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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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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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