(46 days)
The VECTEC Disposable Monopolar Connection Cable is a sterile single-use device used to connect high frequency monopolar electrosurgical generators to various models of electrosurgical surgical instruments during laparoscopic and endoscopic surgery.
The VECTEC Disposable Monopolar Cable is a 2.5 m cable used during routine laparoscopy and endoscopy procedures as the means of conveying high frequency electrical energy from a standard electrosurgical generator to standard electrosurgical instruments during surgery. Examples of such instruments include the range of VECTEC monopolar Scissors, Forceps, Dissectors, and Hook. VECTEC Disposable Monopolar Cables are single-use, sterile devices that are packaged individually and have a 2 or 5-year shelf life providing that the packaging is not damaged. The VECTEC monopolar cable is convenient for use in the operating room while having the high degree of performance expected from a surgical monopolar cable.
The provided text describes the regulatory clearance for the "VECTEC Disposable Monopolar Connection Cable," which is a cable used in electrosurgery. The information requested in the prompt, such as detailed acceptance criteria with numerical performance targets, a specific study proving those targets are met, sample sizes for test and training sets, data provenance, number and qualifications of experts, and adjudication methods, are typically associated with performance evaluations of AI/ML-based medical devices or diagnostics.
The VECTEC Disposable Monopolar Connection Cable, however, is a physical accessory for electrosurgical equipment, not an AI/ML device or diagnostic tool that analyzes data or images. Its performance is assessed through compliance with established safety and electrical standards relevant to medical electrical equipment.
Therefore, much of the requested information does not directly apply to this type of device. I will extract the relevant information from the provided text as it pertains to the device's assessment and then address the non-applicable items.
Acceptance Criteria and Device Performance for VECTEC Disposable Monopolar Connection Cable
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Aspect | Standard/Requirement | Reported Device Performance |
|---|---|---|
| Electrical Safety and Performance | IEC 60601-2-2:2006 (Medical electrical equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment) | "The monopolar cable has been tested against all applicable requirements of IEC 60601-2-2:2006." (Implies successful compliance). This standard covers aspects like high-frequency current leakage, breakdown voltage, insulation, and general safety of electrosurgical equipment to ensure the cable safely and effectively conveys electrical energy. |
| Sterilization Assurance | ISO 11135-1:2007 (Sterilization of health care products – Ethylene oxide – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices) | "Sterilization is performed using ethylene oxide in accordance with ISO 11135-1:2007, with a SAL of 10-6." (Demonstrates compliance with validated sterilization process to achieve a sterility assurance level of 10^-6, meaning a one-in-a-million chance of a non-sterile unit). |
| Substantial Equivalence | Comparison to predicate device: Karl Storz Endoscopic High Frequency Monopolar Cord (K934985) | "Based on the technical testing and dimensional information and intended use information provided, the VECTEC Disposable Monopolar Cable has been shown to be substantially equivalent to the predicate device listed above." This implies that its safety and effectiveness are comparable to a legally marketed device. |
2. Sample Size Used for the Test Set and the Data Provenance
This information is not provided in the summary. For devices compliant with international standards like IEC and ISO, testing is typically performed on a representative sample to validate design and manufacturing processes. The document doesn't specify the exact number of units tested.
Data provenance (country of origin, retrospective/prospective) is not relevant in the context of device hardware testing against engineering standards. The testing would have been done in a laboratory setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This is not applicable as the "ground truth" concept, in the sense of expert consensus on clinical data (e.g., radiology images), is not relevant for the testing of a monopolar connection cable. Compliance with engineering standards (like IEC 60601-2-2 and ISO 11135-1) is verified through objective measurements and validated processes, not expert clinical interpretation.
4. Adjudication Method for the Test Set
This is not applicable for the reasons stated above. Adjudication methods (like 2+1, 3+1) are used in studies involving subjective interpretation of data, typically by human readers, which is not the case here.
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
This is not applicable. The device is a physical cable, not an AI or imaging diagnostic tool. An MRMC study is completely irrelevant for this product.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
This is not applicable. The device is a physical cable, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is objective compliance with the specified international standards (IEC 60601-2-2 and ISO 11135-1) and demonstrating substantial equivalence to a predicate device. This is established through:
- Objective measurements and tests against the requirements outlined in IEC 60601-2-2 for electrical safety and performance.
- Validation records for the sterilization process according to ISO 11135-1.
- Engineering analysis and comparison (technical specifications, intended use, materials) to show equivalence to the predicate device.
8. The Sample Size for the Training Set
This is not applicable. The concept of a "training set" refers to data used to train AI/ML models. This device is not an AI/ML product.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the reasons stated in point 8.
§ 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.