(26 days)
The RITA® StarBurst SDE Electrosurgical Device is designed to supply energy (generated by the RITA Medical Systems' electrosurgical generator) for use in electrosurgery and is indicated for use in percutaneous, laparoscopic, or intraoperative coagulation and ablation of soft tissue including:
The partial or complete ablation on non-resectable liver lesions and
The palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standard therapy.
The RITA StarBurst SDE device is 12-cm in length and can be used for a variety of medical applications. Each secondary electrode deploys out from the side of the trocar through a hole in the wall of the trocar (primary electrode). The RITA device consists of the following components: primary electrode: tubing with a portion exposed as an electrode secondary electrodes: tubing at the distal end of probe trocar insulation: shrink tubing handle: with markings to indicate the amount of secondary electrode deployment from the trocar RF pathway: connection through nine-pin Lemo connector built into the handle fluid infusion: delivery through Luer port at side of the handle temperature sensors: three temperature sensors in the distal section of the secondary electrodes depth indicators: incremental 1 cm marks denote needle penetration depth
The provided text is a 510(k) Summary for the RITA® StarBurst SDE Electrosurgical Device. This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. It typically focuses on demonstrating equivalence through device description, intended use, and performance data that shows the device meets its own specifications, rather than clinical studies rigorously proving efficacy against specific acceptance criteria for AI/ML devices.
Therefore, much of the requested information regarding AI/ML device study parameters (sample size for test set, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) is not applicable or not available in this document.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated Goal) | Reported Device Performance |
|---|---|
| Electrical, mechanical, and functional specifications (exact specifications not detailed in the summary) | "The StarBurst SDE devices were subjected to a battery of electrical, mechanical, and functional testing to verify that the devices met the specifications. The devices met the specifications." |
2. Sample size used for the test set and the data provenance:
- Not applicable / Not available. This document describes a physical electrosurgical device, not an AI/ML diagnostic or predictive system that uses a "test set" of data in the common AI/ML sense. The "testing" referred to is likely engineering and bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not available. Ground truth as understood in AI/ML (e.g., expert consensus on images) is not relevant to the testing described for this electrosurgical device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable / Not available. Adjudication methods are not relevant to the type of device testing described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and what was the effect size of how much human readers improve with AI vs. without AI assistance:
- No. This is an electrosurgical device, not an AI-assisted diagnostic or treatment planning tool that would involve human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is an electrosurgical tool and not an AI algorithm. Its performance is inherent to its design and function when operated by a human, not a standalone algorithmic output.
7. The type of ground truth used:
- For the "performance data" section, the "ground truth" would be the engineering and design specifications for the device. The testing verified that the device's electrical, mechanical, and functional properties conformed to these pre-defined specifications.
8. The sample size for the training set:
- Not applicable / Not available. This device does not involve a "training set" in the context of machine learning.
9. How the ground truth for the training set was established:
- Not applicable / Not available. (See point 8).
Summary of the Study:
The "study" referenced in the document is a pre-market regulatory submission (510(k)) for a physical electrosurgical device. The performance data consists of:
- "A battery of electrical, mechanical, and functional testing" conducted on the StarBurst SDE devices.
- The objective of this testing was to "verify that the devices met the specifications."
- The outcome was that "The devices met the specifications."
This is fundamentally different from the type of studies typically conducted for AI/ML-based medical devices, which focus on diagnostic accuracy, sensitivity, specificity, and comparative effectiveness against human performance using patient data. For this electrosurgical device, the "acceptance criteria" were the internal design and performance specifications, and the "study" was the in-house engineering and bench testing to demonstrate compliance with those specifications.
§ 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.