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FemoStop® Femoral Compression System is indicated for use in the compression for the femoral artery or vein after vessel cannulation, and in ultrasounded-guided compression repair of a femoral artery pseudoaneurysm

The FemoStop®Femoral Compression System consists of an arch with a sterile pneumatic pressure dome attached to an arch, a belt, and a reusable pump with manometer. With this application a sterile hemostatic dressing, HD, is added to the system. The dressing has an active agent made of calcium/sodium salt of micro dispersed oxidized cellulose for topical control of bleeding.

This is a 510(k) summary for the FemoStop® Femoral Compression System. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, the provided text does not contain any information regarding specific acceptance criteria, study details, or performance data beyond stating substantial equivalence. Therefore, a complete answer as requested cannot be generated from the given input.

The document primarily focuses on establishing substantial equivalence based on technical characteristics and intended use, comparing the new device (with an added hemostatic dressing) to existing FemoStop models and other relevant products.

Based on the provided text, the following information is missing or cannot be extracted:

• A table of acceptance criteria and the reported device performance: This information is not present. The document claims technical characteristics are "identical" or "substantially equivalent" to predicate devices, but no performance metrics or specific acceptance criteria are listed.
• Sample size used for the test set and the data provenance: No test set or data provenance is mentioned.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no test set or ground truth establishment is described.
• Adjudication method: Not applicable.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No such study is mentioned.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, this is a medical device, not an AI algorithm.
• The type of ground truth used: Not applicable, as no ground truth is established for performance evaluation.
• The sample size for the training set: Not applicable, as this is a medical device, not a machine learning algorithm.
• How the ground truth for the training set was established: Not applicable.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and study details based on the provided text. The document is strictly a 510(k) summary aiming for substantial equivalence.

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