(112 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 laparoscopic instruments by filling the abdominal cavity with gas to distend it, by creating and maintaining a gas sealed obstruction-free instrument path and by evacuating surgical smoke. This instrument is 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 hospitals and clinics.
The provided text describes the SurgiQuest AirSeal® iFS System, a laparoscopic insufflator. Here's a breakdown of the requested information, based solely on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics in the format typically used for AI/ML device evaluations (e.g., sensitivity, specificity, accuracy against a threshold). Instead, it discusses the device's adherence to various engineering and quality standards, and the results of a bench test demonstrating "substantial equivalence."
However, we can infer some "performance" from the bench test mentioned:
| Acceptance Criterion (Inferred from study goal) | Reported Device Performance |
|---|---|
| Substantial equivalence in performance for insufflation in a small cavity (compared to predicate device) | The engineering in-vitro bench test "demonstrates conclusively that there is substantial equivalence in performance" between the AirSeal® iFS System and the Olympus High Flow Insufflation Unit UHI-4 when tested in a small cavity. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the context of this document. The study described is an "engineering in-vitro bench test," not a human clinical trial or a dataset of patient cases.
- Data Provenance: Not applicable. The "data" comes from an in-vitro bench test, not from patient data (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided in the document, as the "ground truth" for an engineering bench test is typically defined by the physical parameters being measured and the established performance of a predicate device, rather than expert consensus on medical images or diagnoses.
4. Adjudication Method for the Test Set
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical data (e.g., image interpretation), which is not the nature of the described engineering bench test.
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
- No. This document does not mention an MRMC study. The device described is a physical medical device (laparoscopic insufflator), not an AI-powered diagnostic or therapeutic tool that would assist human readers in interpreting medical cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. The AirSeal® iFS System is a physical device with embedded software for its operation, but it is not an "algorithm only" device in the sense of an AI/ML diagnostic or predictive algorithm. Its performance is evaluated through engineering tests, not standalone clinical performance as an AI algorithm.
7. The Type of Ground Truth Used
- For the described engineering bench test, the "ground truth" or reference for comparison appears to be the performance of a legally marketed predicate device (Olympus High Flow Insufflation Unit UHI-4) in a controlled in-vitro environment, as well as adherence to various industry standards (IEC for electrical safety, ISO for sterilization, biocompatibility, etc.). The goal was to demonstrate "substantial equivalence" to this predicate.
8. The Sample Size for the Training Set
- Not applicable. The device described is a physical medical device. It does not involve a "training set" in the context of machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. There is no training set for this type of device.
Summary of the Study Discussed:
The document primarily describes an engineering in-vitro bench test (Engineering Test No. 0206151530 01) comparing the SurgiQuest AirSeal® iFS System with its predicate device, the Olympus High Flow Insufflation Unit UHI-4. This test was conducted in a "small cavity" to demonstrate substantial equivalence in performance for the purpose of maintaining pneumorectum. The study concluded that the AirSeal® iFS System is "safe and effective in creating and maintaining pneumorectum" and that its performance is "substantially equivalent" to the predicate. The document also lists adherence to numerous ISO and IEC standards for various aspects of the device (sterilization, biocompatibility, electrical safety, etc.).
§ 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.