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The Irrigation/Aspiration/Coagulation Electrodes, ICE-311 and ICE-511, are indicated for electrosurgical fulguration (coagulation) of the uterine cervix as part of the procedure called Loop Excision of the Transformation Zone (LETZ®), or other loop electrosurgery procedures where simultaneous electrosurgical fulguration and small-volume fluid irrigation and/or aspiration is needed.

The device consists of a stainless steel spherical ball electrode attached to an ULTEM® irrigation and aspiration head that has PVC irrigation and aspiration tubes. The posterior end of the electrode shaft fits snugly into a standard electrosurgical pen which is connected to an electrosurgical generator that has been cleared for marketing by the FDA. The irrigation tube has a PVC female Luer fitting for connection to a fluid source and the aspiration tube has an ABS suction adapter for connection to a standard vacuum suction system.

The provided document is a 510(k) summary for a medical device called the "TBD Irrigation Aspiration Coagulation Electrode" (ICE). This summary describes the device and its substantial equivalence to previously cleared devices. However, it does not include a detailed study proving the device meets specific acceptance criteria in the format requested.

The document primarily focuses on demonstrating substantial equivalence based on technological characteristics and functional comparisons with predicate devices, rather than presenting a performance study with defined acceptance criteria.

Here's a breakdown of the information that can be extracted or inferred from the provided text, and what is missing:

Information that can be extracted/inferred:

• Device Performance Reported: The document reports that:
  • "Laboratory tests of the UMP ICE and the MMP #0055 have demonstrated that the irrigation fluid flow differs by less than 4% and that the aspiration capability differs by less than 8%."
  • "The coagulation capabilities of the UMP ICE and the UMP ACE are equivalent since they are based on the same UMP DBL electrodes."

Information that is missing or not explicitly detailed in the provided text:

• A table of acceptance criteria: Specific, quantifiable acceptance criteria are not explicitly defined in the document as "acceptance criteria." Instead, the performance metrics mentioned above (e.g., <4% difference in irrigation flow, <8% difference in aspiration capability) act as implicit performance targets based on comparison to predicate devices.
• Sample size used for the test set and the data provenance: The document mentions "Laboratory tests" but does not specify the sample size (e.g., number of devices tested, number of measurements taken) or the provenance of the data (country of origin, retrospective/prospective).
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for these tests would be the measured performance of the predicate device. Expert consensus is not a factor for these types of engineering/laboratory tests.
• Adjudication method: Not applicable, as expert adjudication is not relevant for these types of laboratory tests comparing physical attributes.
• Multi-reader multi-case (MRMC) comparative effectiveness study: No, this type of study is not mentioned or described. The device is a surgical tool, and the focus is on its physical performance rather than diagnostic accuracy or human interpretation of images.
• Standalone (i.e., algorithm only without human-in-the-loop performance) study: No, this is not applicable as the device is a physical electrosurgical tool, not an AI algorithm.
• Type of ground truth used:
  • For irrigation flow and aspiration capability: The "ground truth" was the measured performance of the predicate device (MMP #0055).
  • For coagulation capabilities: The "ground truth" was the performance of the UMP ACE electrodes, as the ICE electrodes use the "same UMP DBL electrodes."
• Sample size for the training set: Not applicable, as this is a physical medical device, not an AI model that requires a training set.
• How the ground truth for the training set was established: Not applicable for the same reason as above.

Attempt to present the information in the requested format, acknowledging missing details:

Acceptance Criteria and Device Performance Study for Utah Medical Products Inc.'s ICE electrodes

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified in the document. The text only refers to "Laboratory tests."
• Data Provenance: Not specified. It can be inferred that these were internal laboratory tests conducted by Utah Medical Products, Inc.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts: Not applicable. The ground truth for these engineering tests was based on direct measurement of physical properties of the predicate devices.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

• Adjudication Method: Not applicable. Expert adjudication is not relevant for objective laboratory measurements of device performance.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done

• No, an MRMC comparative effectiveness study was not done. The device is a surgical instrument, not a diagnostic imaging or AI-driven system that would typically undergo such a study.

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

• No, a standalone (algorithm-only) performance study was not done. The device is a physical electrosurgical tool, not an AI algorithm.

7. The type of ground truth used

• Ground Truth Type: For irrigation fluid flow and aspiration capability, the ground truth was the measured performance of the identified predicate device (MegaDyne Medical Products, Inc.'s All-In-One Hand Control #0055). For coagulation capabilities, the ground truth was the performance of Utah Medical Products, Inc.'s ACE-311 and ACE-511 Aspiration/Coagulation Electrodes, as the ICE electrodes use the same core coagulating components (UMP DBL electrodes).

8. The sample size for the training set

• Sample Size: Not applicable. The device is a physical medical device, not an AI model that requires a training set.

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

• Ground Truth Establishment: Not applicable.

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