(9 days)
The System 7500® -B is used for the destruction of human tissue in surgical procedures to provide a therapeutic benefit. The ABCFlex™ Probe is intended for use with the System 7500® -B for non-contact superficial ablation and hemostasis through a flexible endoscope to the operative site.
The System 7500 -B is an electrosurgical generator with Argon Beam Coagulation (ABC) capability. The basic modes of operation are conventional electrosurgical cutting, coagulation plus argon beam coagulation. When cutting, the edge of the electrode is drawn across the tissue while electrosurgical energy is being applied. When coagulating, the accessory electrode or argon beam may be held in contact with the tissue for desiccation or separated from the tissue by distance for fulguration to achieve the desired result. The ABCFlex™ Probe has applications in endoscopic surgical procedures such as upper and lower gastroenterology and bronchoscopy to provide a means of coagulation using electrosurgical current and argon gas. The device consists of a connector for delivering argon gas to the operative site as well as an internal cable to carry high frequency (HF) electrosurgical current to a tungsten electrode tip at the end of the tubing. A ceramic tip insulates the thermal plastic tubing from the heat generated during coagulation. The electrode is positioned in the ceramic tip such that it cannot contact the patient's tissue during the coagulation procedure. Current and gas flow is controlled by the surgeon activating and deactivating a switching element part of the System 7500 -B ESU.
The provided document is a 510(k) premarket notification for the CONMED System 7500-B ESU and ABCFlex™ Probe. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria as you might see for novel devices.
Therefore, the document does not contain the detailed information requested regarding acceptance criteria studies, such as:
- A table of acceptance criteria and reported device performance (in the sense of a clinical outcome study).
- Sample sizes used for test sets, data provenance, ground truth establishment, or expert qualifications.
- Adjudication methods.
- MRMC comparative effectiveness studies.
- Standalone algorithm performance.
- Training set details.
Instead, the submission relies on demonstrating technological characteristics equivalency and compliance with recognized standards to establish substantial equivalence.
Here's what can be extracted based on the document:
1. A table of acceptance criteria and the reported device performance
The document does not present acceptance criteria in the form of performance metrics from a clinical study or a table demonstrating specific clinical outcomes. Instead, the "acceptance criteria" for this 510(k) submission are implicitly met by:
- Compliance with recognized voluntary standards:
- ANSI/AAMI American National Standard for Electrosurgical Devices HF-18
- International Electrotechnical Commission Standard for Electrosurgical Devices (IEC 60601-1, 60601-1-1, 60601-1-2, 60601-1-4, 60601-2-2)
- ISO 11135 (for sterilization)
- ISO 10993 (for biocompatibility)
- Demonstration of substantial equivalence to a predicate device:
The reported device performance is implicitly that the device functions according to its intended use (destruction of human tissue, non-contact superficial ablation, and hemostasis) and meets the safety and performance requirements outlined in the above standards, making it substantially equivalent to the cleared predicate devices.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This was a 510(k) submission demonstrating substantial equivalence through technological characteristics and compliance with standards, not typically clinical performance studies with "test sets" in the context of AI/diagnostic devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Ground truth establishment for test sets is not detailed as this submission doesn't describe clinical performance studies with human interpretation of 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 device is an electrosurgical unit, not an AI-powered diagnostic or assistive technology.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For this type of device, "ground truth" would relate to engineering specifications, electrical performance, biocompatibility, and sterilization effectiveness as verified against the recognized standards, rather than clinical outcomes or diagnostic accuracy.
8. The sample size for the training set
Not applicable. This device is not an AI/ML algorithm that requires 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.