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

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 an actuating handle, a tube to accommodate the optics, and a mechanism to which the disposable Roei Cutting Loops are attached. The proximal end of the Roei Working Element has a connection port for connection of a resectoscope optics element. The opposite end of the Roei Working Element has a connection port that accommodates a resectoscope sheath used to encase the tube and the Roei Cutting Loop. Additionally, the Roei Working Element 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. Furthermore, the Roei Working Element allows for a linear motion of the loop allowing complete retraction of the loop within the sheath during surgical procedures.

The provided text describes a 510(k) summary for the Roei Working Element and Roei Cutting Loops, focusing on substantial equivalence to a predicate device. It does not contain information about acceptance criteria or a study proving that the device meets such criteria. The document explicitly states that the substantial equivalence is confirmed by the company's design control system requirements and compliance with recognized consensus standards (IEC 6061-2-2 and AAMI/ANSI HF 18).

Therefore, the requested information, particularly regarding specific numerical acceptance criteria and a study with detailed performance metrics, sample sizes, expert ground truth, adjudication methods, or comparative effectiveness, is not present in the provided text.

Here's an overview of what is available based on your request, and what is absent:

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

• Not Available: The document does not provide a table of acceptance criteria or quantitative performance metrics for the device. It relies on substantial equivalence to a predicate device and compliance with standards.

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

• Not Available: No information regarding a specific test set, its sample size, or data provenance is provided. The document highlights the company's design control system as confirmation of safety and efficacy.

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 Available: No information on experts establishing ground truth is present, as there is no mention of a formal test set with expert adjudicated ground truth.

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

• Not Available: No adjudication method is mentioned, as there is no specific test set or associated ground truth establishment process 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 / Not Available: This device is a urological medical instrument (resectoscope accessories), not an AI diagnostic/imaging device. Therefore, an MRMC study related to human reader performance with or without AI assistance is not relevant and not mentioned.

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

• Not Applicable / Not Available: This device is a physical medical instrument, not an algorithm. Standalone algorithm performance is not relevant and not discussed.

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

• Not Available: No ground truth type is mentioned as there is no specific study or test set with a defined ground truth in the provided text.

8. The sample size for the training set

• Not Available: No information about a training set or its sample size is provided.

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

• Not Available: No information about how ground truth for a training set was established is provided.

Summary of Device Acceptance Rationale from Text:

The device's acceptance (clearance in this case) is based on:

• Substantial Equivalence: The modified Roei Working Element and Roei Cutting Loops are deemed substantially equivalent to a previously cleared predicate device (K050910). The document states they have a similar intended use, indications for use, and principles of operation.
• Minor Technological Differences: The minor differences (longitudinal movement mechanism and adjustment of cutting wire connection) are claimed not to raise new questions of safety or efficacy, as confirmed by the company's design control system requirements.
• Compliance with Recognized Consensus Standards: The device will be in compliance with IEC 6061-2-2 (Safety of High Frequency Surgical Equipment) and AAMI/ANSI HF 18 (Electrosurgical devices) prior to marketing.

This 510(k) summary focuses on regulatory clearance through the substantial equivalence pathway, rather than reporting on a clinical or performance study with detailed acceptance criteria and results.

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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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