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The Gyrus G3 System is intended for use for ablation. resection and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (Head and Neck) surgery coagulation of soft tissue.

This device is intended for use by qualified medical personnel trained in the use of electrosurgery.

The Bipolar Generator section of the G3 RF Workstation is indicated for ablation, resection and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (Head and Neck) surgery including:

• Adenoidectomy .
• Cysts .
• Head, Neck, Oral, and Sinus Surgery
• Mastoidectomy
• Myringotomy with effective Hemorrhage Control
• Nasal Airway Obstruction by Reduction of Hypertrophic Nasal Turbinates
• Nasopharyngeal / Laryngeal indications including Tracheal Procedures, Laryngeal
• Polypectomy, and Laryngeal Lesion Debulking
• Neck Mass
• Papilloma Keloids
• Submucosal Palatal Shrinkage
• Tonsillectorny
• Traditional Uvulopalatoplasty (RAUP)
• Tumors
• Tissue in the Uvula/Soft Palate for the Treatment of Snoring
• Uvulopaiatopharyngoplasty (UPPP)
• Parotidectomy
• Radical Neck Disection

The Gyrus Somnoplasty TCRF Generator section of the G3 RF Workstation with the Temperature Controlled Radio-frequency (Somnoplasty®) Electrodes is indicated for coagulation of soft tissue including:

The coagulation of enlarged tonsils in patients 13 years of age and older; the reduction of the incidence of airway obstructions, e.g., base of tongue, soft palate, etc., in patients suffering from UARS or OSAS: tissue coagulation in the inferior turbinates; and tissue coagulation in the uvula/soft palate which may reduce the severity of snoring in some individuals.

The system is intended for use by qualified medical personnel trained in the use of electrosurgical equipment and familiar with potential complications that may arise during or following fead and Neck surgery.

The Gyrus G3 System Generator has two principal modes of operation:

• The monopolar mode has controls for maximum temperature and energy delivered. The unit has readouts for total energy delivered, impedance. temperature for two thermocouples and time of energy delivery.
• -The bipolar mode has controls for output waveform type and power. The unit has readouts for set power and waveform.

Connectors on the front panel include the monopolar connector for active electrode and dispersive electrode and separate dual bipolar connectors for PlasmaCision electrodes and bipolar instruments. The foot pedal is connected on the back panel.

Accessories included with the generator are the electrodes, connector cable, footswitch and a power cable.

The provided text is related to a 510(k) Premarket Notification for the Gyrus G3 Generator System & Accessories, an electrosurgical device. It outlines the device's description, intended use, and a comparison to predicate devices, but does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

Therefore, I cannot fulfill your request for the following information based on the provided text:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size
6. If a standalone performance (algorithm only) study was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

The document primarily focuses on regulatory approval (510(k)) based on substantial equivalence to predicate devices and states that "performance testing has been done to validate the performance of the device," but it does not detail the specifics of such testing, acceptance criteria, or study results.

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The Gyrus Endourology System, when used with a Gyrus Axipolar Resectoscope Electrode, is a radio frequency bipolar electrosurgical device system intended for use in urological surgical procedures involving the ablation or removal of soft tissue and where associated hemostasis is required. The specific urological indications where the system can be used are in transurethral prostatectorny (TURP) for benign prostatic hypertrophy, transurethral incision of the prostate (TUIP) or bladder neck, resection of bladder tumors and in cystodiathermy.

The Axipolar Resectoscope Electrode devices described in this 510(k) are sterile, disposable electrodes designed for use with the Gyrus Endourology System.

The provided document, K994166 "Gyrus Axipolar Resectoscope Electrode (ARE) Special 510(k) Premarket Notification: Device Modification," describes a device modification and asserts substantial equivalence to a predicate device. It does not present a study with specific acceptance criteria and reported device performance metrics in the way one would expect for a new diagnostic or AI-driven device.

This submission is a Special 510(k): Device Modification for an electrosurgical electrode. The focus of such a submission is to demonstrate that a modified device is still substantially equivalent to its original predicate device, often by showing continued compliance with design control requirements and risk analysis procedures, rather than conducting a new, extensive performance study with detailed acceptance criteria.

Therefore, many of the requested elements for describing an acceptance criteria study are not directly applicable or available in this document.

