(116 days)
The Solero Microwave Tissue Ablation (MTA) System is indicated for the ablation of soft tissue during open procedures. The Solero MTA System is not indicated for cardiac use.
The Solero Microwave Tissue Ablation (MTA) System and Accessories are indicated for the ablation of soft tissue during open procedures. The Solero MTA System is not intended for cardiac use.
This document is an FDA 510(k) summary for the AngioDynamics Solero Microwave Tissue Ablation (MTA) System and Accessories. It details the device, its intended use, comparison to a predicate device, and the testing performed to demonstrate substantial equivalence.
The document does not describe a study related to an AI/ML device, nor does it provide acceptance criteria and performance metrics for such a device. The changes described are software updates to reduce a specific error ("Error 0001") related to NAND flash memory errors, not the introduction of new AI/ML functionality.
Therefore, I cannot provide the information requested in the prompt, as the provided text does not contain any details about:
- A table of acceptance criteria and the reported device performance for an AI/ML device.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method.
- MRMC comparative effectiveness study or human reader improvement.
- Standalone (algorithm only) performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document primarily focuses on demonstrating substantial equivalence to a predicate device based on:
- Identical design, materials, manufacturing, specifications, dimensions, and indication for use.
- Software updates not introducing new risks or affecting biocompatibility, electrical safety, or sterilization.
- Software verification and validation testing to ensure the changes did not create unintended issues.
The performance data section (L) explicitly states: "Software correction verification and validation testing was conducted based on the impact of the software changes. Results from the following tests ensure that the changes did not create any unintended issues in the operation of the system overall: Unit Verification Testing, BSP Verification Testing, Integration Testing, System Integration Testing, Validation Testing, Language Validation and Regression Testing. All testing completed successfully. Additionally, software testing was conducted in compliance with IEC 62304:2006+A1:2015 Medical Device Software – Software Life-cycle Processes."
This is standard software testing for a medical device firmware update, not an AI/ML performance study.
§ 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.