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Rudolf's laparoscopic and electrosurgical instruments are designed for dissecting, cutting and optional monopolar or bipolar coagulation of tissue during general surgical procedures.

These devices have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures.

Laparoscopic and electrosurgical instruments are used in various surgical applications. Therefore they are varying in size and build-up, though the general principle remains unchanged. By using a suitable connecting cable, the monopolar and bipolar instruments can be connected to high-frequency electrosurgical generators.

The provided text describes a 510(k) premarket notification for "Rudolf Laparoscopic and Electrosurgical Instruments". However, it does not contain a study that proves the device meets specific acceptance criteria in the way a clinical study or performance verification study would be described for a diagnostic AI device.

Instead, this document focuses on demonstrating substantial equivalence to legally marketed predicate devices, which is the primary pathway for 510(k) clearances. The "performance" in this context refers to conformity with international safety and performance standards rather than a quantitative measure of diagnostic accuracy or effect size with human readers.

Therefore, I cannot populate most of the requested fields because the information is not present in the provided text.

Here's what I can extract and what I cannot, based on the input:

• Designed for dissecting, cutting, and optional monopolar or bipolar coagulation of tissue during general surgical procedures.
• Not effective for tubal sterilization or coagulation for sterilization procedures.
• Conformity to international standards ANSI/AAMI HF18, IEC 60601-1, IEC 60601-1-1, IEC 60601-2-2, IEC 60601-2-18.
• Sterilizable by steam sterilization at 134°C (273°F) and 5 minutes minimum holding time.

Reported Device Performance:
The document does not provide quantitative performance metrics beyond stating conformity to the listed standards. Its primary claim is substantial equivalence to predicate devices, implying similar performance and safety profiles. |
| 2. Sample size used for the test set and the data provenance | Not applicable. This submission is for surgical instruments, not an AI/diagnostic device that would typically involve a test set of data. The "test" here refers to compliance with engineering and safety standards. |
| 3. Number of experts used to establish the ground truth for the test set and their qualifications | Not applicable. Ground truth establishment by experts for a test set is not relevant for this type of device submission. |
| 4. Adjudication method for the test set | Not applicable. Adjudication methods are not relevant for this type of device submission. |
| 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size | No. This is not an AI/diagnostic device, so an MRMC study is not relevant or mentioned. |
| 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done | No. This is not an AI/diagnostic device. |
| 7. The type of ground truth used | Not applicable. The "ground truth" here is the established safety and performance requirements for similar surgical instruments, defined by predicate devices and international standards. |
| 8. The sample size for the training set | Not applicable. This submission is not for an AI/machine learning device that would require a training set. |
| 9. How the ground truth for the training set was established | Not applicable. |

In summary: The provided document is a 510(k) summary for traditional laparoscopic and electrosurgical instruments. The "study" referenced is the demonstration of adherence to recognized international standards and substantial equivalence to existing predicate devices, rather than a clinical trial or performance study typical for AI/diagnostic devices assessing diagnostic accuracy.

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