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The Multi4 System is intended for use by trained urologists for endoscopically controlled tissue resection and coagulation, and removal of bladder tumors (TURBT) via suction channel under controlled flow conditions following resection using a monopolar resectoscope. The Multi4 System is also intended to deliver injectable materials into the urinary bladder wall during transurethral endoscopic procedures.

The Multi4 System is an electrosurgical system used during urethral resection procedures of adult patients. The system, intended to remove and collect tissue from the bladder, includes a single-use electrosurgical instrument, known as the Multi4 B, as well as the reuseable Multi4 Pump. The Multi4 Pump administers energy from an external electrosurgical unit to the handheld Multi4 B instrument, which has electrosurgical functions and allows for fluid transport and tissue sample collection. The Multi4 B instrument accesses the bladder through the working channel of a commercially available cystoscope. The Multi4 System is a prescription device intended for use in professional healthcare facilities by healthcare professionals (HCPs).

The Multi4 System consists of the following components:
• Multi4 Pump (with Integrated Fluid Control)
o Footswitch
• Multi4 B
o Resectoscope & Needle
o Simple4tainer (For collection of gross resected tissue pieces for pathology)

The provided FDA 510(k) clearance letter and summary for the Multi4 System primarily focuses on demonstrating substantial equivalence to predicate devices through design similarity, material composition, intended use, and technological characteristics. The document details extensive non-clinical testing performed to ensure safety and effectiveness.

However, the provided text does not contain details about acceptance criteria, the study design, or performance metrics in a way that allows for the construction of a table comparing acceptance criteria with reported data, nor does it provide information on sample sizes for test sets, data provenance, expert involvement for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance.

The document does mention:

• Non-Clinical Testing: Software Verification and Validation Testing, Sterility Testing, Packaging Testing, Shelf-life Testing, Biocompatibility Testing (Cytotoxicity, Irritation, Sensitization, Acute Systemic Toxicity, Pyrogenicity), Electrical Safety & EMC (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, and IEC 60601-2-2), Integrity Testing, Functional Testing (Cut and coagulation, aspiration, irrigation, injection), Dimensional Inspection and Testing, Simulated Use Testing.
• Lack of Clinical Study: The "SUMMARY OF NON-CLINICAL TESTING" section and the overall context strongly suggest that the clearance was based on non-clinical data demonstrating equivalence to predicate devices, rather than a clinical study evaluating specific performance metrics against acceptance criteria for a new AI/algorithm. There is no mention of "ground truth" as it would apply to an AI study (e.g., expert consensus, pathology, outcomes data).

Therefore, I must state that the requested information regarding acceptance criteria, study data for AI performance, sample sizes for AI test/training sets, expert roles, adjudication, and MRMC studies is not present in the provided text. The document focuses on demonstrating substantial equivalence via engineering and bench testing, not clinical performance or AI/algorithm validation with a test set and ground truth in the manner typically required for AI-driven devices.

Without this specific information from the provided text, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the context of an AI-driven device with performance metrics.

If this were an AI device, the missing information would be crucial for understanding its validation. For this specific device and the information provided, the "acceptance criteria" were met by demonstrating that the Multi4 System performs as safely and effectively as its predicate devices through rigorous non-clinical testing.

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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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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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Electrodes with HF-cable are part of a resectoscope system for endoscopic diagnosis and treatment in urological applications: Cutting, ablation, resection, vaporization and coagulation with HF current.

Electrodes with HF-cable are part of a resectoscope system for endoscopic diagnosis and treatment in gynecological applications. The general indications include transcervical resection, vaporization, cutting and coagulation of tissue in the uterus in conductive irrigation fluid as part of a resectoscope system. Specific indications: transcervical diagnosis and treatment (resection, vaporization, biopsy, cutting and coagulation) of intrauterine myomas, intrauterine polyps, synechias and endometrium (TCRis), lysis of intrauterine septa, endometrial ablation.

