(21 days)
The GMP|Surgical Solutions Inc. Laparocision™ Scope Controller System is indicated for thoracic, gynecologic, orthopedic, and abdominal procedures for the purpose of holding and controlling the movement of standard laparoscopes or rigid endoscopes within inflated surgical cavities during minimally invasive laparoscopic surgery.
The GMP|Surgical Solutions Laparocision™ Scope Controller System allows for surgeons to control the movement and position of conventional laparoscopes or endoscopes during thoracic, gynecologic, orthopedic, and abdominal laparoscopic procedures by means of an electromechanical arm which is controlled by either a hand controller or a foot controller. The purpose of an endoscope is to allow visualization of a surgical cavity during minimally invasive laparoscopic procedures.
The device is comprised of the following five main components:
- The Laparocision™ Reusable Arm Assembly
- The Disposable Zoom Assembly (DZA)
- The Foot Control and the Hand Control
- The Steri-Sleeves
- The Power Supply
The GMP|Surgical Solutions Inc. Laparocision™ Scope Controller System is a device designed to assist surgeons in controlling the movement and position of laparoscopes during various minimally invasive surgical procedures.
Here's an analysis of the acceptance criteria and the study proving the device meets these criteria, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance |
|---|---|---|
| Electrical Safety | "UL 60601-1-UL Standard for Safety of Medical Device Equipment, Part 1: General Requirements for Safety First Edition" | In-vitro electrical safety testing met all requirements of the specified standards. |
| "CSA C22.2 NO 601.1-M90 -Medical Electrical Equipment - Part 1: General Requirements for Safety General Instructions No 1; Supplement 1; 1994 R(1997)" | In-vitro electrical safety testing met all requirements of the specified standards. | |
| "IEC 60601-2-18 (1996-08) - Medical Electrical Equipment -- Part 2: Particular Requirements for the Safety of Endoscopic Equipment Second Edition; Amendment 1, 07-2000" | In-vitro electrical safety testing met all requirements of the specified standards. | |
| Electromagnetic Compatibility (EMC) | "IEC 60601-1-2 (2001-09) - Medical Electrical Equipment Part 1-2; General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility -Requirements and Tests Second Edition" | In-vitro Electromagnetic Compatibility (EMC) testing met all requirements of the specified standard. |
| Mechanical and Functional Performance | Device's design and performance requirements | In-vitro mechanical and functional testing demonstrated that the device's design and performance requirements were met. This also supported a determination of substantial equivalence to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify a sample size for a "test set" in the context of clinical trials or data analysis. The testing described is in-vitro (laboratory-based) electrical, EMC, mechanical, and functional testing of the device itself, rather than studies involving patient data or human subjects. Therefore, data provenance (country of origin, retrospective/prospective) is not applicable in this context.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to the provided document. The testing conducted was technical validation against engineering and safety standards, not a diagnostic or clinical performance study that would require expert-established ground truth.
4. Adjudication Method for the Test Set
This information is not applicable. The testing involved objective measurements against established technical standards, not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This information is not applicable. The Laparocision™ Scope Controller System is an electromechanical arm for controlling an endoscope, not an AI-powered diagnostic or interpretive tool that assists human readers. Therefore, an MRMC study related to AI assistance is not relevant to this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
This information is not applicable. The device is a physical, electromechanical system controlled by a human operator (surgeon). It does not operate as an algorithm only. The "functional testing" performed likely evaluated its standalone mechanical and control capabilities as intended.
7. The Type of Ground Truth Used
The "ground truth" for the tests performed was established by recognized industry standards and engineering specifications. For electrical safety and EMC, the ground truth was compliance with UL, CSA, and IEC standards. For mechanical and functional testing, the ground truth was the device's design and performance requirements as defined by the manufacturer, likely benchmarked against the predicate device.
8. The Sample Size for the Training Set
This information is not applicable. The device is an electromechanical system that does not utilize a "training set" in the context of machine learning or AI algorithms. Development and validation rely on engineering design, manufacturing processes, and adherence to technical standards.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated above.
§ 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.