IMAGYN FALLOPOSCOPY SYSTEM by IMAGYN MEDICAL, INC.

I am sorry, but the provided text does not contain sufficient information to describe the acceptance criteria and the study that proves the device meets those criteria in the structured format you requested.

The document is a 510(k) summary for the Imagyn Falloposcopy System and primarily focuses on:

Identification of the device and manufacturer.
Identification of predicate devices.
Description of the device and its intended use.
Technological comparisons to predicate devices.
A general statement that "Clinical and non-clinical tests were performed to demonstrate that the device performed according to its description and intended use."

However, it does not provide details on:

Specific acceptance criteria (e.g., sensitivity, specificity, accuracy targets).
Any performance metrics achieved by the device.
Sample sizes for test sets or training sets.
Data provenance.
The number or qualifications of experts used for ground truth.
Adjudication methods.
Whether MRMC studies were performed.
Whether standalone algorithm performance was assessed (the device described is a physical medical device, not an AI algorithm).
The type of ground truth used (beyond the general statement of "clinical tests").
How ground truth for the training set was established.

Therefore, I cannot populate the requested table or answer the specific questions about the study design with the given input.

Summary

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510(k) Summary

Submitted By:	Imagyn Medical, Inc.27651 La Paz RoadLaguna Niguel, CA 92677-3917(714) 362-2500Contact: Debra A. Rinderer
Summary Preparation:	September 5, 1996
Device:	Imagyn Falloposcopy System
Predicate Devices:	Baxter Healthcare Corp. LE PTA CatheterConceptus Fallopian Tube Catheterization SystemOvaMed GyneSys Dx Uterine Ostial Access CatheterOvaMed Saratoga Modular Miniature Endoscope SystemOptimed Technologies, Inc. Flexible Fiber Optic Hysteroscopes
Device Description:	The Imagyn Falloposcopy System consists of the following components:Linear Everting (LE) Fallopian Tube Access CatheterFalloposcope
Intended Use of Device:	The Imagyn Falloposcopy System is indicated for intratubal catheterization for evaluation of occlusions in the fallopian tube.
Technological Comparisons:	The device has equivalent technological characteristics to the predicate devices to achieve intratubal catheterization for evaluation of occlusions in the fallopian tube.
Performance Summary:	Clinical and non-clinical tests were performed to demonstrate that the device performed according to its description and intended use.

Imagyn Medical, Inc. 27651 La Paz Road
Laguna Niguel, CA 92677 Tel: (714) 362-2500
Fax: (714) 362-2520

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Juríagyn

K963580

Regulation Number and Section

§ 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.