(45 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 and to evacuate smoke. The trocar may be used with or without visualization for primary and secondary insertions. (Note: This Indication has been expanded to include smoke evacuation)
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 and evacuate surgical smoke. 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.
This 510(k) submission does not describe a study involving an AI/ML device, but rather a medical device (trocar and cannula system). Therefore, some of the requested information regarding AI/ML device studies (such as sample sizes for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for training) is not applicable in this context.
Here's an analysis of the provided text in relation to your request, focusing on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document mentions various tests but largely defines them by their purpose rather than explicit quantitative acceptance criteria with corresponding performance metrics. It indicates adherence to standards as the form of "acceptance."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Pneumoperitoneum Maintenance | Tested to show ability to maintain adequate pneumoperitoneum during laparoscopic surgery. |
| Port of Entry Creation/Maintenance | Tested to show ability to create and maintain a port of entry during simulated laparoscopic surgery. |
| Smoke Evacuation | Tested to show ability to aid in the evacuation of smoke. (Referenced Addendum 3 for test data, but not provided here.) |
| Safety & Emissions | Tested in accordance with IEC60601-1 (General Requirements for Safety) and IEC60601-1-2 (EMC Requirements and Tests). |
| Sterility Validation | Achieved a Sterility Assurance Level (SAL) of 10⁻⁶ in accordance with ISO 11137:2006 and AAMI TIR 27:2001. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable as this is a physical medical device, not an AI/ML system tested on a dataset. The "tests" described are functional and safety verification tests. The document does not specify the number of units tested for functional performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth as typically defined for AI/ML does not apply here. Performance for a physical device is assessed through engineering tests and adherence to standards.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
Not applicable.
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 not an AI/ML device or an imaging device requiring human interpretation, so an MRMC study is irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the functional aspects, "ground truth" would be established by direct measurement of physical parameters (e.g., CO2 pressure for pneumoperitoneum, smoke particle reduction for evacuation) against predefined engineering specifications. For safety and sterility, it's compliance with established international standards (IEC, ISO, AAMI).
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
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.