Here's a breakdown based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document as a formal table of acceptance criteria and performance metrics from a study. As a Special 510(k) for a device modification, the submission likely relies on demonstrating that the modified device continues to meet the safety and effectiveness profile of the original predicate device through design controls and risk analysis, rather than new, quantitative performance testing with explicit acceptance criteria.

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

This information is not provided. The document makes no mention of a "test set" in the context of performance evaluation as it would for a new diagnostic device.

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

This information is not applicable/provided. No "test set" and corresponding "ground truth establishment" by experts is described in this regulatory submission for a device modification.

4. Adjudication Method for the Test Set

This information is not applicable/provided. There is no described "test set" requiring an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not mentioned or conducted. This type of study is more relevant for diagnostic devices (especially those involving image interpretation) to assess the impact of AI on human reader performance. This document concerns an electrosurgical system electrode.

6. Standalone (Algorithm Only) Performance Study

No, a standalone performance study was not conducted or described. This document describes a physical medical device (an electrosurgical electrode), not an algorithm or AI system.

7. Type of Ground Truth Used

This information is not applicable/provided. No "ground truth" in the context of diagnostic performance evaluation is mentioned. The "ground truth" for an electrosurgical device's safety and effectiveness would implicitly be adherence to engineering specifications, material biocompatibility, and functional performance (e.g., cutting, coagulation efficiency) which are typically assessed through bench testing and animal/cadaver studies, but specifics are not detailed in this summary.

8. Sample Size for the Training Set

This information is not applicable/provided. The device is an electrosurgical electrode, not an AI or machine learning model that would require a "training set."

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

This information is not applicable/provided. As explained above, there is no "training set."

Summary of Device in the Context of the Request:

The provided document details a Special 510(k) Premarket Notification for a modification to the Gyrus Axipolar Resectoscope Electrode. The core of this type of submission is to demonstrate substantial equivalence to an existing, legally marketed predicate device (K990628 in this case) despite a modification. This is typically achieved by:

• Certification of compliance to 21 CFR 820.30 Design Control requirements: Showing that the design changes were controlled and documented to ensure the device still meets its intended use.
• Risk Analysis procedures: Demonstrating that the modifications do not introduce new or increased risks.
• Comparison to predicate: Arguing that the modified device maintains the same safety and effectiveness profile as the predicate.

The document explicitly states: "This submission is a Special 510(k): Device Modification as described in FDA's guidance document entitled 'The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications.' In support of this 510(k), Gyrus has provided certification of compliance to 21 CFR 820.30 design Control requirements, and Risk Analysis procedures."

Therefore, the "study" demonstrating the device meets "acceptance criteria" here is primarily the design control and risk analysis process that concludes the modified device remains substantially equivalent and performs as safely and effectively as its predicate. This is a qualitative and process-oriented demonstration rather than a quantitative, performance study with specific metrics and thresholds akin to those expected for a new diagnostic device or AI algorithm.

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Used to permit direct viewing of the cervical canal and the uterine Cavity for the purpose of performing diagnostic and surgical procedures. As used with the Gynecare Versapoint System, the indications for use include: Excision on intrauterine myomas Excision of intrauterine polyps Lysis of intrauterine adhesions Incision of uterine septa When used for resection of endometrial tissue with the G-VAP Electrode, the device is indicated for Endometrial Ablation.

The Gyrus Hysteroscopic Resectoscope that we intend to market employs an electrode specific resectoscope-working element. All other sheaths, etc., are standard COMEG components. A "Quick Connection" feature is used to attach the working element to the sheath. Endoscopic electrosurgical instruments and accessories are described under "Endoscope and Accessories" in 21 CFR 876.1500, and Hysteroscopes and described in 21 CFR 884.1690. The Hysteroscopic Resectoscope is intended to enable the viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures. The surgeon performs the examination through the cervical canal. The working elements are the devices that house and control various electrodes and lasers used to remove, cut, coagulate, and transect tissue. The surgeon controls the back and forth movement of the electrode using finger controls. The working elements also house a telescope for visualization. Current is transmitted to the electrode through a high frequency cable. These devices are composed of stainless steel, stainless steel chrome plated, plastic and brass chrome plated parts. The Gyrus Hysteroscopic Resectoscope as cleared in K982771, is identical to the COMEG Resectoscope cleared via K971882, with the working element modified to fit the Gyrus Medical Ltd. electrode. Endoscopic electrosurgical instruments and accessories are described in endoscope and accessories, 21 CFR 876.1500, and endoscope ESU units and accessories are described in 21 CFR 876.4300. Hysteroscopes are described in 21 CFR 884.1690. The Rotating Outer Sheath connection for the working element is of a "snap-on" construction, identical to the cleared device. The principal difference is in the rotating collar which allows 360 degree rotation of the fluid inlet. The Visual Obturator provides the same functionality as the standard obturator facilitating insertion to the uterus. In addition, the Visual Obturator allows use of the hysteroscope (telescope) during insertion, allowing visualization.

