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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, mouth, scalp, extremities, and in 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 surgeon. 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.

Symani is designed to provide surgeons with increased precision while leveraging the surgeon's own surgical experiences. The Symani Surgical System consists of three components, the CMM, Console, and Instruments, with selectable scaling factors (between 7x to 20x) to improve motion control and scale down any physiological tremor of the operator in a similar fashion to conventional robotic-assisted surgical device (RASD) systems, and the instruments with wristed end-effectors to improve dexterity for tissue manipulation and suturing.

Here's an analysis of the acceptance criteria and study proving the device meets those criteria, based on the provided text.

Note: The provided document is an FDA 510(k) clearance letter and an accompanying 510(k) summary. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than explicitly defining and meeting pre-defined performance acceptance criteria with numerical targets. However, the document does describe the performance data used to support the claim of substantial equivalence for the new indications (mouth and scalp). Therefore, the "acceptance criteria" inferred below are based on the comparison of the device's performance to the predicate device and general expectations for safety and effectiveness in this medical context.

1. Table of Acceptance Criteria and Reported Device Performance

Strict numerical "acceptance criteria" for the new indications are not explicitly stated in the document as a pass/fail threshold. Instead, the performance is compared to the predicate device and general clinical expectations. The implicit acceptance criteria are that the device is "as safe and effective" as the predicate for the added indications.

The study concludes that the device is "as safe and effective as the predicate device" for the new indications, despite the lower initial patency rate for the scalp, due to the 100% confirmed patency post-procedure and favorable safety profile.

2. Sample Size and Data Provenance

• Test Set Sample Size: A total of 62 patients were analyzed for the specific free tissue transfer procedures using Symani with mouth or scalp as recipient sites.
  • Mouth: 40 patients
  • Scalp: 20 patients
  • (Note: The patient counts for SADE and SAE are slightly different (e.g., 41 mouth, 20 scalp for SADE) which might indicate minor variations in data availability for specific endpoints or inclusion/exclusion for analysis. The total of 62 patients is the overall 'subset' considered.)
• Data Provenance: The data comes from a prospective, non-randomized, single-arm, multicenter, post-market clinical follow-up (PMCF) study.
  • Retrospective/Prospective: 55 patients were prospective enrollments, and 7 were retrospective enrollments.
  • Country of Origin: Not explicitly stated in the provided text. The submitter's address is Pisa, Italy, which suggests a European origin for the study, but this is not confirmed for the patients themselves.

3. Number of Experts and Qualifications for Ground Truth

The document does not describe the establishment of a "ground truth" using a panel of experts for the test set. Instead, the clinical outcomes (e.g., patency, adverse events, reoperations) are the direct data points collected from patient procedures. These are presumably assessed by the treating surgeons and study staff involved in the PMCF study.

4. Adjudication Method for the Test Set

No explicit adjudication method (like 2+1 or 3+1 consensus) for the "test set" (clinical outcomes) is described. The outcomes presented are directly from the clinical study data collection.

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

No MRMC study was performed or described. This type of study is typically used for diagnostic devices to assess how AI affects reader performance. The Symani Surgical System is an electromechanical surgical system, not a diagnostic AI. The study evaluated real-world surgical outcomes, not AI assistance to human readers interpreting images.

6. Standalone Performance Study (Algorithm Only)

The Symani Surgical System is a robotic-assisted surgical device with human-in-the-loop control. Therefore, a "standalone" or "algorithm-only" performance study (without human involvement) is not applicable or described, as the device's function is inherently a human-device interaction.

7. Type of Ground Truth Used

The ground truth used is primarily clinical outcomes data obtained directly from patient procedures in a post-market clinical follow-up (PMCF) study. This includes:

• Intraoperative findings (e.g., patency confirmed prior to closure)
• Adverse events (SAE, AE)
• Reoperation rates

8. Sample Size for the Training Set

The document does not mention a "training set" in the context of an AI algorithm being trained. The Symani Surgical System is described as having "selectable scaling factors" and "wrested end-effectors" for "motion control" and "dexterity." This suggests a mechanical/software system guided by explicit programming and control algorithms, not a machine learning model that requires a "training set" in the contemporary AI sense (e.g., for image recognition). The "predicate device" is the same Symani Surgical System, implying improvements or expanded indications of an existing (already developed) system rather than a new de novo AI system.

9. How Ground Truth for the Training Set Was Established

As there is no mention of an AI "training set" in the provided document for this device, this question is not applicable.

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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 surgeon. 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.

Symani is designed to provide surgeons with increased precision while leveraging the surgeon's own surgical experiences. The Symani Surgical System consists of three components, the CMM, Console, and Instruments, with selectable scaling factors between 7x to 20x to improve motion control and scale down any physiological tremor of the operator in a similar fashion to conventional robotic-assisted surgical device (RASD) systems, and the instruments with wristed end-effectors to improve dexterity for tissue manipulation and suturing. The subject device has the same intended use and indications for use, and same technological characteristics as the predicate device, DEN230032. The Supermicro Needle Holder Suture Cut instrument has been added to the NanoWrist Instruments' portfolio.

This document describes a 510(k) submission for the Symani Surgical System, specifically for the addition of a new instrument called the Supermicro Needle Holder Suture Cut.

Here's an analysis of the acceptance criteria and study information provided, noting what is and isn't available in the document:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present acceptance criteria in a table format with specific quantitative thresholds. Instead, it describes performance tests conducted to demonstrate that the new instrument maintains the safety and effectiveness of the existing system. The reported performance is an overall conclusion of substantial equivalence.

Implied Acceptance Criteria and Reported Performance from the Text:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified. The document only lists "Simulated use test," "Gripping force & torque," and "Structural integrity tests" without detailing the number of test runs, materials used, or specific data points.
• Data Provenance: Not specified. It's implied that the testing was conducted by Medical Microinstruments, Inc. in Pisa, Italy, as that's their location, but no direct statement on data origin is provided. The study appears to be prospective testing of the new instrument's performance characteristics.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This device is a surgical instrument and the performance tests described (simulated use, gripping force & torque, structural integrity) are engineering and functional tests, not clinical studies requiring expert interpretation or ground truth establishment in the traditional sense of diagnostic imaging or AI performance. The assessment is against established device performance parameters and comparison to a predicate.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. As described above, this is not a study requiring human adjudication of results in the context of diagnostic interpretation. The performance tests would be evaluated against engineering specifications and comparison to the predicate.

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 is not an AI-powered diagnostic device, but a surgical instrument. Therefore, MRMC studies and AI-assistance effect sizes are not relevant to this submission.

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

Not applicable. This is a physical surgical instrument, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The "ground truth" for the performance tests of a surgical instrument involves engineering specifications, material properties, mechanical testing standards, and comparison to the functionally equivalent predicate device's performance. There is no biological or diagnostic "ground truth" in this context.

8. The sample size for the training set

Not applicable. As noted, this is a physical medical device, not an AI/ML algorithm requiring a training set.

9. How the ground truth for the training set was established

Not applicable. No training set is involved.

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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

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