(396 days)
This device is designed to carefully deliver large flow rates for rapid insufflation, and monitor the amounts of CO2 gas needed to establish and maintain proper distention of the peritoneal cavity during Ob/Gyn laparoscopic surgical and diagnostic procedures
The KSEA Thermoflator (model 26 4320 20) is a microprocessor-based system, with gas output that is user adjustable from 0-30 liters/minute, and pressure that is user adjustable from 0-30 mmHg. The unit uses contemporary technology in pressure and flow-sensing, and incorporates a wide variety of safety features.
The provided document is a 510(k) summary for the Karl Storz Endoscopy-America, Inc. KSEA Thermoflator (model 26 4320 20), a laparoscopic insufflator. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study with performance metrics in the way a novel AI/ML device would.
Therefore, most of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth establishment, which are typical for studies validating AI/ML-driven medical devices, are not applicable to this 510(k) submission.
Here's a breakdown of what can be extracted from the provided text according to your request:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the context of specific quantitative acceptance criteria or a performance study where the device's output is measured against such criteria. The document states: "The KSEA Thermoflator (model 26 4320 20) is substantially equivalent to the predicate devices, since the basic features, design and intended uses are the same. The minor differences between the KSEA Thermoflator (model 26 4320 20) and the predicate device raise no new issues of safety and effectiveness, as these design differences have no effect on the performance, function or intended use of the devices."
This implies that the "acceptance criteria" are met by demonstrating that the device's design, intended use, and fundamental functionality are consistent with existing legally marketed devices, and any differences do not negatively impact safety or effectiveness. There are no performance metrics or numerical targets given.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This submission is based on a comparison to predicate devices, not on a clinical trial with a test set of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. There is no "ground truth" establishment in the context of a clinical performance study described here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set or adjudication process is mentioned.
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
Not applicable. This is a device for insufflation, not an AI-driven diagnostic tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a hardware device; the concept of "standalone algorithm performance" does not apply.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No ground truth in the sense of a clinical or diagnostic reference standard is used or required for this type of submission. The "ground truth" for substantial equivalence is the established safety and effectiveness of the predicate devices.
8. The sample size for the training set
Not applicable. This submission does not involve machine learning algorithms that require a training set.
9. How the ground truth for the training set was established
Not applicable. (See #8)
§ 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.