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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 models only)

The Plasma Edge system is a manual surgical device, consisting of a single-use electrode, an active and passive working element reusable and an adaptor or only socket with memory (fixed cable) to connect them 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, an endoscopic electrosurgical unit and accessories, and its substantial equivalence to a predicate device (K213135: Plasme EDGE System - manufactured by LAMIDEY NOURY MEDICAL).

Here's an analysis of the acceptance criteria and study information:

1. Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device. It addresses performance through various validation and testing activities rather than specific numerical acceptance criteria. The underlying acceptance criteria for each test are implicitly the successful fulfillment of the standards mentioned.

• Acute systemic toxicity test (ISO 10993-11:2018) - Reported as successfully completed.
• Pyrogen detection assay (European Pharmacopeia chapter 2.6.8 and ISO 10993-11:2018) - Reported as successfully completed.
• Acute skin irritation test (ISO 10993-23:2021) - Reported as successfully completed.
• Skin sensitization test on Guinea pig (ISO 10993-10:2021) - Reported as successfully completed.
• ISO MTS cytotoxicity test (ISO 10993-5:2009) - "Nettoyage X3_Cytotoxicité_QP2" & "Nettoyage X3 Cytotoxicité QP3" - Reported as successfully completed. Previous biocompatibility tests were also available. |
  | Electrical Safety | Tested by an independent laboratory according to IEC 60601-1: 2012 and IEC 60601-2-2:2009. - Implied successful completion to meet substantial equivalence. |
  | Electromagnetic Compatibility (EMC) | Tested by an independent laboratory according to IEC 60601-1-2:2007. Electrode Plasma Edge was tested on the HF generator Gyrus, and a comparison was realized with the assembly Electrode Gyrus on the HF generator Gyrus. - Implied successful completion to meet substantial equivalence. |
  | Cleaning & Sterilization Validation (Reusable Working Element) | Tested by an independent laboratory following ISO 17664 and AAMI TIR Nº30 (manual cleaning). Steam sterilization validation tested following AAMI TIR Nº12, ISO 17664, and ISO 17665 (132ºC for 4 min). - Implied successful completion. |
  | Sterilization Validation & Shelf-Life (Single-Use Electrode) | Validated sterilization method: ethylene oxide. Product has a shelf life of four (4) years. - Implied successful validation. |
  | Bench Top Validation Testing | End of life simulation report, breakdown simulation report, working element compatibility report, and test on ex vivo tissues. These were tested on the Plasma Edge System to demonstrate product safety and efficiency on Gyrus Superpulse electrosurgical unit and MCB electrosurgical unit. - Implied successful demonstration of safety and efficiency, performing as well as or better than the predicate. |

The document states: "Comparative performance testing demonstrate that the device performed as well as, or better than, the predicate device." This is the ultimate reported performance outcome relative to acceptance (substantial equivalence).

2. Sample size used for the test set and the data provenance:

• Sample Size: Not explicitly stated for any of the performance tests. For biocompatibility, tests are typically conducted on a small number of samples to represent the device materials. For electrical/EMC, typically one or a few devices are tested. For cleaning/sterilization, a specified number of cycles/samples are used based on the standard, but the exact number isn't provided here. For bench top validation, no specific sample size is mentioned.
• Data Provenance: Not specified (e.g., country of origin). The studies appear to be internal or contracted out to independent laboratories, as indicated by phrases like "established in-house acceptance criteria" and "tested by an independent laboratory." The document mentions European Pharmacopeia, suggesting some European standard compliance. The submission itself is from France. The studies are essentially retrospective in the context of the device's development and marketing submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. The studies described are primarily technical performance validations against established standards, not clinical studies requiring expert ground truth for interpretation (e.g., imaging diagnostic devices).

4. Adjudication method for the test set:

This information is not applicable and therefore not provided, as the studies are not clinical trials that would typically involve adjudication of endpoints or diagnoses by multiple experts. The validation is against technical specifications and standard requirements.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No, an MRMC comparative effectiveness study was not conducted. This type of study is relevant for diagnostic imaging AI, where human readers interpret cases with and without AI assistance. The PLASMA EDGE System is a surgical tool, and its efficacy is evaluated through bench testing, biocompatibility, and electrical safety, not by human reader interpretation. No effect size improvement with AI assistance for human readers is mentioned as it's not relevant.

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

Not applicable. The device is an electrosurgical system, not an AI algorithm. Its performance is inherently "standalone" in mechanical and electrical testing, but it requires a human surgeon for operation (human-in-the-loop for its clinical use, but not in the context of AI performance evaluation).

7. The type of ground truth used:

• For Risk Analysis, Electrical Safety, EMC, Cleaning, Sterilization, and Bench Top Validation: The "ground truth" is defined by the requirements of the specified international and national standards (e.g., ISO 14971, IEC 60601 series, ISO 10993 series, AAMI TIRs) and internal design specifications. Successful adherence to these standards constitutes the "ground truth" for compliance and performance.
• For Biocompatibility: The "ground truth" is established by the biological response observed in standardized in vitro and in vivo tests as per ISO 10993 series, with criteria for acceptable biological reactions.

