(90 days)
This instrument is indicated for use during gynecologic laparoscopic murgical procedures, and, using additional accessories, to perform various diagnostic and therapeutic procedures.
Specific Indications for Use
- unexplained pelvic pain (acute, chronic) .
- infertility work-up ●
- tubal sterilization .
- unexplained primary or secondary amenorthea .
- diagnosis and/or treatment of ectopic pregnancy ●
- evaluation, diagnosis and/or treatment of small pelvic turnors, including ● myomata
- evaluation of congenital anomalies of the pelvic organs .
- retrieval of foreign bodies ●
- determination of the presence and extent of pelvic endometriosis .
- determination of the presence and extent of pelvic inflammatory disease ●
- laparoscopic assisted vaginal hysterectomy ◆
- evaluation of ovarian endocrinopathy ●
- visualization, diagnosis and/or treatment of perforate abdominal organs .
The KSEA MVM 3.3 mm Microendoscope is comprised of a video module, and a endoscope module. The endoscope module is a rigid, panoramic telescope which utilizes rod lens technology. The video module is an imaging device which connects to a camera control unit. The body contact portions of the KSEA MVM 3.3 mm Microendoscope are composed of surgical grade stainless steel, which is commonly used in medical devices for a wide range of applications and has a long history of biocompatibility for human use.
The provided document is a 510(k) summary for the Karl Storz MVM 3.3 mm Microendoscope. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study proving the device meets those criteria.
Therefore, the information requested below cannot be fully extracted from the provided text, as it describes a clearance process based on substantial equivalence, not a performance study against predefined acceptance criteria for AI/diagnostic devices.
Here's an attempt to answer based on the available information and highlight what is missing:
1. A table of acceptance criteria and the reported device performance
No explicit acceptance criteria or reported device performance metrics (e.g., sensitivity, specificity, accuracy) are provided in this 510(k) summary. The document states that "minor differences between the KSEA MVM 3.3 mm Microendoscope and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no affect on the performance, function or intended use of the devices." This implies that the device's performance is considered to be equivalent to the predicate devices, but no specific performance data is given.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is not a performance study against a test set with clinical data.
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. No ground truth establishment for a test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set or adjudication method is 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. This device is a video endoscope, not an AI-powered diagnostic tool. No MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a video endoscope, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No ground truth for a performance study is described. The "ground truth" in 510(k) for substantial equivalence often refers to the understanding and performance of the predicate devices.
8. The sample size for the training set
Not applicable. This document is not describing an AI/machine learning model where a training set would be used.
9. How the ground truth for the training set was established
Not applicable. No training set or associated ground truth establishment is described.
§ 884.1720 Gynecologic laparoscope and accessories.
(a)
Identification. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), scissors, and suction/irrigation probe. 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.