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The Oncobionic System with 6 probe output is indicated for use for surgical ablation of soft tissue.

The Oncobionic System with 6 probe output is identical in design specification to the Oncobionic System cleared under K060054. The only change to the Oncobionic System with 6 probe output is the addition of 4 output ports to allow for the connection of up to six electrodes to the Generator. This design addition has been added for convenience to the use. The user can connect multiple pairs of probes thus to removing the need to connect and disconnect pairs of electrodes when treating multiple treatment sites.

Here's an analysis of the provided text, focusing on the acceptance criteria and study information:

The provided documents do not contain information about acceptance criteria or a study proving the device meets those criteria in the context of clinical performance or diagnostic accuracy. This 510(k) submission is for a modification to an existing device, specifically adding more output ports for convenience. The primary "study" mentioned is a benchtop test to confirm the new configuration still meets the output specifications of the original device, not a performance study in a clinical setting.

Therefore, many of the requested categories cannot be filled as the information is not present in the provided text.

Acceptance Criteria and Device Performance

Study Details (Based on available information)

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

• Sample Size: Not specified in terms of units or cases. The study was a "Bench Top Test of Generator Output," implying measurement of the device itself rather than patient data.
• Data Provenance: Benchtop testing, not clinical data from a specific country or population.

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

• Not applicable. This was a technical benchtop test, not a clinical study requiring expert ground truth.

4. Adjudication method for the test set:

• Not applicable. No clinical test set or human interpretation was involved.

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:

• No MRMC or human-in-the-loop study was done. This device is an electrosurgical ablation system, not an AI-assisted diagnostic tool.

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

• Not applicable. This is not an algorithm-based device. The "standalone" performance here refers to the device's technical output, which was confirmed through bench testing.

7. The type of ground truth used:

• The "ground truth" for this technical assessment was the established output specifications of the predicate Oncobionic System (K060054).

8. The sample size for the training set:

• Not applicable. This is not a machine learning or AI device that requires a training set.

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

• Not applicable. No training set was used.

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