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The Mapping Suction Probe is a surgical instrument that allows the surgeon to remove secretions and test surgical tissue with nerve stimulation simultaneously and with the same instrument is intended for use only by a licensed physician and in conjunction with compatible nerve locator monitor systems.

The Mapping Suction Probe is a surgical instrument which combines surgical suction instrument and a monopolar stimulation probe in one instrument. The stimulation function of the Mapping Suction Probe is used for monopolar stimulation during intraoperative surgical interventions and is connected to electrical stimulators of neuromonitoring devices outside the sterile field via an appropriate integrated connection cable. To ensure a correct monopolar stimulation, a counter electrode is also included in the sterile package which must be placed at the resection marqin. The suction function of the Mapping Suction Probe is used for aspiration during tumor resection and is connected to suction devices via a tube, which is not part of the delivered package.

The provided text is an FDA 510(k) summary for a medical device called the "Mapping Suction Probe." It contains information about the device's indications for use, comparison to a predicate device, and performance data related to biocompatibility and bench testing.

However, the request asks for specific details about acceptance criteria and a study that proves the device meets those criteria, particularly in the context of an AI/Software as a Medical Device (SaMD).

The provided document does NOT contain any information about AI, software, or clinical studies that would align with the detailed acceptance criteria and study design requested (e.g., MRMC studies, expert ground truth, training/test set sample sizes for AI models).

The document explicitly states:

• "The Mapping Suction Probe does not contain any kind of software, Software: and therefore, this section does not apply to it." (Page 8)
• "Clinical testing was not performed for the Mapping Suction Probe." (Page 9)

Therefore, based on the provided text, it's impossible to answer the majority of the questions related to AI/SaMD acceptance criteria and performance studies. The information available pertains to the physical device's safety and performance characteristics (biocompatibility, electrical safety, mechanical tests, etc.) compared to a predicate device, which is typical for a 510(k) submission for a non-software, non-AI hardware device.

Given the limitations of the provided text, I must state that the requested information (related to AI/SaMD acceptance criteria and studies) is not present in the document.

I will indicate which sections cannot be answered based on the input.

Acceptance Criteria and Device Performance (Based on available data, primarily biocompatibility and bench testing for a hardware device)

Since this is a physical device without AI/software components, the "acceptance criteria" are related to its physical and functional safety and equivalence to the predicate, rather than AI performance metrics.

Table of Acceptance Criteria and Reported Device Performance:

| Category | Acceptance Criteria (based on standards/tests) | Reported Device Performance |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Biocompatibility | Cytotoxicity: No reduction of cell proliferation/viability. | Cytotoxicity (Device): No reduction of cell proliferation/viability observed; dehydrogenase activity 101% at 100% extract conc.; no inhibition/lysis microscopically. Conclusion: Non-cytotoxic. |
| | Sensitization: 0% sensitization rate. | Sensitization (Device): 0% sensitization rate after application. Conclusion: No sensitizing properties. |
| | Irritation / Intracutaneous Reactivity: Primary irritation index of 0. | Irritation / Intracutaneous Reactivity (Device): Primary irritation index of 0 for polar and non-polar extracts. Conclusion: Not irritant. |
| | Acute Systemic Toxicity: No compound-related mortalities or signs of toxicity. | Acute Systemic Toxicity (Device): No compound-related mortalities or signs of toxicity within 72 hours post-dose. Conclusion: No acute systemic toxic characteristics. |
| | Material Mediated Pyrogenicity: Temperature increase for each rabbit not > 0.50°C. | Material Mediated Pyrogenicity (Device): Temperature increase for each rabbit not > 0.50°C. Conclusion: Materials considered non-pyrogenic. |
| | Hemolysis: Haemolytic indices

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