(200 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 hyperplasia
- · 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 hyperplasia, 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 adaptator to an HF generator 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 reaches the operative site through a resectoscope. The HF energy delivered from the generator to the electrode ionizes the gas of the saline solution, creating a plasma for the cutting, coagulation and vaporization of tissues.
The provided text describes the Plasma EDGE System and its performance testing for a 510(k) premarket notification. However, it does not contain specific acceptance criteria with numerical targets or detailed results that demonstrate the device meets those criteria from a clinical study. Instead, it focuses on demonstrating substantial equivalence to predicate devices through various non-clinical tests and a comparison of technological characteristics.
Therefore, many of the requested elements for a study proving device performance against acceptance criteria cannot be fully extracted.
Here's an analysis of the provided text in relation to your request:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics like sensitivity, specificity, accuracy, or other quantitative measures typically found in clinical performance studies of AI/diagnostic devices. The "Performance testing" section instead lists various types of engineering and non-clinical evaluations that were conducted.
If we interpret "acceptance criteria" broadly to mean successful completion of required testing, the table would look like this (though actual numerical results for "reported device performance" are missing for most items):
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility in accordance with ISO-10993 standards | Testing for Cytotoxicity, Chemical Analysis, Biological Safety conducted and passed. |
| Electrical safety according to AAMI/ANSI ES 60601-1 | Tested by an independent laboratory and passed. |
| Electromagnetic compatibility (EMC) according to IEC 60601-1-2 | Tested by an independent laboratory and passed. |
| Cleaning and sterilization validation for reusable components | Validated by an independent laboratory (Steam Sterilization per AAMI TIR N°12, ISO 17664, ISO 17665; Cleaning/Disinfection per AAMI TIR N°30). |
| Shelf life validation (3 years for electrodes) | Validated (sterilization method: ethylene oxide). |
| Bench top validation testing (End of life, breakdown, compatibility, ex vivo tissues) | Tested to demonstrate product safety and efficiency (details of "efficiency" missing). |
| Risk analysis according to ISO-14971 | Carried out in accordance with established in-house acceptance criteria based on ISO-14971:2007. |
The document states, "Comparative performance testing demonstrate that the device performed as well as, or better than, the predicate device," but does not provide the specific comparative results or metrics.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily describes non-clinical performance and benchtop testing. It does not mention a "test set" in the context of clinical data, nor does it specify sample sizes for any clinical or human-in-the-loop evaluation, or data provenance. The "ex vivo tissues" mentioned in benchtop testing do not constitute a clinical "test set."
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)
Not applicable. The document does not describe a clinical study involving human judgment or interpretation that would require expert-established ground truth. The evaluations are technical and benchtop in nature.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as there is no clinical "test set" or human interpretation requiring adjudication.
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 device is an electrosurgical unit and accessories, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance for human readers would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device, not an algorithm. Its performance is inherent in its physical and electrical characteristics when used by a surgeon. The device itself operates "standalone" in the sense that its electrosurgical function is performed directly, but it is always "human-in-the-loop" as it requires a surgeon for operation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for the tests described are engineering specifications, standardized test methods (e.g., ISO, AAMI, IEC standards), and physical/biological properties (e.g., cytotoxicity, electrical safety, sterilization efficacy).
8. The sample size for the training set
Not applicable. The Plasma EDGE System is a hardware device; it does not involve machine learning or AI models that require a "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of 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).