(42 days)
The Reusable Monopolar Active Cord is intended to deliver monopolar electrical current from the electrosurgical unit to electrosurgical devices or accessories requiring monopolar electrical current during endoscopic procedures.
The Reusable Monopolar Active Cord is used during endoscopic procedures to provide monopolar energy from an Electrosurgical Generator Unit (ESU) to an Active Endoscopic accessory. The Reusable Monopolar Active Cord consists of a male ESU end and a female device end connected via an insulated cable. The male ESU end uses a bovie style connector to connect to an ESU. The female device side connects to the active connector of an Active Endoscopic accessory.
The provided text describes the acceptance criteria and performance testing for a medical device called the "Reusable Monopolar Active Cord." However, it does not describe a study that uses a test set, ground truth established by experts, or any of the elements typically found in studies for AI/Machine Learning devices (like MRMC studies, standalone performance, training set details, etc.).
This document is a 510(k) Premarket Notification for a traditional medical device, specifically an accessory (an active cord) for electrosurgical units. The "studies" described are standard engineering verification and validation tests to ensure the device meets its design specifications and functions as intended, not clinical trials or AI performance evaluations.
Therefore, for most of the requested points, the information is not present in the provided text.
Here's an attempt to answer based only on the provided text, indicating where information is not available:
1. Table of Acceptance Criteria and Reported Device Performance:
| Testing | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Structural Integrity Testing | All Reusable Monopolar Active Cord structural components must, minimally, meet or exceed the structural integrity limits by the predicate active cord | PASS |
| Dimensional | All Reusable Monopolar Active Cord dimensional components must meet the dimensional specification for each active cord | PASS |
| Functional Testing | The Reusable Monopolar Active Cord must function as intended. | PASS |
| Simulation Testing | The Reusable Monopolar Active Cord must provide monopolar energy to hot devices. | PASS |
| Electrical Testing | All Reusable Monopolar Active Cord electrical requirements must meet current industry standards according to IEC 60601-2-2:2017 and IEC 60601-1:2005 | PASS |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document refers to "verification activity" and "performance testing" but does not detail sample sizes for each test type. These are physical product tests, not data-based studies.
- Data Provenance: Not applicable in the context of data for an AI/ML model. The tests are performed on physical units of the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is a traditional device; "ground truth" in the context of AI/ML is not relevant here. The "truth" is whether the device meets engineering specifications and functions correctly.
4. Adjudication method for the test set:
- Not applicable. There is no expert adjudication process described, as it's not an AI/ML model being assessed.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. An MRMC study is not mentioned as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used:
- Not applicable in the AI/ML sense. The "ground truth" for the device's performance is its adherence to predefined engineering specifications, industry standards (IEC 60601-x), and functional intent.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device and does not have a "training set."
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML device and does not have a "training set."
§ 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.