(119 days)
The Karl Storz Model 264305 20 Electronic Endoflator is designed to facilitate the use of laparoscopes by distending the abdomen with CO2 gas during laparoscopic surgical and diagnostic procedures.
The Karl Storz Model 264305 20 Electronic Endoflator for laparoscopy is a microprocessor controlled insufflator system with a maximum gas flow rate of 20 liters per minute. The insufflation pressure is user adjustable between 0 and 30 mmHg. The safety features include acoustic and visual alarms for overpressure, negative pressure and low gas supply.
I'm sorry, but without further context or additional documents describing specific acceptance criteria and study results related to the Karl Storz Model 264305 20 Electronic Endoflator, I cannot provide the requested information. The provided text is a 510(k) summary for a medical device submitted in 1990, which primarily focuses on substantial equivalence to predicate devices rather than detailed performance study methods, acceptance criteria, or AI elements.
The document states: "The Karl Storz Model 264305 20 Electronic Endoflator for laparoscopy is substantially equivalent to the predicate devices since the basic features, design and intended uses are the same. The minor differences between the KSEA Endoflator and the predicate devices raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or intended use of this device."
This indicates that the device's acceptance was based on its similarity to existing, legally marketed devices, rather than a specific performance study with the types of criteria and methodologies you've listed (e.g., sample sizes for test/training sets, expert adjudication, MRMC studies, AI performance metrics, etc.). These types of detailed performance evaluations, especially those involving AI, were not standard practice for device clearance in 1990 for a device of this nature.
§ 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.