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The HF-Resection Electrodes are a bipolar instrument series designed and intended for use in endoscopic urological surgical procedures involving the resection, ablation or removal of soft tissue and where hemostatis is required. The specific urological indications include use in the prostate, bladder and bladder neck. The procedures for which the devices can be used for are transurethral resection in saline (TURis), transurethral prostatectorny, transurethral resection of the prostate (TURP) for benign prostatic hypertplasia, transurethral incision of the prostate (TUIP) or bladder neck, transurethral resection of bladder tumors (TURBT) and cystodiathermy. These devices are intended to be used in an irrigated environment. These devices are not intended to be used to treating cancer of the prostate.

The HF-Resection Electrode for Plasma Vaporization is a bipolar instrument designed and intended for use in urological procedures involving the vaporization, ablation, coagulation, cutting, removal of soft tissue and coagulation where hemostatis is required. The specific soft tissue indications include use in the prostate, bladder neck. The specific treatment indications include benign prostate hyperplasia BPH, bladder cancer, tumors, lesions and neoplasms. The specific urological indications include transurethral electrovaporization (TUVP, TVP, TUEVP), also known as transurethral vapor resection of the prostate (TUVRP) or transurethral vaporization in saline (TUVis). These devices are intended to be used in an irrigated environment. These devices are not intended to be used to treating cancer of the prostate.

The HF-Resection Electrodes and HF Resection Button Electrode for Plasma Vaporization consist of an active tip, PTFE color code identification, an insulator between the electrode and electrode tube, a guiding tube, telescope clip and arm (shaft).

The design and dimensions of the electrodes vary to accommodate various procedural conditions. The active tips of the various electrodes may consist of loops, bands, rollers, needles or buttons.

The provided document is a 510(k) summary for electrosurgical resection and vaporization electrodes and does not contain any information about acceptance criteria, device performance metrics, or details of a study that proves the device meets specific criteria.

The document primarily focuses on:

• General Information: Applicant, official correspondent, manufacturer.
• Device Identification: Device name, common name, regulation number, regulation name, regulatory class, product code, classification panel.
• Predicate Device Information: Lists predicate devices used for comparison.
• Device Description: Explains the components and variations of the electrodes.
• Indications for Use: Details the intended uses for the HF-Resection Electrodes and the HF-Resection Electrode for Plasma Vaporization.
• Comparison of Technological Characteristics: States that the devices are "basically identical to the predicate devices in intended use, design and material specifications."
• Conclusion: Concludes that there are no significant changes affecting safety or effectiveness compared to predicate devices.
• FDA Correspondence: Official letter from the FDA determining substantial equivalence.

Without this information in the provided text, I cannot complete the table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader studies.

Therefore, for your request:

1. A table of acceptance criteria and the reported device performance:

• Acceptance Criteria: Not specified in the provided text.
• Reported Device Performance: Not specified in the provided text.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• No test set or study data is mentioned.

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):

• No test set or ground truth establishment is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• No test set or adjudication method is mentioned.

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:

• No MRMC study is mentioned. This device is an electrosurgical tool, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• This device is an electrosurgical tool, not an algorithm. No standalone performance study is mentioned or relevant in this context.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• No ground truth is mentioned as no study evaluating diagnostic or interpretive performance is discussed.

8. The sample size for the training set:

• No training set is mentioned.

9. How the ground truth for the training set was established:

• No training set or ground truth for a training set is mentioned.

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