(90 days)
The Blue Value Line of Electrosurgical Electrodes is a line of non-sterile, reusable electrosurgical electrodes designed to be used in conjunction with an electrosurgical generator and handpiece where cutting, blended cutting, coagulation, desiccation, or fulguration procedures are to be performed.
Utilized for basic electrosurgical procedures such as cutting, Utilized for basic electrosurgicul problement of desiccation.
blended cutting, coagulation, fulguration, or desiccation.
The Blue Value Line of Electrosurgical Electrodes is a line of non-sterile, reusable electrosurgical electrodes designed to be used in conjunction with an electrosurgical generator and handpiece where cutting, blended cutting, coagulation, desiccation, or fulguration procedures are to be performed.
The provided document is a 510(k) summary for the "Blue Value Line of Electrosurgical Electrodes." This type of document is for medical device clearance, not for AI/ML-based medical devices, so many of the requested details about acceptance criteria, study design, and ground truth for AI models are not applicable.
However, I can extract the information that is present concerning the device's performance justification.
Acceptance Criteria and Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Compliance with ANSI/AAMI HF-18-1993, Sec. 5.2.5.4 requirements | The Blue Value Line of Electrosurgical Electrodes meets ANSI/AAMI HF-18-1993, Sec. 5.2.5.4 requirements. |
| Substantial Equivalence to Predicate Devices | The Blue Value Line of Electrosurgical Electrodes is substantially equivalent to listed predicate devices in design, operation, intended use, materials, method of preparation, and performance claims. |
Study Details (as relevant to a traditional medical device 510(k)):
- Sample size used for the test set and the data provenance: Not applicable. This is a traditional device clearance based on substantial equivalence and compliance with a standard, not a data-driven AI/ML study.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI/ML studies (e.g., expert consensus on medical images) is not relevant here. The "ground truth" for this device is its physical performance characteristics and adherence to a recognized standard.
- Adjudication method for the test set: Not applicable.
- 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 not an AI/ML device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: For compliance with the ANSI/AAMI standard, the "ground truth" would be the results of objective engineering and performance tests as defined by the standard. For substantial equivalence, the "ground truth" is the established performance and safety of the predicate devices.
- The sample size for the training set: Not applicable. This is not an AI/ML device, so there is no training set in the context of machine learning.
- How the ground truth for the training set was established: Not applicable.
Summary of the Device's Claimed Performance Basis:
The "Blue Value Line of Electrosurgical Electrodes" meets its acceptance criteria by demonstrating conformance to a specific industry standard (ANSI/AAMI HF-18-1993, Sec. 5.2.5.4) and by proving substantial equivalence to several previously cleared predicate electrosurgical electrodes. The supporting "study" is the testing performed to demonstrate compliance with this standard and the comparison of the device's characteristics to those of the predicate devices. This is a standard approach for 510(k) clearance of non-AI medical devices.
§ 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.