(182 days)
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.
| Criterion (Inferred from Clinical Outcomes) | Device Performance (Mouth) | Device Performance (Scalp) | Comparison/Narrative towards "Acceptance" |
|---|---|---|---|
| Effectiveness: | |||
| Intraoperative patency at first attempt (Robotic approach) | 90.9% (60/66) [95% CI: 81.3%, 96.6%] | 69.2% (18/26) [95% CI: 48.2%, 85.7%] | Mouth: "similar to the predicate device." Scalp: "lower than the predicate device," but "patency of all anastomoses (100%) was confirmed prior to closure." (i.e., issues at first attempt were resolved). |
| Operative time (average hours) | 11.66 hours | 12.30 hours | Provided for context; no direct comparison to a specific target or predicate. |
| Suturing time (average minutes) - Robotic | 37.4 min | 41.2 min | Provided for context; no direct comparison to a specific target or predicate. |
| Rate of intra-operative change from robotic to manual suturing | 4.2% (3/72) [95% CI: 0.9%, 11.7%] | 7.7% (2/26) [95% CI: 0.9%, 25.1%] | Overall estimated change rate 5.1% (5/98); no explicit target, but implies the system allows for manual fallback. |
| Safety: | |||
| Freedom from Serious Adverse Device Effects (SADE) | 100.0% (0/41) [95% CI: 0.0%, 8.6%] | 100.0% (0/20) [95% CI: 0.0%, 16.8%] | 100% freedom from SADE across both sites. This is a strong safety indicator. |
| Serious Adverse Events (SAE) Rate (patient-based) | 12.2% (5/41) | 10.0% (2/20) | "lower than the predicate device" (implied as a positive outcome). |
| Adverse Events (AE) Rate (patient-based) | 41.0% (25/61 patients across both sites) | Consistent with literature range (21.5% - 61.3%). | Presented as being "consistent with the range identified in the literature search." |
| Rate of adverse events resulting in anastomosis revision | 5% (2/40) for Mouth | 0% (0/20) for Scalp | No specific target, but provides insight into the clinical impact of AEs. |
| 3-Day Reoperation Rate (anastomosis specific) | 5.00% (2/40) [95% CI: 0.61% - 16.92%] | 0.00% (0/20) [95% CI: 0.00% - 16.84%] | Presented as a critical clinical outcome; no direct comparison to a target or predicate given here, but low rates are favorable. |
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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