(50 days)
The Oncobionic System is indicated for surgical ablation of soft tissue
The Oncobionic System includes additional treatment parameters. These additional treatment parameters allow for the application of the Oncobionic System to target and ablate additional volumes of soft tissue. The Oncobionic System with additional treatment parameters applies a I .EDC pulse or series of pulses between two clectrodes to cause an ablation clicel to occur. The fundamental application and design of the device has not changed, but new treatment parameters have been tested and added to the device to cause additional volumes of soft tissue ablation
The provided 510(k) summary for the Oncobionic System (K080376) primarily focuses on demonstrating substantial equivalence to predicate devices through in-vivo testing related to tissue ablation efficacy and safety.
Here's an analysis of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| At least as safe as predicate devices (K060054, K070101) | In-vivo test data (Attachment 1) shows the Oncobionic System to be at least as safe as the predicate devices. |
| At least as effective as predicate devices (K060054, K070101) in creating tissue ablation volumes | In-vivo test data (Attachment 1) shows the Oncobionic System to be at least as effective as the predicate devices. Specifically, it creates equivalent tissue ablation to the Rita Medical UniBlate Device (K070101). |
| Functional requirements of controlling software met | "The testing demonstrated that the functional requirements were met, and system specifications over a fulfilled." |
| System specifications of controlling software fulfilled | "The testing demonstrated that the functional requirements were met, and system specifications over a fulfilled." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the sample size used for the in-vivo test set. It only mentions "in-vivo test data, Attachment 1."
- Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It only mentions "in-vivo test data."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The study described is an in-vivo test, likely involving direct measurement of ablation zones or assessment of safety parameters, rather than expert interpretation of images or other data requiring a "ground truth" established by human experts in the way an AI diagnostic device might.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided, as the study described is an in-vivo performance test rather than an expert-adjudicated study.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a tissue ablation system, not an AI-assisted diagnostic tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable in the context of this device. The Oncobionic System is a physical device used for surgical ablation, not an algorithm, and thus standalone performance in this sense is not relevant. The software validation mentioned refers to the controlling software for the device's functional operation, not a diagnostic algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the in-vivo performance study would be direct physiological measurements or observations of the effects of tissue ablation within the test subjects. This could include:
- Physical dimensions (volume, diameter, depth) of the ablated tissue.
- Histopathological assessment of the ablated and surrounding tissue to confirm the extent of ablation and any non-target tissue damage (safety).
- Physiological parameters confirming the "safety" aspect mentioned.
8. The Sample Size for the Training Set
This information is not applicable and therefore not provided, as the Oncobionic System and its evaluation as described do not involve machine learning or a "training set" in the typical sense. The software validation refers to functional testing of the controlling software, not training of an AI model.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated in point 8.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.