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The Roei Working Element and Roei Cutting Loops are endoscopic electrosurgical accessories intended for use with monopolar resectoscope systems for the resection of soft tissue in transuretheral bladder tumor resection (TURBT), transurethral prostatic and bladder biopsy, and transurethral resection of the prostate (TURP) procedures.

The Roei Working Element and Cutting Loops use the same fundamental operating characteristics as other resectoscope working elements and electrode cutting loops. The Roei Working Element includes a handle and rod to which the disposable Roei Cutting Loops are attached. One end of the handle has a connection port for connection of a resectoscope optics element. The opposite end of the Roei Working Element handle has a connection port that accommodates a resectoscope sheath used to encase a Roei Cutting Loop. Additionally, the Roei Working Element handle provides an electrical connection box with an inlet receptacle for connection of a resectoscope's electrosurgical cable that is then attached to a monopolar electrosurgical generator. Once the Roei Working Element and Cutting Loop are attached to a resectoscope system, the Roei Cutting Loop receives electrical current from the electrosurgical generator. The electrical current transmitted to the Cutting Loop is then used to resect the targeted soft tissue.

In addition to serving as the housing for the Roei Cutting Loops, optics and electrical connections, the Roei Working Element permits translation of the axial motion of the handgrip into a circular axis movement of the Cutting Loop independent of the resectoscope sheath. This circular axis movement provides the ability for the surgeon to move the Cutting Loop in a side-to-side clockwise or counterclockwise direction through the soft tissue, according to the operating handle position.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Roei Working Element and Roei Cutting Loops:

Acceptance Criteria and Device Performance Study

1. Table of Acceptance Criteria and Reported Device Performance

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

The document mentions "Animal testing" as the basis for performance data.

• Sample Size: Not specified. The document only states "Animal testing conducted...".
• Data Provenance: The country of origin of the animal testing data is not specified. The study is prospective as it involves active animal testing to evaluate the device.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

• Number of Experts: Not specified. The document does not provide details on who assessed the animal testing results or how "safely and effectively resects soft tissue" was determined.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

Not specified. There is no mention of an adjudication method as the evaluation appears to be based on observed outcomes from animal testing and compliance with standards.

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

No, an MRMC comparative effectiveness study was not done. The submission is for a medical device (surgical tools) and does not involve image-based diagnosis or human interpretation in the context of an MRMC study. The comparison made is against predicate devices in terms of intended use, technological characteristics, and principles of operation, rather than a comparative effectiveness study with human readers assisted by AI.

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

Yes, in a way. The "performance data" section focuses on the device itself (the Roei Working Element and Roei Cutting Loops) functioning independently to resect soft tissue in animal models and its compliance with safety and electrosurgical standards. This can be considered a standalone evaluation of the device's functional and safety characteristics, without human intervention for interpreting results in the way an AI algorithm would be evaluated. It's a standalone test of the physical device's performance.

7. The Type of Ground Truth Used

The ground truth used for the animal testing was the observed outcome of soft tissue resection in an animal model. The statement "safely and effectively resects soft tissue" implies direct observation of the surgical outcome (e.g., successful removal of targeted tissue, lack of excessive collateral damage, appropriate healing). For the standards compliance, the ground truth would be the parameters and requirements outlined in IEC 6061-2-2 and AAMI/ANSI HF 18.

8. The Sample Size for the Training Set

Not applicable. This device is a surgical instrument, not an AI/ML algorithm that requires a training set.

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 Henke Sass Wolf Hysterscopic Resectoscopes and Accessories are intended to enable the viewing and resection/coagulation of soft tissue encountered in but not limited to gynecologic, urologic diagnostic and surgical procedures.

The HENKE SASS WOLF Hysteroscopic Resectoscopes are intended to provide the physician with a means for endoscopic diagnostic and therapeutic surgical procedures. The HENKE SASS WOLF Resectoscopes and Accessories will include the Sheaths - to establish portals for visualization and surgical access and the electrode devices indicated for resection/coagulation for soft tissue and are intended for the use with the compatible resectoscopes.

The Resectoscopes and Accessories are indicated for use in diagnostic examination and therapeutic surgical procedures of but not limited Urological and Gynecological Fields. The surgical applications to: may include:

Tissue Cutting, removal, and dissection as required or encountered in but not limited to:

• Excision of intrauterine myomas
• Excision of intrauterine polyps
• Lysis of intrauterine adhesions
• . Incision of uterine septa

The HENKE-SASS, WOLF Hysteroscopic Resectoscopes and Accessories are reusable handheld instruments designed for a means of performing diagnostic and therapeutic procedures. The HENKE-SASS, WOLF Hysteroscopic Resectoscopes and Accessories (available in various lengths and Sizes) have the same operating principals and intended uses as many of the competitive hysteroscopic resectoscopes and accessories already in commercial distribution

This document is a 510(k) summary for a medical device (Hysteroscopic Resectoscope and Accessories), and as such, it focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study report with specific performance metrics.

Therefore, the information requested for a detailed study demonstrating acceptance criteria is not present in the provided text. The document relies on the "same operating principles and intended uses" and "identical material and design" as already marketed predicate devices to establish safety and efficacy.

Here's a breakdown of why each requested point cannot be answered from the provided text:

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

• Not available. The document does not specify quantitative acceptance criteria for device performance (e.g., specific thresholds for cutting efficacy, coagulation efficiency, or instrument durability). It states that the device is "same as the predicate devices" in function and "utilize material and design is identical to the predicate devices."

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

• Not available. There is no mention of a specific test set, clinical study, or data associated with direct performance evaluation of this new device. The "data" implicitly refers to the long-standing safety record and performance of the predicate devices.

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 available. No ground truth establishment experts are mentioned because there's no specific test set or clinical data presented for this new device.

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

• Not applicable / Not available. No test set or adjudication process is mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This device is a surgical instrument (Hysteroscopic Resectoscope), not an AI-powered diagnostic or imaging interpretation tool. Therefore, MRMC studies and AI assistance are not relevant to its function.

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

• Not applicable. This is a physical surgical instrument, not an algorithm.

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

• Not applicable / Not available for this specific device. The "ground truth" for demonstrating safety and efficacy indirectly relies on the established performance and safety record of the predicate devices in clinical use.

8. The sample size for the training set

• Not applicable. This is a physical surgical instrument, not a learning algorithm or AI.

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

• Not applicable. See point 8.

Summary of available information regarding safety and effectiveness:

The provided 510(k) summary establishes substantial equivalence based on the following:

• Identical Operating Principles and Intended Uses: "The HENKE SASS WOLF Resectoscope and Accessories have the same operating principals and intended uses as many of the competitive resectoscopes and accessories already in commercial distribution."
• Identical Material and Design: "The resectoscope and accessories utilize material and design is identical to the predicate devices (Manufactured by HENKE SASS WOLF on an OEM basis)."
• Predicate Devices: A list of several predicate hysteroscopic resectoscopes and accessories is provided, implying that the safety and efficacy of the new device are derived from the established safety and efficacy of these legally marketed devices.
• Manufacturing Standards: The device is manufactured according to cGMPs, ISO 9001/EN 46001, AAMI/ASTM standards, and EN/IEC 60601 Standards.

In essence, for a Class II device like this undergoing a 510(k) process, the "study that proves the device meets the acceptance criteria" is the demonstration of substantial equivalence to predicate devices, which are already accepted as safe and effective. No new, specific performance study with acceptance criteria is presented in this summary document.

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