The Olympus Resection Electrodes with HF cable that are subject to this submission are for application in saline. Depending on the characteristics of electrical current, which is provided by the electrosurgical generator, electrosurgery can be used for coagulation, vaporization and cutting. The subject HF-Resection Electrodes 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 accompanying HF cables consist of two lantern plugs on the instrument side and one generator plug on the generator side. 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 electrodes have a shaft diameter of 24 Fr, range in length from 261.8-336.7mm, and range in tip angle from 12° - 30° tips. The design of the HF cable plugs fits Olympus electrosurgical generators with Universal Socket. All subject Resection Electrodes are single-use electrodes and are delivered sterile. All subject Resection Electrodes are provided with a single-use, sterile cable to connect the electrode to the generator.

This document is a 510(k) Premarket Notification from the FDA regarding Olympus Winter & Ibe GmbH's Resection Electrodes with HF cable. It describes the device, its intended use, and its equivalence to a predicate device.

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

The document does not explicitly present a table of "acceptance criteria" in terms of performance metrics like sensitivity, specificity, or accuracy, as this is a traditional medical device (electrodes) rather than a diagnostic device or AI algorithm with such measures. Instead, the acceptance criteria are based on demonstrating comparable safety and effectiveness to the predicate device through various non-clinical performance and safety tests, and compliance with relevant standards.

Here's a summary of the performed tests as evidence of meeting safety and effectiveness requirements:

The study concluded that "The performance data support the safety and effectiveness of the subject device and demonstrate that the subject device is substantially equivalent to the predicate device."

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

The document describes non-clinical performance and safety testing. It does not refer to "test sets" in the context of patient data. The samples for testing would be units of the device itself (electrodes and cables). The specific number of devices tested for each non-clinical test (e.g., how many electrodes were subjected to lifetime connection/disconnection tests) is not explicitly stated in this summary.

The provenance of this data is from regulatory submissions to the FDA, originating from the manufacturer, Olympus Winter & Ibe GmbH, which is located in Hamburg, Germany. The tests are non-clinical (laboratory/bench tests), not clinical studies; therefore, terms like retrospective/prospective or country of origin of patient data are not applicable.

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 is not applicable as the document describes non-clinical testing for a traditional medical device (electrosurgical electrodes and cables), not a diagnostic device or AI algorithm requiring expert-established ground truth from patient data.

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

This is not applicable for the reasons stated above.

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 is not applicable for the reasons stated above. The device is an electrosurgical tool, not an AI-assisted diagnostic or interpretative system.

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

This is not applicable for the reasons stated above. The device is a physical electrosurgical electrode and cable, not an algorithm.

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

For the non-clinical tests conducted, the "ground truth" or reference for evaluating performance is typically defined by:

• Engineering specifications and design requirements: For mechanical, electrical, and functional performance.
• Applicable national and international standards: For electrical safety (e.g., IEC 60601 series), sterilization (ISO 11135), packaging (ISO 11607-1, ASTM D4169, ASTM F88, ASTM F1929, ASTM F2096), and biocompatibility (ISO 10993 series).
• Comparison to the predicate device: The goal is to demonstrate that the subject device is substantially equivalent in terms of safety and effectiveness to the legally marketed predicate device.

8. The sample size for the training set

This is not applicable. The device is a traditional medical device, not an AI or machine learning model that requires a training set.

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

This is not applicable for the reasons stated above.

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The Dornier Bipolar Cable is indicated to be used with a compatible electrosurgical generator and an HF electrode for endoscopic treatment in urological applications: Cutting, ablation, resection, vaporization and coagulation with HF current.

The Dornier Bipolar Cable is a sterile, single use, disposable device that allows connection of an electrosurgical generator to an HF electrosurgical resection and vaporization electrode. The outer body of the Dornier Bipolar Cables are constructed of a medical grade thermoplastic elastomer. The cable consists of a double wire zip cord with one plug end which has four (4) banana and one (1) straight pin, style of connector that is then attached to the generator. The other end is separated and has two (2) overmolded connectors, one male pin on a wire and one female pin on a wire which are compatible with the HF Electrode.

The provided text describes the 510(k) summary for the Dornier Bipolar Cable. This is a submission for a medical device that does not involve Artificial Intelligence (AI). The submission focuses on demonstrating substantial equivalence to a predicate device through conventional engineering and safety testing.

