(319 days)
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.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Safety and Effectiveness (overall) | "The Oncobionic System is at least as safe and effective as the predicate devices." |
| Ablation of pig liver tissue | "as safe and effective as the Guidant Device in ablating soft tissue" |
| Ablation of pig cardiac tissue | "as safe and effective as the Guidant Device in ablating cardiac tissue" |
| Achieve target lesion size (minimum voltage) | In-vivo animal tissue testing performed "to determine the minimum voltage needed to achieve the target lesion size." |
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.
§ 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.