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The RF instruments are used for tissue and vessel coagulation (hemostasis) by means of radio-frequency current. The products are intended for use in endoscopically performed or supported surgery intended are:

• • Endoscopic procedures
• • Orthopedic coagulation
• • Neurosurgical coagulation
    The products are exclusively intended for use by specialized medical personnel and may only be used by adequately qualified and trained medical personnel.

The TipControl RF (Radio Frequency) Instruments, bipo are disposable single-use, sterile packaged electrosurgical devices, used for tissue and vessel coagulation (hemostasis) by means of radio-frequency current. The products are intended for use in endoscopic performed or supported surgeries. The types of surgery intended are: Endoscopic procedures, orthopedic coagulation, and neurosurgical coagulation. These products are exclusively intended for use by specialized medical personnel and may only be used by adequately qualified and trained medical personnel.
The TipControl RF Instrument, bipo consists of a handle, a sheath tube, the TipControl RF electrode and a connection cable with an US 2-PIN device connector. The just mentioned components comprise a complete unit for disposable use and cannot be dismantled. They are currently available in a working length of 280 mm or 350 mm.
The TipControl RF Instruments, bipo are designed to be used in conjunction with the electrosurgical bipolar radiofrequency generators Surgitron and Surgi-Max Plus up to 4 MHz and endoscopic accessories. The RF generator provides power and delivers electrical current to the distal tips of the RF instruments.

This document is a 510(k) premarket notification for the "TipControl RF Instrument bipo Ø 2.5mm WL 280mm" and "TipControl RF Instrument bipo Ø 2.5mm WL 350mm". The device is an electrosurgical cutting and coagulation device and accessories. The filing seeks to establish substantial equivalence to a predicate device, the "Trigger Flex™ Bipolar Electrode (K003126)".

Here's an analysis of the acceptance criteria and study data based on the provided text:

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

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

The document does not specify a distinct "test set" in the context of an AI/algorithm-based device, as this is a traditional medical device (electrosurgical instrument). The tests performed are laboratory-based and conducted on samples of the device itself.

• Sample Size: Not explicitly stated for specific tests (e.g., how many devices were tested for biocompatibility or bench testing). These are generally conducted with a sufficient number of samples to ensure statistical validity for the relevant standard.
• Data Provenance: The device manufacturer (Richard Wolf GmbH) is located in Germany. It can be inferred that the testing and data originate from within the company's quality assurance and R&D processes, likely conducted in Germany or by certified contract laboratories. The document does not specify if data is retrospective or prospective, but as it pertains to device design verification and validation, it would be prospective for the evaluated 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)

This is not applicable as the document describes a physical electrosurgical device, not an AI/diagnostic algorithm that requires ground truth established by experts. The "ground truth" for this type of device is established through compliance with recognized standards and successful performance in defined laboratory tests (e.g., measuring electrical parameters, biological responses).

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

Not applicable. This device does not involve expert adjudication as it is not a diagnostic device requiring interpretation of data by multiple experts.

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 does not incorporate AI, therefore no MRMC study or AI assistance evaluation was performed.

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

Not applicable. This device does not have an algorithm component.

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

As mentioned in point 3, the concept of "ground truth" as it applies to AI/image analysis is not directly relevant here. For this electrosurgical device, the "ground truth" is defined by:

• Compliance with recognized international standards: e.g., ISO 11135, ISO 10993 series, IEC 60601 series.
• Successful performance in bench tests: Meeting predefined specifications for electrical performance, mechanical integrity, and functional capabilities as outlined in relevant FDA guidances.
• Biocompatibility testing results: Demonstrating non-cytotoxicity, non-hemolysis, non-irritation, non-sensitization, and non-toxicity based on established biological evaluation protocols.

8. The sample size for the training set

Not applicable. This device does not involve machine learning or AI, and therefore does not have a "training set."

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

Not applicable, as there is no training set for this device.

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