The provided text describes a 510(k) premarket notification for the Gyrus Hysteroscopic Resectoscope. It details the device's description, intended use, and indications for use, as well as a statement about performance data. However, the document does not contain specific acceptance criteria, a detailed study description, or quantitative performance metrics typically found in a study report.

Based on the provided text, here's what can be extracted and what information is missing:

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

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

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified. The testing is referred to as "Preclinical as well as bench top testing," implying laboratory or in-vitro settings rather than clinical trials with human subjects.

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/Not specified. The document does not describe a study involving expert assessment or ground truth establishment in a diagnostic or interpretive context.

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

• Not applicable/Not specified.

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. This document describes a medical device, specifically a surgical resectoscope, not an AI or imaging diagnostic device that would typically undergo an MRMC study.

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

• Not applicable. This is not an algorithm or AI device.

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

• Not applicable/Not specified. The "performance requirements" would likely be related to the mechanical, electrical, and functional aspects of the resectoscope (e.g., cutting efficacy, coagulation ability, visualization clarity, structural integrity), which are verified through various physical and functional tests rather than a ground truth in the diagnostic sense.

8. The sample size for the training set

• Not applicable. This is not a machine learning or AI device.

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

• Not applicable.

Summary of the Study (as described in the document):

The document mentions that "Preclinical as well as bench top testing has been performed to verify that The product meets the performance requirements described." This testing was conducted to substantiate the efficacy of the resectoscope for hysteroscopic usage. However, the document does not provide details on:

• The specific "performance requirements" or acceptance criteria.
• The methodology of the preclinical and bench top tests.
• The quantitative results of these tests.
• Any sample sizes (number of devices tested, number of simulated procedures, etc.).

Essentially, the document states that testing was done and the device performed as required, and this was sufficient for a 510(k) submission based on substantial equivalence to a predicate device. It is not a detailed scientific study report with explicit acceptance criteria and quantitative results.

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The Gyrus Endourology System is a radio frequency bipolar electrosurgical device system intended for use in urological surgical procedures involving the ablation or removal of soft tissue and where associated hemostasis is required. The specific urological indications where the system can be used are in transurethral prostatectomy (TURP) for benign prostatic hypertrophy, transurethral incision of the prostate (TUIP) or bladder neck, resection of bladder tumors and in cystodiathermy.

The Gyrus Endourology System is comprised of four key components: the Electrode, the Connector Cable, an Axipolar Resectoscope and an electrosurgical generator called the Controller. The Connector Cable connects the Controller to the Electrode. The Electrode is provided in a variety of models, ranging in size from 5 Fr. to 24 Fr. A system specific Resectoscope is provided for use with one of the Electrode models. Other Electrode models are available for use with available cystoscopes with a 5Fr or larger operating channel. The Electrode is supplied sterile and intended for single patient use. The Connector Cable is designed for a number of sterilizations and the Resectoscope for repeat sterilizations using steam autoclaving methods. The Controller is an electronic radio frequency generator. The Gyrus Endourology System is bipolar, incorporating a return electrode as a part of the electrode tip. This means that a return pad is not required for system operation. The return energy in a bipolar device with an integral return electrode does not penetrate the tissue as in a monopolar device. In a monopolar device, the energy passes through the patient's body to reach the return pad.

The provided document is a 510(k) Premarket Notification for the Gyrus Endourology System. This type of FDA submission aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, rather than proving its safety and effectiveness through extensive clinical trials with acceptance criteria.

