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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 CO2 Endoflator is a gas insufflator designed to deliver CO2 gas to the abdominal cavity to facilitate the use of endoscope and accessories.

The provided text describes a 510(k) summary for the Karl Storz CO2 Endoflator, a gas insufflator for Ob/Gyn laparoscopic surgical and diagnostic procedures. This document is a regulatory submission for medical device clearance, not a study evaluating device performance against specific acceptance criteria. Therefore, most of the requested information about acceptance criteria, study design, and performance metrics is not available in the provided text.

Here's what can be extracted and what cannot:

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

• Not Available: The document does not provide specific acceptance criteria or quantitative performance data. The clearance is based on substantial equivalence to predicate devices, meaning it is deemed as safe and effective as existing, legally marketed devices, rather than meeting new, specific performance thresholds.

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: No test set or associated data provenance is mentioned as this is a regulatory submission for device clearance via substantial equivalence, not a clinical study report.

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 test set or ground truth establishment process is described.

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

• Not Available: No test set or adjudication method 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 CO2 insufflator, not an AI-powered diagnostic or imaging device used by human readers, so MRMC studies or AI-assistance metrics are irrelevant.

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

• Not Applicable: This device is a CO2 insufflator, not an algorithm, so standalone algorithm performance is irrelevant.

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

• Not Available: No ground truth is mentioned, as this is a regulatory submission document for substantial equivalence, not a clinical performance study. The "ground truth" for 510(k) clearance is typically the performance and safety of legally marketed predicate devices.

8. The sample size for the training set

• Not Applicable: There is no mention of a training set as this is not an algorithm being developed. The device's design and manufacturing are based on established engineering principles and comparison to existing devices.

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

• Not Applicable: As above, no training set is mentioned.

Summary of what is available from the SENS document:

The device, Karl Storz CO2 Endoflator, was cleared for marketing based on its substantial equivalence to predicate devices. This means the FDA determined that the device is as safe and effective as other similar devices already on the market, and raises no new issues of safety or effectiveness. The minor differences noted have no effect on performance, function, or intended use.

• Intended Use: For Ob/Gyn laparoscopic surgical and diagnostic procedures to deliver CO2 gas to the abdominal cavity to facilitate the use of an endoscope and accessories.
• Predicate Devices: The submission states the device is "substantially equivalent to the predicate devices" but does not name them or provide their specific performance metrics.
• Regulatory Class: Class II (Product code: 85 HIF, per 21 CFR §884.1730 for a Laparoscopic Insufflator).

In conclusion, the provided document is a regulatory notice of 510(k) clearance based on substantial equivalence, not a detailed study report with specific acceptance criteria and performance data.

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