(193 days)
The DYONICS Electroblade Resector is indicated in arthroscopic surgical procedures of large and small articular cavities for resection and excision of soft and osseous tissues. The DYONICS EletroBlade Resector is effective in tissue resection and hemostasis of bleeding vessels. It is intended for arthroscopic procedures using saline solution, Ringer's lactate or other conductive solutions as an irrigant under direct or video-assisted fiber-optic visualization.
The DYONICS ElectroBlade Resector combines the rotary cutting technology of Dyonics Arthroscopic Surgery Blades with the electrosurgical capabilities of a bipolar electrosurgery probe. The inner rotational blade is electrified by connection to a standard generator. Insulation on the outer blade isolates the electrical energy to the inner tube where it is exposed to tissue at the cutting window of the blade. The DYONICS ElectroBlade Resector operates in conjunction with the standard Dyonics shaver system and standard electrosurgical generator systems.
This 510(k) summary is for the DYONICS ElectroBlade Resector, a device combining rotary cutting technology with electrosurgical capabilities. The submission establishes substantial equivalence to the DYONICS ElectroBlade (K994365).
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not contain a table of acceptance criteria or specific quantitative performance metrics for the DYONICS ElectroBlade Resector. The submission focuses on demonstrating substantial equivalence to a predicate device (DYONICS ElectroBlade) based on intended use, materials, and method of operation rather than presenting a detailed performance study with predefined acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not mention any specific test set, sample size, or data provenance because the submission appears to be a substantial equivalence claim based on comparison to an existing predicate device rather than a de novo marketing application requiring extensive clinical performance data with a separate test set.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
As there is no mention of a specific test set or a study requiring ground truth establishment, there is no information on the number or qualifications of experts.
4. Adjudication Method for the Test Set
Again, with no description of a test set, there is no mention of an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The provided text does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed. The submission is a 510(k) seeking substantial equivalence, not typically requiring such a study to demonstrate improvement with AI assistance (which is not relevant here as the device is not an AI diagnostic).
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This is not applicable as the DYONICS ElectroBlade Resector is a surgical tool, not an AI algorithm. Therefore, "standalone" algorithm performance is not a concept pertinent to this device.
7. Type of Ground Truth Used
As there is no mention of a clinical study generating specific performance data that required ground truth, this information is not available. The determination of substantial equivalence relies on comparison of design, materials, and intended use, not on a detailed clinical performance study with established ground truth.
8. Sample Size for the Training Set
This is not applicable. The DYONICS ElectroBlade Resector is a physical surgical device, not a machine learning model, so there is no concept of a "training set" for an algorithm.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as the device is not an AI algorithm and therefore does not have a training set or associated ground truth.
§ 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.