Therefore, the document does not contain the following information typically associated with a study proving a device meets specific acceptance criteria:

1. A table of acceptance criteria and the reported device performance: This document focuses on demonstrating equivalence to predicate devices, not meeting pre-defined performance thresholds.
2. Sample size used for the test set and the data provenance: No new performance data specific to the Gyrus Endourology System is presented from a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Ground truth establishment is not relevant to a substantial equivalence demonstration for this type of device.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is an electrosurgical device, not an AI/algorithm-based system.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable, as there's no mention of a training set for an algorithm.
9. How the ground truth for the training set was established: Not applicable.

Instead, the document focuses on demonstrating substantial equivalence to existing predicate devices based on:

• Identical intended use: The Gyrus Endourology System's indications for use are described and implicitly compared to those of the predicate devices.
• Similar technological characteristics: The document explicitly states, "The technological characteristics of the Gyrus Endourology System are the same as those of the Scuba (Gynecare Versapoint™) Electrosurgery System, Electrodes (K962482, K982738) and its dedicated Resectoscope and accessories (K982771). The devices are substantially equivalent in terms of design, materials, principle of operation, product specifications and sterilization."
• Safety and effectiveness demonstrated by predicate devices: The submission asserts that "Equivalent monopolar and bipolar electrosurgery devices have been cleared via 510(k), such as those manufactured by Erbe (K933002) and COMEG (K971881). These devices have been demonstrated to be safe and effective in removing tissue during urological surgery." By demonstrating equivalence to these devices, the Gyrus system is presumed to also be safe and effective.

The provided text does not contain any information about specific acceptance criteria or performance studies in the way you've outlined for an AI/algorithm-based device. It is a regulatory submission focused on comparing the new device to existing, legally marketed devices.

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Used to permit direct viewing and access to the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures. As used with the Gynecare Versapoint System, the indications for use include: Excision of intrauterine myomas Excision of intrauterine polyps Lysis of intrauterine adhesions Incision of uterine septa

The Gyrus Hysteroscopic Resectoscope that we intend to market employs an electrode specific resectoscope-working element. All other sheaths etc., are standard COMEG components. A "Quick Connection" feature is used to attach the working element to the sheath. Endoscopic electrosurgical instruments and accessories are described under "Endoscope and Accessories" in 21 CFR 876.1500, and Hysteroscopes are described in 21 CFR 884.1690. The Hysteroscopic Resectoscope is intended to enable the viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures. The surgeon performs the examination through the cervical canal. The working elements are the devices that house and control various electrodes and lasers used to remove cut, coagulate, and transect tissue. The surgeon controls the back and forth movement of the electrode, using finger controls. The working elements also house a telescope for visualization. Current is transmitted to the electrode through a high frequency cable. These devices are composed of stainless steel, stainless steel chrome plated, plastic and brass chrome plated parts.

Here's an analysis of the provided text regarding the Gyrus Hysteroscopic Resectoscope's acceptance criteria and the study that proves it meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided document, specific numerical acceptance criteria and detailed performance metrics are not explicitly stated in a quantifiable way. The document focuses on demonstrating substantial equivalence to predicate devices rather than quantitative performance against a predefined set of criteria.

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

• Sample Size: The document does not specify a sample size for any test set.
• Data Provenance: The document states "Pre-clinical as well as bench top testing has been performed." This implies controlled laboratory settings. There is no mention of human subject data, country of origin, or whether the data was retrospective or prospective.

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

• Number of Experts: Not specified.
• Qualifications: Not specified.

4. Adjudication Method for the Test Set

• No adjudication method is mentioned, as the type of "test set" and the nature of the "ground truth" (see point 7) are not detailed.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is more common for diagnostic imaging AI systems and not typically for a resectoscope device.

  • Effect Size of Human Reader Improvement: Not applicable, as no MRMC study was conducted.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study Was Done

• No, a standalone (algorithm only) performance study was not done. This device is an instrument used by a human surgeon, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this medical device's performance relies on engineering verification and validation. This includes:

• Confirmation that the device functions as designed (e.g., proper control of electrodes, effective cutting/coagulation).
• Compliance with material specifications and safety standards.
• Functional equivalence to predicate devices.

There is no mention of ground truth established by expert consensus, pathology, or outcomes data from patient studies.

8. The Sample Size for the Training Set

• Not applicable. This device is a physical instrument, not an AI algorithm that requires a "training set" in the context of machine learning.

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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