(79 days)
The pure Wrist™ electrocautery laparoscopic instruments have application in a variety of minimally invasive procedures to facilitate grasping, mobilization, dissection, and transection of tissue.
The pureWrist™ electrocautery laparoscopic instruments are sterile, single use disposable instruments for use through appropriately sized surgical trocars. The instruments consist of a rotating insulated shaft with a 5mm diameter. The distal end of the shaft has the respective end effector attached (scissors, dissector, or hook). The proximal end of the shaft is attached to an ergonomically shaped handle with a rotating knob that allows the shaft to rotate 360 degrees in either direction. The handle contains the actuation mechanism for the respective end effector. The lever on the handle is compressed and released to activate the instrument jaws or scissor blades. Each instrument has a monopolor cautery connector that extends from the bottom of the handle. The connector is used for electrosurgery when properly attached to a standard cautery cable and proper generator.
The Cambridge Endoscopic Devices, Inc. pureWrist™ electrocautery laparoscopic instruments underwent preclinical testing to demonstrate substantial equivalence to the predicate device, Ethicon Endo-Surgery, Inc. ENDOPATH® Endoscopic Instruments (K984240).
Here's an overview of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Ergonomics of the handle and rotating knob | Studies demonstrated acceptable reliability and design performance relative to the predicate device. |
| Tissue trauma | Studies demonstrated acceptable reliability and design performance relative to the predicate device. |
| Grasping and dissecting ability | Studies demonstrated acceptable reliability and design performance relative to the predicate device. |
| Electrical insulation requirements | Studies demonstrated acceptable reliability and design performance relative to the predicate device. |
| Overall safety and effectiveness for intended use (grasping, mobilization, dissection, and transection of tissue in minimally invasive procedures) | The preclinical testing supported that the device can be used as designed and achieved acceptable reliability and design performance, leading to a determination of substantial equivalence to the predicate device. |
2. Sample Size and Data Provenance
The document states "Pre-clinical testing was used to evaluate performance to ensure that the device can be used as designed." However, specific sample sizes for this testing are not provided in the given text.
The data provenance (country of origin, retrospective or prospective) is also not specified. Given it's preclinical testing for a medical device in the US, it's highly likely the testing was conducted in a controlled laboratory setting within the US and would be considered prospective in nature for a new device.
3. Number of Experts and Qualifications
The document does not specify the number of experts used to establish ground truth or their qualifications. The testing involved evaluating ergonomics, tissue trauma, grasping/dissecting ability, and electrical insulation, suggesting engineers, material scientists, and potentially clinicians (e.g., surgeons) would have been involved in assessing performance.
4. Adjudication Method
The document does not describe any adjudication method (e.g., 2+1, 3+1). Preclinical testing often relies on objective measurements and established standards, with consensus among the testing team, rather than a formal adjudication process as seen in clinical trials with human readers.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was done. This type of study is more common for diagnostic imaging devices where human interpretation is a key factor. For a surgical instrument like this, the focus is on its functional performance and safety.
6. Standalone Performance (Algorithm Only)
This point is not applicable as the device is a physical electrocautery laparoscopic instrument, not an AI algorithm. Its performance is always in conjunction with a human surgeon.
7. Type of Ground Truth Used
The ground truth used for this preclinical testing would have been based on:
- Engineering specifications and design requirements: Ensuring the device met its intended mechanical and electrical properties.
- Established industry standards: For electrical insulation, tissue interaction, and ergonomic design relevant to surgical instruments.
- Comparison to predicate device performance: The acceptability was determined "relative to the predicate device," implying the predicate's known performance characteristics (e.g., its ability to grasp, dissect, and cut tissue effectively and safely) served as a benchmark.
- Qualitative assessment by experts: For aspects like ergonomics and ease of use, direct assessment by engineers or clinical users would have contributed.
8. Sample Size for Training Set
This question is not applicable as the device is a physical instrument and does not involve AI or machine learning models that require training data.
9. How Ground Truth for Training Set was Established
This question is not applicable as there is no training set for a physical surgical instrument.
§ 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.