(224 days)
This device is used to vaporize and coagulate soft prostatic tissue during the treatment of Benign Prostatic Hyperplasia and for use with a compatible resectoscope.
The Plasmatrode™ Saline Safe TUR Electrode (also known as the Plasmatrode™) is a monopolar electrode used to deliver radio frequency energy supplied by a general purpose electrosurgical generator for the purpose of vaporization and coagulation of soft prostatic tissue during the treatment of Benign Prostatic Hyperplasia (BPH). The Plasmatrode™ comprises of the following: - A tip assembly, which in turn consists of an active electrode, a tip insulator and a floating electrode. • Ceramic shields • A conductive shaft • Insulating heat shrink The PlasmatrodeTM is compatible for use with ACMI USA/Elite Olympus OES and Karl Storz Single Stem and Double Stem resectoscopes.
The Cook Ireland Plasmatrode™ Saline Safe TUR Electrode is a monopolar electrode designed to deliver radio frequency energy for the vaporization and coagulation of soft prostatic tissue during the treatment of Benign Prostatic Hyperplasia (BPH). The device's acceptance criteria and performance were established through a series of non-clinical tests.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Standard | Acceptance Criteria | Reported Device Performance | Comments |
|---|---|---|---|---|
| Functional Performance | Electrosurgical Safety | Conformance to applicable electrosurgical safety standards. | Successfully completed. | Provides assurance of safe electrical operation. |
| Functional Performance | Simulated Use (Reliability/Activation Testing) | Device functions as intended during simulated use. | Successfully completed. | Demonstrates device's ability to activate and fulfill its intended function reliably. |
| Functional Performance | Resectoscope Interaction | Compatibility and proper interaction with compatible resectoscopes (ACMI USA/Elite Olympus OES and Karl Storz Single Stem and Double Stem resectoscopes). | Successfully completed. | Ensures the device can be used effectively with designated resectoscopes. |
| Mechanical Performance | Tensile Testing | Device integrity and strength under specified tensile loads. | Successfully completed. | Demonstrates structural integrity and resistance to breakage during use. |
| Stability | Shelf Life Testing | Maintains safety and effectiveness over its specified shelf life. | Successfully completed. | Ensures the device remains viable and safe for use throughout its shelf life. |
| Biological Safety | Biocompatibility | Conformance to ISO 10993-1 and FDA Guidance for BPH devices. | Successfully completed. | Supports the biological safety of the device when in contact with human tissue. |
| Therapeutic Effect | Animal Testing | Demonstrate intended therapeutic effect (vaporization and coagulation of prostatic tissue). | Successfully completed. | Provides evidence of the device's ability to achieve its primary clinical function in a biological model. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not explicitly state specific sample sizes for each bench or animal test. The tests were "successfully completed," implying sufficient samples were used to meet the predetermined validation requirements for each study.
The data provenance is from non-clinical testing (bench and animal testing) conducted by Cook Ireland Ltd. The country of origin for the data generation would therefore be Ireland. The data is retrospective in the sense that it was collected and analyzed as part of the premarket notification process to demonstrate substantial equivalence.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
The document does not mention the involvement of "experts" in establishing ground truth for individual test results within the non-clinical studies. The ground truth for bench tests would be defined by the specifications and measurable outcomes against established ASTM standards. For animal testing, the ground truth would be based on direct observation and pathological assessment of the tissues post-procedure. Compliance with FDA Guidance for BPH devices and ISO 10993-1 for biocompatibility also implicitly sets the standard for "ground truth" in these areas.
4. Adjudication Method for the Test Set
Not applicable. The tests performed are objective, measurable outcomes of physical and biological interactions, not subjective assessments requiring expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No multi-reader multi-case (MRMC) comparative effectiveness study was mentioned. The device is a surgical instrument, and its performance is evaluated through objective physical and biological tests rather than diagnostic interpretation by multiple readers.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
Not applicable. The device is a physical electrosurgical electrode, not an algorithm or AI system. Its performance is inherently tied to human operative skill and does not function in a standalone, automated capacity.
7. Type of Ground Truth Used
The ground truth used for performance evaluation included:
- Standards-based measurements: For electrosurgical safety, resectoscope interaction, tensile testing, and shelf-life testing, the ground truth was adherence to specified ASTM standards and internal performance specifications.
- Biological/Pathological outcomes: For animal testing, the ground truth would be the observable and measurable effect of vaporization and coagulation on prostatic tissue, likely assessed histologically or macroscopically.
- Regulatory guidance compliance: For biocompatibility, the ground truth was conformance to ISO 10993-1 and FDA Guidance for BPH devices.
8. Sample Size for the Training Set
Not applicable. The device is a physical medical device, not an AI or machine learning algorithm, and therefore does not have a "training set" in the computational sense. The data generated from performance testing serves as verification and validation data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this 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.