Therefore, many of the requested categories related to AI performance, such as sample sizes for test and training sets, expert consensus, adjudication methods, and MRMC studies, are not applicable to this document.

Here's the information that can be extracted or deduced from the provided text:

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

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

This information is not applicable as the device is a physical electrosurgical cable and its evaluation did not involve a "test set" in the context of an AI algorithm or data analysis study. The testing performed was engineering and safety validation. The provenance of test data for physical components is not usually detailed in this manner for 510(k) submissions.

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. "Ground truth" in this context typically refers to the confirmed diagnostic or clinical reality for evaluating an AI model. For a physical medical device, the "ground truth" is established through adherence to engineering standards and validated test methods by qualified engineers and technicians, not through expert consensus on medical images or diagnoses.

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

This information is not applicable as there was no test set requiring expert adjudication in the context of an AI system.

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 information is not applicable as the device is a physical electrosurgical cable and does not involve AI assistance for human readers or direct comparative effectiveness in that manner.

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

This information is not applicable as there is no algorithm or AI component in this device.

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

The "ground truth" for this device's performance is based on meeting established engineering standards and validated test methods for its physical and electrical properties. This is typically determined by physical measurements, electrical tests, and adherence to regulatory standards (e.g., IEC 60601 series).

8. The sample size for the training set

This information is not applicable as there is no AI component or training set for this device.

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

This information is not applicable as there is no AI component or training set for this device.

Ask a specific question about this device

Electrodes with HF-cable are part of a resectoscope system for endoscopic diagnosis and treatment in urological applications: Cutting, ablation, resection, vaporization and coagulation with HF current.

Electrodes with HF-cable are part of a resectoscope system for endoscopic diagnosis and treatment in gynecological applications.

The general indications include transcervical resection, vaporization, ablation, cutting and coagulation of tissue in the uterus in conductive irrigation fluid as part of a resectoscope system.

Specific indications:

• transcervical diagnosis and treatment (resection, vaporization, ablation, biopsy, cutting and coagulation) of intrauterine myomas, intrauterine polyps, synechias and endometrium (TCRis)
• lysis of intrauterine septa -
• endometrial ablation -

The subject HF-Resection Electrodes 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 accompanying HF cables consist of two lantern plugs on the instrument side and one generator plug on the generator side.

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 electrodes have a shaft diameter of 24 Fr. range in length from 261.8-336.7mm, and range in compatibility with telescopes with a direction of view of 12° - 30°. The design of the HF cable plugs vary depending on which electrosurgical generator they are compatible with.

All subject Resection Electrodes are single-use electrodes and are delivered sterile. All subject Resection Electrodes are provided with a single-use, sterile cable to connect the electrode to the generator.

The provided document is a 510(k) summary for Olympus Winter & Ibe GmbH's Resection Electrodes with HF cable (K171965). This is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device, not necessarily to prove its absolute safety and effectiveness through a standalone clinical study involving acceptance criteria as typically understood for new major medical devices or AI algorithms.

Therefore, the acceptance criteria and study information typically requested for AI/ML performance are not present in this type of submission. This device is an accessory to electrosurgical units, and its substantial equivalence is primarily demonstrated through comparisons to predicate devices in terms of design, materials, indications for use, and adherence to recognized electrical safety and sterilization standards.

Here's how to interpret the available information against your request:

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

This document does not present "acceptance criteria" for device performance in the typical sense of a clinical outcome or diagnostic accuracy. Instead, it relies on demonstrating compliance with recognized standards and equivalence to a predicate device. The "reported device performance" refers to its ability to meet these standards and exhibit similar characteristics 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)

This information is not applicable and therefore not provided in the 510(k) summary. The submission focuses on engineering and bench testing, not clinical performance data that would involve a "test set" in the context of AI/ML or clinical trials. The performance data relies on testing previously reviewed and deemed acceptable in K152092.

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 is not applicable to the type of device and submission. There is no "ground truth" to be established by clinical experts for the electrical safety, sterilization, or shelf-life testing of these electrodes.

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

This is not applicable for the reasons stated above.

