(233 days)
AirSeal iFS System: The ConMed AirSeal® iFS System is intended for use in diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas, to create and maintain a gas-sealed obstruction-free path of entry for endoscopic instruments, and to evacuate surgical smoke. It is indicated for use in abdominal, thoracic, and pediatric procedures where insufflation is desired 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.
AirSeal dV Solution: The AirSeal Robotic Solution (ARS) is intended for use in diagnostic and/or therapeutic endoscopic procedures in conjunction with the ConMed AirSeal iFS and an Intuitive da Vinci X Cannula and Cannula Seal to distend a cavity by filling it with gas, to create and maintain a gas-sealed obstruction-free path of entry for endoscopic instruments, and to evacuate surgical smoke. It is indicated for use in abdominal, thoracic, and pediatric procedures where insufflation is desired to facilitate the use of various laparoscopic and thoracoscopic 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. The Cannula Cap is indicated for use with or without visualization. The ARS System must be used with the Intuitive da Vinci X 8mm Instrument Cannula, an Intuitive Cannula Seal and the AirSeal iFS in AirSeal mode. When used in AirSeal mode, the Cannula Cap and Bifurcated Tube Set are designed to provide CO2 gas delivery with stable pneumoperitoneum and continuous smoke evacuation during robotic assisted laparoscopic and thoracoscopic procedures using the da Vinci Xi or da Vinci X systems. The Bifurcated Filtered Tube Set is used to connect the Cannula Cap and Cannula Seal to the AirSeal iFS.
The ConMed AirSeal iFS System consists of the following major components: (1) a trocar, (2) a cannula, (3) tube sets, and (4) a microprocessor-controlled insufflation, recirculation and filtration unit. 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 (Adult and Pediatric); or (c) Smoke Evacuation Mode. The ConMed AirSeal dV Solution (or AirSeal Robotic Solution) consists of the following major components: (1) AirSeal® Cannula Cap with a cannula cap and an obturator (in standard and long lengths), and (2) AirSeal® Bifurcated Filtered Tube Set. The cannula cap, obturator and tube set are sterile, single-use products. The AirSeal dV Solution, in conjunction with Intuitive daVinci XiX Cannula and Cannula Seal, is operated in the Airseal Mode with the AirSeal iFS System to distend a cavity by filling it with gas, to create and maintain a gas-sealed obstruction-free path of entry for endoscopic instruments, and to evacuate surgical smoke. The ConMed AirSeal dV Solution is a sterile, single use device, primarily composed of polycarbonate, and stainless steel.
The provided FDA 510(k) summary describes the AirSeal iFS System and AirSeal dV Solution, which are laparoscopic insufflators. This document is a premarket notification for a medical device seeking substantial equivalence to a predicate device. As such, the "acceptance criteria" and "device performance" in this context refer to engineering and regulatory compliance testing rather than clinical performance metrics typically associated with AI/ML algorithms.
Here's an analysis based on the provided text, addressing your questions where applicable and noting when particular information is not present in this type of regulatory submission:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists performance data categories. The specific quantitative acceptance criteria and detailed reported performance values for each test are not explicitly provided in this summary document. This level of detail is typically found in full test reports submitted to the FDA but is summarized for the 510(k) public abstract.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Packaging testing | Compliant (ISO 11607-1) |
| Software verification and validation | Compliant (IEC 62304) |
| Electrical safety | Compliant (IEC 60601-1) |
| Electromagnetic compatibility (EMC and Immunity) | Compliant (IEC 60601-1-2) |
| Set pressure | Performance validated |
| Initial insufflation | Performance validated |
| Obturator removal and Instrument insertion | Performance validated |
| Leak compensation | Performance validated |
Study Proving Acceptance Criteria Met:
The study proving the device meets the acceptance criteria consists of benchtop testing and non-clinical testing. The document states:
- "Benchtop testing was completed to support substantial equivalence to the predicate as it relates to safety and effectiveness."
- "The following tests were conducted to support substantial equivalence for the expanded indication..." (followed by the list in the table above).
- "Based upon the findings of non-clinical testing, the differences present no issues of safety and efficacy and the subject AirSeal iFS System and AirSeal dV Solution are substantially equivalent to the predicate PneumoSure (K063367)."
2. Sample Size Used for the Test Set and Data Provenance
This document does not specify sample sizes for individual tests. The testing conducted is primarily engineering verification and validation (V&V) on device prototypes or production units. Data provenance (e.g., country of origin, retrospective/prospective) is not applicable or provided for these types of engineering tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not relevant to the described studies, as they are engineering performance tests of a physical medical device, not clinical studies involving expert interpretation of data or images. "Ground truth" in this context refers to established engineering specifications and regulatory standards.
4. Adjudication Method for the Test Set
Not applicable. The tests are objective measurements against predefined engineering specifications and regulatory standards, not subjective interpretations requiring adjudication.
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
An MRMC comparative effectiveness study was not done. This device is not an AI/ML algorithm that assists human readers; it is a laparoscopic insufflator.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable. The device is a physical medical instrument, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the tests described would be established engineering specifications, design requirements, and recognized international standards (e.g., ISO, IEC) to which the device's performance is compared. For example, for "set pressure," the ground truth is the specified pressure values the device is designed to maintain.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm developed with a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for an AI/ML algorithm.
§ 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.