Search Results

The Auto Suture* SurgiStitch** suture passer is indicated for the placement of interrupted sutures for soft tissue approximation in surgical procedures such as cardiovascular and gastrointestinal surgery.

The Auto Suture* SurgiStitch** suture passer is designed to pass either one or both needles of a double armed suture through tissue for the creation of interrupted stitches.

The provided document, a 510(k) summary for the Auto Suture SurgiStitch suture passer, does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The 510(k) summary is primarily focused on establishing substantial equivalence to a predicate device (Modified Endoscopic Suturing device K961173) for market clearance. It describes the device, its intended use, and materials, and clarifies the regulatory process.

Therefore, I cannot provide the requested information from the given text.

Here's a breakdown of why each point cannot be answered:

1. A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on regulatory clearance, not performance metrics.
2. Sample sized used for the test set and the data provenance: No performance testing data is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no performance study is detailed.
4. Adjudication method (e.g., 2+1, 3+1, none) 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: Not applicable. This device is a manual surgical instrument, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical surgical tool.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document mainly covers administrative and regulatory aspects for market clearance, not detailed performance studies or AI-related evaluations.

Ask a specific question about this device