(123 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, cholecystectomy, 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 "Additional" surgical instruments and adapters are intended as additions to the predicate suite of instruments and adapters previously cleared for use with the TransEnterix Surgical System (Model Senhance™ - K171120 and K180163). All instruments and adapters are multi-use components that are steam sterilized by the end user before the first use and after each use. The instrument designs are adaptations of standard laparoscopic instruments that are commonly used in surgery. Each instrument type has a corresponding system adapter.
The provided text describes performance testing for new instruments and adapters for the TransEnterix Senhance Surgical System to demonstrate substantial equivalence to previously cleared predicate devices. It does not contain an acceptance criteria table with reported device performance in the format requested, nor does it detail a study that proves the device meets such criteria as an AI-enabled medical device would typically require. The document focuses on demonstrating that new accessories do not raise new safety or effectiveness concerns compared to existing cleared devices.
However, I can extract the relevant information from the document that addresses some of your points. The "acceptance criteria" are implied by the summary statements of each test, confirming the devices "perform as intended", "met requirements", "demonstrated compatibility", or "fulfilled all applicable requirements".
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present a formal table of acceptance criteria with numerical performance data. Instead, for each test, it provides a summary statement indicating that the device met the requirements or performed as intended.
| Test Category | Implied Acceptance Criteria (Summary from document) | Reported Device Performance (Summary from document) |
|---|---|---|
| Bench Testing | ||
| Senhance System Force Feedback Response | The Senhance system should provide force feedback by measuring forces and conveying information proportionally to the user. | "Demonstrated that the Senhance system provides force feedback by measuring the forces presented to the device and conveying the force information proportionally to the user." |
| Force Feedback Stability and Sensitivity | The force feedback feature should properly dampen haptic response signals from the instruments to the cockpit handles. | "Demonstrated that the force feedback feature of the Senhance system properly dampens the haptic response signals from the Additional instruments to the cockpit handles." |
| Manipulator Arm Fulcrum Feature | The fulcrum feature should be properly established for the Additional instruments. | "Demonstrated that the fulcrum feature of the Senhance system can be properly established for the Additional instruments." |
| ESU Compatibility | All compatible third-party electrosurgical units (ESUs) should be compatible with the Additional instruments and adapters, with rated voltages matching ESU manufacturer settings. | "Demonstrated that all third-party electrosurgical units (ESUs) that are compatible with the Senhance system are also compatible with the Additional instruments and adapters. Testing compared the rated voltage of the instruments with each ESU's manufacturer settings." |
| Mechanical Verification Testing | Devices should perform as intended when subjected to mechanical integrity tests under simulated use conditions, including Cantilever Bending Reliability, Instrument Jaw Output Force Reliability, and Force to Jaw Failure. | "Demonstrated that the devices perform as intended when subjected to tests of mechanical integrity under conditions of simulated use. Cantilever Bending Reliability Testing, Instrument Jaw Output Force Reliability Testing and Force to Jaw Failure Testing" |
| Clip Applier Ligation Performance | Burst pressure of clips delivered by the Senhance Weck® Hem-o-lok Clip Applier should not be statistically different from the burst pressure of clips delivered by the legally marketed Teleflex Medical Hem-o-Lok® Clip Applier. | "Demonstrated that the burst pressure of clips delivered by the Senhance Weck® Hem-o-lok Clip Applier when used with the Senhance system was not statistically different than the burst pressure of clips delivered by the legally marketed Teleflex Medical Hem-o-Lok® Clip Applier were not statistically different." |
| Biocompatibility | Patient-contacting portions should meet applicable safety requirements related to material toxicity and biological responsiveness (Cytotoxicity, Sensitization, Irritation/Inflammatory Response (IR), Acute Systemic Toxicity, and Pyrogenicity) as per ISO 10993-1. | "The results demonstrated that these components met the requirements of ISO 10993-1 with regard to Cytotoxicity, Sensitization, Irritation/Inflammatory Response (IR), Acute Systemic Toxicity, and Pyrogenicity." |
| Reprocessing, Cleaning, Sterilization | ||
