(26 days)
Tissue cutting, removal, and desiccation as required or encountered in gynecologic hysteroscopic electrosurgical procedures for the treatment of intrauterine myomas, polyps, adhesions, and septa, and benign conditions requiring endometrial ablation.
Excision of intrauterine myomas
Excision of intrauterine polyps
Lysis of intrauterine adhesions
Incision of uterine septa
Endometrial ablation
The Loop Electrode is an Bipolar Electrosurgical Electrode. It is used in conjunction with the Scuba Electrosurgical Generator.
This document describes an electrosurgical electrode and does not contain information related to AI/ML device performance or studies with acceptance criteria as typically found in medical imaging AI submissions. Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, ground truth establishment, or multi-reader studies.
The provided text focuses on:
- Device Name: Versapoint Electrosurgery Loop Electrode Accessory
- Predicate Device: Scuba Electrosurgical System and Versapoint Electrosurgery G-VAP Electrode Accessory
- Device Description: Bipolar Electrosurgical Electrode used with the Scuba Electrosurgical Generator.
- Intended Use: Gynecologic hysteroscopic electrosurgical procedures.
- Indications Statement: Tissue cutting, removal, and desiccation in gynecologic hysteroscopic electrosurgical procedures for treatment of intrauterine myomas, polyps, adhesions, septa, and benign conditions requiring endometrial ablation.
- Technological Characteristics: Stated to have the "same technological characteristics as the predicate device" with similar form, fit, function, and method of operation.
- Preclinical Testing: "Preclinical testing has been performed to verify that the product meets the Performance Data performance requirements described. It was determined that the device performs safely and effectively."
Summary of what is present and what is missing based on your request:
- Acceptance Criteria & Reported Device Performance: The document states that "Preclinical testing has been performed to verify that the product meets the Performance Data performance requirements described. It was determined that the device performs safely and effectively." However, it does not list specific acceptance criteria (e.g., in a table) or quantitative performance metrics (e.g., sensitivity, specificity, accuracy, precision) as would be expected for an AI/ML device. It's a general statement of compliance for a traditional medical device (electrosurgical electrode).
- Sample size: Test set: Not applicable/not provided. This is not a study involving a test set of data points in the AI/ML context.
- Data provenance: Not applicable.
- Number of experts and qualifications: Not applicable.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: Not applicable.
- Standalone performance: Not applicable.
- Type of ground truth: Not applicable.
- Sample size for training set: Not applicable.
- How ground truth for training set was established: Not applicable.
This document serves as a 510(k) summary for a traditional medical device, specifically an electrosurgical electrode, emphasizing substantial equivalence to a predicate device based on technological characteristics and preclinical testing. It does not provide the type of performance evaluation details (like those related to AI/ML algorithms and their test sets) that your questions are designed to cover.
§ 884.1690 Hysteroscope and accessories.
(a)
Identification. A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for hysteroscope accessories that are not part of a specialized instrument or device delivery system; do not have adapters, connectors, channels, or do not have portals for electrosurgical, laser, or other power sources. Such hysteroscope accessory instruments include: lens cleaning brush, cannula (without trocar or valves), clamp/hemostat/grasper, curette, instrument guide, forceps, dissector, mechanical (noninflatable), and scissors. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.