(290 days)
The electrodes are accessories to the Ellman electrosurgical generators for cutting of tissue and coagulation by use of high frequency electrical current.
Ellman has been manufacturing and distributing electrodes for many years. The Ellman electrodes are used with an electrosurgical generator (such as Ellman Surgi Max K061174, Ellman Surgitron K052241). The electrical power operating at radio frequency (RF) is transferred to tissue at the surgical site. The time-varying voltage produced by the RF electrical power source yields a predetermined electrosurgical effect, such as tissue cutting or coagulation. The Ellman family of electrodes are available in various shapes and sizes depending on the need of the surgeon. The Ace-Tip electrodes are composed of the new noble alloy. Several of the classical Ellman electrodes are now available in the new noble alloy including: Loop Electrode 3mm and 5mm, Micro Incision Needle Electrode, Ball Electrode 2mm, Tapered Ball Electrode 3mm, Fine Wire Electrode, VariTip Electrode.
The provided 510(k) document (K071343) for Ellman Ace-Tip Electrodes describes a device intended for electrosurgical cutting and coagulation. However, it does not include detailed acceptance criteria or a specific study proving the device meets performance criteria in the way typically expected for complex AI/ML medical devices.
Instead, the submission relies on demonstrating substantial equivalence to a predicate device (Ellman Electrodes Preamendment) based on technological characteristics and material properties. The provided text details the device, its intended use, and a general statement about its performance, but lacks the specific, quantifiable performance metrics, study designs, and statistical analyses requested in your prompt.
Here's a breakdown of why the requested information cannot be fully extracted and what is available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as quantifiable metrics. The document focuses on demonstrating substantial equivalence to a predicate device, rather than meeting specific performance thresholds. | "The subject device is composed of biocompatible materials, has passed dielectric testing, and performs similarly to the predicate device." |
| Implicitly: Biocompatibility | Passed (as stated) |
| Implicitly: Electrical safety/integrity | Passed dielectric testing (as stated) |
| Implicitly: Functionality for tissue cutting and coagulation | "performs similarly to the predicate device" |
Reasoning for "Not explicitly stated": The document claims "The device is substantially equivalent to the predicate device based on a comparison on physical and performance characteristics." This type of 510(k) relies on the similarity to a device already on the market, rather than a de novo demonstration of performance against predefined criteria.
2. Sample size used for the test set and the data provenance
- Sample size: Not applicable or not provided. There is no mention of a clinical or in vitro performance test set with a defined sample size for evaluating the device's cutting or coagulation performance against a specific ground truth.
- Data provenance: Not applicable or not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable or not provided. There is no mention of a test set requiring expert-established ground truth.
4. Adjudication method for the test set
- Not applicable or not provided. As there's no described test set, no adjudication method is mentioned.
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
- No. This device is an electrosurgical electrode, not an AI/ML diagnostic or assistive device for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a physical electrosurgical electrode, not an algorithm.
7. The type of ground truth used
- The concept of "ground truth" as it applies to AI/ML or diagnostic devices is not relevant here. The "proof" of performance for these electrodes is based on their physical and electrical specifications, biocompatibility, and functionality being similar to existing (predicate) electrodes. The ground truth for such a device would likely be its ability to safely and effectively cut and coagulate tissue, which is implicitly accepted by its substantial equivalence to a pre-amendment device.
8. The sample size for the training set
- Not applicable. This is a physical medical device, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable.
Summary of the Study (as described in the 510(k)):
The "study" or justification for equivalence presented in this 510(k) is a comparison to a predicate device (Ellman Electrodes Preamendment). The core argument is based on:
- Technological Characteristics: The Ace-Tip electrodes are described as using a "new noble alloy" and are available in various shapes and sizes, similar to existing Ellman electrodes.
- Performance Data: The document states, "The subject device is composed of biocompatible materials, has passed dielectric testing, and performs similarly to the predicate device." This implies that material safety (biocompatibility) and electrical integrity/functionality have been verified to be acceptable and comparable to the predicate.
- Conclusion: The changes in the new electrodes are considered "minor," and the devices are concluded to be "as safe and effective as the predicate device."
In essence, this 510(k) relies on the principle of substantial equivalence, where detailed de novo performance studies with specific statistical metrics are not required or provided, because the device is deemed sufficiently similar to a device already on the market.
§ 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.