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The Somnus Model 1000 - Needle Sleeve Bending Tool is intended to change the angle of deployment of the needle for the Model 1000 - Single Needle Coagulating Electrodes by creating a radial bend in the needle sleeve.

This device is intended for use by qualified medical personnel trained in the use of Somnus Tissue Coagulating Electrodes.

The Somnus™ Bendable Tissue Coagulating Electrode is used to deliver radiofrequency (RF) energy for selective thermal ablation of tissues. The needle is deployed from a guide tube. The guide tube can be bent using the Electrode Bending Tool to allow deployment of the needle at angles ranging from 0 to 45°.

The provided text focuses on the 510(k) summary for the Somnus™ Electrode Bending Tool and does not contain detailed information about specific acceptance criteria or a study that rigorously proves the device meets such criteria with quantitative measures. The document is primarily a regulatory submission for substantial equivalence.

Here's what can be extracted and what information is missing based on your request:

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

• Acceptance Criteria: Not explicitly stated in a quantifiable manner within the provided text. The document states "performance validation testing has been done to validate the performance of the device," but the specific criteria are not detailed.
• Reported Device Performance: Not reported with specific metrics. The text only mentions that the tool allows for "deployment of the needle at angles ranging from 0 to 45°" by creating a "radial bend in the needle sleeve." There are no reported numerical outcomes or success rates for this bending function.

Missing Information for this table: Specific, measurable acceptance criteria (e.g., minimum bending angle achieved, precision of bend, tool durability, etc.) and quantitative results from performance validation.

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

• Sample Size: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).

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

This type of information is irrelevant for this device. The Somnus™ Electrode Bending Tool is a mechanical accessory, not a diagnostic or AI-driven device requiring expert interpretation for ground truth establishment. Its performance would be assessed through mechanical engineering tests or usability studies, not through expert consensus on medical images or diagnoses.

4. Adjudication method for the test set

Not applicable, as ground truth establishment by experts for a test set is not relevant for this type of device.

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 is not an AI-driven device, and no human-in-the-loop performance study with or without AI assistance would be relevant.

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

Not applicable. This is a physical tool, not an algorithm.

7. The type of ground truth used

Not applicable in the sense of expert consensus, pathology, or outcomes data, as this is a mechanical tool. The "ground truth" for its performance would be defined by engineering specifications and direct measurement of its mechanical function (e.g., measuring the achieved bend angle).

8. The sample size for the training set

Not applicable. This is a physical medical device accessory, not a machine learning model. There is no concept of a "training set."

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

Not applicable, as there is no training set for a physical tool.

Summary of available information:

The provided document describes the intended use and compares the Somnus™ Electrode Bending Tool to predicate devices, stating that "performance validation testing has been done to validate the performance of the device." However, it does not provide details about the specific acceptance criteria, test methodologies, sample sizes, or quantitative results of these validation tests. The nature of the device (a mechanical accessory) means that many of the requested elements pertaining to AI or diagnostic studies are not applicable.

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