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

The Opus® SmartStitch™Suture Device with PerfectPasser is designed to allow the surgeon the option to place a simple stitch or a mattress stitch through soft tissue in endoscopic and other limited access procedures.

The provided document is a 510(k) summary for the Opus® SmartStitch™ Suture Device with PerfectPasser™ Connector. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a standalone study with detailed statistical analysis.

Therefore, many of the requested elements (like acceptance criteria, sample sizes for test sets, ground truth establishment methods, MRMC studies, or training set details) are not applicable or not provided in this type of regulatory document.

Here's the breakdown of what can be extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for the device itself. For a 510(k) submission, the primary "acceptance criterion" is demonstrating substantial equivalence to a predicate device.
• Reported Device Performance: Not reported in terms of specific performance metrics or clinical outcomes. The document states that the "modification incorporates the same principal of operation and fundamental technology as the previously cleared Opus SmartStitch Suture Device with PerfectPasser Connector" and "the device, as designed, is as safe and effective as the predicate device." This is the core "performance" claim for substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance:

• Not applicable / Not provided. A formal "test set" in the context of an algorithm or statistical study proving performance is not detailed in this 510(k) submission. The submission is based on demonstrating equivalence, not on a new, comprehensive clinical performance study. There's no mention of specific data or its provenance.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

• Not applicable / Not provided. As there's no defined "test set" and a requirement to establish ground truth for it, this information is not present.

4. Adjudication Method for the Test Set:

• Not applicable / Not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size:

• No. This document does not describe an MRMC comparative effectiveness study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Not applicable. This device is a surgical instrument (suture device), not an algorithm or AI. Therefore, the concept of "standalone algorithm performance" is not relevant.

7. The Type of Ground Truth Used:

• Not applicable / Not provided. The device is a physical surgical tool; the concept of "ground truth" as used for AI/algorithm validation doesn't apply directly here. The "proof" for substantial equivalence relies on comparing the device's design, materials, and intended use against a previously cleared device.

8. The Sample Size for the Training Set:

• Not applicable / Not provided. This is not an AI/ML device, so there is no training set.

9. How the Ground Truth for the Training Set was Established:

• Not applicable / Not provided.

Summary of the Study (as described in the 510(k)):

The "study" presented in this 510(k) is a substantial equivalence comparison to a predicate device, rather than a de novo clinical trial or performance study.

• Predicate Device: Opus® SmartStitch™ Suture Device with PerfectPasser™ Connector (K062244, Cleared 10/02/06).
• Nature of the "Study": The submission argues that the modified device is substantially equivalent because it "incorporates the same principal of operation and fundamental technology as the previously cleared Opus SmartStitch Suture Device with PerfectPasser Connector."
• The "primary difference includes the addition of a material." The document asserts that this difference "does not raise any questions regarding the safety and effectiveness" and that "the materials are well characterized."
• Conclusion of the "Study": The device, as designed, is "as safe and effective as the predicate device."

This document primarily focuses on regulatory approval by demonstrating that a modified version of an already approved device remains safe and effective relative to its predicate, rather than providing detailed performance metrics from a new, extensive study.

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