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The Symani® Surgical System is intended for soft tissue manipulation to perform anastomosis. suturing, and ligation microsurgery techniques on small blood vessels and lymphatic ducts between 0.1 and 2.5 mm in open free-flap surgery of the breast and extremities and open lymphatic surgery of the extremities.

The Symani® Surgical System is indicated for use during microsurgical procedures when use of a motion scaling function is deemed appropriate by the System is indicated for use in adults. It is intended to be used by trained physicians in an appropriate operating environment in accordance with the Instructions for Use.

The Symani Surgical System is designed for open microsurgery procedures, featuring articulated and interchangeable instruments.

The surgeon manipulates the Master Controllers, which in turn drive the articulated (wristed) robotic Instruments at the operating table/site, replicating and scaling down the surgeon movements using a chosen scaling factor. Symani is used in combination with conventional surgical microscopes, either optical or digital.

Symani is composed of three main components (Figure 1):

• The Console, which is a reusable equipment and not sterile; .
• The Cart with Macropositioner and two Micromanipulators, which is a reusable equipment . and not sterile: and
• . Two articulated Instruments, which are single-use and terminally sterilized via ethylene oxide

Here's a detailed breakdown of the acceptance criteria and the study that proves the Symani Surgical System meets them, based on the provided text:

Overview of Device and Intended Use:

The Symani Surgical System is an electromechanical system for open microsurgery, specifically intended for soft tissue manipulation to perform anastomosis, suturing, and ligation microsurgery techniques on small blood vessels and lymphatic ducts (between 0.1 and 2.5 mm). Its primary indications are in open free-flap surgery of the breast and extremities and open lymphatic surgery of the extremities for adults. It's designed to provide motion scaling and tremor reduction, assisting trained physicians in an appropriate operating environment.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Symani Surgical System are primarily derived from the "Special Controls" section and the "Performance Testing - Bench" table (Table 5). The reported device performance is indicated as "PASS" for all listed bench tests.

*Note: "(b)(4)" indicates redacted proprietary information, implying the specific numerical criteria were defined and met but are not publicly disclosed in this document.

2. Sample Sizes and Data Provenance

The primary clinical evidence for this device comes from a multicenter clinical study and a cadaver/simulated use study.

• Clinical Study:

  • Sample Size:
    • Free-Flap Procedures: 93 evaluable patients.
    • Lymphatic Surgery: 70 evaluable patients.
    • Total: 163 evaluable patients.
  • Data Provenance: The Symani study is an OUS (Outside US), prospective, single-arm, multicenter, post-market clinical follow-up (PMCF) study. It also allowed for retrospective data collection. This indicates data from European centers ("6 European centers" mentioned in Commercial Data and Literature section). Therefore, the data provenance is European (OUS) and a mix of retrospective and prospective collection.

• Cadaver Testing: Not specified in terms of sample size for cadavers, but "several standard procedures" were simulated.

• Simulated Use Testing: 20 experienced surgeons (>5 years of microsurgery practice) and 16 users with no microsurgery experience participated.

3. Number of Experts and Qualifications for Ground Truth

• Cadaver Testing: "a team composed of two expert surgeons and six residents" participated. Their specific qualifications (e.g., years of experience) are not detailed beyond "expert surgeons."
• Simulated Use Testing: "20 experienced surgeons (>5 years of microsurgery practice)" and "16 users with no microsurgery experience." Their input was used to assess precision in stitch placement by measuring distances and angles. This serves as a form of ground truth for performance comparison.
• Clinical Studies: The "ground truth" for clinical effectiveness and safety endpoints (e.g., anastomosis patency, adverse events, reoperation rates) was based on direct observation and clinical assessment by the participating trained physicians (surgeons) and potentially study staff at the multicenter sites. The study design does not specify adjudication by independent experts for these clinical outcomes, but rather the direct clinical results.

