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GIMMI ALPHA® Hysteroscopes and Accessories are intended to be used by qualified physicians to provide access, illumination and visualization of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. These generic devices are used to perform diagnostic and surgical procedures.

Device Description

GIMMI ALPHA Hysteroscopes are comprised of rigid, panoramic telescopes using rod lens technology. The body contact portions 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.

Laparoscopic and obstetric-gynecologic accessories are composed of reusable handle and shaft assemblies and removable, reusable tip assemblies. Some specialized instruments, such as the gynecologic fibroid screw and uterine tenaculum are one-piece.

The instruments are designed and manufactured specifically for the purpose of manipulating soft tissue structures (grasping, cutting, dissecting, coagulating and suturing).

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Gimmi Alpha Hysteroscopes & Accessories:

Based on the provided 510(k) summary (K012869), the device is cleared based on substantial equivalence to predicate devices, rather than meeting specific quantifiable performance metrics through a clinical study with detailed acceptance criteria as one might expect for novel technology. This is a common approach for medical devices that are similar in design, materials, and intended use to products already on the market.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Intended Use	Identical to predicate devices.	"The GIMMI "ALPHA Hysteroscopes & Accessories have the same intended use as predicate devices." The intended use describes the device's function: "to provide access, illumination and visualization of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix... used to perform diagnostic and surgical procedures."
Performance Attributes	Equivalent to predicate devices.	"performance attributes ... are identical and/or substantially equivalent to SE devices." This is a general statement indicating that the device performs as expected for its class.
Materials	Identical to predicate devices, biocompatible.	"They are made of the same material [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."
Basic Design	Fundamentally similar to predicate devices, with slight modifications not adversely affecting safety/effectiveness.	"basic design are identical and/or substantially equivalent to SE devices. Slight modifications in design do not adversely affect the safety and effectiveness of these devices." The description notes "rigid, panoramic telescopes using rod lens technology."
Safety & Effectiveness	No new issues of safety and effectiveness compared to predicates.	"The results of design validation raise no new issues of safety and effectiveness." All materials "were subjected to performance and physical tests to evaluate safety, effectiveness, and reliability of the devices. All results were in conformance with the cited harmonized device standards."
Compliance with Standards	Compliance with relevant international and national device standards (ISO/EN/ASTM/AAMI/ANSI/IEC).	"GIMMI certifies compliance with relevant ISO/EN/ASTM/ AAMI/ANSI/IEC and other device-related standards that apply to the manufacture, packaging, labeling, and reprocessing of subject devices including the validation of these processes."

2. Sample Size Used for the Test Set and Data Provenance

This document does not describe a clinical "test set" with human subjects or a specific data provenance in the way a clinical trial for a novel device would. The evaluation is based on engineering and material testing and a comparison to known predicate devices. The "Summary of Testing" states: "All materials used in the composition of GIMMI ALPHA Hysteroscopes and Accessories were subjected to performance and physical tests to evaluate safety, effectiveness, and reliability of the devices." No sample size or data provenance details like country of origin or retrospective/prospective nature are provided for these internal tests, as it's not a clinical study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This information is not applicable to this 510(k) submission. There was no "test set" requiring expert ground truth establishment in the context of a clinical performance study. The evaluation focused on material properties, design similarity, and compliance with manufacturing standards.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical test set requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed to evaluate reader performance (e.g., radiologists interpreting images) with and without AI assistance, which is not relevant for the type of device (hysteroscopes) being discussed here.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

No, this is not an AI algorithm. It is a physical medical device (hysteroscopes and accessories). Therefore, a standalone algorithm performance study is not applicable.

7. The Type of Ground Truth Used

The "ground truth" in this context is established by:

Predicate Device Performance: The safety, effectiveness, and performance of existing, legally marketed hysteroscopes serve as the primary reference point.
Engineering Standards and Material Specifications: Compliance with established international and national standards (ISO/EN/ASTM/AAMI/ANSI/IEC) for medical devices, materials, manufacturing, and reprocessing.
Biocompatibility Data: The historical biocompatibility of surgical grade stainless steel for human use.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no AI training set.

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