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510(k) Data Aggregation
(66 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safe and effective resection of soft tissue (functional performance) | Animal testing demonstrated that the device "safely and effectively resects soft tissue." |
| Compliance with IEC 6061-2-2, Third Ed. (1998-09): Medical Electrical Equipment - Part 2: Particular Requirements for the Safety of High Frequency Surgical Equipment (Electrical Safety) | The device "will be in compliance with the following recognized consensus standards prior to marketing the device." This implies an intention to comply, rather than direct reporting of achieved compliance in this document. |
| Compliance with AAMI/ANSI HF 18 (2001): Electrosurgical devices (Electrosurgical Performance) | The device "will be in compliance with the following recognized consensus standards prior to marketing the device." This implies an intention to comply, rather than direct reporting of achieved compliance in this document. |
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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