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The Opus® SmartStitch™ Suture Device with PerfectPasser™ Connector is indicated for use for placement of braided polyester or polyethylene suture through soft tissue in endoscopic and other limited access procedures.

The Opus® SmartStitch™Suture Device with PerfectPasser™ Connector is designed to allow the surgeon the option to place a simple stitch or a mattress stitch.

The provided text describes a 510(k) premarket notification for a medical device and focuses on its substantial equivalence to a predicate device, rather than presenting a performance study with acceptance criteria.

Therefore, I cannot provide the requested information about acceptance criteria or a study proving the device meets them because such details are not present in the given text.

The document does not contain any information regarding:

• Acceptance criteria
• Reported device performance against any criteria
• Sample sizes for test sets or training sets
• Data provenance
• Number or qualifications of experts for ground truth
• Adjudication method
• Multi-reader multi-case (MRMC) comparative effectiveness study
• Standalone algorithm performance
• Type of ground truth used
• How ground truth for the training set was established

The document is a regulatory submission for a modified medical device, asserting its "substantial equivalence" to a previously cleared device. The key argument for substantial equivalence is that the modification involves a change to the suture delivery system and alternative materials, but the fundamental technology and principle of operation remain the same. The text explicitly states: "The differences between the Opus® SmartStitch™ Suture Device with PerfectPasser™ Connector and the predicate device does not raise any questions regarding the safety and effectiveness." This indicates that the regulatory pathway relies on demonstrating fundamental similarity and not requiring new clinical performance data.

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