds (abrasions, lacerations, second-degree burns, and skin tears),
• draining wounds.

The device is supplied sterile and is intended for one-time use.

The ATLAS Wound Matrix is a sterile, decellularized fenestrated or non-fenestrated processed porcine collagen dermal material, which is rehydrated at the time of implant, is designed to be thin enough to conform to the wound it will cover. The matrix material will be made available in a variety of sizes depending on surgical use.

This 510(k) summary describes a medical device, the ATLAS Wound Matrix, which is a processed porcine collagen dermal material used for wound management. However, this document does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.

Instead, the document focuses on demonstrating substantial equivalence to existing predicate devices. This means the manufacturer is asserting that the new device is as safe and effective as a legally marketed device, and therefore does not require a new scientific study with specific acceptance criteria to prove its performance.

Therefore, I cannot fulfill your request for the following information based on the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not provided because the submission relies on substantial equivalence.
2. Sample size used for the test set and the data provenance: No performance testing data is presented.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no ground truth for performance testing is discussed.
4. Adjudication method for the test set: Not applicable.
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 wound matrix, not an AI-powered diagnostic tool, so this type of study is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is not an algorithm, but a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No ground truth for performance testing is discussed.
8. The sample size for the training set: Not applicable as this is not an AI/algorithmic device with a training set.
9. How the ground truth for the training set was established: Not applicable.

Summary of available information related to the device and its approval process:

• Device Name: ATLAS Wound Matrix
• Intended Use: Management of various wounds including partial and full thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds, trauma wounds (abrasions, lacerations, second-degree burns, and skin tears), and draining wounds.
• Device Description: Sterile, decellularized fenestrated or non-fenestrated processed porcine collagen dermal material, rehydrated at the time of implant, thin and conformable to the wound.
• Approval Basis: Substantial Equivalence to previously cleared predicate devices. The document states: "The intended use, type of interface, operating principles, shelf life, and design features of the ATLAS Wound Matrix are substantially equivalent to the previously cleared predicates. Additionally, the safety and effectiveness of the ATLAS Wound Matrix is adequately supported by the substantial equivalent information and materials data provided within this Premarket Notification."

In essence, this 510(k) summary is a declaration that the new device is sufficiently similar to existing approved devices that it doesn't require new, independent clinical trials with performance acceptance criteria.

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