(269 days)
The ENDOFLATOR 40 & 50 are used to create and/or to distend a cavity in the following diagnostic and therapeutic interventions:
- · Laparoscopy
- · Pediatric Laparoscopy
- · Endoscopy of the Lower Gastrointestinal Tract (e.g., TEO, colonoscopy)
- · Endoscopic Vessel Harvesting
This submission includes two microprocessor controlled CO2 insufflators that have been developed in parallel: ENDOFLATOR 40 (Model Number: UI400) and ENDOFLATOR 50 (Model Number: U1500), both of which come with HIGH FLOW and PEDIATRICS modes. The HIGH FLOW mode has the pressure range of 1-30 mmHg and the flow rate range of 1-40 LPM (ENDOFLATOR 40) and 1-50 LPM (ENDOFLATOR 50). The PEDIATRICS mode has the pressure range of 1-15 mmHg and the flow range of 0.1-15 LPM.
The ENDOFLATOR 40 &50 have redundant pressure and flow monitoring, automatic pressure relief, user control via graphical user interface and display of pressures/flow rates/ volume/operating mode.
The ENDOFLATOR 50 has three extra features not included in the ENDOFLATOR 40: (1) the higher maximum flow rate (50LPM), (2) the integrated gas heater, and (3) the ability for the user to save up to 30 procedure settings. Because the ENDOFLATOR 40 does not have the integrated gas heater, it can only be used with non-heated insufflation tubing set (Model Number: 031200-01). On the other hand, the ENDOFLATOR 50 (Model Number: UI500) can be used with either the non-heated insufflation tubing set (Model Number: 031200-01) or the heatable insufflation tubing set (Model Number: 031210-01).
The provided document is a 510(k) Summary for a medical device (ENDOFLATOR 40 & 50), which focuses on demonstrating substantial equivalence to predicate devices rather than proving a statistical meets of performance. Therefore, many of the requested details about acceptance criteria for AI algorithms, such as sample sizes for test/training sets, expert adjudication methods, MRMC studies, and detailed ground truth establishment, are not applicable to this type of regulatory submission and are not found in the document.
This document describes a physical medical device (laparoscopic insufflator), not an AI algorithm. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to engineering and functional performance tests for the insufflator itself, not measures of AI diagnostic accuracy.
However, I can extract the information that is present concerning the device's non-clinical performance data which serves as its "acceptance criteria" and "proof of meeting criteria."
Acceptance Criteria and Device Performance for ENDOFLATOR 40 & 50 (Non-Clinical Bench Testing)
The document details performance and safety criteria for the insufflator, verified through bench testing. The "acceptance criteria" for this device are defined by its ability to meet specified limits and functions during these tests.
1. Table of Acceptance Criteria and Reported Device Performance
| Verification Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Safety - Overpressure | The device informs user, if an unintended high cavity pressure is measured and activates appropriate valves if the activation threshold is exceeded. | Pass |
| Performance - Pressure | The difference between the measured and the set point pressures is within the specified limits. | Pass |
| Safety - Maximum pressure | The measured pressure shall not exceed the mode related specified limits. | Pass |
| Safety - Overpressure | The gas flow is stopped if a cavity pressure is measured is higher than mode related limits. | Pass |
| Performance - Gas supply | The device informs the user if the pressure gas supply falls under specified limits. | Pass |
| Performance - Flow | The difference between the measured and the set point flow is within the specified limits. | Pass |
| Safety - Pressure Controller | The pressure controller temperature shall stain within the specified limits. | Pass |
| Safety - Overtemperature | (ENDOFLATOR 50 only) The heater is switched off if the fault arises. | Pass |
| Performance - Heater connection symbol | (ENDOFLATOR 50 only) The heater connection symbol is correctly displayed. | Pass |
| Comparative - Adult and Pediatric Laparoscopy | To support laparoscopy indication of the subject device, the pressure control of High Flow mode must be substantially equivalent to the primary predicate device's Standard/Bariatric modes and the secondary predicate device's Normal Cavity mode. Similarly, to support Pediatric Laparoscopy indication of the subject device, the pressure control of Pediatrics mode must be substantially equivalent to the primary predicate device's Pediatric mode. | SE to predicate devices |
| Comparative - Lower Gastrointestinal Tract | In order to support lower gastrointestinal indication of the subject device, the pressure control of High Flow mode must be substantially equivalent to the secondary predicate device's Small Cavity mode. | SE to predicate devices |
| Comparative - Endoscopic Vessel Harvesting | In order to support Endoscopic Vessel Harvesting indication of the subject device, the pressure control of High Flow mode must be substantially equivalent to the primary predicate device's Vessel Harvesting mode and the secondary predicate device's Small Cavity mode. | SE to predicate devices |
2. Sample Size Used for the Test Set and Data Provenance:
The document refers to "bench testing" but does not specify the sample size of devices or the number of tests performed. It states "Software verification and validation testing were conducted," and "bench testing has been performed for following safety and performance requirements." Given this is a hardware device, "test set" here refers to the physical units undergoing testing, not a dataset in the AI sense.
Data provenance: Not explicitly stated beyond "bench testing." It is implied to be internal testing by the manufacturer (Karl Storz Endoscopy-America, Inc.) as part of their submission. It is a retrospective summary of performed tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. Ground truth for a physical device's performance (e.g., pressure, flow rate accuracy) is established through engineering specifications, calibration standards, and direct measurement by instruments, not human experts.
4. Adjudication Method for the Test Set:
Not applicable. Adjudication methods like 2+1 or 3+1 are used for human-expert consensus in AI ground truth establishment. For a physical device, performance is measured objectively.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No. This is not an AI-assisted device, nor a diagnostic imaging device requiring human reader studies. The "comparative" tests listed were to show "substantial equivalence" of the device's technical specifications and intended use to existing predicate devices, not improvement of human reader performance with AI.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
Yes, in the sense that the device's performance was tested independently of human operation. The tests mentioned are for the device itself (e.g., pressure control, flow rate, safety mechanisms) and determine its inherent operational characteristics.
7. The Type of Ground Truth Used:
Technical specifications and direct objective measurements against calibrated instruments and pre-defined engineering limits. For example, "The difference between the measured and the set point pressures is within the specified limits."
8. The Sample Size for the Training Set:
Not applicable. This device does not use machine learning, so there is no "training set."
9. How the Ground Truth for the Training Set was Established:
Not applicable. There is no training set for a machine learning model. Software validation and verification (mentioned as IEC 60601-1-18 relevant and a "major" level of concern) refer to traditional software development and testing, not AI model training.
§ 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.