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 is not applicable. This is a medical device accessory, not an AI/ML diagnostic or assistive tool.

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

This is not applicable. This is a physical medical device, not an algorithm.

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

For the technical aspects (electrical safety, sterilization, shelf life), the "ground truth" is adherence to established international and national standards (e.g., ISO, AAMI/ANSI IEC standards) and validated engineering test results. For substantial equivalence, the "ground truth" is the previously cleared predicate device (K152092) and its established safety and effectiveness.

8. The sample size for the training set

This is not applicable. There is no software algorithm or AI model being trained for this device.

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

This is not applicable.

Ask a specific question about this device

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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RESECTION ELECTRODES: The Omnitech 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 hemostasis is required. The specific urological indications in the prostate, bladder and bladder neck. The procedures for which the devices can be used are: Transurethral resection in saline (TURis). Transurethral prostatectomy, transurethral resection of the prostate (TURP), for benign prostatic hyperplasia, 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 in treating cancer of the prostate.

VAPORIZATION ELECTRODE: The Omnitech HF Vaporization electrode for plasma vaporization is a bipolar instrument designed and intended for use in urological surgical procedures involving vaporization, cutting, removal of soft tissue and coagulation where hemostasis is required. The specific soft tissue indications include: Use in the prostate, bladder, and bladder neck. The specific treatment indications include benign prostate hyperplasia (BPH), bladder cancer, tumors, lesions and neoplasms. The specific urological indications include Transurethral Electro vaporization (TUVP), (TVP), (TVP), (TVP), (TVP), (TUEVP) also known as Transurethral Vapor Resection of the prostate (TUVRP), Transurethral Vaporization in Saline (TUVis). These devices are intended to be used in an irrigated environment. These devices are not intended to be used in treating cancer of the prostate.

Not Found

I am sorry, but the provided text is a 510(k) summary document from the FDA for medical device clearance. It does not contain the detailed information about acceptance criteria, study methodologies, sample sizes, ground truth establishment, or expert qualifications that you are requesting.

The document primarily focuses on:

• Device Identification: Trade/Device Name, Regulation Number, Product Code.
• Regulatory Determination: Substantial Equivalence (SE) to a predicate device.
• Indications for Use: What the device is intended for (resection and vaporization of soft tissue in urological procedures).
• Regulatory Compliance: General controls and other regulations the manufacturer must adhere to.

Therefore, I cannot extract the information requested for point 1 through 9 from the provided text. This type of detailed study information is usually found in the supporting technical documentation submitted by the manufacturer to the FDA, not in the final clearance letter.

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Electrodes are part of a resectoscope system for endoscopic diagnosis and treatment in urological applications. Cutting, ablation, resection, vaporization and coagulation with HF current.

Gynecology: Electrodes are part of a resectoscope system for endoscopic diagnosis and treatment in gynecological applications. The general indications include transcervical resection, vaporization, ablation, cutting and coagulation of tissue in the uterus in nonconducting irrigation fluid.

Specific intended use Gynecology:

• -Transcervical diagnosis and treatment (resection, vaporization, ablation, biopsy, cutting and coagulation) of intrauterine myomas, intrauterine polyps, synechias and endometrium
• -Lysis of intrauterine septa
• -Endometrial ablation

The Olympus Resection Electrodes that are subject to this submission are either monopolar or for application in saline. The main difference between monopolar electrosurgery and electrosurgery in saline is that while in monopolar electrosurgery a neutral electrode is required, whereas in electrosurgery in saline the (neutral) return electrode is part of the surgical device.

Depending on the characteristics of electrical current, which is provided by the electrosurgical generator, electrosurgery can be used for coagulation, vaporisation and cutting.

The subject HF-Resection Electrodes 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.

All subject Resection Electrodes are single-use electrodes and are delivered sterile.

This document is a 510(k) Premarket Notification from the FDA for Olympus Winter & Ibe Gmbh's electrodes. It focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study to prove a device meets specific acceptance criteria in the typical sense of algorithm performance metrics.

