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

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

The Cooper Surgical ALLY Uterine Positioning System™ (UPS) consists of a single multisegmented, articulated Arm that attaches to a standard OR bed rail and a separate, sterile distal adapter to accommodate a uterine manipulator. When unlocked, the articulation of the Arm allows the attached manipulator to be positioned by the user. The Arm is then locked in the desired position by depressing a foot pedal, activating a linear actuator which applies tension to an internal cable, drawing the segments together and locking the Arm.

The segmented design of the Arm allows lateral/medial movement from a single point, allowing the System to be attached to one side of the OR table.

The ALLY Uterine Positioning System™ (UPS) is not intended for patient contact. The Adapter Drape for the ALL Y Uterine Positioning System™ (UPS) is provided sterile (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 Arm. After attaching the Adapter, the sterile Drape is deployed to cover the non-sterile ALLY UPS Arm, maintaining the sterile field and protecting the Arm from contamination during the procedure.

The provided document is a 510(k) premarket notification for the Cooper Surgical ALLY Uterine Positioning System™ (UPS) and its Adapter Drape. It asserts that the device is substantially equivalent to a predicate device, the Intuitive Surgical "Probe Holder System, K071405. The document describes performance data and testing conducted, but it does not describe a clinical study with human patients to prove the device meets acceptance criteria in the context of clinical outcomes or diagnostic accuracy. Instead, the performance data focuses on mechanical and functional aspects relevant to substantial equivalence determination for a surgical tool's positioning system.

Here's a breakdown of the information requested, based on the provided text:

1. A table of acceptance criteria and the reported device performance

Note: The document primarily outlines the types of testing performed rather than specific quantitative acceptance criteria or exact performance values. The "Determination" column in the table of "Comparison of Technological Characteristics with the Predicate Device" consistently states "Substantially Equivalent," implying that the device's performance in these areas was deemed comparable to the predicate.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the sample sizes used for the mechanical and functional tests conducted (e.g., number of units tested for holding force, durability, etc.). It describes device testing, not a clinical study involving patients or patient data. Therefore, data provenance in terms of country of origin or retrospective/prospective is not applicable in the context of clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable. The testing described is for the mechanical and functional performance of a surgical positioning system, not for diagnostic accuracy or clinical outcomes that would require expert-established ground truth.

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

This is not applicable as the document describes device safety and performance testing, not a clinical study requiring adjudication of expert interpretations.

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

No MRMC comparative effectiveness study was done. This device is a mechanical surgical positioning system, not an AI-powered diagnostic or assistive tool for "human readers."

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

This is not applicable. The device is a physical surgical tool, not an algorithm.

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

This is not applicable. The "ground truth" for the device's performance would be engineering specifications, physical measurements, and compliance with standards, rather than clinical ground truth like pathology or outcomes data.

8. The sample size for the training set

This is not applicable. The document describes a physical medical device, not an AI algorithm that requires a "training set."

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

This is not applicable, as there is no "training set."

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