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The ViKY UP device is indicated for computer-controlled laparoscopic hysterectomies (such as da Vinci-assisted laparoscopic hysterectomies) for the purpose of holding and controlling the movement of a uterine manipulator.

ViKY UP is a motorized uterine manipulator positioner for computer-controlled laparoscopic hysterectomies. ViKY UP holds and moves the uterine manipulator in three directions according to surgeon orders by means of either a foot controller or a voice controller. Use of the ViKY UP allows surgeon to remotely gain control on uterine manipulator positioning from his operating position. The ViKY UP includes two attachment mechanisms: one at its first end for mounting the system to the operating room table and the other at the second end for securely grasping a uterine manipulator. The ViKY UP remains external to the patient's body at all times and can be steam sterilized.

The provided text describes the ViKY UP device, a motorized uterine manipulator positioner, and its submission for 510(k) clearance. However, the document does not contain a typical "acceptance criteria" table with specific metrics (like sensitivity, specificity, accuracy) and corresponding performance targets, nor does it detail a study designed to prove the device meets such criteria in a quantitative, statistical sense.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through design analysis, bench testing, and a clinical study assessing safety and effectiveness.

Here's a breakdown of the information that can be extracted, addressing your specific points:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, a formal table of quantitative acceptance criteria and corresponding performance metrics is not provided in this document. The "acceptance criteria" are implied by the overall goal of demonstrating safety and effectiveness for its intended use and substantial equivalence to predicate devices.

The reported device performance is qualitative:

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

• Test Set Sample Size: 30 patients
• Data Provenance: Prospective clinical study, conducted in France (based on submitter's address and lack of other indications).

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

The document does not specify the number of experts used or their qualifications for establishing ground truth. The clinical study evaluated the device's performance in actual surgical procedures by surgeons, implying an assessment by the treating surgeons. There is no mention of an independent panel or formal "ground truth" establishment outside of the surgical outcomes.

4. Adjudication Method for the Test Set

The document does not specify any formal adjudication method (e.g., 2+1, 3+1, none) for the clinical study's observations. The reporting of "no adverse effects or complication" and "safety and effectiveness" suggests that the clinical outcomes were observed and reported without a described multi-reviewer adjudication process.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a surgical manipulator, not an imaging or diagnostic device typically evaluated with MRMC studies. The study assessed the device's performance during surgery, not human reader interpretation of data.

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

This question is not applicable to the ViKY UP device. The ViKY UP is a motorized surgical assistant (a hardware device), not an algorithm or AI system that operates in a "standalone" mode without human interaction inherent in surgical procedures. It is explicitly described as "computer-controlled" by a "surgeon" using a foot/voice controller, so human-in-the-loop operation is its only mode.

7. The Type of Ground Truth Used

The "ground truth" for the clinical study was based on clinical outcomes and observations during laparoscopic hysterectomies. This includes:

• Absence of adverse effects or complications.
• Confirmation that the device could safely and effectively manipulate the uterine manipulator.
• Observations regarding set-up time and overall procedural impact.

Essentially, the "ground truth" was derived from the real-world performance and clinical judgment of the surgical team using the device in a clinical setting.

8. The Sample Size for the Training Set

The document does not mention a training set in the context of an algorithm or AI. The "training" for a hardware device development would typically involve engineering tests and design iterations, not a data-based training set as understood for AI/ML.

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

This question is not applicable as there is no mention of a training set for an algorithm described in the document. The "ground truth" for the development of such a device would instead be engineering specifications met through bench testing, and design validation processes.

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