Therefore, many of the requested sections about acceptance criteria and study design for performance metrics, sample sizes, ground truth establishment, expert qualifications, and MRMC studies are not applicable or cannot be extracted from this type of regulatory submission. The document primarily details the device's technical specifications, indications for use, and a comparison to predicate devices based on safety and effectiveness, rather than a clinical performance study with numerical acceptance criteria.

However, I can extract information related to the safety and material performance testing mentioned in the document.

1. Table of acceptance criteria and the reported device performance

The document does not provide specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy) or quantitative performance metrics for the device's clinical efficacy in the way an AI or diagnostic device submission might. Instead, the "acceptance criteria" are implied by adherence to recognized international standards for various non-clinical tests. The reported "performance" is that these tests were conducted and the device complied with the requirements of these standards, supporting its safety and effectiveness.

• AAMI/ANSI ES 60601-1:2005 + A1:2012, C1:2009 and A2:2010 (Medical Electrical Equipment - Part 1.1 General requirements for safety and essential performance).
• AAMI/ANSI/IEC 60601-2-2 2009 (Medical Electrical Equipment - Part 2-2: Particular Requirements for the Basic Safety And Essential Performance of High Frequency Surgical Equipment and High Frequency Surgical Accessories).
• IEC 60601-2-18:2009 (Medical Electrical Equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment). The implied acceptance is that the device is electrically safe for its intended use. | Electrical Safety was tested according to the listed standards. |
  | Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 and IEC 60601-2-2 for the resectoscope system. The implied acceptance is that the device, as part of the system, operates without causing or being unduly affected by electromagnetic disturbances. | EMC testing was conducted for the resectoscope system (not standalone electrodes). It was demonstrated that "the compatible resectoscope system complies with all requirements of IEC 60601-1-2 and IEC 60601-2-2." It is assumed that since electrodes are made of similar conductive materials and contain no electrical components, they will not affect the electrical properties of the system. |
  | Thermal Safety | Compliance with AAMI/ANSVIEC 60601-2-2 2009 (Medical Electrical Equipment - Part 2-2: Particular Requirements for the Basic Safety and Essential Performance of High Frequency Surgical Equipment and High Frequency Surgical Accessories). The implied acceptance is that the device does not reach unsafe temperatures during operation. | Tested according to AAMI/ANSVIEC 60601-2-2 2009. |
  | Sterilization | Compliance with ISO 11135 for the EtO sterilization cycle and conformity with AAMI ANSI ISO 11607-1:2006 for packaging. A Sterility Assurance Level (SAL) of 10-6 must be reached. EtO residuals must be within limits. | Sterilization is performed according to ISO 11135 and packaging conforms with AAMI ANSI ISO 11607-1:2006. The EtO sterilization cycle has been validated, and an SAL of 10-6 was reached. EtO residuals are within limits. |
  | Shelf Life | Adequate performance and package integrity over the declared shelf life. | Shelf life testing was conducted, including performance testing and package integrity testing, to support a shelf life of 5 years. |
  | Performance Testing Bench | Mechanical and electrical performance, resection/coagulation effectiveness, durability, and transport/packaging integrity. Implied acceptance is that the devices perform their intended functional tasks reliably and safely. | Conducted tests include mechanical and electrical performance testing, resection/coagulation testing, durability testing, and transport/packaging testing. (No specific numerical results or thresholds provided, but the statement indicates compliance was achieved to support substantial equivalence). |

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

This document describes non-clinical performance and safety testing. It does not refer to a "test set" in the context of diagnostic performance or AI model evaluation. The tests mentioned (biocompatibility, electrical safety, thermal safety, sterilization, shelf life, bench testing) were conducted on device samples to ensure compliance with standards. The sample sizes for these engineering and materials tests are not specified in the summary but would be determined by the specific test protocols for each standard. Data provenance is not applicable as it is laboratory testing for device characteristics, not 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 is not applicable to the type of testing described. "Ground truth" in the context of expert consensus on medical images or diagnoses is not a component of this submission for an electrosurgical device. The ground truth for the performance tests would be the established scientific and engineering principles and the requirements defined within the referenced international standards.

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

Not applicable. This concept applies to human reader studies or similar diagnostic performance evaluations, which were not part of this 510(k) submission.

