(167 days)
The Senhance Surgical System is intended to assist in the accurate control of laparoscopic instruments for visualization and endoscopic manipulation of tissue including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, mobilization, and retraction. The Senhance Surgical System is intended for use in general laparoscopic surgical procedures and laparoscopic gynecological surgery. The system is indicated for adult and pediatric use. It is intended for use by trained physicians in an operating room environment in accordance with the instructions for use.
Use of the device is limited to patients two (2) years of age and older and a weight equal to or above 10kg, who are suitable to be subjected to a conventional endoscopic technique.
The Senhance Surgical System is a multi-arm, console-based robotic system that allows a surgical team to perform laparoscopic surgery in the abdomen and pelvis in a manner similar to a manual laparoscopic approach. Each robotic arm can hold either a laparoscopic surgical instrument or an endoscope to facilitate a surgeon remotely operating the instrument from the cockpit.
More specifically, the Senhance Surgical System consists of: a surgeon console (cockpit), which provides remote manipulators or handles to allow the surgeon to maneuver the surgical instruments and a video monitor to display the endoscopic signal; manipulator arms, which hold and maneuver the instruments and endoscope based on inputs from the surgeon: Intelligent Surgical Unit (ISU), which is the system communication hub, connecting the cockpit and manipulator arms; and instruments, which manipulate the tissue of interest.
In addition, force feedback provides an optional tactile sensory input to the surgeon control handles to give a sense of tissue elasticity. An eye tracking feature provides the surgeon an optional method to control the endoscope from the cockpit, rather than using the surgeon control handles. The ISU allows for three additional methods of camera control, in addition to the optional eye tracking method.
The purpose of this submission is to expand the indications for use to include pediatric patients, two (2) years of age and older and a weight equal to or above 10kg.
This document describes the regulatory submission for the Senhance Surgical System to expand its indications for use to include pediatric patients. The core of the information addresses the acceptance criteria and the study proving the device meets these criteria as adapted for the new pediatric indication.
Here's a breakdown of the requested information based on the provided text:
Acceptance Criteria and Device Performance
The provided text does not explicitly state pre-defined acceptance criteria in terms of numerical thresholds for performance metrics. Instead, the study aimed to demonstrate that the Senhance System's performance for pediatric use is "as safe and effective as its predicate" and "comparable" to existing surgical techniques (robotic, laparoscopic, and open surgery) based on a set of clinical endpoints.
The "acceptance criteria" can be inferred as showing non-inferiority or comparability to established techniques across these clinical endpoints.
Table of Acceptance Criteria (Inferred Comparability) and Reported Device Performance
| Performance Metric (Inferred Acceptance Criteria: Comparability to Literature Averages) | Senhance System (Reported Performance) | Literature Review Averages (for comparison) |
|---|---|---|
| Robotic | Laparoscopy | Open |
| Length of Stay (days) | 3.88 | 2.63 |
| Surgical Complication (%) | 3.13 | 1.91 |
| Estimated Blood Loss (ml) | 10.78 | 22.74 |
| Conversion Rate (%) | 12.50 | 2.55 |
| 30 Day Readmission Rates (%) | 3.13 | 6.83 |
| 30 Day Re-operation Rates (%) | 6.25 | 7.04 |
| Mortality (%) | 0 | 0.50 |
| Post-operation Complication (%) | 15.62 | 16.90 |
| Operative Time (min) | 141.47 | 195 |
Conclusion from data: "Operative times and complication rates were comparable between the retrospective clinical data with the Senhance system and the systematic literature review."
Study Details
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Sample sizes used for the test set and the data provenance:
- Test Set (Retrospective Clinical Data): 32 pediatric patients.
- Data Provenance: The data was collected from "real-world evidence" on the Senhance Surgical System for the pediatric population. It appears to be retrospective clinical data collected from a hospital (or hospitals) where the Senhance system was used. The specific country of origin is not explicitly stated, but the inclusion criteria for the literature review specify "US or EU study" to reduce variation in surgical method, which might suggest a similar geographic focus for the clinical data. The study states it was a "retrospective clinical data review."
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document describes a retrospective clinical data review and a systematic literature review. It does not mention experts establishing "ground truth" for a test set in the context of an AI device's performance evaluation against expert readings. The "ground truth" here is the real-world clinical outcomes as recorded in patient charts (for the 32 patients) and reported in peer-reviewed literature. Therefore, no specific number of experts or their qualifications for establishing ground truth for a test set (in the typical AI validation sense) are provided.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable in this context. This study is an evaluation of clinical outcomes based on real-world data and literature comparison, not an AI performance study requiring human adjudication of AI outputs.
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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:
- No, an MRMC study was not done. This study is not evaluating the improvement of human readers with AI assistance. It's evaluating the clinical safety and effectiveness of a robotic surgical system for a new patient population.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. The Senhance Surgical System is a human-controlled robotic system; its "performance" is inherently tied to the surgeon's use of the device. This study evaluates the clinical outcomes of procedures performed with the device, not a standalone AI algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the 32 pediatric cases was clinical outcomes data (e.g., intra-operative complications, post-operative complications, conversion rates, length of stay, blood loss, etc.) as recorded in patient records.
- For the comparative data, the ground truth was derived from peer-reviewed research publications (literature review) reporting clinical outcomes for alternative surgical techniques.
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The sample size for the training set:
- Not applicable. This is not an AI algorithm development study that requires a training set. The device (Senhance Surgical System) itself is already developed, and this submission is for an expanded indication for use.
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How the ground truth for the training set was established:
- Not applicable, as no training set for an AI algorithm was used in this evaluation.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.