(211 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 use. It is intended for use by trained physicians in an operating room environment in accordance with the instructions for use.
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. The purpose of this submission is to seek clearance for modifications to the indications for use to expand the types of surgical procedures for which the Senhance Surgical System may be used.
In this submission, the indications for use have been expanded to cover laparoscopic general surgical procedures. The new indications for use statement does not create a new intended use for the system.
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 Senhance instruments are similar in design and materials to traditional laparoscopic instrumentation.
Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria & Reported Device Performance
The FDA clearance is for expanding the indications for use of the Senhance Surgical System. The acceptance criteria, while not explicitly stated as numerical targets in a formal table, are implicitly demonstrated by showing the device performs comparably to established alternative surgical techniques for the expanded indications. The study aims to show that the Senhance Surgical System is as safe and effective as traditional laparoscopic and robotically-assisted surgery for Nissen fundoplication, a representative general surgical procedure.
| Acceptance Criterion (Implicit) | Reported Device Performance (Senhance System for Nissen Fundoplication) |
|---|---|
| Length of Hospital Stay (days) (Comparable to standard techniques) | Mean (range): 5 (3-6) for Cohort 1, 2 (1-4) for Cohort 2. |
| Intraoperative Complication Rates (Low/Comparable to standard techniques) | 0 for both Cohort 1 and Cohort 2. |
| Estimated Blood Loss (EBL) Volumes and Blood Transfusion Rates (Low/Comparable to std.) | Transfusion Rate: 0 (Cohort 1, for 16/18 patients), Estimated Blood Loss: 14 mL (Range 0-50) (Cohort 2). |
| Conversion Rates (Low/Comparable to standard techniques) | 2 (11%) for Cohort 1, 4 (25%) for Cohort 2. (Note: These were conversions to hybrid technique, not open surgery). |
| Readmission Rates (Low/Comparable to standard techniques) | 0 for Cohort 1, 2 (13%) for Cohort 2. |
| Reoperation Rates (Low/Comparable to standard techniques) | 1 (6%) for Cohort 1, 0 for Cohort 2. |
| Mortality Rates (Low/Comparable to standard techniques) | 0 for both Cohort 1 and Cohort 2. |
| Postoperative Complication Rates (Low/Comparable to standard techniques) | 5 (14.7%) for N=34 (combined cohorts), 0 for Cohort 2. |
| Operative Times (Comparable to standard techniques) | Mean (range): 111.5 (68-194) for N=34. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 34 patients.
- Cohort 1: 18 patients
- Cohort 2: 16 patients
- Data Provenance: Retrospective chart review.
- Cohort 1: Germany
- Cohort 2: Netherlands
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number of experts, nor their qualifications, used to establish the ground truth for the retrospective chart review data. The chart review itself implies that the data recorded by the medical professionals involved in those cases formed the "ground truth."
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the retrospective chart review data. The data appears to have been extracted directly from patient charts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. The study compares the device's performance based on real-world evidence (retrospective chart review) to published clinical literature on alternative surgical techniques (traditional laparoscopic and robotically-assisted surgery). It does not involve human readers evaluating cases with and without AI assistance for an effect size.
6. Standalone Performance Study
Yes, in a way, a standalone performance was done for the device in the context of real-world use. The retrospective chart review of Nissen fundoplication procedures using the Senhance system provides data on the device's performance without comparison to concurrent human performance. The comparison is made against historical data from other techniques.
7. Type of Ground Truth Used
The ground truth for the Senhance System's performance in the test set (the 34 Nissen fundoplication cases) is derived from clinical outcomes data from patient charts. This includes recorded metrics like hospital stay, complications, blood loss, conversion rates, etc.
8. Sample Size for the Training Set
The document does not provide information about a training set. The Senhance Surgical System is a robotic surgical system, not an AI or imaging device that typically requires a large training dataset for a model. The clinical data presented is for proving the safety and effectiveness of the device for expanded indications, not for training a specific algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as a training set for an AI/algorithm is not described in this document. The device itself is a surgical system whose performance is being evaluated based on clinical outcomes.
§ 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.