4. Adjudication Method for the Test Set

• Clinical Study (Test Set/Clinical Data): The document does not explicitly describe an independent adjudication method (e.g., 2+1, 3+1 consensus) for the clinical outcomes in the human clinical study. The intraoperative patency and adverse events are reported as direct outcomes from the clinical settings. Anastomosis revisions, for example, were performed by the operating surgeon if patency was not achieved on the first attempt.
• Simulated Use Testing: Data analysis of needle passage parameters (distance and angle) was conducted through a paired T-test. The measurements were taken through a digital microscope, implying a quantitative, objective assessment rather than subjective expert consensus requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No formal Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with AI vs. without AI assistance was reported. The device is a surgical system, not an AI-assisted diagnostic or imaging interpretation tool.

However, a simulated use study did compare the precision of stitch placement with the system (robotic) versus manual instruments.

• Comparison: Use of Symani vs. manual execution.
• Effect Size/Performance Improvement:
  • Precision (stitch placement): Use of Symani was associated with greater precision (smaller difference between right and left distances from the cut on latex tissue) compared to manual execution.
    • Experienced microsurgeons: p = 0.02 (statistically significant improvement).
    • Users with no microsurgery experience: p = 0.36 (no statistically significant difference, but trend suggests improvement).
  • Angular Precision: Higher precision using Symani for angular precision (entry/exit angles relative to the vertical cut).
    • Users with no microsurgery experience: p < 0.01 (statistically significant improvement).
    • Experienced microsurgeons: p = 0.19 (no statistically significant difference).
  • Conclusion: The Symani system enabled greater precision in needle placement, with novice users benefiting significantly in needle angulation.
• Trade-off: Both experienced and novice users had longer suture and anastomosis times when using Symani compared to the manual technique.

6. Standalone (Algorithm Only) Performance

The concept of "standalone" performance typically applies to algorithms that autonomously make a decision. The Symani Surgical System is an electromechanical device operated by a human surgeon. Therefore, a "standalone (i.e. algorithm only without human-in-the-loop performance)" study would not be applicable, as the system always requires a human operator for its intended use. Performance is inherently coupled with the human operator.

7. Type of Ground Truth Used

• Bench Testing: Engineering specifications and direct physical measurements (e.g., accuracy, resolution, latency, force, structural integrity).
• Cadaver Testing: Expert judgment and qualitative assessment of system ergonomics and usability in a simulated OR environment.
• Simulated Use Testing: Quantitative measurements of needle passage parameters (distance and angle) using a digital microscope on synthetic models, serving as objective ground truth for precision comparisons.
• Animal Testing: Patency evaluated by "Acland milking" test, and stricture/thrombi formation evaluated by light microscopy, micro-CT, and histology – these pathology-based methods serve as objective ground truth.
• Clinical Studies: Intraoperative patency (clinical observation by the surgeon), adverse events (reported clinical occurrences), reoperation rates (clinical outcomes), and other clinically observed parameters. This is effectively clinical outcomes data and direct surgeon observation as ground truth.

8. Sample Size for the Training Set

The document does not explicitly describe a "training set" in the context of an AI/ML algorithm that is trained on data. This device is an electromechanical system, not an AI diagnostic tool that learns from a dataset.

However, if "training set" refers to the data used for non-clinical performance characterization or design verification, the samples used were:

• Bench Tests: Not explicitly stated as "sample sizes" but rather as tests performed on the system.
• Cadaver Testing: Number of cadavers not specified, but multiple simulations were performed.
• Simulated Use Testing: 20 experienced surgeons and 16 novice users.
• Animal Testing: 24 animals (rats).

9. How Ground Truth for the Training Set Was Established

As noted above, there isn't a traditional "training set" for an AI/ML algorithm in this context. The "ground truth" for the various performance evaluations supporting the device's design and validation were established through:

• Bench Testing: Established engineering standards and predefined mechanical/electrical parameters.
• Cadaver/Animal Testing: Direct observation by expert surgeons, pathologist analysis (histology, micro-CT), and established medical tests (Acland milking test).
• Simulated Use Testing: Objective measurements using a digital microscope, comparing robotic assistance to manual techniques.

These methods collectively served to validate the device's intended performance and safety, forming the "ground truth" for its development and regulatory acceptance.

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