(92 days)
The Surgery System is indicated for cutting and coagulation of soft tissue during General, Plastic and Reconstructive (including but not limited to skin incisions and development of skin flaps), ENT, Gynecologic, Orthopaedic, Arthroscopic, Spinal and Neurological procedures.
The PlasmaBlade™ X 3.0S LIGHT is a single-use, monopolar RF device. It is designed to be used with the qualified Generator as part of the Surgery System. It can be operated with the integrated hand switch or a qualified Footswitch. The PlasmaBlade™ X 3.0S LIGHT consists of a single bendable blade and telescoping shaft that can be configured in both standard and extended length. The finger grip also incorporates a suction lumen for the evacuation of smoke and fluids. The device also has integrated LED-based illumination.
The provided document is a 510(k) premarket notification for a medical device called the PlasmaBlade X 3.0S LIGHT. This document outlines the regulatory approval process and includes summaries of non-clinical testing conducted to demonstrate substantial equivalence to previously cleared predicate devices.
It is important to note that this document describes a conventional electrosurgical device, NOT an AI/Algorithmic Decision Support (ADS) device. Therefore, the specific questions regarding acceptance criteria and studies that prove an AI device meets those criteria (e.g., sample size, expert consensus for ground truth, MRMC studies, standalone performance, training set details) are not applicable to the content provided.
The document demonstrates a different type of substantial equivalence claim, which is based on demonstrating that the new device has the same intended use, technological characteristics, and performs as safely and effectively as a legally marketed predicate device, with any differences not raising new questions of safety or effectiveness.
However, I can extract the closest analogous information from the provided text to answer the spirit of your request as it pertains to this type of medical device submission.
Here's an interpretation of the requested information based on the provided 510(k) summary for the PlasmaBlade X 3.0S LIGHT:
Acceptance Criteria and Device Performance (Analogous to a non-AI device submission):
For this conventional medical device, "acceptance criteria" are not defined as statistical metrics for an AI algorithm's performance (e.g., sensitivity, specificity, AUC). Instead, they relate to demonstrating that the new device's performance characteristics are equivalent to its predicate devices and meet established safety and performance standards for electrosurgical devices. The "study that proves the device meets the acceptance criteria" refers to the non-clinical (bench and animal) testing conducted.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category (Analogous to performance metrics) | Reported Device Performance (Summary from submission) |
|---|---|
| Functional Equivalence to Predicates | - The PlasmaBlade X 3.0S LIGHT shares the same operational characteristics as the predicate platforms (RF-based cutting and coagulation). |
- Bench testing was completed to ensure the new blade geometry did not affect the performance of the blade compared to predicates.
- Updated blade coating incorporates material from a previous generation predicate (K093695).
- All design features (including new ones like geometry and coating) were met, demonstrating performance equivalent to predicates. |
| Power Output | - Max power: 50W +/- 20% (Cut 8, Cut 10 and Coag 10) - Min power: ~0.5W +/- 1W (Cut 1)
- Acceptance: "Same" as predicate devices. |
| Biocompatibility | - External communicating device
§ 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.