| Reprocessing/Cleaning | Cleaning procedures should allow the devices to be effectively cleaned according to processing instructions. | "The test results demonstrated that the cleaning procedures for the Additional instruments and adapters allow them to be effectively cleaned according to the processing instructions provided in the labeling." |
| Sterilization | A Sterility Assurance Level (SAL) of at least 10^-6 should be demonstrated. | "A validation of the steam sterilization process was conducted to demonstrate a Sterility Assurance Level (SAL) of at least 10^-6." |
| Electrical Safety and Compatibility | ||
| Electrical Safety and Electromagnetic Compatibility | The electrosurgical instruments should be compliant with IEC 60601-2-2:2017 for basic safety and essential performance of high-frequency surgical equipment and accessories. | "The Additional electrosurgical instruments fulfilled all applicable requirements to demonstrate that the instruments are compliant 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 | ||
| Software | The Senhance system software should continue to reliably operate as designed with the addition of the new instruments and adapters. | "Software testing was conducted to demonstrate that the Senhance system software continues to reliably operate as designed with the addition of the new instruments and adapters." |
| Design Validation | ||
| Design Validation | The Additional instruments and adapters should perform as intended according to defined user needs and intended uses, demonstrating substantial equivalence to predicate devices (K171120). | "Design Validation was conducted to ensure that the subject Additional instruments and adapters perform as intended according to defined user needs and intended uses, and to support substantial equivalence to the predicate devices cleared under K171120. The design validation was conducted in a porcine model, which was used to simulate key human anatomy. This validation used production-equivalent instruments and adapters in a simulated use environment." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not explicitly stated with a specific number of cases or samples for each test. The descriptions imply various tests were conducted on the "Additional instruments and adapters" as a group.
- Data Provenance: The design validation was conducted in a porcine model, simulating key human anatomy. This indicates animal data. The other bench tests and compatibility tests would likely be conducted in a laboratory setting. There is no mention of human clinical data or geographical origin.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This information is not provided in the document. The tests described are primarily engineering, mechanical, electrical, software, and biological safety tests, not diagnostic performance evaluations that would typically involve human expert consensus for "ground truth". The "design validation" involved a porcine model, but the role or number of experts involved in evaluating its success is not detailed.
4. Adjudication Method for the Test Set:
- This information is not provided. The nature of the tests (bench, biocompatibility, sterilization, electrical, software) does not typically involve an adjudication method in the way a diagnostic study with human readers would.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, and effect size:
- No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Due to the similarity of the subject devices to the predicate devices, new usability and clinical testing were not necessary." The study is focused on demonstrating substantial equivalence of accessories, not evaluating the effectiveness of human readers with vs. without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This document describes physical surgical instruments and adapters for a robotic surgical system, not a standalone AI algorithm. Therefore, this question is not applicable. The "software" section refers to the existing system's software continuing to operate reliably with the new instruments, not a new algorithm's standalone performance.
7. The type of ground truth used:
- Ground Truth varies by test type:
- Bench Testing: Engineering specifications, physical measurements (e.g., force, voltage), statistical comparisons (for clip applier).
- Biocompatibility: ISO 10993-1 standards (e.g., cytotoxicity, sensitization levels).
- Reprocessing/Cleaning: Effectiveness against established microbial or soil removal standards.
- Sterilization: Sterility Assurance Level (SAL) of 10^-6.
- Electrical Safety: IEC 60601-2-2:2017 standard compliance.
- Software: Expected software behavior and functionality without errors or unexpected changes.
- Design Validation: Performance within a simulated use environment (porcine model) against defined user needs and intended uses.
8. The sample size for the training set:
- This document is about physical devices and their compatibility/safety, not an AI model that requires a training set. Therefore, this question is not applicable.
9. How the ground truth for the training set was established:
- As this document is not about an AI model with a training set, this question is not applicable.
§ 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.