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The Ally Uterine Positioning System™ (UPS) is intended to assist the surgical staff in mounting, positioning and holding uterine manipulators during gynecological laparoscopic surgical procedures. It is intended for use by trained operating room personnel in an operating room environment.

The Advincula Delineator™ Adapter Drape for the Ally Uterine Positioning System™ UPS is intended to assist the surgical staff in mounting, positioning, and holding uterine manipulators during gynecological laparoscopic surgical procedures. It is intended for use by trained operating room personnel in an operating room environment.

The CooperSurgical Ally Uterine Positioning System™ (UPS) consists of a single, multi- segmented, articulating arm that attaches to a standard operating room bed rail, and a separate, sterile, disposable Ally UPS Adapter Drape that is used to attach a uterine manipulator to the Ally UPS. When unlocked, the articulation of the arm allows the attached manipulator to be positioned by the user. The segmented design of the arm allows lateral/medial movement from a single point to position the uterine manipulator. The arm is then locked in the desired position by releasing a food pedal, activating a linear actuator that applies tension to an internal cable, drawing the segments together and thus locking the arm.

The Ally UPS is not intended for patient contact. The Adapter Drape for the Ally UPS is single- use and sterilized by ethylene oxide. The Ally UPS Adapter Drape secures either the Cooper Surgical RUMI II Uterine Manipulator Handle, or the Advincula Arch Uterine Manipulator Handle, to the distal end of the Ally UPS arm. The purpose of this submission is to gain clearance to add the new Advincula Delineator™ Adapter Drape to the system, which allows the Ally UPS to be used with the CooperSurgical Advincula Delineator™ Uterine Manipulator.

This document describes a 510(k) premarket notification for the CooperSurgical Ally Uterine Positioning System™ (UPS), specifically an update to include the Advincula Delineator™ Adapter Drape. This is a medical device, and the information provided focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of diagnostic performance or AI effectiveness.

Therefore, many of the requested categories for AI-related studies (like MRMC, human-in-the-loop, training set details) are not applicable here. The document details non-clinical performance testing for a physical device.

Here's an analysis based on the provided text, focusing on the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state sample sizes for each specific test (e.g., number of adapters tested for pull-off force). This is common for this type of summary, where the focus is on the type of test and the outcome rather than the granular details of the test execution (which would be in a full test report).

The data provenance is from non-clinical performance testing conducted by CooperSurgical, Inc. The document does not specify country of origin for the data; it's assumed to be part of the manufacturer's internal testing process. The testing is prospective in the sense that it was conducted specifically to evaluate the modified device before market clearance.

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

This information is not applicable. This is a physical medical device, not an AI or diagnostic tool where human experts establish ground truth. The "ground truth" here is determined by engineering specifications, safety standards, and performance metrics measured in laboratory settings.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring adjudication of human-interpreted data.

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 type of study is relevant for evaluating the impact of AI on human diagnostic performance, which is not the purpose of this device submission. The document explicitly states: "Clinical testing was not required to support the conclusion of substantial equivalence."

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

Not applicable. This device is a physical instrument, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance evaluation is based on:

• Engineering Specifications and Performance Metrics: Pre-defined thresholds for forces (pull-off, push), material properties, and functionality.
• International Standards: Compliance with standards like ISO 11135, ISO 10993, ASTM F1980, and IEC 60601 for sterilization, shelf life, and electrical safety. These standards themselves are established through expert consensus and scientific validation.

8. The Sample Size for the Training Set

Not applicable. This is a physical device, not an AI algorithm that requires a training set.

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

Not applicable.

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