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 a premarket notification for electrosurgical electrodes, not an AI-assisted diagnostic device. No MRMC study or AI component is mentioned.

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

Not applicable. This device does not involve an algorithm.

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

The "ground truth" for this submission is based on adherence to recognized international standards and engineering principles. For example:

• Biocompatibility: Defined by ISO 10993-1.
• Electrical Safety: Defined by AAMI/ANSI ES 60601-1, AAMI/ANSI/IEC 60601-2-2, IEC 60601-2-18.
• EMC: Defined by IEC 60601-1-2 and IEC 60601-2-2.
• Sterilization: Defined by ISO 11135 and AAMI ANSI ISO 11607-1:2006.
• Thermal Safety: Defined by AAMI/ANSVIEC 60601-2-2.
• Functional Performance: Evaluated against design specifications and predicate device performance.

There is also a "Clinical Evaluation" mentioned, which was a "comprehensive literature review" rather than new clinical data or expert consensus on cases.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI models. It's a medical device, and the testing outlined is for manufacturing, material properties, and safety.

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

Not applicable, as there is no "training set" for this device.

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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 hemostasis 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 for treating cancer of the prostate.

The HF-Resection Electrode for Plasma Vaporization is a bipolar instrument designed and intended for use in urological surgical procedures involving the vaporization, ablation, coagulation, cutting, removal of soft tissue and coagulation where hemostasis 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, The specific urological indications include transurethral and neoplasms. lesions 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 in 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 system includes Electrodes, working elements, and an HF bipolar cable that can be connected to an electrical surgical unit.

HF Resection Electrodes (K100275) can now be used with the newly compatible electrosurgical generator, the ESG-400 (K103032). For the HF Resection Electrodes to be used with the ESG-400, an additional HF cable is needed (WA00014A). The WA00014A bipolar reusable cable is an electrosurgical accessory designed to transfer electrosurgical power to electrosurgical working elements from the electrosurgical generator ESG-400 (K103032). The cable is designed to connect the working elements WA22366A and WA22367A (K100275).

The provided text describes a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a novel clinical study with acceptance criteria in the typical sense of evaluating a new therapeutic or diagnostic claim. The "study" here is a set of performance tests to ensure the new device (specifically, a new cable) does not raise new safety concerns and maintains the same functionality as the predicate device.

Here's a breakdown based on the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a "sample size" in the context of a clinical trial or a dataset for an AI model. This is a submission for a physical medical device (electrosurgical electrodes and a new cable) demonstrating equivalence, not a data-driven AI device.

• Sample Size (Test Set): Not applicable in the context of a dataset; refers to the testing of the physical device components. The document implies sufficient units were tested to perform design verification, electrical safety tests, and risk analysis.
• Data Provenance: Not applicable in the context of clinical data. The tests performed are bench tests and risk analyses conducted by the manufacturer, Olympus Winter & Ibe GmbH, in Germany.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided. "Ground truth" in this context would refer to the established engineering and safety standards (e.g., IEC standards, ISO 14971) against which the device's performance was measured. These standards are developed by expert committees, but the specific individuals involved in this particular submission's verification of adherence to those standards are not listed.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of expert adjudication or consensus methods for evaluating the results of the bench tests or risk analysis. The results are compared directly against established engineering and safety standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices (e.g., imaging AI) to compare human reader performance with and without AI assistance. This submission is for surgical instruments, not a diagnostic or AI-assisted device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm performance study was not done. This is not an AI-driven device. The "performance" refers to the physical and electrical characteristics of the surgical electrodes and cable.

7. The Type of Ground Truth Used

The "ground truth" for this submission consists of:

• Established engineering and performance specifications: The device is expected to function according to its intended use, which is defined by its design.
• International Consensus Standards:
  • IEC 60601-1: Medical electrical equipment – Part 1: General requirements for basic safety and essential performance.
  • IEC 60601-2-2: Medical electrical equipment – Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories.
  • ISO 14971:2007: Medical devices – Application of risk management to medical devices.

These standards serve as the objective benchmarks against which the device's safety and performance were evaluated.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for an AI model.

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