(52 days)
The SurgiQuest AirSeal™ Optical Trocar & Cannula System has applications in abdominal and thoracic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The trocar may be used with or without visualization for primary and secondary insertions.
The subject is a surgical trocar and cannula composed of medical grade materials. The device is used to create and maintain a port of entry during endoscopic surgery. It incorporates a gas seal utilizing CO2, to maintain pneumoperitoneum during the course of surgery. It is supplied with a re-circulation and filtration pump designed-to maintain pneumoperitoneum and minimize CO2 consumption during minimally invasive surgery. The recirculation and filtration pump is reusable. The AirSeal™ Trocar & Cannula and Tube Set are fully disposable and are intended for single use only.
Acceptance Criteria and Device Performance Study for SurgiQuest™ AirSeal™ Optical Trocar & Cannula System
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state numerical acceptance criteria with pass/fail thresholds. Instead, it describes functional requirements and the types of testing performed to demonstrate compliance. The "Reported Device Performance" column reflects what the document states the testing showed.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Performance for Surgical Use: | |
| Ability to create and maintain a port of entry during simulated laparoscopic surgery. | The device has been tested to show its ability to create and maintain a port of entry during simulated laparoscopic surgery. |
| Ability to maintain adequate pneumoperitoneum during simulated laparoscopic surgery. | It has also been tested to show its ability to maintain adequate pneumoperitoneum during the course of simulated laparoscopic surgery. |
| Minimize CO2 consumption during minimally invasive surgery. | The recirculation and filtration pump is designed-to maintain pneumoperitoneum and minimize CO2 consumption during minimally invasive surgery. (Testing is implied for this design feature but not explicitly stated as a direct test of CO2 consumption rates in the summary). |
| Safety and Sterility: | |
| Compliance with electrical safety and emissions standards (IEC60601-1, IEC60601-1-2). | The unit will be tested for safety and emissions in accordance with IEC60601-1, General Requirements for Safety 1: Collateral Standard: Safety Requirements for Medical Electrical Systems and IEC60601-1-2, General Requirements for Safety -Collateral Standard: Electromagnetic Compatibility -Requirements and Tests. (Implies compliance was achieved). |
| Achieves a Sterility Assurance Level (SAL) of 10-6. | Sterility validation is in accordance with ISO 11137:2006 (Part 1) and AAMI TIR 27:2001. A Sterility Assurance Level (SAL) of 10-6 is achieved. |
| Biocompatibility (implied for medical devices) | Composed of medical grade materials. (Specific testing for biocompatibility is not detailed in this summary). |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify the sample size used for the functional performance testing (e.g., number of simulated procedures or test subjects). It states "simulated laparoscopic surgery" for the functional tests.
For sterility validation, ISO 11137:2006 and AAMI TIR 27:2001 are referenced, which are standards for radiation sterilization dose substantiation. These standards inherently involve a statistically significant number of samples, but the exact number for this specific device is not detailed in the summary.
Data Provenance: The data provenance is internal to the manufacturer, SurgiQuest, Inc., as evidenced by the statement "The device has been tested to show..." and "The unit will be tested...". The testing appears to be primarily prospective as it's for pre-market notification to determine substantial equivalence. The country of origin for the data is implicitly the USA, where the company is based.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This document does not describe the use of experts to establish a "ground truth" for the functional performance testing. The description indicates engineering and performance testing against industry standards and simulated conditions, rather than expert clinical evaluation for a specific medical outcome. For the safety and sterility testing, the "ground truth" is established by adherence to recognized international standards (IEC, ISO, AAMI).
4. Adjudication Method for the Test Set
Not applicable. There is no mention of an adjudication method as the testing described does not involve subjective interpretations or multiple readers requiring consensus.
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. The SurgiQuest™ AirSeal™ Optical Trocar & Cannula System is a physical surgical device, not an AI or imaging diagnostic tool. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study regarding "human readers improving with AI vs without AI assistance" is not relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not a software algorithm.
7. The Type of Ground Truth Used
For functional and safety testing, the ground truth is established by:
- Performance against defined simulated conditions: For creating/maintaining port of entry and pneumoperitoneum.
- Adherence to recognized international standards: IEC60601-1, IEC60601-1-2 for electrical safety and emissions; ISO 11137:2006 and AAMI TIR 27:2001 for sterility.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI algorithm, so there is no concept of a "training set" in the context of machine learning. The "training" for the device would be its manufacturing and design optimization processes.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this type of device.
§ 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.