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intraperitoneal high flow introduction of CO2 gas, under voice-activation control, for abdominal distention to facilitate laparoscopic vísualization

The Surgiflator-20 ECU described in this notification is a modified version of and substantially equivalent to the Surgiflator 20-PIM (K955791) which is manufactured by W.O.M. GmbH. The Surgiflator-20 ECU incorporates the same design features as the Surgiflator-20 PIM. The only difference is that the function adjustment feature of the Surgiflator-20 ECU has been modified. The modification consists of a serial interface to allow for surgeon selection of device settings utilizing the HERMES Operating Room Control Center (K980787).

The provided text is a 510(k) summary for the SURGIFLATOR-20 ECU, a laparoscopic insufflator. This document focuses on demonstrating substantial equivalence to a predicate device (Surgiflator 20-PIM) and does not contain the kind of detailed study data, acceptance criteria, or performance metrics typically found in clinical trial reports or academic papers for devices that rely on complex algorithms or diagnostic capabilities.

Instead, the submission leverages existing literature and the substantial equivalence pathway for a modified version of an already cleared device. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth, and expert involvement is not available within this document.

Here's how the provided information relates to your request:

1. A table of acceptance criteria and the reported device performance:

   • Not available. The document states the device "incorporates the same design features" as the predicate and the "only difference" is a modification to a function adjustment feature (serial interface for surgeon selection of device settings via the HERMES Operating Room Control Center). This suggests that the acceptance criteria for performance would implicitly be the same as the predicate, but these are not explicitly stated or quantified in this 510(k) summary. No specific performance data for the modified device is reported.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Not available. There is no mention of a dedicated test set or clinical study for the SURGIFLATOR-20 ECU in this document. The submission relies on existing literature and the equivalence to a previously cleared device.

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 available. No ground truth establishment is described as there's no test set or clinical study.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not available. No test set or related adjudication process is described.

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 device is a laparoscopic insufflator, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance is irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This is a hardware device; no standalone algorithm performance is relevant or described.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Not available. No ground truth is described. The safety and effectiveness are supported by referencing existing literature on laparoscopic techniques and the substantial equivalence to a predicate device.

8. The sample size for the training set:

   • Not applicable. This device does not involve machine learning or a training set.

9. How the ground truth for the training set was established:

   • Not applicable. This device does not involve machine learning or a training set.

Summary of Device Rationale provided in the document:

The argument for safety and effectiveness is based on:

• Substantial Equivalence: The SURGIFLATOR-20 ECU is a modified version of the SURGIFLATOR 20-PIM (K955791), with the only difference being a modified function adjustment feature (serial interface to allow surgeon selection of device settings utilizing the HERMES Operating Room Control Center).
• Existing Literature: The submission references several books detailing the utility and safety of laparoscopic techniques and the use of high-flow insufflators. This literature serves as general background and support for the established safety and efficacy of the procedure and device type, rather than presenting specific study data for the new device. The provided references are:
  • "Operative Laparoscopy" by M.-A. Bruhat, 1992.
  • "Laparoscopy in gynecology, surgery and pediatrics" by H. Frongenheim, 1977.
  • "Minimal Invasive Surgery" by John G. Hunter and Jonathan M. Sackier, 1993.

In conclusion, this 510(k) summary uses the substantial equivalence pathway and reliance on established medical literature for the device type, rather than presenting a de novo study with specific acceptance criteria, performance metrics, or ground truth data for the modified device itself.

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