8. The sample size for the training set:

Not applicable. This device is a medical instrument (hardware with integrated controls), not an AI/ML model that requires a training set.

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

Not applicable, as no training set for an AI/ML model is involved.

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Electrosurgical unit « MCB » is intended for use for the ablation, removal, resection, and coagulation of soft tissue, and where associated hemostasis is required in endoscopic urological surgical procedures.

The device is intended for use by qualified medical personnel trained in the use of electrosurgical equipment.

MCB is a reusable, non-sterile electrosurgical bipolar generator with cutting and coagulation modes. The maximum output power is 500 W.

The front panel GUI (graphical user interface) features soft keys and digital displays for:
• the connection status of accessories connected to the electrosurgical generator.
• the current settings of the chosen output mode (Cut/ Coag), and possibility to adjust it
• Sound Level adjustment and LEDs (Green for Sound and Yellow/Blue for output activation)
• Electrode shortcut Alarm reset

At switch on, Serial Number and Software Version are displayed

The provided text is a 510(k) summary for the MCB UNIT Model: V10GMCBUS electrosurgical unit. It includes information about the device, its intended use, and the studies conducted to demonstrate substantial equivalence to a predicate device. However, it does not contain the detailed acceptance criteria and a specific study proving the device meets those criteria, as typically found in clinical performance studies.

The document primarily focuses on non-clinical testing and regulatory compliance, not on clinical performance metrics with acceptance criteria.

Therefore, I cannot fulfill all parts of your request based on the provided text. I can, however, extract the relevant non-clinical performance data and what is described regarding the validation studies.

Here's what can be extracted and inferred:

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

The document does not explicitly state numerical acceptance criteria for specific device performance metrics in a format that would allow for a table comparing "acceptance criteria" against "reported device performance" in a clinical context (e.g., sensitivity, specificity, accuracy for an AI device).

Instead, the non-clinical performance data section refers to validation studies based on recognized standards and FDA guidance for electrosurgical devices. The conclusion states that "Slight differences do not raise any questions regarding safety and effectiveness," implying that the device's performance, as evaluated against these standards, demonstrated sufficient safety and effectiveness to be substantially equivalent to the predicate.

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 mentions "Thermal Effect studies on representative tissues for urological Application" in the "Summary of the Non-Clinical performance data" section. However, it does not provide any details regarding:

• The sample size of these "representative tissues."
• The data provenance (e.g., country of origin, retrospective or prospective nature of the tissue samples).

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 provided in the document. The studies mentioned are non-clinical, focusing on the electrosurgical unit's physical characteristics and compliance with electrical safety and usability standards. The concept of "ground truth" established by experts, as it would apply to diagnostic AI devices, does not directly apply here.

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

This information is not provided as the studies are non-clinical and do not involve human interpretation of diagnostic data 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:

This device is an electrosurgical unit, not an AI diagnostic tool. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study to assess human reader improvement with AI assistance is not applicable and was not performed.

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

This is an electrosurgical hardware device, not an AI algorithm. So, a standalone algorithm performance study is not applicable.

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

For the non-clinical performance data, the "ground truth" would be established by the physical and electrical safety standards outlined (e.g., IEC 60601-2-2 for Safety of Electrosurgical Generator, IEC 60601-1-2 for EMC). The "Thermal Effect studies on representative tissues" would presumably use objective measurements of tissue effects (e.g., lesion depth, coagulation extent) against expected outcomes based on the device's settings and the predicate device's known performance. However, the specific methodology and objective measures are not detailed.

8. The sample size for the training set:

This device is an electrosurgical unit. There is no mention of a training set as it is not an AI/ML device that requires data for training algorithms.

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

As there is no training set for an AI/ML algorithm, this question is not applicable.

Summary of what is present:

• Non-clinical performance data: Validation studies were based on recognized standards (ISO 14971, IEC 62304, IEC 62366-1, IEC 60601-2-2, IEC 60601-1-2) and FDA guidance for electrosurgical devices (March 9, 2020), specifically for "Thermal Effect studies on representative tissues for urological Application."
• Software validation: Based on "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005), with the software considered a "Moderate Level of Concern."
• Usability: Assessed and found to be safe and effective for its intended uses.
• Overall Conclusion: Substantial equivalence to the predicate device (GYRUS ACMI Inc. PK SUPERPULSE SYSTEM GENERATOR MODEL 744000, 510k Number : K100816) based on same Indications for Use, similar technological and technical characteristics, and results of non-clinical tests.

The document primarily demonstrates compliance with regulatory and safety standards, rather than clinical performance against specific acceptance criteria like an AI diagnostic device would.

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