(116 days)
The AccENT Head and Neck Electrosurgery System is indicated for ablation and coagulation of soft tissue in otolaryngological (ENT) surgery including head, neck, oral, and sinus surgery.
The AccENT Head and Neck Electrosurgery System is comprised of three components: the AccENT Wand, the AccENT Cable, and an electrosurgical generator called the Controller. The Cable connects the Controller to the Wand. The Wand is provided in a variety of models, ranging in diameters from 1.5 mm to 4.5 mm. The Wand offset and distal tip angles range from 0 to 90 degrees. The AccENT wand shaft is configured as straight or offset to allow for better access to the treatment area. The distal tip is configured with multi-electrodes. The Wand is supplied sterile and intended for single patient use. The Cable is designed for repeat sterilization by either ethylene oxide gas or steam autoclaving methods, as selected by the user. The Controller is a high frequency electronic instrument. There is no software utilized in the operation of the Controller.
The AccENT Head and Neck Electrosurgery System is bipolar, incorporating a return electrode on the shaft of the device. This means that a return pad is not required for operation. The return energy in a bipolar device with an integral return electrode does not penetrate the tissue as in a monopolar device. In a monopolar device, the energy passes through the patient's body to reach the return pad.
The provided text is a 510(k) Premarket Notification for the ArthroCare AccENT Head and Neck Electrosurgery System. This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study with acceptance criteria and detailed performance metrics as would be typical for a novel device or software.
Therefore, many of the requested elements for describing an acceptance criteria study are not present in this document. The submission relies on demonstrating that the new device has "technological characteristics...the same as those of the ArthroCare Arthroscopic, Dental, and General Dermatology Systems." In other words, its acceptance is based on its similarity to already cleared devices, implying similar performance.
Here's an analysis based on the information available:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The submission focuses on substantial equivalence to predicate devices, implying that the performance is expected to be similar to already-cleared devices for ablation and coagulation. No specific performance metrics or acceptance criteria are listed.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. As this is a 510(k) submission based on substantial equivalence, there is no mention of a specific test set or clinical study conducted to establish performance in the way implied by this question.
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)
This information is not provided. No specific test set with ground truth established by experts is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided.
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
This information is not provided. This device is an electrosurgical system, not an AI-powered diagnostic device, so an MRMC study comparing human readers with and without AI assistance is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided. This device is an electrosurgical system, not an algorithm. Its operation involves direct use by a surgeon.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided. No specific ground truth establishment is described, as the submission focuses on substantial equivalence to existing devices.
8. The sample size for the training set
This information is not provided. There is no mention of a training set as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
This information is not provided.
Summary of Device Acceptance Criteria (Implied by Substantial Equivalence):
While no explicit acceptance criteria are stated for a study of the AccENT Head and Neck Electrosurgery System, the 510(k) submission process itself implies the following:
- Acceptance Criteria (Implied): The device must be "substantially equivalent" to legally marketed predicate devices in terms of intended use, technological characteristics (design, materials, principle of operation, product specifications), and safety and effectiveness.
- Study Proving Acceptance (Implied): The submission is the "study" proving acceptance. It demonstrates this by:
- Identifying Predicate Devices: Listing several predicate electrosurgical and surgical systems (ArthroCare Arthroscopic Electrosurgery System, Valleylab Force 2 Electrosurgical Generator, etc.).
- Detailing Device Description: Explaining the components (Wand, Cable, Controller), its bipolar nature, and how it operates.
- Stating Intended Use: Clearly defining its use for ablation and coagulation of soft tissue in otolaryngological surgery.
- Comparing Technological Characteristics: Explicitly stating that the "technological characteristics of the AccENT Head and Neck Electrosurgery System are the same as those of the ArthroCare Arthroscopic, Dental, and General Dermatology Systems. These devices are equivalent in terms of design, materials, principle of operation, product specifications and sterilization."
In essence, the "proof" for this 510(k) submission is the argument that the AccENT system is fundamentally the same as devices already on the market and has no new questions of safety or effectiveness.
§ 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.