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To be used as an occlusive wound dressing. To be used as a temporary bandage to treat penetrating chest wounds that could compromise the pleural space of the chest cavity, such as: gunshot wounds, stab wounds and fragment wounds, and to be used in emergency situations and to be left in place only while the patient is transported to the hospital.

SAM Chest Seal with Valve: The SAM Chest Seal with valve is an adhesive dressing composed of a hydrogel based adhesive with a clear backing and check valve. The chest seal is placed over the open chest wound. The skin adhesive holds it in place over the wound. The one way valve prevents air pressure from increasing in the pleural space.
SAM Chest Seal: The SAM Chest Seal is an adhesive dressing composed of a hydrogel based adhesive with a clear backing. The chest seal is placed over the open chest wound. The skin adhesive holds it in place over the wound.

The provided text is a 510(k) summary for the SAM Chest Seal product family, which includes the SAM Chest Seal with Valve and the SAM Chest Seal. It describes the device, its intended use, and its comparison to predicate devices. It states that the device is substantially equivalent to the predicate devices.

However, the document does not contain information regarding a clinical study with acceptance criteria, reported device performance, sample sizes, ground truth establishment, or expert evaluations.

Here's a breakdown of why the requested information cannot be provided from this document:

1. Clinical Data: Section H explicitly states, "Clinical data are not included in this submission." This means no study was performed to demonstrate performance against specific acceptance criteria.
2. Performance Testing (Non-clinical): Section G states, "Performance testing demonstrated that the Chest Seal devices perform as well as, or better than, the predicate device." This refers to non-clinical data, likely bench testing or engineering evaluations, and does not provide specific metrics or acceptance criteria in the document.
3. Regulatory Nature: This is a 510(k) submission, which aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than requiring extensive new clinical trials with detailed performance metrics.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and a study that proves the device meets them because the provided text indicates that no clinical data was included in this submission to establish such criteria or performance.

The document concludes that the devices are "substantially equivalent" to predicate devices based on non-clinical data, design, function, materials, and intended use. This is the primary "proof" used for 510(k) clearance in this case, not a clinical study with detailed performance metrics.

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