Search Results

The Uterine Manipulators are intended for use by qualified surgeons to manipulate the uterus during laparoscopic procedures including laparoscopic assisted vaginal hysterectomy.

The Uterine Manipulators are manual reusable surgical devices. The KSEA Uterine Manipulators are intended for use by qualified surgeons to manipulate the uterus during laparoscopic procedures including laparoscopic assisted vaginal hysterectomy. The body contact materials are surgical grade stainless steel, PTFE, silicone.

This submission is for a Uterine Manipulator, which is a manual surgical device. The provided text is a 510(k) summary for a medical device and does not contain the kind of information typically found in a study proving a device meets acceptance criteria related to AI/ML performance.

Therefore, most of the requested information regarding acceptance criteria, study design, expert involvement, and AI performance metrics is not applicable to this type of device submission.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not present in the provided 510(k) summary. For a manual surgical device like a uterine manipulator, acceptance criteria would typically involve engineering specifications (e.g., material strength, dimension tolerances, biocompatibility, sterilization efficacy) and functional testing without specific performance metrics like sensitivity or specificity that are common for diagnostic AI tools.

2. Sample size used for the test set and the data provenance:

This information is not applicable as there is no "test set" in the context of an AI/ML-driven device evaluation. The device is a manual surgical tool.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable. Ground truth is not established for a manual surgical device in the same way it would be for an AI diagnostic device.

4. Adjudication method for the test set:

This information is not applicable. There is no "test set" requiring adjudication for this type of manual device.

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:

This information is not applicable. This device is a manual surgical instrument, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

This information is not applicable. This device is entirely human-in-the-loop; it is a manual surgical instrument.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

This information is not applicable. Ground truth, in the context of AI/ML evaluation, is not a concept applied to the regulatory review of a manual surgical device. Safety and effectiveness are typically demonstrated through substantial equivalence to predicate devices, material testing, and functional assessments.

8. The sample size for the training set:

This information is not applicable. There is no "training set" for a manual surgical device.

9. How the ground truth for the training set was established:

This information is not applicable. There is no "training set" for this device.

Summary of the 510(k) Submission for this Device:

The 510(k) submission (K992027) for the KONINCKX, KECKSTEIN-SCHIFF, and CLERMONT Uterine Manipulators focuses on demonstrating Substantial Equivalence to legally marketed predicate devices.

• Intended Use: "The Uterine Manipulators are intended for use by qualified surgeons to manipulate the uterus during laparoscopic procedures including laparoscopic assisted vaginal hysterectomy."
• Device Description: "The Uterine Manipulators are manual reusable surgical devices. The body contact materials are surgical grade stainless steel, PTFE, silicone."
• Basis for Substantial Equivalence: The applicant states, "The KSEA Uterine Manipulators are substantially equivalent to the predicate devices since the basic features, design and intended uses are similar. The minor differences in design and dimensions between the KSEA Uterine Manipulators and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no effect on the performance, function or intended use of these devices."

In the context of this 510(k), compliance with general controls provisions of the Act (e.g., annual registration, listing of devices, good manufacturing practice, labeling) and the Quality System Regulation (QS) for Medical Devices (21 CFR Part 820) are assumed for a substantial equivalence determination.

Ask a specific question about this device