(232 days)
The Cobra® Cardiac Surgical Probe (Probe) is intended for the coagulation of cardiac tissue using radiofrequency (RF) energy during cardiac surgery. The Probe can be used during general surgery to coagulate soft tissues. The Probe may also be used to coagulate blood and soft tissue to produce hemostasis.
The Boston Scientific Electrosurgical System is comprised of three components: the Surgical Probe, Electrosurgical Unit (ESU) and Instrument Cable. The Electrosurgical Unit measures temperatures from the thermocouples and uses the temperature measurements to regulate radiofrequency power delivery to the electrodes. The ESU is a software-controlled monopolar high frequency electronic instrument, provided with controls for set temperature, power limit, and number of active electrodes. The ESU has readouts for temperature, time of energy delivery, and delivered power. The ESU operates in a temperature controlled, power limited manner, based on operator settings and temperature feedback provided by thermocouples in the Surgical Probe. Front panel connectors include connections for the Instrument Cable, ESU Remote Cable, and DIP electrodes.
The Surgical Probe is provided in a variety of models, ranging from 2 electrodes to 7 electrodes, with either a malleable or flexible shaft that can be bent to the desired shape, providing improved tissue contact and maneuverability in hard-to-reach areas. The Instrument Cable connects the ESU to the Surgical Probe. Accessories included with the ESU include ESU Remote Cable, Footswitch, Instrument Cable, and mains power cord.
The provided text is a 510(k) summary for the Cobra® Cardiac Surgical Probe, a medical device for tissue coagulation. The document states that "This submission includes only an expanded indication for use, therefore there are no new issues of safety or efficacy, and the previously documented performance reports are still valid and applicable to the system. Specifically, previous non-clinical tests conducted for the Device showed the device met its design-input criteria, and support substantial equivalence. Additional testing showed the device to perform predictably (based on delivery temperature and time) when compared to an equivalent device in an animal model."
Based on this statement, the study detailed in this document did not involve establishing new acceptance criteria or conducting a new study to prove device performance against them. Instead, it relies on previously documented performance and non-clinical tests. Therefore, many of the requested fields cannot be directly extracted from the provided text for this specific submission.
However, here's what can be inferred or stated based on the text:
1. Table of Acceptance Criteria and Reported Device Performance:
Since this submission is for an expanded indication and relies on previous testing, no specific acceptance criteria or reported performance unique to this submission are provided in the text. The document refers to "design-input criteria" being met by previous non-clinical tests, but the specific criteria are not detailed.
| Acceptance Criteria (from previous tests) | Reported Device Performance (from previous tests) |
|---|---|
| Design-input criteria (specifics not provided in this document) | Device met its design-input criteria. |
| Predictable performance based on delivery temperature and time (when compared to an equivalent device in an animal model) | Performed predictably (based on delivery temperature and time) when compared to an equivalent device in an animal model. |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified for this submission, as it relies on "previously documented performance reports" and "previous non-clinical tests." The "animal model" mentioned does not have a specified sample size.
- Data Provenance: The previous non-clinical tests may have been conducted internally by Boston Scientific Corporation/EP Technologies, Inc. The animal model study would also be considered internal or contracted. There is no mention of country of origin of the data or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable to this submission as it references non-clinical testing and an animal model, not expert-based ground truth for human subject data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable.
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 a surgical probe, not an AI diagnostic device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical surgical probe, not an algorithm.
7. The type of ground truth used:
For the previous non-clinical tests:
- "Design-input criteria" would likely be based on engineering specifications and possibly internal biological or physiological benchmarks.
- The "animal model" would have its own objective outcomes (e.g., tissue coagulation depth, temperature profiles, histological assessment).
8. The sample size for the training set:
Not applicable, as this is a physical device being cleared based on substantial equivalence and previous non-clinical testing, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established:
Not applicable.
§ 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.