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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.

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.

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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):

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.

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