(29 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 laparoscopic gynecological surgery, colorectal surgery, cholecystectorny, and inguinal hernia repair. 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 3 mm bipolar surgical instruments and adapters are additions to the suite of bipolar instruments and adapters previously cleared for use with the Senhance Surgical System (K181517). The instrument designs are adaptations of standard laparoscopic instruments that are commonly used in surgery. Each instrument type has a corresponding system adapter. All instruments and adapters are multi-use devices that are steam sterilized by the end user before the first use and after each use. The Senhance 3 mm bipolar instruments include:
- . Bipolar Maryland Dissector – diameter 3 mm / length 280 mm
- . Bipolar Grasping Forceps - diameter 3 mm / length 280 mm
This document describes the 510(k) summary for the TransEnterix Senhance Surgical System, focusing on the acceptance criteria and study proving its substantial equivalence to a predicate device. This is primarily a regulatory submission, so instead of typical "AI/ML model" performance metrics, the "acceptance criteria" here refer to meeting performance standards that demonstrate safety and effectiveness for a medical device, particularly in comparison to a previously cleared device.
Given the nature of the provided document, which is a 510(k) summary for a surgical instrument, many typical AI/ML study components (like expert consensus for ground truth, MRMC studies, training set details) are not applicable. The device is a surgical instrument system, not an AI diagnostic algorithm.
Here's an interpretation of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance:
Since this is a 510(k) for new instruments within an existing surgical system, the acceptance criteria are generally to demonstrate that the new instruments (3mm bipolar) perform as intended, are safe and effective, and do not raise new questions of safety or effectiveness compared to predicate devices. The performance is reported in terms of successful completion of various tests.
| Acceptance Criteria (General Goal) | Reported Device Performance |
|---|---|
| Mechanical Integrity / Intended Performance (Simulated Use) | Demonstrated that the devices perform as intended when subjected to tests of mechanical integrity under conditions of simulated use, including: |
| Cantilever Bending Reliability Testing | |
| Instrument Jaw Output Force Reliability Testing and Jaw Force to Failure Testing | |
| Bipolar Jaw Spreading Force | |
| Electrosurgical Unit (ESU) Compatibility | Demonstrated that all third-party ESUs compatible with the Senhance Surgical System are also compatible with the 3mm bipolar instruments and adapters. Testing compared the rated voltage of the instruments with each ESU's manufacturer settings. |
| Reprocessing/Cleaning Effectiveness | A cleaning effectiveness validation study confirmed the overall effectiveness of the prescribed cleaning procedures. Test results demonstrated that cleaning procedures for the 3mm bipolar adapters allow them to be effectively cleaned according to instructions. |
| Sterilization Efficacy | Validation of the steam sterilization process for the 3mm bipolar adapters demonstrated a Sterility Assurance Level (SAL) of at least 10^-6. |
| Electrical Safety Compliance | The 3mm bipolar instruments and adapters fulfilled all applicable requirements to demonstrate compliance with the current electrical safety standard, IEC 60601-2-2:2017 (Medical electrical equipment Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories). |
| Software Compatibility and Reliability (with new instruments) | Software testing demonstrated that the Senhance system software continues to reliably operate as designed with the addition of the new instruments and adapters. |
| Design Validation (Performance in Simulated Clinical Environment) / Substantial Equivalence to Predicate | Design Validation was conducted in a porcine model (simulating key human anatomy) using production-equivalent instruments and adapters in a simulated use environment. This supported that the instruments perform as intended according to defined user needs and intended uses, and are substantially equivalent to the predicate devices (K181517), not raising any new issues of safety or effectiveness. The intended use/indications for use are identical to the predicate. |
2. Sample size used for the test set and the data provenance:
- Sample size: The document does not specify a numerical sample size for individual tests like mechanical testing or ESU compatibility, but indicates "testing" was conducted. For "Design Validation," it states "a porcine model" was used, implying more than one animal or multiple procedures within one animal, but no specific count is provided.
- Data Provenance: The origin of the data is from in-house testing conducted by TransEnterix, Inc. The studies appear to be prospective for the purpose of this 510(k) submission, specifically designed to test the new 3mm bipolar instruments.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable in the context of this device and study type. The "ground truth" here is established by engineering and medical device performance standards (e.g., successful mechanical function, proper sterilization, electrical safety compliance) rather than expert interpretation of medical images or diagnoses. The "Design Validation" involved simulating use, implying evaluation by qualified personnel, but "experts" in the sense of clinical reviewers for ground truth is not relevant.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This type of adjudication method is common in studies involving human interpretation (e.g., radiology reads), not for performance testing of a surgical instrument.
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 a surgical instrument, not an AI-assisted diagnostic tool. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. The device isn't an algorithm. Its performance is inherent to its mechanical, electrical, and material properties, and its interaction with the Senhance Surgical System.
7. The type of ground truth used:
The "ground truth" is based on:
- Engineering specifications and performance standards (e.g., force measurements, voltage ratings, mechanical integrity).
- Validated regulatory standards (e.g., IEC 60601-2-2 for electrical safety, established SAL for sterilization).
- Demonstrated functionality in a simulated use environment (porcine model) comparing to the established performance of predicate devices.
8. The sample size for the training set:
Not applicable. This device is not an AI/ML model that requires a "training set."
9. How the ground truth for the training set was established:
Not applicable. No training set for an AI/ML model.
§ 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.