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The CooperSurgical Advincula Delineator™ Uterine Manipulator is indicated to provide delineation of the vaginal fornices and maintain pneumoperitoneum as a uterine manipulator during Total Laparoscopic Hysterectomy (TLH), Laparoscopic Assisted Vaginal Hysterectomy (LAVH) and/or Laparoscopic Supra-Cervical Hysterectomy (LSH).

The CooperSurgical Advincula Delineator™ Uterine Manipulator is a single use device, supplied sterile to the end user. It includes a cup shaped sliding colpo-pneumo occluder used to delineate the vaginal fornices, providing an anatomical marker to facilitate resection of the uterus, and a balloon to occlude the vaginal vault to maintain pneumoperitoneum during uterine resection.

The provided document is a 510(k) summary for the CooperSurgical Advincula Delineator™ Uterine Manipulator. It focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a study to prove a device meets those criteria from an AI/algorithm performance perspective.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, sample size for training set, how ground truth for training set was established) are not applicable to this type of medical device submission. This document describes a physical medical device, not an AI or algorithmic device.

However, I can extract the relevant performance data and conclusions presented in the document based on the provided text.

Here's a breakdown of the information that is available in the document, formatted as requested where possible:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative manner as one would for an AI algorithm (e.g., "sensitivity must be > 90%"). Instead, performance assessments were conducted to ensure the device performs comparably to its predicate and is safe and effective. The "acceptance" is implied by demonstrating substantial equivalence.

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

• Sample Size: Not specified in the 510(k) summary. These would typically be engineering bench tests involving a certain number of manufactured units, not patient data.
• Data Provenance: Not applicable as this relates to bench testing of a physical device, not patient data or geographical origin of data.
• Retrospective/Prospective: Not applicable.

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)

• Not Applicable. This is a physical device, not an AI or image-based diagnostic tool requiring expert ground truth for performance evaluation of an algorithm. "Ground truth" for this device would be established by engineering specifications and physical measurements.

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

• Not Applicable. This relates to clinical interpretations, not bench testing of a physical 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

• Not Applicable. This is not an AI-assisted device or diagnostic tool.

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

• Not Applicable. This is not an AI or algorithmic device.

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

• Not Applicable in the traditional sense. The "ground truth" for this device's performance would be derived from engineering specifications, material properties testing, and comparison to the predicate device's established performance through bench testing (e.g., measuring actual burst volume, tensile strength, confirming no leakage).

8. The sample size for the training set

• Not Applicable. This is not an AI or machine learning device that requires a training set.

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

• Not Applicable. This is not an AI or machine learning device.

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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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The Cooper Surgical Leisegang Colposcope Systems are intended for the magnified viewing of the tissues of the vagina, cervix, and external genitalia in order to assist doctors in diagnosing abnormalities such as lesions or cancer, and selecting areas for biopsy. The images from Cooper Surgical Leisegang Colposcope Systems may be viewed directly and/or on a color monitor (if so equipped). The Cooper Surgical Leisegang Colposcope Systems are intended for use in hospitals, clinics, and doctor's offices.

The Cooper Surgical Leisegang Colposcope(s) and accessories are optical colposcopes designed for non-contact visualization of the tissues of the cervix, vulva, vagina, and anogenital areas. Depending on the model and/or mode selected, they provide direct visual, photographic, and/or high resolution color imaging of the selected area.

The provided text describes the Cooper Surgical Leisegang Colposcope System, a medical device for magnified viewing of tissues. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the typical sense for an AI/CADe device.

Therefore, the information typically requested for AI/CADe devices (such as clinical study sample sizes, expert ground truth establishment, MRMC studies, standalone performance, and training set details) is not applicable or available in this document. The "Performance Data" section specifically states "Non-clinical testing and attribute comparisons have been used to establish that the features and performance of the subject devices are substantially equivalent to the predicates."

The acceptance criteria here are implicitly met if the device's technical specifications and non-clinical performance are deemed substantially equivalent to the predicate devices, and if it complies with relevant electrical safety and electromagnetic compatibility standards.

Here's a breakdown based on the information provided, recognizing that it pertains to a traditional medical device and not an AI/CADe system:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:
Not applicable. This is a traditional optical device, not an AI/CADe system. Testing involved non-clinical attribute comparisons and compliance with electrical/EMC standards. No patient data or test set in the AI/CADe sense was utilized.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No ground truth based on expert medical review was established for the technical performance of this optical colposcope for the purpose of regulatory submission. The document refers to "non-clinical testing."

4. Adjudication method for the test set:
Not applicable. No expert adjudication process was described for this type of device submission.

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 a colposcope, an optical instrument for direct viewing, not an AI or CADe system. No MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is not an algorithm or AI system.

7. The type of ground truth used:
For the technical specifications, the "ground truth" was derived from measurements against engineering and performance standards (e.g., USAG Chart NBS 1963A for resolution, direct measurements for depth of field, distortion, and illumination properties). For regulatory purposes, the primary "ground truth" for substantial equivalence was the performance and characteristics of the predicate devices.

8. The sample size for the training set:
Not applicable. This device does not involve a training set as it is not an AI/machine learning system.

9. How the ground truth for the training set was established:
Not applicable. No training set was used.

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