(21 days)
The Numeris™ Guided Coagulation System with VisiTrax® is intended for the coagulation of cardiac tissue using Radiofrequency (RF) energy using thoracoscopic, endoscopic, and laparoscopic surgical techniques.
The modified nContact Coagulation System (Numeris Guided Coaquiation System with VisiTrax) consists of a sterile, single-use, disposable coagulation electrode device (1cm, 2cm, & 5cm sizes provided) intended to be used to coagulate cardiac tissue. The flexible, cooled electrode device, with a suction stabilizer feature, transmits radiofrequency (RF) energy from an Electrosurgical Generator (non-sterile, re-useable) connected through an Instrument Cable (sterile). The functionality of this System is the same as the cleared predicate guided system, however two additional RF coil electrode lengths have been added to the product offering (1cm and 3cm).
The provided documents describe a Special 510(k) submission for the Numeris™ Guided Coagulation System with VisiTrax®, which introduces modifications to a previously cleared device. This type of submission focuses on demonstrating substantial equivalence to a predicate device, primarily through bench testing to assure that the modifications do not significantly affect safety or efficacy.
Therefore, the study supporting this submission is a performance bench test study, rather than a clinical trial with acceptance criteria for a specific device performance metric in human subjects.
Here's a breakdown of the requested information based on the provided text, with explanations where information is not explicitly stated:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text states: "Performance bench tests were executed to ensure that the Numeris Guided Coagulation System with VisiTrax performed as intended and met design specifications."
However, the specific acceptance criteria (e.g., maximum temperature, impedance range, coagulation depth) and the detailed reported device performance against these criteria are not provided in this summary. Instead, it makes a general statement that the device "met design specifications."
| Acceptance Criteria (Example - Not explicitly stated in document) | Reported Device Performance (Summary statement) |
|---|---|
| (Specific design specifications, e.g., RF energy delivery accuracy, temperature profile, coagulation zone dimensions, electrical safety parameters) | "Performed as intended and met design specifications." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "Performance bench tests," implying a series of tests performed on the modified devices. These tests would involve a certain number of units or test conditions, but the exact sample size is not detailed.
- Data Provenance: Not explicitly stated, but assumed to be internal laboratory testing conducted by the manufacturer, nContact Surgical, Inc., in the USA. The study is retrospective in the sense that it's performed on manufactured devices to verify design specifications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable/not stated. Bench tests generally rely on established engineering standards and design specifications, not expert interpretation of results in the way clinical studies do. The "ground truth" is defined by the device's design specifications and performance standards.
- Qualifications of Experts: Not applicable for establishing ground truth in this context. The testing would be performed by qualified engineers or technicians.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. Bench testing for substantial equivalence evaluates physical and electrical performance against predefined specifications, which does not typically involve adjudication by experts in the same way clinical image interpretation or diagnosis would.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was it done? No. This submission is for a medical device which transmits RF energy, not an AI-assisted diagnostic tool. An MRMC study is relevant for evaluating the impact of an AI algorithm on human reader performance, which is not the nature of this device.
- Effect size: Not applicable.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
- Was it done? Not applicable in the context of an AI algorithm. This device is an electrosurgical device; its performance is inherent to its physical and electrical characteristics, rather than an algorithm performing a task. The "standalone performance" is the device's ability to coagulate tissue as designed, which was assessed via bench testing.
7. Type of Ground Truth Used
- Type of Ground Truth: Design specifications and engineering standards. The "ground truth" for these performance bench tests would be the established acceptable ranges and values for various physical and electrical parameters as defined by the device's design and applicable medical device standards.
8. Sample Size for the Training Set
- Sample Size: Not applicable. This is not an AI/machine learning device, so there is no "training set." The device is built and tested against design specifications.
9. How the Ground Truth for the Training Set Was Established
- How Established: Not applicable, as there is no training set for this type of 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.