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These instruments are intended for use by qualified surgeons and provide gas insufflation designed for

• diagnostic laparoscopic procedures, and .
• laparoscopic sterilization procedures. .

The Karl Storz No Endoflator is a gas insufflator designed to deliver NoO gas to the abdominal cavity to facilitate the use of endoscope and accessories.

This document is a 510(k) summary for the Karl Storz N2O Endoflator, a gas insufflator for diagnostic laparoscopic and laparoscopic sterilization procedures. This type of device does not involve AI or algorithms, and therefore, most of the requested information, such as acceptance criteria, sample sizes for test and training sets, expert ground truth establishment, adjudication methods, multi-reader multi-case studies, and standalone algorithm performance, is not applicable.

Here's the relevant information based on the provided text:

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

The document does not specify quantitative acceptance criteria or detailed performance results in the format requested. The approval is based on "substantial equivalence" to predicate devices. The implicit acceptance criterion is that the device performs similarly to legally marketed predicate devices without raising new issues of safety and effectiveness.

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

Not applicable. This is a medical device (gas insufflator), not an AI/algorithm-based diagnostic tool. The submission focuses on device design and comparison to predicate devices, not clinical study data in the context of an algorithm's performance.

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. Ground truth establishment by experts is relevant for diagnostic algorithms.

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

Not applicable. Adjudication methods are relevant for resolving discrepancies in expert interpretations for algorithmic ground truth.

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 gas insufflator, not an AI-assisted diagnostic tool.

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

Not applicable. This device does not involve an algorithm.

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

Not applicable. For this device, the "ground truth" would be its ability to perform its intended function (delivering N2O gas to the abdominal cavity) safely and effectively, which is assessed through engineering principles, bench testing, and comparison to predicate devices rather than a diagnostic 'ground truth'.

8. The sample size for the training set

Not applicable. This device does not use a training set as it's not an AI/ML algorithm.

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

Not applicable. This device does not have a training set or associated ground truth in the context of an algorithm.

Summary based on the provided text:

The Karl Storz N2O Endoflator received 510(k) clearance by demonstrating substantial equivalence to predicate devices. The claim is that "The minor differences between the Karl Storz N2O 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 these devices." This implies that the device meets existing safety and effectiveness standards, as demonstrated by the predicate devices, and that its performance is comparable. No specific performance metrics or clinical study data (in the context of an AI device) are presented in this summary document.

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