(156 days)
The Plasma Edge System single use bipolar resection electrodes are used for the ablation and hemostasis of tissues under endoscopic control, in association with endoscopic accessories. They are intended for endoscopic surgeries with saline irrigation, in the field of urology. The use of the Plasma Edge System is restricted to surgeons, specialized in urological surgery, for specific use in: - Transurethral resection of prostate (TURP) for benign prostatic hypertrophy - Transurethral incision of the prostate (TUIP) or bladder neck - Transurethral resection of bladder tumors (TURBT) - Cystodiathermy • Transurethral Vaporization of the prostate (TUVP/TVP) for benign prostatic hypertrophy, and for Transurethral Vaporization of bladder tumors. (MVVS and MVV models only)
The Plasma Edge system is a manual surgical device, consisting of a single-use electrode with cable range, an active and passive working element reusable and an adaptor to an HFgenerator compatible. The electrodes consist of an active tip, two wires threaded through ceramic tubes to connect the active tip to the body of the loop, allowing the HF energy to reach the active tip. It has to be used with continuous flow irrigation of saline solution (NaCl 0,9%) that reachesthe operative site through a resectoscope. The HF energy delivered from the generator tothe electrode ionizes the gas of the saline solution, creating a plasma for the cutting, coagulation and vaporization of tissues.
The provided text is a 510(k) Summary for the Plasma EDGE system, which is an endoscopic electrosurgical unit and accessories. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study of the device's performance against specific acceptance criteria for diagnostic tasks.
Therefore, much of the requested information regarding diagnostic accuracy studies, sample sizes for test and training sets, expert qualifications, and ground truth establishment is not present in this document. The document describes engineering and safety testing.
Here's the information that can be extracted or deduced from the document:
1. A table of acceptance criteria and the reported device performance
The document lists performance tests conducted to ensure the device functions as intended and meets design specifications, based on in-house acceptance criteria derived from ISO-14971:2007 (Risk analysis) and various other standards. Specific quantitative acceptance criteria or reported performance results (e.g., in terms of measurements or thresholds) are not provided in detail in this summary, other than stating that the tests were completed successfully.
| Acceptance Criteria Category | Applied Standard(s) | Reported Device Performance |
|---|---|---|
| Risk Analysis | ISO-14971:2007 | Carried out in accordance with established in-house acceptance criteria. |
| Biocompatibility | ISO 10993-1:2018, ISO 10993-5, ISO 10993-11, ISO 10993-10 | Evaluation conducted. Testing included cytotoxicity, acute systemic toxicity, intracutaneous irritation, and sensitization tests. (Results are not specified, only that tests were done). |
| Electrical Safety | IEC 60601-1:2012, IEC 60601-2-2:2009 | Tested by an independent laboratory. |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2:2007 | Tested by an independent laboratory. Device (Plasma Edge electrode) tested on HF generator Gyrus, with comparison to predicate. |
| Cleaning & Sterilization Validation (Reusable Working Element) | ISO 17664, AAMI TIR N°30, AAMI TIR N°12, ISO 17665 | Tested by an independent laboratory. Cleaning, disinfection, and steam sterilization (132°C for 4 min) validated. |
| Sterilization Validation & Shelf-Life (Single Use Electrode) | ISO 11135, ISO 11607-1, ISO 11607-2, ISO 11737-1 | Ethylene oxide sterilization method validated. Shelf life of one (1) year. |
| Bench Top Validation Testing | (Implicit in general performance goals) | End of life simulation report, breakdown simulation report, working element compatibility report and test on ex vivo tissues have been tested. Demonstrated product safety and efficiency. |
Study that Proves the Device Meets Acceptance Criteria:
The document refers to a series of performance tests and usability studies conducted to ensure the system functions as intended and meets design specifications. These studies are collectively referred to as "Performance testing" (Section iii).
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The studies mentioned are engineering and safety tests, not clinical studies involving patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable and therefore not provided, as the tests described are technical validations (biocompatibility, electrical safety, sterilization, bench-top) rather than clinical evaluations requiring expert-derived ground truth for diagnostic or therapeutic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is related to expert review of clinical data, which is not described.
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
Not applicable. This is not a diagnostic AI device, but an electrosurgical system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI algorithm. The performance tests are focused on the device's technical and physical characteristics.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the technical performance aspects, "ground truth" would be established through adherence to recognized standards (e.g., ISO, IEC), material specifications, and validated processes. For example:
- Biocompatibility: Results of standardized in-vitro and in-vivo tests according to ISO 10993 series.
- Electrical Safety/EMC: Compliance with IEC 60601 series, measured electrical parameters within specified limits.
- Sterilization: Demonstrated sterility assurance level (SAL) according to ISO 11135 and other related standards.
- Bench-top testing: Physical measurements, visual inspection, and functional verification against design specifications and predicate performance (e.g., cutting efficacy on ex vivo tissues).
8. The sample size for the training set
Not applicable, as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable, as this is not an AI/machine learning device.
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).