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The SIS Hernia Repair Device is intended to be implanted to reinforce soft tissue where weakness exists. Indications for use include the repair of a hernia and body wall defect. The device is intended for one-time use.

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The provided text describes a Special 510(k) Premarket Notification for the SIS Hernia Repair Device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific performance criteria through clinical studies or extensive testing against defined acceptance criteria.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and comparative effectiveness studies is not applicable to this type of regulatory submission as presented in the provided documents.

The core of this 510(k) summary is to assert that the SIS Hernia Repair Device is substantially equivalent to an existing, legally marketed device with respect to its intended use, operating principles, basic design, materials, shelf-life, internal tests/release criteria, packaging, and sterilization. The only difference noted is a process change that did not affect specifications or performance. This means the existing evidence for the predicate device's safety and effectiveness implicitly applies to this device.

In summary, based on the provided text, the following apply:

• Acceptance Criteria Table: Not applicable. Performance is demonstrated through substantial equivalence to a predicate device, not by meeting new, explicitly defined acceptance criteria.
• Sample size and data provenance: No new studies are presented with sample sizes or data provenance. The submission relies on the established safety and effectiveness of the predicate device.
• Number of experts and qualifications: Not applicable. Ground truth for a test set is not established in this type of submission.
• Adjudication method: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
• Standalone (algorithm only) performance study: Not applicable, as this is a physical medical device, not an AI or algorithm-based device.
• Type of ground truth used: Not applicable. No new ground truth is established for this device as no new clinical or performance studies are presented.
• Sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

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