(207 days)
This apparatus is an insufflator for performing laparoscopic procedures. It was designed for the purpose of creating the pneumoperitoneum (distension of the abdominal cavity with CO2) as part of these procedures.
Not Found
The provided document does not contain any information regarding acceptance criteria or a study proving device performance related to AI/algorithm performance.
The document is a 510(k) clearance letter for a laparoscopic insufflator (S698 Symbioz Flow), indicating it has been deemed substantially equivalent to a legally marketed predicate device. This type of clearance focuses on demonstrating equivalence in terms of safety and effectiveness, often through comparison to existing devices and adherence to relevant standards, rather than conducting a detailed performance study with acceptance criteria in the way you've described for an AI/algorithm-based device.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The requested information (e.g., sample sizes, ground truth, expert qualifications, MRMC studies, standalone performance) is relevant to the evaluation of AI/ML-driven medical devices, which is not what this document addresses.
§ 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.