(227 days)
The EVA15 Insufflator is intended for use in diagnostic and/or therapeutic endoscopic and laparoscopic procedures to distend the abdomen, rectum, colon, esophagus, stomach or thoracic cavity with up to 25 mmHg pressure, by filling it with gas and to evacuate surgical smoke.
The EVA15 insufflator is intended for use in diagnostic and/or therapeutic endoscopic and laparoscopic procedures to distend a cavity by filling it with gas and to evacuate surgical smoke. It is indicated to facilitate the use of various endoscopic instruments by filling the abdominal cavity or rectum with gas to distend it, and by evacuating surgical smoke. The EVA15 Insufflator is used in an operating room or endoscopic suite. It consists of the following major components: (1) a micro-processor-controlled insufflation and smoke evacuation unit, and (2) a disposable tube set.
The laparoscopic tube set is a sterile, single-use product. The EVA15 Insufflator is an active medical device, nonsterile and reusable and is intended to insufflate a body cavity up to 25 mmHg and with up to 40 SLPM instantaneous flow. The EVA15 is powered by AC and uses compressed 50 psi CO2 and air gas supply the pneumatic circuitry for insufflation and smoke evacuation respectively.
This appears to be a 510(k) premarket notification summary for a medical device, the EVA15 insufflator with an AutoEvac accessory. The document describes the device, its intended use, technological characteristics, and a comparison to a predicate device, as well as non-clinical testing performed.
However, the provided text does not contain information related to an AI/ML driven device study, nor does it detail acceptance criteria and a study proving the device meets those criteria in the context of AI/ML performance.
The EVA15 insufflator is a physical medical device (a laparoscopic insufflator) with a new accessory (AutoEvac) that automatically activates/deactivates smoke evacuation based on sensing surgical energy. The core technology involves gas insufflation and venturi-based smoke evacuation, not AI/ML algorithms that require complex efficacy studies based on ground truth, expert readers, or MRMC studies.
Therefore, I cannot extract the information requested in your prompt because it is not present in the provided document. The questions you've asked (e.g., sample size for test/training set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, type of ground truth) are typically relevant for AI/ML medical devices, especially those for diagnostic or prognostic purposes, which this device is not.
The "Non-clinical Testing" section mentions:
- "Performance testing of the insufflator has demonstrated the ability to activate and de-activate smoke evacuation when electrosurgical energy is switched on and off."
- "including testing to IEC 60601-1:2005/AMD1:2012 / AMD 2:2020 (Edition 3.2) - Medical Electrical Equipment - Part 1: General Requirements For Safety"
- "and IEC 60601-1-2:2014 / A1:2020 (Edition 4.1) – Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests."
These are standard electrical safety and EMC (Electromagnetic Compatibility) tests for medical devices, which are functional performance tests, not AI/ML model validation studies.
In summary, the provided text describes a traditional medical device modification for which the acceptance criteria and study described in your prompt are not applicable.
§ 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.