(15 days)
The Arthrex electrosurgical cutting and coagulation devices and accessories are monopolar in structure, allowing for use in a range of surgical procedures. The Arthrex electrosurgical ablation devices and accessories are intended for use in resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels and tissue in general, arthroscopic, and orthopedic procedures. Specifically, these devices and their accessories will be used for general surgeries, and open and arthroscopic surgery of the shoulder, wrist, hand, elbow, hip, knee, and ankle.
The Arthrex electrosurgical cutting and coagulation devices and accessories are monopolar in structure, allowing for a range of surgical repairs. The electrodes are sold sterile, single use in a pouch/pouch configuration.
This 510(k) premarket notification for the Arthrex OPES Electrodes and Accessories is a submission for a Class II electrosurgical cutting and coagulation device. The submission declares substantial equivalence to predicate devices.
Substantial equivalence claims are based on demonstrating that the new device has the same intended use and technical characteristics as a predicate device, or if it has different technological characteristics, that it can be demonstrated to be as safe and effective as the predicate device.
Crucially, this type of submission (510(k) for substantial equivalence) typically does not include new clinical study data or performance metrics against specific acceptance criteria in the way a PMA (Premarket Approval) application would for novel devices. Instead, it relies on demonstrating that the device is similar enough to already marketed devices that new studies are not required to prove safety and effectiveness.
Therefore, many of the requested elements for a study proving device acceptance criteria will not be present in this document.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
This document describes a substantial equivalence claim for a Class II medical device (electrosurgical cutting and coagulation device). There is no table of acceptance criteria and reported device performance within this 510(k) summary. Substantial equivalence claims are primarily based on comparing the new device's design, materials, intended use, and performance to a legally marketed predicate device, rather than establishing and meeting novel acceptance criteria through a new clinical study. The assertion given is: "The difference between the Arthrex product line and the predicate devices with similar indications do not raise any questions regarding the safety and effectiveness. Furthermore, the device and accessories are well characterized and have been used in surgical applications with similar indications. The devices, as designed, are as safe and effective as predicate devices."
Regarding a study that proves the device meets the acceptance criteria:
Based on the information provided, no new clinical or comparative effectiveness study is presented in this 510(k) summary to establish or prove performance against specific acceptance criteria. The basis for clearance is substantial equivalence to predicate devices. This means that Arthrex asserted that their device is as safe and effective as a device already on the market without needing to conduct a new comprehensive study with novel acceptance criteria.
Therefore, the following points associated with a new clinical study are not applicable or cannot be extracted from this 510(k) summary:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. No specific new test set or associated data provenance is described in this substantial equivalence submission.
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. No new test set or ground truth establishment by experts is detailed for this substantial equivalence submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No new test set or adjudication method is described.
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 tool, not an AI-assisted diagnostic or imaging device, and there is no mention of an MRMC or AI component.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is an electrosurgical tool, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. No new ground truth data is presented for a novel study. The "ground truth" for substantial equivalence is the safety and effectiveness profile of the predicate device(s).
8. The sample size for the training set
- Not applicable. This device is not an AI/machine learning device that would require a training set.
9. How the ground truth for the training set was established
- Not applicable. (See point 8)
§ 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.