(207 days)
The SurgiQuest AirSeal® iFS System is intended for use in diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas, to establish and maintain a path of entry for endoscopic instruments and to evacuate surgical smoke.
It is indicated to facilitate the use of various thoracoscopic and laparoscopic instruments by filling the abdominal or thoracic cavity with gas to distend it, by creating and maintaining a gas sealed obstruction-free instrument path and by evacuating surgical smoke. This instrument can also be used to insufflate the rectum and colon to facilitate endoscopic observation, diagnosis and treatment. The trocar of the AirSeal® iFS System is indicated for use with or without visualization.
The SurgiQuest AirSeal®iFS System (cleared as AirSeal® Optical Trocar & Cannula System with integrated Insufflator DPIS 2000) consists of the following major components: (1) a trocar, (2) a cannula, (3) tube sets, and (4) a micro-processor-controlled insufflation, recirculation and filtration unit (the "AirSeal" iFS"). The cannula, trocar and tube sets are sterile, single-use products. The AirSeal iFS System is an active medical device, nonsterile and reusable and is intended to insufflate a body cavity. The AirSeal iFS System is designed to function in one of three (3) separate modes of operation: (a) Insufflation Mode; (b) AirSeal Mode; or (c) Smoke Evacuation Mode. The device contains software. The device is designed for use in Medical Centers, hospitals and medical clinics.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device: SurgiQuest AirSeal iFS System
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily derived from the device's functional and performance specifications, ensuring it operates as intended. The "Results" column in the table below directly indicates compliance.
| Acceptance Criteria (Verification/Validation Test) | Reported Device Performance |
|---|---|
| Verification AirSeal mode launches automatically after initial insufflation is completed. | Pass |
| Verification the iFS will maintain the actual pressure within a specified range of the set pressure. | Pass |
| Verification the AirSeal System venting feature activates appropriately and effectively reduces cavity pressure within the specified time. | Pass |
| Verification the iFS will maintain an average actual pressure within a specified range of the set pressure when an instrument is inserted into the Access Port and manipulated. | Pass |
| Compliance with AAMI ANSI ES60601-1 (Basic safety and essential performance) | Confirmed (listed as standard followed) |
| Compliance with IEC 60601-1-2 (Electromagnetic compatibility) | Confirmed (listed as standard followed) |
| Compliance with IEC 60601-2-18 (Endoscopic equipment safety and performance) | Confirmed (listed as standard followed) |
| Compliance with IEC 62304 (Medical device software life cycle processes) | Confirmed (listed as standard followed) |
| Compliance with ISO 10993-1, -5, -7, -10, -11 (Biocompatibility) | Confirmed (listed as standard followed) |
| Compliance with ISO 11135, ISO 11137-1, ISO 11137-2 (Sterilization) | Confirmed (listed as standard followed) |
| Compliance with ISO 11607-1 (Packaging for sterile medical devices) | Confirmed (listed as standard followed) |
| Compliance with ISO 14971 (Risk management) | Confirmed (listed as standard followed) |
| Compliance with AAMI ANSI ST67 (Sterility assurance level) | Confirmed (listed as standard followed) |
| Meeting all system medical/clinical design input requirements (via clinical/in vivo and simulated use testing) | Validated (confirmed by studies) |
| Absence of adverse events in clinical evaluations for thoracic use (Robotically-Assisted Thoracic Surgery / Video Assisted Thoracoscopic Surgery) | None reported across 4 studies |
2. Sample Size Used for the Test Set and Data Provenance
The test set for clinical/in vivo and simulated use testing involved a total of 71 patients across four cited studies.
- Cerfolio et al. 2016: 8 patients
- Gonde et al. 2017: 10 patients
- Kneuertz et al. 2017: 20 patients
- Suda et al. 2014: 33 patients
The text does not explicitly state the country of origin for these clinical studies. It also doesn't specify if they were retrospective or prospective, though the nature of supporting clinical evidence often leans towards prospective or a mix. The phrase "real-world clinical evaluation" suggests observation in actual clinical settings.
For the bench/in vitro verification testing, the sample size is not quantified in terms of units tested, but it's stated that "extensive bench testing" was performed to confirm "all functional and performance attributes."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The clinical studies are referenced by author names and publication years, but details on how the ground truth (e.g., successful procedure, absence of complications) was established by experts, or the qualifications of those experts, are absent. The mention of "testimonial letter from the author" for Cerfolio et al. 2016 confirms the study's findings but doesn't detail the expert review process within the study itself.
4. Adjudication Method for the Test Set
The adjudication method for establishing ground truth in the clinical studies is not explicitly stated.
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 aspect is not applicable to the SurgiQuest AirSeal iFS System. This device is an insufflation system, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance was not performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This aspect is not applicable. The SurgiQuest AirSeal iFS System is a physical medical device with software control, but it's not a standalone algorithm/AI system whose performance would be measured without human interaction. It's an instrument used by surgeons.
7. The Type of Ground Truth Used
For the clinical/in vivo testing, the ground truth appears to be based on clinical outcomes and observations during surgical procedures, specifically the successful use of the device without reported adverse events. This implies confirmation by the physicians performing the procedures.
For the bench/in vitro verification testing, the ground truth was established by meeting predefined engineering specifications and requirements for functional and performance attributes. Compliance with recognized industry standards also serves as a ground truth baseline for safety and performance characteristics.
8. The Sample Size for the Training Set
The document does not provide information regarding a "training set" in the context of machine learning or AI. The device contains software ("The device contains software"), but it is not described as an AI/ML device that requires a separate training set for its algorithms to learn. Its software likely orchestrates control functions (e.g., pressure regulation, mode switching) based on hard-coded logic and control loops, rather than learned patterns from a training dataset.
9. How the Ground Truth for the Training Set Was Established
Since no training set for AI/ML is mentioned, this information is not applicable. The software's "ground truth" or correct functioning would have been established through traditional software verification and validation, ensuring it correctly implements its design specifications and requirements.
§ 884.1730 Laparoscopic insufflator.
(a)
Identification. A laparoscopic insufflator is a device used to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.(b)
Classification. (1) Class II (performance standards).(2) Class I for tubing and tubing/filter kits which include accessory instruments that are not used to effect intra-abdominal insufflation (pneumoperitoneum). The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.