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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).

Device Description

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.

AI/ML Overview

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.

Performance Characteristic	Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance
Vaginal Occlusion (Pneumoperitoneum)	The vagianl occluder balloon should maintain an adequate inflation capacity to create and maintain pneumoperitoneum, similar to the predicate device, and the difference in inflation capacity should not affect safety or effectiveness. The maximum inflation pressure should be the same as the predicate device. Burst volume testing should confirm safety. (Predicate: 90-120cc inflation capacity, same maximum inflation pressure, burst volume testing).	Subject Device: Occluder balloon with inflation capacity of 60-120cc. Predicate Device: Occluder balloon with inflation capacity of 90-120cc. Performance: The document states, "The primary technological difference between the subject and predicate devices is the inflation capacity of the vaginal occluder balloon. However, this minor difference does not raise different questions of safety or effectiveness as the maximum inflation pressure is the same for both the subject and predicate devices. In addition, burst volume testing was conducted to demonstrate that the difference in inflation pressure does not affect the safety and effectiveness of the subject device." The specific "burst volume" results are not detailed in this summary, but the conclusion is that the difference is acceptable.
Biocompatibility	Patient-contacting components must meet biocompatibility standards appropriate for their contact classification (external communicating, tissue/bone/dentin, ≤ 24 hours).	Components "have been evaluated for biocompatibility as appropriate for their contact classification." (Claimed as "Substantially Equivalent")
Sterilization & Shelf Life	Must achieve a Sterility Assurance Level (SAL) of 10-6 and have a confirmed shelf life.	Subject Device: Sterilized by ETO to an SAL of 10-6, with an initial shelf life of 1 year. Predicate Device: Sterilized by ETO gas to an SAL of 10-6, with a shelf life of 2 years. (Claimed as "Substantially Equivalent," implying the 1-year shelf life is acceptable).
Distal & Proximal Balloon Burst Volume	Balloons must withstand appropriate pressure/volume without bursting, comparable to the predicate.	Testing was conducted. The conclusion is that the difference in inflation capacity (which relates to burst volume) does not affect safety and effectiveness. (Details not provided in this summary, but implied satisfactory).
Distal & Proximal Balloon Leakage	Balloons must not leak when inflated.	Testing was conducted. (Details not provided in this summary, but implied satisfactory).
Distal & Proximal Balloon Fill Tube Tensile Strength	Fill tubes must have adequate tensile strength.	Testing was conducted. (Details not provided in this summary, but implied satisfactory).
Tube Bending, Compression, Tension Forces	The device tube must withstand anticipated forces during surgical use without failure.	Testing was conducted. (Details not provided in this summary, but implied satisfactory).
Security of Sliding Colpo-Pneumo Occluder	The occluder must remain securely locked once positioned.	Testing was conducted. (Details not provided in this summary, but implied satisfactory).

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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