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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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The ViKY System is a motorized device whose intended use is to allow a surgeon to hold and position a rigid endoscope during endoscopic surgical procedures. Its light architecture allows the ViKY System to be maintained above the patient by a dedicated arm attached to the table. The ViKY System movements are controlled by the surgeon either by a foot controller or a voice controller.

The ViKY System is indicated for thoracic and laparoscopic minimally invasive procedures for the purpose of holding and controlling the movement of standard rigid endoscopes within surgical cavities during endoscopic surgery.

ViKY is a motorized endoscope holder for thoracic, abdominal, and pelvic minimally invasive procedures. ViKY is maintained by a dedicated arm attached to the table. It is moved according to surgeon orders by means of either a foot controller or a voice controller, in caudal, cranial and lateral directions, as well as zoom in and zoom out of the field.

This is a 510(k) premarket notification for a medical device called ViKY, a motorized endoscope holder. The document focuses on establishing substantial equivalence to predicate devices, rather than presenting a study with specific acceptance criteria and detailed device performance metrics in the format requested.

Therefore, many of the requested sections regarding acceptance criteria, sample sizes, ground truth, and expert involvement are not applicable or cannot be extracted from the provided text.

Here is an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not detail specific acceptance criteria for performance metrics (e.g., accuracy of movement, speed, stability) for the ViKY device. Instead, it focuses on general safety and effectiveness through substantial equivalence and compliance with established electrical and EMC standards.

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

• Sample Size for Test Set: Not specified. The document mentions "summaries of testing on animals and clinical experience with the system were provided," but does not give specific sample sizes for these tests.
• Data Provenance: Not specified.
  • Animal testing: Country of origin and whether retrospective or prospective are not mentioned.
  • Clinical experience: Country of origin and whether retrospective or prospective are not mentioned.

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

This information is not provided. The 510(k) submission focuses on regulatory compliance and substantial equivalence to existing devices, not on a detailed clinical study with ground truth established by experts in the context of AI or diagnostic performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. The document does not describe a study involving expert adjudication for a test set.

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 an endoscope holder, not an AI diagnostic tool that assists human readers/interpreters. Therefore, an MRMC study and AI assistance effect size are not relevant to this submission.

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

Not applicable. This device is a robotic assistant, always used with a human surgeon in the loop. It does not operate as a standalone algorithm for diagnosis or interpretation.

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

The concept of "ground truth" as typically applied to diagnostic AI studies (e.g., pathology as ground truth for cancer detection) is not applicable here. The "truth" for this device relates to its functional performance (e.g., does it hold the endoscope as intended, does it move accurately) and safety. The document refers to "testing on animals and clinical experience with the system," which likely serve as evidence of functional validation and safety, but specific "ground truth" definitions in this context are not provided.

8. The sample size for the training set:

Not applicable. This is a mechanical/robotic medical device, not an AI/machine learning algorithm that requires a "training set" in the conventional sense.

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

Not applicable, as there is no training set for an AI algorithm.

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