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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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The Oncobionic System is indicated for surgical ablation of soft tissue, including cardiac and smooth muscle.

The Oncobionic System comprises a low energy direct current (LEDC) Generator and two Electrodes. The Oncobionic System applies a LEDC pulse or series of pulses between two electrodes to ablate tissue.

Here's a breakdown of the acceptance criteria and the study that proves the Oncobionic System meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state quantitative "acceptance criteria" for performance metrics like lesion size, or specific safety thresholds. Instead, the primary acceptance criterion is establishing "substantial equivalence" to predicate devices in terms of safety and effectiveness.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The text does not provide specific numerical sample sizes for the "in-vivo animal tissue testing" or the comparative studies. It mentions "pig liver and cardiac tissue" but not the number of animals or tissue samples.
• Data Provenance: The studies were prospective animal studies conducted by Oncobionics. No country of origin is specified beyond the company's address in the USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not mention the use of experts to establish a "ground truth" for the test set in the traditional sense of medical image analysis or diagnostic performance. The ground truth for ablation effectiveness (e.g., lesion size, tissue damage) would likely have been determined directly through anatomical and histological examination of the ablated animal tissues by veterinarians, pathologists, or other relevant scientific personnel. However, the document does not specify the number or qualifications of these individuals.

4. Adjudication Method for the Test Set

Not applicable. The reported studies are focused on direct physical effects of ablation on tissue, not on subjective interpretations or diagnoses that would require adjudication among multiple readers or 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 is an ablation system, not an AI-powered diagnostic or decision-support tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant to this submission.

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

This question is not entirely applicable in the context of an ablation device. The device itself is "standalone" in that it performs the ablation based on operator-selected parameters. However, there isn't a "standalone algorithm performance" in the way one might evaluate an AI diagnostic tool. The performance evaluated was the direct effect of the device on tissue.

7. The Type of Ground Truth Used

The ground truth used in the studies described was likely:

• Physiological/Anatomical Data: Direct measurement and observation of the ablated tissue, including lesion size, in-vivo.
• Histopathological Data: Microscopic examination of tissue samples to confirm the extent and nature of tissue damage caused by ablation (though not explicitly stated, this is standard practice for such studies).

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML product developed with a training set. The "in-vitro testing to confirm the proof of concept" and "in-vivo animal tissue testing regarding the use of different voltages" served as developmental and optimization studies, but not a "training set" in the machine learning sense.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" in the context of this device. The "ground truth" for optimizing the device's parameters (like minimum voltage for target lesion size) would have been established through direct experimental observation and measurement in the in-vivo animal studies.

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